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Randomized Controlled Trial

A study in which the participants are divided by chance into separate groups that compare different treatments or other interventions. Using chance to divide people into groups means that the groups will be similar and that the effects of the treatments they receive can be compared more fairly. At the time of the trial, it is not known which treatment is best. A Randomized Controlled Trial or (RCT) design randomly assigns participants into an experimental group or a control group. As the study is conducted, the only expected difference from the control and experimental groups in a randomized controlled trial (RCT) is the outcome variable being studied.

Advantages

  • Easier to blind/mask than from observational studies
  • Good randomization which washes out any population bias
  • Populations of participating individuals are clearly identified
  • Results can be analyzed with well known statistical tools

Disadvantages

  • Does not reveal causation
  • Expensive in time and money
  • Loss to follow-up attributed to treatment
  • Volunteer biases: the population that participates may not be representative of the whole

For Answers to any questions you may have please call Dr. Jimenez at 915-850-0900


Work Injury Health Guidelines for Low Back Pain in El Paso, TX

Work Injury Health Guidelines for Low Back Pain in El Paso, TX

Low back pain represents one of the most common complaints in healthcare settings. While a variety of injuries and/or conditions associated with the musculoskeletal and nervous system can cause low back pain, many healthcare professionals believe that work injury may have a prevalent connection to low back pain. For instance, improper posture and repetitive movements may often be the cause of work-related injuries. In other instances, environmental accidents at work may be the cause of work injuries. In any case, diagnosing the source of a patient’s low back pain to properly determine which would be the best treatment method to restore the individual’s original health and wellness is generally challenging.

 

As a result, several work injury treatment guidelines have been established for the management of low back pain in healthcare settings. First and foremost, getting the right doctors for your specific source of low back pain is important towards finding relief from your symptoms. Many healthcare professionals are qualified and experienced in the treatment of work-related low back pain, including doctors of chiropractic, or chiropractors. Chiropractic care focuses on the diagnosis, treatment and prevention of a variety of injuries and/or conditions, such as LBP, associated with the musculoskeletal and nervous system. By carefully correcting the misalignment of the spine, chiropractic care can help improve symptoms of low back pain, among other symptoms. The purpose of the following article is to discuss occupational health guidelines for the management of low back pain.

 

Occupational Health Guidelines for the Management of Low Back Pain: an International Comparison

 

Abstract

 

  • Background: The enormous socioeconomic burden of low back pain emphasises the need for effective management of this problem, especially in an occupational context. To address this, occupational guidelines have been issued in various countries.
  • Aims: To compare available international guidelines dealing with the management of low back pain in an occupational health care setting.
  • Methods: The guidelines were compared regarding generally accepted quality criteria using the AGREE instrument, and also summarised regarding the guideline committee, the presentation, the tar- get group, and assessment and management recommendations (that is, advice, return to work strategy, and treatment).
  • Results and Conclusions: The results show that the quality criteria were variously met by the guidelines. Common flaws concerned the absence of proper external reviewing in the development process, lack of attention to organisational barriers and cost implications, and lack of information on the extent to which editors and developers were independent. There was general agreement on numerous issues fundamental to occupational health management of back pain. The assessment recommendations consisted of diagnostic triage, screening for “red flags” and neurological problems, and the identification of potential psychosocial and workplace barriers for recovery. The guidelines also agreed on advice that low back pain is a self limiting condition and, importantly, that remaining at work or an early (gradual) return to work, if necessary with modified duties, should be encouraged and supported.

 

Dr. Alex Jimenez’s Insight

Low back pain is one of the most prevalent health issues treated in chiropractic offices. Although the following article describes low back pain as a self limiting condition, the cause of an individual’s LBP can also trigger debilitating and severe pain and discomfort of left untreated. It’s important for an individual with symptoms of low back pain to seek proper treatment with a chiropractor to properly diagnose and treat their health issues as well as prevent them from returning in the future. Patients who experience low back pain for more than 3 months are less than 3 percent likely to return to work. Chiropractic care is a safe and effective alternative treatment option which can help restore the original function of the spine. Furthermore, a doctor of chiropractic, or chiropractor, can provide lifestyle modifications, such as nutritional and fitness advice, to speed up the patient’s recovery process. Healing through movement is essential for LBP recovery.

 

Low back pain (LBP) is one of the most common health problems in industrial countries. Despite its benign nature and favourable course, LBP is commonly associated with incapacity, productivity loss due to sick leave, and correspond- ing high costs to the society.[1]

 

In view of that impact, there is an obvious need for effective management strategies, based on scientific evidence derived from studies of sound methodological quality. Usually, these are randomised controlled trials (RCTs) on the effectiveness of therapeutic interventions, diagnostic studies, or prospective observational studies on risk factors or side effects. The scientific evidence, which is summarised in systematic reviews and meta-analyses, provides a solid basis for guidelines on the management of LBP. In a previous paper, Koes et al compared various existing clinical guidelines for the management of LBP targeted at primary health care professionals, which showed a large measure of commonality.[2]

 

However, LBP is also an important issue in occupational health care because of the associated incapacity for work, productivity loss, and sick leave. The problems in the field of occupational health care are different and management focuses mainly on counselling the worker with LBP, and addressing the issues of assisting him or her to continue working, or to return to work (RTW) after sick listing. Several guidelines, or sections of guidelines, have now been published dealing with the specific issues of management in an occupational health care setting. Since the evidence is international, it would be expected that the recommendations of different occupational guidelines for LBP would be more or less similar. However, it is not clear whether the guidelines meet currently accepted quality criteria.

 

This paper critically appraises available occupational guidelines on the management of LBP, and compares their assessment and management recommendations.

 

Main Messages

 

  • In various countries occupational health guidelines are issued to improve the management of low back pain in an occupational context.
  • Common flaws of these guidelines concern the absence of proper external reviewing in the development process, lack of attention to organisational barriers and cost implications, and lack of information on the independence of editors and developers.
  • In general the assessment recommendations in the guidelines consisted of diagnostic triage, screening for “red flags” and neurological problems, and the identification of potential psychosocial and workplace barriers for recovery.
  • There is general agreement on advice that low back pain is a self limiting condition and that remaining at work or an early (gradual) return to work, if necessary with modified duties, should be encouraged and supported.

 

Methods

 

Guidelines on the occupational health management of LBP were retrieved from personal files of the authors. Retrieval was checked by a Medline search using the keywords “low back pain”, “guidelines”, and “occupational” up to October 2001, and personal communication with experts in the field. Guide- lines had to meet the following inclusion criteria:

 

  • Guidelines aimed at the management of workers with LBP (in occupational health care settings or addressing occupational issues), or separate sections of guidelines that dealt with these topics.
  • Guidelines available in English or Dutch (or translated into these languages).

 

The exclusion criteria were:

 

  • Guidelines on primary prevention (that is, prevention before the onset of the symptoms) of work related LBP (for example, lifting instructions for workers).
  • Clinical guidelines for the management of LBP in primary care.[2]

 

The quality of the included guidelines was appraised using the AGREE instrument, which is a generic tool designed primarily to help guideline developers and users assess the methodological quality of clinical practice guidelines.[3]

 

The AGREE instrument provides a framework for the assessment of quality on 24 items (table 1), each rated on a four point scale. The full operationalisation is available on www.agreecollaboration.org.

 

Two reviewers (BS and HH) independently rated the quality of the guidelines, and then met to discuss disagreements and to reach consensus on the ratings. When they could not reach consensus, a third reviewer (MvT) reconciled remaining differences and made a final decision on the ratings. To facilitate analysis in this review, ratings were transformed into dichotomous variables of whether each quality item was or was not met.

 

The selected guidelines were further characterised and compared regarding the guideline committee, the presentation of the guideline, the target group, and the extent to which the recommendations were based on available scientific evidence. The assessment recommendations were also summarised and compared, as were recommendations on advice, treatment, and return to work strategies. All of this information was extracted directly from the published guidelines.

 

Policy Implications

 

  • The management of low back pain in occupational health care should be in accordance with the recommendations of evidence based guidelines.
  • Future occupational guidelines for the management of low back pain and updates of those guidelines should consider the criteria for proper development, implementation, and evaluation of guidelines as suggested by the AGREE collaboration.

 

Results

 

Selection of Studies

 

Our search found 10 guidelines,[4–18] but four were excluded because they dealt with the management of LBP in primary care,[15] were aimed at the guidance of sick listed employees in general (not specifically LBP),[16] were intended for the primary prevention of LBP at work,[17] or were not available in English or Dutch.[18] The final selection therefore consisted of the following six guidelines, listed by date of issue:

 

(1) Canada (Quebec). Scientific approach to the assessment and management of activity related spinal disorders. A monograph for clinicians. Report of the Quebec Task Force on Spinal Disorders. Quebec Canada (1987).[4]

 

(2) Australia (Victoria). Guidelines for the management of employees with compensable low back pain. Victorian WorkCover Authority, Australia (1996).[5] (This guideline is a revised version of guidelines developed by the South Australian WorkCover Corporation in October 1993.)

 

(3) USA. Occupational Medicine Practice Guidelines. American College of Occupational and Environmental Medicine. USA (1997).[6]

 

(4) New Zealand

 

(a) Active and working! Managing acute low back pain in the workplace. Accident Compensation Corporation and National Health Committee. New Zealand (2000).[7]

 

(b) Patient guide to acute low back pain management. Accident Compensation Corporation and National Health Committee. New Zealand (1998).[8]

 

(c) Guide to assessing psychosocial yellow flags in acute low back pain. Accident Compensation Corporation and National Health Committee. New Zealand (1997).[9]

(5) Netherlands. Dutch guideline for the management of occupational physicians of employees with low back pain. Dutch Association of Occupational Medicine (NVAB). Netherlands (1999).[10]

 

(6) UK

 

(a) Occupational health guidelines for the management of low back pain at work—principal recommendations. Faculty of Occupational Medicine. UK (2000).[11]

 

(b) Occupational health guidelines for the management of low back pain at work—leaflet for practitioners. Faculty of Occupational Medicine. UK (2000).[12]

 

(c) Occupational health guidelines for the management of low back pain at work—evidence review. Faculty of Occupational Medicine. UK (2000).[13]

 

(d) The Back Book, The Stationery Office. UK (1996).[14]

Two guidelines (4 and 6) could not be evaluated independently from additional documents to which they refer (4b–c, 6b–d) so these documents were also included in the review.

 

Appraisal of the Quality of the Guidelines

 

Initially, there was agreement between the two reviewers regarding 106 (77%) of the 138 item ratings. After two meetings, consensus was reached for all but four items, which required adjudication by the third reviewer. Table 1 presents the final ratings.

 

All included guidelines clearly presented the different options for the management of LBP in occupational health. In five of the six guidelines the overall objectives of the guideline were described specifically,[4–6, 10–14] the target users of the guideline were clearly defined,[5–14] easily identifiable key recommendations were included,[4, 6–14] or key review criteria were presented for monitoring and/or audit purposes.[4–9, 11–14]

 

The results of the AGREE appraisal showed that none of the guidelines paid sufficient attention to potential organisational barriers and cost implications in implementing the recommendations. It was also unclear for all included guidelines whether or not they were editorially independent from the funding body, and whether or not there were conflicts of interest for the members of the guideline development committees. Furthermore, it was unclear for all guidelines whether experts had externally reviewed the guidelines prior to publication. Only the UK guideline clearly described the method used for the formulation of the recommendations, and provided for updating the guideline.[11]

 

Table 1 Ratings of the Occupational Health Guidelines

 

Development of the Guidelines

 

Table 2 presents background information on the development process of the guidelines.

 

The target users for the guidelines were physicians and other health care providers in the field of occupational health care. Several guidelines were also directed at informing employers, workers,[6–8, 11, 14] or members of organisations interested in occupational health.[4] The Dutch guideline was only targeted at the occupational health physician.[10]

 

The guideline committees responsible for the development of the guidelines were generally multidisciplinary, including disciplines like epidemiology, ergonomics, physiotherapy, general practice, occupational medicine, occupational therapy, orthopaedics, and representatives of employers’ associations and trade unions. Chiropractic and osteopathic representatives were in the guideline committee of the New Zealand guidelines.[7–9] The Quebec task force (Canada) also included representatives of rehabilitation medicine, rheumatology, health economics, law, neurosurgery, biomechanical engineering, and library sciences. In contrast, the guideline committee of the Dutch guideline consisted only of occupational physicians.[10]

 

The guidelines were issued as a separate document,[4, 5, 10] as a chapter in a textbook,[6] or as several interrelated documents.[7–9, 11–14]

 

The UK,[13] USA,[6] and Canadian[4] guidelines provided information on the search strategy applied to the identification of relevant literature and the weighing of the evidence. On the other hand, the Dutch[10] and the Australian[5] guidelines supported their recommendations only by references. In the New Zealand guidelines there were no direct links between recommendations and references,[7–9] and the reader was referred to other literature for background information.

 

Table 2 Background Information of the Guidelines

 

Table 3 Occupational Guidelines Recommendations

 

Table 4 Occupational Guidelines Recommendations

 

Patient Population and Diagnostic Recommendations

 

Despite the fact that all guidelines focused on workers with LBP, it was often not clear whether they dealt with acute or chronic LBP or both. Acute and chronic LBP were often not defined, and when cut off points were given (for example, <3 months) it was usually not clear whether these referred to the onset of symptoms or to absence from work. However, the Canadian guideline introduced a classification system (acute/subacute/ chronic) based on the distribution of claims of spinal disorders by time since absence from work.[4]

 

All guidelines distinguished specific and non-specific LBP. Specific LBP concerns the potentially serious “red flag” conditions like fractures, tumours, or infections, and the Dutch and UK guidelines also distinguished the radicular syndrome or nerve root pain.[10–13] All guidelines were consistent in their recommendations to take a clinical history and to carry out a physical examination including neurological screening. In cases of suspected specific pathology (“red flags”), x ray examinations were recommended by most guidelines. In addition, the New Zealand and the US guideline also recommended x ray examination when symptoms did not improve after four weeks.[6, 9] The UK guideline stated that x ray examinations are not indicated and do not assist occupational health management of the patient with LBP (as distinct from any clinical indications).[11–13]

 

Most of the guidelines considered psychosocial factors—“yellow flags”—as obstacles to recovery that should be addressed by health care providers. The New Zealand[9] and UK guideline[11, 12] explicitly listed factors and suggested questions in order to identify those psychosocial “yellow flags”.

 

All guidelines addressed the importance of the clinical history identifying physical and psychosocial workplace factors relevant to LBP, including physical demands of work (manual handling, lifting, bending, twisting, and exposure to whole body vibration), accidents or injuries, and perceived difficulties in returning to work or relationships at work. The Dutch and the Canadian guidelines contained recommendations to carry out a workplace investigation[10] or an assessment of occupational skills when necessary.[4]

 

Summary of Recommendations for the Assessment of LBP

 

  • Diagnostic triage (non-specific LBP, radicular syndrome, specific LBP).
  • Exclude “red flags” and neurological screening.
  • Identify psychosocial factors and potential obstacles to recovery.
  • Identify workplace factors (physical and psychosocial) that may be related to the LBP problem and return to work.
  • X Ray examinations restricted to suspected cases of specific pathology.

 

Recommendations Regarding Information and Advice, Treatment, and Return to Work Strategies

 

Most of the guidelines recommended reassuring the employee and providing information about the self limiting nature and good prognosis of LBP. Encouragement of return to ordinary activity as normally as possible was frequently advised.

 

In line with the recommendation to return to normal activity, all guidelines also stressed the importance of returning to work as rapidly as possible, even if there is still some LBP and if necessary starting with modified duties in more severe cases. Work duties could then be increased gradually (hours and/or tasks), until full return to work was reached. The US and Dutch guidelines provided explicit time schedules for return to work. The Dutch guideline proposed return to work within two weeks with adaptation of duties when necessary.[10] The Dutch guideline also stressed the importance of time contingent management with regard to return to work.[10] The US guideline proposed every attempt to maintain the patient at maximal levels of activity, including work activities; targets for disability duration in terms of return to work were given as 0–2 days with modified duties, and 7–14 days if modified duties are not used/available.[6] In contrast to the others, the Canadian guideline advised return to work only when symptoms and functional restrictions had improved.[4]

 

In general, the most frequently recommended treatment options in all the included guidelines were: medication for pain relief,[5, 7, 8] gradually progressive exercise programmes,[6, 10] and multidisciplinary rehabilitation.[10–13] The US guideline recommended referral within two weeks to an exercise programme consisting of aerobic exercises, conditioning exercises for trunk muscles, and exercise quota.[6] The Dutch guideline recommended that if there is no progress within two weeks of work absence, workers should be referred to a graded activity programme (gradually increasing exercises) and if no progress by four weeks, then to a multidisciplinary rehabilitation programme.[10] The UK guideline recommended that workers who have difficulty returning to normal occupational duties by 4–12 weeks, should be referred to an active rehabilitation programme. This rehabilitation programme should include education, reassurance and advice, a progressive active exercise and fitness programme, and pain management according to behavioural principles; it should be embedded in an occupational setting and directed strongly towards return to work.[11–13] Extensive lists of possible treatment options were presented in the guidelines of Canada and Australia,[4, 5] although most of these were not based on scientific evidence.

 

Summary of Recommendations Regarding Information, Advice, Return to Work Measures, and Treatment in Workers with LBP

 

  • Reassure the worker and provide adequate information about the self limiting nature and good prognosis of LBP.
  • Advise the worker to continue ordinary activities and working or to return to normal activity and work as soon as possible, even if there is still some pain.
  • Most workers with LBP manage to return to more or less normal duties quite rapidly. Consider temporary adaptations of work duties (hours/tasks) only when necessary.
  • When a worker fails to return to work within 2–12 weeks (there is considerable variation in the time scale in different guidelines), refer them to a gradually increasing exercise programme, or multidisciplinary rehabilitation (exercises, education, reassurance, and pain management following behavioural principles). These rehabilitation programmes
    should be embedded in an occupational setting.

 

Discussion

 

The management of LBP in an occupational health setting must address the relation between low back complaints and work, and develop strategies aimed at a “safe” return to work. This review compared available occupational health guidelines from various countries. Guidelines are rarely indexed in Medline, so when searching for guidelines we had to rely pri- marily on personal files and personal communication.

 

Quality Aspects and Development Process of the Guidelines

 

The assessment by the AGREE instrument[3] showed some differences in the quality of the guidelines reviewed, which may partly reflect the variation in the dates of development and publication of the guidelines. The Canadian guideline, for example, was published in 1987 and the Australian guideline in 1996.[4, 5] The other guidelines were more recent and incorporated a more extensive evidence base and more up to date guideline methodology.

 

Several common flaws related to the development process of the guidelines were shown by the assessment by the AGREE instrument. Firstly, it is important to make clear whether a guideline is editorially independent from the funding body, and whether there are conflicts of interest for the members of the guideline committee. None of the included guidelines clearly reported these issues. Further, reported external review of the guideline by clinical and methodological experts prior to publication was also lacking in all guidelines included in this review.

 

Several guidelines provided comprehensive information on the way relevant literature was searched and translated into recommendations.[4, 6, 11, 13] Other guidelines supported their recommendations by references,[5, 7, 9, 10] but this does not permit assessment of the robustness of the guidelines or their recommendations.

 

Guidelines depend on the scientific evidence, which changes over time, and it is striking that only one guideline provided for future update.[11, 12] Possibly there are updates planned for the other guidelines but they are not explicitly stated (and conversely stating there will be future update does not mean it will actually occur). This lack of reporting may also hold true for other AGREE criteria that we rated negatively. The use of the AGREE framework as a guide for both the development and the reporting of guidelines should help to improve the quality of future guidelines.

 

Assessment and Management of LBP

 

The diagnostic procedures recommended in the occupational health guidelines were largely similar to the recommendations of clinical guidelines,[2] and, logically, the main difference was the emphasis on addressing occupational issues. The reported methods for addressing workplace factors in the assessment of LBP of the individual worker concerned the identification of difficult tasks, risk factors, and obstacles for return to work by occupational histories. Obviously, these obstacles for return to work not only concern physical load factors, but also work related psychosocial problems regarding responsibilities, cooperation with co-workers, and the social atmosphere at the workplace.[10] Screening for work related psychosocial “yellow flags” may help to identify those workers who are at risk for chronic pain and disability.[11–13]

 

A potentially important feature of the guidelines is that they were consistent regarding their recommendations to reassure the employee with LBP, and to encourage and support return to work even with some persisting symptoms. There is general consensus that most workers do not have to wait until they are completely free of pain before returning to work. The lists of treatment options provided by the Canadian and Australian guidelines may reflect the lack of evidence at that time,[4, 5] leaving users of the guidelines to choose for themselves. It is, however, questionable whether such lists really contribute to improved care, and in our view guideline recommendations should be based on sound scientific evidence.

 

The US, Dutch, and UK occupational guidelines[6, 10–13] recommend that active multidisciplinary treatment is the most promising intervention for return to work, and this is supported by strong evidence from RCTs.[19, 20] However, more research is still needed to identify the optimum content and intensity of those treatment packages.[13, 21]

 

Despite some evidence for a contribution of workplace factors in the aetiology of LBP,[22] systematic approaches for workplace adaptations are lacking, and are not offered as recommendations in the guidelines. Perhaps this represents a lack of confidence in the evidence on the overall impact of workplace factors, a difficulty of translation into practical guidance, or because these issues are confounded with local legislation (which was hinted at in the UK guideline[11]). It may be that the “participatory ergonomics” intervention, which proposes consultations with the worker, the employer, and an ergonomist, will turn out to be a useful return to work intervention.[23, 24] The potential value of “getting all the players onside”[25] was stressed in the Dutch and the UK guidelines,[11–13] but further evaluation of this approach and its implementation is required.

 

Development of Future Guidelines in Occupational Health Care

 

The purpose of this review was to give both an overview and a critical appraisal of occupational guidelines for the management of LBP. The critical appraisal of the guidelines is meant to help direct future development and planned updates of guide- lines. In the still emerging field of guideline methodology we consider all past initiatives as laudable; we recognise the need for clinical guidance, and appreciate that guidelines developers cannot wait for research to provide all the methodology and evidence required. However, there is room for improvement and future guidelines and updates should consider the criteria for proper development, implementation, and evaluation of guidelines as suggested by the AGREE collaboration.

 

The implementation of the guidelines is beyond the scope of this review, but it was noted that none of the guideline documents specifically described implementation strategies, so it is uncertain to what extent the target groups may have been reached, and what effects that may have had. This may be a fruitful area for further research.

 

The very existence of these occupational health guidelines shows that existing primary care clinical guidelines for LBP2 are considered inappropriate or insufficient for occupational health care. There is a clear perception internationally that the needs of the worker experiencing back pain are intrinsically linked to a variety of occupational issues not covered by usual primary care guidance and, consequently, practice. What emerges is that, despite the methodological flaws, considerable agreement is evident on a range of fundamental occupational health strategies for managing the worker with back pain, some of which are innovative and challenge previously held views. There is agreement on the fundamental message that prolonged work loss is detrimental, and that early work return should be encouraged and facilitated; there is no need to wait for complete symptom resolution. Although the recommended strategies vary somewhat, there is considerable agreement on the value of positive reassurance and advice, availability of (temporary) modified work, addressing workplace factors (“getting all the players onside”), and rehabilitation for workers having difficulty returning to work.

 

Acknowledgements

 

This study was supported by the Dutch Health Care Insurance Council (CVZ), grant DPZ no. 169/0, Amstelveen, Netherlands. J B Staal is currently working at the Department of Epidemiology, Maastricht University, PO Box 616 6200 MD Maastricht, Netherlands. W van Mechelen is also part of the Research Centre on Physical Activity, Work and Health, [email protected] TNO-VUmc.

 

In conclusion, symptoms of low back pain are one of the most common health issues associated with work injuries. Because of it, several occupational health guidelines have been established for the management of low back pain. Chiropractic care, among other treatment methods, may be utilized in order to help the patient find relief from their LBP. Furthermore, the article above demonstrated the safety and effectiveness of a variety of traditional as well as alternative treatment options in the diagnosis, treatment and prevention of a variety of low back pain cases. However, further research studies are required in order to properly determine the efficiency of each individual treatment method. Information referenced from the National Center for Biotechnology Information (NCBI). The scope of our information is limited to chiropractic as well as to spinal injuries and conditions. To discuss the subject matter, please feel free to ask Dr. Jimenez or contact us at 915-850-0900 .

 

Curated by Dr. Alex Jimenez

 

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Additional Topics: Back Pain

 

According to statistics, approximately 80% of people will experience symptoms of back pain at least once throughout their lifetimes. Back pain is a common complaint which can result due to a variety of injuries and/or conditions. Often times, the natural degeneration of the spine with age can cause back pain. Herniated discs occur when the soft, gel-like center of an intervertebral disc pushes through a tear in its surrounding, outer ring of cartilage, compressing and irritating the nerve roots. Disc herniations most commonly occur along the lower back, or lumbar spine, but they may also occur along the cervical spine, or neck. The impingement of the nerves found in the low back due to injury and/or an aggravated condition can lead to symptoms of sciatica.

 

blog picture of cartoon paperboy big news

 

EXTRA IMPORTANT TOPIC: Migraine Pain Treatment

 

 

MORE TOPICS: EXTRA EXTRA: El Paso, Tx | Athletes

 

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References

1. Van Tulder MW, Koes BW, Bouter LM. A cost-of-illness study of back pain in the Netherlands. Pain 1995;62:233–40.
2. Koes BW, van Tulder MW, Ostelo R, et al. Clinical guidelines for the management of low back pain in primary care: an international
comparison. Spine 2001;26:2504–14.
3. The AGREE Collaboration. Appraisal of Guidelines Research &
Evaluation Instrument, www.agreecollaboration.org.
4. Spitzer WO, Leblanc FE, Dupuis M. Scientific approach to the
assessment and management of activity-related spinal disorders. A monograph for clinicians. Report of the Quebec Task Force on Spinal Disorders. Spine 1987;12(suppl 7S):1–59.
5. Victorian WorkCover Authority. Guidelines for the management of employees with compensable low back pain. Melbourne: Victorian WorkCover Authority, 1996.
6. Harris JS. Occupational medicine practice guidelines. Beverly, MA: OEM Press, 1997.
7. Accident Compensation Corporation and National Health Committee. Active and working! Managing acute low back pain in the workplace. Wellington, New Zealand, 2000.
8. Accident Compensation Corporation and National Health Committee, Ministry of Health. Patient guide to acute low back pain management. Wellington, New Zealand, 1998.
9. Kendall, Linton SJ, Main CJ. Guide to assessing psychosocial yellow flags in acute low back pain. Risk factors for long-term disability and work loss. Wellington, New Zealand, Accident Rehabilitation & Compensation Insurance Corporation of New Zealand and the National Health Committee, 1997.
10. Nederlandse Vereniging voor Arbeids- en Bedrijfsgeneeskunde (Dutch Association of Occupational Medicine, NVAB). Handelen van de bedrijfsarts bij werknemers met lage-rugklachten. Richtlijnen voor Bedrijfsartsen. [Dutch guideline for the management of occupational physicians of employees with low back pain]. April 1999.
11. Carter JT, Birell LN. Occupational health guidelines for the management of low back pain at work—principal recommendations. London: Faculty of Occupational Medicine, 2000 (www.facoccmed.ac.uk).
12. Occupational health guidelines for the management of low back pain at work—leaflet for practitioners. London: Faculty of Occupational Medicine, 2000 (www.facoccmed.ac.uk).
13. Waddell G, Burton AK. Occupational health guidelines for the management of low back pain at work—evidence review. Occup Med 2001;51:124–35.
14. Roland M, et al. The back book. Norwich: The Stationery Office, 1996.
15. ICSI. Health care guideline. Adult low back pain. Institute for Clinical Systems Integration, 1998 (www.icsi.org/guide/).
16. Kazimirski JC. CMA policy summary: The physician’s role in helping patients return to work after an illness or injury. CMAJ 1997;156:680A–680C.
17. Yamamoto S. Guidelines on worksite prevention of low back pain. Labour standards bureau notification, No. 57. Industrial Health 1997;35:143–72.
18. INSERM. Les Lombalgies en milieu professionel: quel facteurs de risque et quelle prevention? [Low back pain at the workplace: risk factors and prevention]. Paris: les editions INSERM, Synthese bibliographique realise a la demande de la CANAM, 2000.
19. Lindström I, Ohlund C, Eek C, et al. The effect of graded activity on patients with subacute low back pain: a randomised prospective clinical study with an operant-conditioning behavioural approach. Physical Therapy 1992;72:279–93.
20. Karjalainen K, Malmivaara A, van Tulder M, et al. Multidisciplinary biopsychosocial rehabilitation for subacute low back pain in working-age adults: a systematic review within the framework of the Cochrane Collaboration Back Review Group. Spine 2001;26:262–9.
21. Staal JB, Hlobil H, van Tulder MW, et al. Return-to-work interventions for low back pain: a descriptive review of contents and concepts of working mechanisms. Sports Med 2002;32:251–67.
22. Hoogendoorn WE, van Poppel MN, Bongers PM, et al. Physical load during work and leisure time as risk factors for back pain. Scand J Work Environ Health 1999;25:387–403.
23. Loisel P, Gosselin L, Durand P, et al. A population-based, randomised clinical trial on back pain management. Spine 1997;22:2911–18.
24. Loisel P, Gosselin L, Durand P, et al. Implementation of a participatory ergonomics program in the rehabilitation of workers suffering from subacute back pain. Appl Ergon 2001;32:53–60.
25. Frank J, Sinclair S, Hogg-Johnson S, et al. Preventing disability from work-related low-back pain. New evidence gives new hope—if we can just get all the players onside. CMAJ 1998;158:1625–31.

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Spinal Manipulation vs. Mobilization for Cervicogenic Headache in El Paso, TX

Spinal Manipulation vs. Mobilization for Cervicogenic Headache in El Paso, TX

A primary headache is characterized as head pain caused by a headache disorder itself. The three types of primary headache disorders include, migraine, tension-type headaches and cluster headaches. Head pain is a painful and debilitating symptom that can also occur as a result of another underlying cause. A secondary headache is characterized as head pain which occurs due to an injury and/or condition. A spinal misalignment, or subluxation, along the cervical spine, or neck, is commonly associated with a variety of headache symptoms.

 

Cervicogenic headache is a secondary headache caused by an injury and/or condition affecting the surrounding structures of the cervical spine, or neck. Many healthcare professionals will recommend the use of drugs/medications to help improve headache, however, several alternative treatment options can be safely and effectively used to treat secondary headaches. The purpose of the following article is to demonstrate the impact of upper cervical and upper thoracic manipulation versus mobilization and exercise in patients with cervicogenic headache.

 

Upper Cervical and Upper Thoracic Manipulation Versus Mobilization and Exercise in Patients with Cervicogenic Headache: a Multi-Center Randomized Clinical Trial

 

Abstract

 

  • Background: Although commonly utilized interventions, no studies have directly compared the effectiveness of cervical and thoracic manipulation to mobilization and exercise in individuals with cervicogenic headache (CH). The purpose of this study was to compare the effects of manipulation to mobilization and exercise in individuals with CH.
  • Methods: One hundred and ten participants (n = 110) with CH were randomized to receive both cervical and thoracic manipulation (n = 58) or mobilization and exercise (n = 52). The primary outcome was headache intensity as measured by the Numeric Pain Rating Scale (NPRS). Secondary outcomes included headache frequency, headache duration, disability as measured by the Neck Disability Index (NDI), medication intake, and the Global Rating of Change (GRC). The treatment period was 4 weeks with follow-up assessment at 1 week, 4 weeks, and 3 months after initial treatment session. The primary aim was examined with a 2-way mixed-model analysis of variance (ANOVA), with treatment group (manipulation versus mobilization and exercise) as the between subjects variable and time (baseline, 1 week, 4 weeks and 3 months) as the within subjects variable.
  • Results: The 2X4 ANOVA demonstrated that individuals with CH who received both cervical and thoracic manipulation experienced significantly greater reductions in headache intensity (p < 0.001) and disability (p < 0.001) than those who received mobilization and exercise at a 3-month follow-up. Individuals in the upper cervical and upper thoracic manipulation group also experienced less frequent headaches and shorter duration of headaches at each follow-up period (p < 0.001 for all). Additionally, patient perceived improvement was significantly greater at 1 and 4-week follow-up periods in favor of the manipulation group (p < 0.001).
  • Conclusions: Six to eight sessions of upper cervical and upper thoracic manipulation were shown to be more effective than mobilization and exercise in patients with CH, and the effects were maintained at 3 months.
  • Trial registration: NCT01580280 April 16, 2012.
  • Keywords: Cervicogenic headache, Spinal manipulation, Mobilization, High velocity low amplitude thrust

 

Dr Jimenez White Coat

Dr. Alex Jimenez’s Insight

In comparison to primary headache, such as migraine, cluster headache and tension-type headache, secondary headache is characterized as head pain caused by another illness or physical issue. In the case of cervicogenic headache, the cause of head pain is due to an injury and/or condition along the cervical spine and its surrounding structures, including the vertebrae, intervertebral discs and soft tissues. In addition, many healthcare professionals believe that primary headache can be associated with health issues in the cervical spine, or neck. Cervicogenic headache treatment should target the source of the symptoms and it can vary depending on the patient. Chiropractic care utilizes spinal adjustments and manual manipulations to carefully restore the original structure and function of the spine, helping to reduce stress and pressure in order to improve cervicogenic headache symptoms, among other type of headache. Chiropractic care can also be utilized to help treat primary headaches, such as migraines.

 

Background

 

The International Classification of Headache Disorders defines cervicogenic headache (CH) as, “headache caused by a disorder of the cervical spine and its component bony, disc, and/or soft tissue elements, usually but not invariably accompanied by neck pain.” [1] (p.760) The prevalence of CH has been reported to be between 0.4 and 20 % of the headache population [2, 3], and as high as 53 % in patients with headache after whiplash injury [4]. The dominant features of CH usually include: unilaterality of head pain without side-shift, elicitation of pain with external pressure over the ipsilateral upper neck, limited cervical range of motion, and the triggering of attacks by various awkward or sustained neck movements [4, 5].

 

Individuals with CH are frequently treated with spinal manipulative therapy including both mobilization and manipulation [6]. Spinal mobilization consists of slow, rhythmical, oscillating techniques whereas manipulation consists of high-velocity low-amplitude thrust techniques. [7] In a recent systematic review, Bronfort and colleagues reported that spinal manipulative therapy (both mobilization and manipulation) were effective in the management of adults with CH [8]. However, they did not report if manipulation resulted in superior outcomes compared to mobilization for the management of this population.

 

Several studies have investigated the effect of spinal manipulation in the management of CH [9–13]. Haas et al. [10] investigated the effectiveness of cervical manipulation in subjects with CH. Jull et al. [11] demonstrated treatment efficacy for manipulative therapy and/or exercise in the management of CH. However the manipulative therapy group included manipulation and mobilization therefore it cannot be determined if the beneficial effect was a result of the manipulation, mobilization or the combination.

 

A few studies have examined the benefits of manipulation versus mobilization for the management of mechanical neck pain with or without exercise [14–16]. However, no studies have directly compared the effects of manipulation versus mobilization and exercise in patients with CH. Considering the purported risks of manipulation [17], it is essential to determine if manipulation results in improved outcomes compared to mobilization for the management of patients with CH. Therefore, the purpose of this randomized clinical trial was to compare the effects of manipulation versus mobilization and exercise in patients with CH. We hypothesized that patients receiving manipulation over a 4-week treatment period would experience greater reductions in headache intensity, headache frequency, headache duration, disability, and medication intake at a 3-month follow-up than patients receiving cervical and thoracic mobilization combined with exercise.

 

Methods

 

Participants

 

In this multi-center randomized clinical trial, consecutive patients with CH presenting to 1 of 8 outpatient physical therapy clinics from a variety of geographical locations (Arizona, Georgia, New York, Ohio, Pennsylvania, South Carolina) were recruited over a 29-month period (from April 2012 to August 2014). For patients to be eligible, they had to present with a diagnosis of CH according to the revised diagnostic criteria [5] developed by the Cervicogenic Headache International Study Group (CHISG) [5, 18, 19]. CH was classified according to the “major criteria” (not including confirmatory evidence by diagnostic anesthetic blockades) and “head pain characteristics” of the CHISG. Therefore, in order to be included in the study, patients had to exhibit all of the following criteria: (1) unilaterality of the head pain without sideshift, starting in the upper posterior neck or occipital region, eventually spreading to the oculofrontotemporal area on the symptomatic side, (2) pain triggered by neck movement and/or sustained awkward positions, (3) reduced range of motion in the cervical spine [20] (i.e., less than or equal to 32 ° of right or left passive rotation on the Flexion-Rotation Test [21–23], (4) pain elicited by external pressure over at least one of the upper cervical joints (C0-3), and (5) moderate to severe, non-throbbing and non-lancinating pain. In addition, participants had to have a headache frequency of at least 1 per week for a minimum of 3 months, a minimum headache intensity pain score of two points (0–10 on the NPRS scale), a minimum disability score of 20 % or greater (i.e., 10 points or greater on the 0–50 NDI scale), and be between 18 and 65 years of age.

 

Patients were excluded if they exhibited other primary headaches (i.e., migraine, TTH), suffered from bilateral headaches, or exhibited any red flags (i.e., tumor, fracture, metabolic diseases, rheumatoid arthritis, osteoporosis, resting blood pressure greater than 140/90 mmHg, prolonged history of steroid use, etc.), presented with two or more positive neurologic signs consistent with nerve root compression (muscle weakness involving a major muscle group of the upper extremity, diminished upper extremity deep tendon reflex, or diminished or absent sensation to pinprick in any upper extremity dermatome), presented with a diagnosis of cervical spinal stenosis, exhibited bilateral upper extremity symptoms, had evidence of central nervous system involvement (hyperreflexia, sensory disturbances in the hand, intrinsic muscle wasting of the hands, unsteadiness during walking, nystagmus, loss of visual acuity, impaired sensation of the face, altered taste, the presence of pathological reflexes), had a history of whiplash injury within the previous 6 weeks, had prior surgery to the head or neck, had received treatment for head or neck pain from any practitioner within the previous month, had received physical therapy or chiropractic treatment for head or neck pain within the previous 3 months, or had pending legal action regarding their head or neck pain.

 

The most recent literature suggests that pre-manipulative cervical artery testing is unable to identify those individuals at risk of vascular complications from cervical manipulation [24, 25], and any symptoms detected during pre-manipulative testing may be unrelated to changes in blood flow in the vertebral artery [26, 27]. Hence, pre-manipulative cervical artery testing was not performed in this study; however, screening questions for cervical artery disease had to be negative [24, 28, 29]. This study was approved by the Institutional Review Board at Long Island University, Brooklyn, NY. The study was registered at www.clinicaltrials.gov with trial identifier NCT01580280. All patients were informed that they would receive either manipulation or mobilization and exercise and then provided informed consent before their enrollment in the study.

 

Treating Therapists

 

Twelve physical therapists (mean age 36.6 years, SD 5.62) participated in the delivery of treatment for patients in this study. They had an average of 10.3 (SD 5.66, range 3–20 years) years of clinical experience, and all had completed a 60 h post-graduate certification program that included practical training in manual techniques including the use of cervical and thoracic manipulation. To ensure all examination, outcome assessments, and treatment procedures were standardized, all participating physical therapists were required to study a manual of standard operating procedures and participate in a 4 h training session with the principal investigator.

 

Examination Procedures

 

All patients provided demographic information, completed the Neck Pain Medical Screening Questionnaire, and completed a number of self-report measures, followed by a standardized history and physical examination at baseline. Self-report measures included headache intensity as measured by the NPRS (0–10), the NDI (0–50), headache frequency (number of days with headache in the last week), headache duration (total hours of headache in the last week), and medication intake (number of times the patient had taken narcotic or over-the-counter pain medication in the past week).

 

The standardized physical examination was not limited to, but included measurements of C1-2 (atlanto-axial joint) passive right and left rotation ROM using the Flexion-Rotation Test (FRT). The inter-rater reliability for the FRT has been found to be excellent (ICC: 0.93; 95 % CI: 0.87, 0.96) [30].

 

Outcome Measures

 

The primary outcome measure used in this study was the patient’s headache intensity as measured by the NPRS. Patients were asked to indicate the average intensity of headache pain over the past week using an 11-point scale ranging from 0 (“no pain”) to 10 (“worst pain imaginable”) at baseline, 1-week, 1-month, and 3-months following the initial treatment session [31]. The NPRS is a reliable and valid instrument to assess pain intensity [32–34]. Although no data exists in patients with CH, the MCID for the NPRS has been shown to be 1.3 in patients with mechanical neck pain [32] and 1.74 in patients with a variety of chronic pain conditions [34]. Therefore, we chose to only include patients with an NPRS score of 2 points (20 %) or greater.

 

Secondary outcome measures included the NDI, the Global Rating of Change (GRC), headache frequency, headache duration, and medication intake. The NDI is the most widely used instrument for assessing self-rated disability in patients with neck pain [35–37]. The NDI is a self-report questionnaire with 10-items rated from 0 (no disability) to five (complete disability) [38]. The numeric responses for each item are summed for a total score ranging between 0 and 50; however, some evaluators have chosen to multiply the raw score by two, and then report the NDI on a 0–100 % scale [36, 39]. Higher scores represent increased levels of disability. The NDI has been found to possess excellent test-retest reliability, strong construct validity, strong internal consistency and good responsiveness in assessing disability in patients with mechanical neck pain [36], cervical radiculopathy [33, 40], whiplash associated disorder [38, 41, 42], and mixed non-specific neck pain [43, 44]. Although no studies have examined the psychometric properties of the NDI in patients with CH, we chose to only include patients with an NDI score of ten points (20 %) or greater, because this cut-off score captures the MCID for the NDI, which has been reported to approximate four, eight, and nine points (0–50) in patients with mixed non-specific neck pain [44], mechanical neck pain [45], and cervical radiculopathy [33], respectively. Headache frequency was measured as the number of days with headache in the last week, ranging from 0 to 7 days. Headache duration was measured as the total hours of headache in the last week, with six possible ranges: (1) 0–5 h, (2) 6–10 h, (3) 11–15 h, (4) 16–20 h, (5) 21–25 h, or (6) 26 or more hours. Medication intake was measured as the number of times the patient had taken prescription or over-the-counter analgesic or anti-inflammatory medication in the past week for their headaches, with five options: (1) not at all, (2) once a week, (3) once every couple of days, (4) once or twice a day, or (5) three or more times a day.

 

Patients returned for 1-week, 4-weeks, and 3-months follow-ups where the aforementioned outcome measures were again collected. In addition, at the 1-week, 4-weeks and 3-months follow-ups, patients completed a 15-point GRC question based on a scale described by Jaeschke et al. [46] to rate their own perception of improved function. The scale ranges from -7 (a very great deal worse) to zero (about the same) to +7 (a very great deal better). Intermittent descriptors of worsening or improving are assigned values from -1 to -6 and +1 to +6, respectively. The MCID for the GRC has not been specifically reported but scores of +4 and +5 have typically been indicative of moderate changes in patient status [46]. However, it should be noted that recently Schmitt and Abbott reported that the GRC might not correlate with changes in function in a population with hip and ankle injuries [47]. All outcome measures were collected by an assessor blind to group assignment.

 

On the initial visit patients completed all outcome measures then received the first treatment session. Patients completed 6–8 treatment sessions of either manipulation or mobilization combined with exercise over 4 weeks. Additionally, subjects were asked if they had experienced any “major” adverse events [48, 49] (stroke or permanent neurological deficits) at each follow-up period.

 

Randomization

 

Following the baseline examination, patients were randomly assigned to receive either manipulation or mobilization and exercise. Concealed allocation was performed by using a computer-generated randomized table of numbers created by an individual not involved with recruiting patients prior to the beginning of the study. Individual, sequentially numbered index cards with the random assignment were prepared for each of 8 data collection sites. The index cards were folded and placed in sealed opaque envelopes. Blinded to the baseline examination, the treating therapist opened the envelope and proceeded with treatment according to the group assignment. Patients were instructed not to discuss the particular treatment procedure received with the examining therapist. The examining therapist remained blind to the patient’s treatment group assignment at all times; however, based on the nature of the interventions it was not possible to blind patients or treating therapists.

 

Manipulation Group

 

Manipulations targeting the right and left C1-2 articulations and bilateral T1-2 articulations were performed on at least one of the 6–8 treatment sessions (Figs. 1 and ​and2).2). On other treatment sessions, therapists either repeated the C1-2 and/or T1-2 manipulations or targeted other spinal articulations (i.e., C0-1, C2-3, C3-7, T2-9, ribs 1–9) using manipulation. The selection of the spinal segments to target was left to the discretion of the treating therapist and it was based on the combination of patient reports and manual examination. For both the upper cervical and upper thoracic manipulations, if no popping or cracking sound was heard on the first attempt, the therapist repositioned the patient and performed a second manipulation. A maximum of 2 attempts were performed on each patient similar to other studies [14, 50–53]. The clinicians were instructed that the manipulations are likely to be accompanied by multiple audible popping sounds [54–58]. Patients were encouraged to maintain usual activity within the limits of pain; however, mobilization and the prescription of exercises, or any use of other modalities, were not provided to this group.

 

Figure 1 HVLA Thrust Manipulation Directed to the right C1-2 Articulation | El Paso, TX Chiropractor

 

Figure 2 HVLA Thrust Manipulation Directed Bilaterally to the Upper Thoracic Spine | El Paso, TX Chiropractor

 

The manipulation targeting C1-2 was performed with the patient in supine. For this technique, the patient’s left posterior arch of the atlas was contacted with the lateral aspect of the proximal phalanx of the therapist’s left second finger using a “cradle hold”. To localize the forces to the left C1-2 articulation, the patient was positioned using extension, a posterior-anterior (PA) shift, ipsilateral side-bend and contralateral side-shift. While maintaining this position, the therapist performed a single high-velocity, low-amplitude thrust manipulation to the left atlanto-axial joint using right rotation in an arc toward the underside eye and translation toward the table (Fig. 1). This was repeated using the same procedure but directed to the right C1-2 articulation.

 

The manipulation targeting T1-2 was performed with the patient in supine. For this technique, the patient held her/his arms and forearms across the chest with the elbows aligned in a superoinferior direction. The therapist contacted the transverse processes of the lower vertebrae of the target motion segment with the thenar eminence and middle phalanx of the third digit. The upper lever was localized to the target motion segment by adding rotation away and side-bend towards the therapist while the underside hand used pronation and radial deviation to achieve rotation toward and side-bend away moments, respectively. The space inferior to the xiphoid process and costochondral margin of the therapist was used as the contact point against the patient’s elbows to deliver a manipulation in an anterior to posterior direction targeting T1-2 bilaterally (Fig. 2).

 

Mobilization and Exercise Group

 

Mobilizations targeting the right and left C1-2 articulations and bilateral T1-2 articulations were performed on at least one of the 6–8 treatment sessions. On other treatment sessions, therapists either repeated the C1-2 and/or T1-2 mobilizations or targeted other spinal articulations (i.e., C0-1, C2/3, C3-7, T2-9, ribs 1–9) using mobilization. The selection of the spinal segments to target was left to the discretion of the treating therapist and it was based on the combination of patient reports and manual examination. However, in order to avoid a “contact” or “attention effect” when compared with the manipulation group, therapists were instructed to mobilize one cervical segment (i.e., right and left) and one thoracic segment or rib articulation on each treatment session.

 

The mobilization targeting the C1-2 articulation was performed in prone. For this technique, the therapist performed one 30 s bout of left-sided unilateral grade IV PA mobilizations to the C1-2 motion segment as described by Maitland [7]. This same procedure was repeated for one 30 s bout to the right atlanto-axial joint. In addition, and on at least one session, mobilization directed to the upper thoracic (T1-2) spine with the patient prone was performed. For this technique, the therapist performed one 30 s bout of central grade IV PA mobilizations to the T1-2 motion segment as described by Maitland [7]. Therefore, we used 180 (i.e., three 30 s bouts at approximately 2 Hz) end-range oscillations in total on each subject for the mobilization treatment. Notably, there is no high quality evidence to date to suggest that longer durations of mobilization result in greater pain reduction than shorter durations or dosages of mobilization [59, 60].

 

Cranio-cervical flexion exercises [11, 61–63] were performed with the patient in supine, with the knees bent and the position of the head standardized by placing the craniocervical and cervical spines in a mid-position, such that a line between the subject’s forehead and chin was horizontal, and a horizontal line from the tragus of the ear bisected the neck longitudinally. An air-filled pressure biofeedback unit (Chattanooga Group, Inc., Hixson, TN) was placed suboccipitally behind the patient’s neck and preinflated to a baseline of 20 mmHg [63]. For the staged exercises, patients were required to perform the craniocervical flexion action (“a nod of the head, similar to indicating yes”) [63] and attempt to visually target pressures of 22, 24, 26, 28, and 30 mmHg from a resting baseline of 20 mmHg and to hold the position steady for 10 s [61, 62]. The action of nodding was performed in a gentle and slow manner. A 10 s rest was allowed between trials. If the pressure deviated below the target pressure, the pressure was not held steady, substitution with the superficial flexors (sternocleidomastoid or anterior scalene) occurred, or neck retraction was noticed before the completion of the 10 s isometric hold, it was regarded as a failure [63]. The last successful target pressure was used to determine each patient’s exercise level wherein 3 sets of 10 repetitions with a 10 s isometric hold were performed. In addition to mobilizations and cranio-cervical flexion exercises, patients were required to perform 10 min of progressive resistance exercises (i.e., using Therabands® or free weights) to the muscles of the shoulder girdle during each treatment session, within their own tolerance, and specifically focusing on the lower trapezius and serratus anterior [11].

 

Sample Size

 

The sample size and power calculations were performed using online software from the MGH Biostatistics Center (Boston, MA). The calculations were based on detecting a 2-point (or 20 %) difference in the NPRS (headache intensity) at the 3 months follow-up, assuming a standard deviation of three points, a 2-tailed test, and an alpha level equal to 0.05. This generated a sample size of 49 patients per group. Allowing for a conservative dropout rate of 10 %, we planned to recruit at least 108 patients into the study. This sample size yielded greater than 90 % power to detect a statistically significant change in the NPRS scores.

 

Data Analysis

 

Descriptive statistics, including frequency counts for categorical variables and measures of central tendency and dispersion for continuous variables were calculated to summarize the data. The effects of treatment on headache intensity and disability were each examined with a 2-by-4 mixed-model analysis of variance (ANOVA), with treatment group (manipulation versus mobilization and exercise) as the between-subjects variable and time (baseline, 1 week, 4 weeks, and 3 months follow-up) as the within-subjects variable. Separate ANOVAs were performed with the NPRS (headache intensity) and NDI (disability) as the dependent variable. For each ANOVA, the hypothesis of interest was the 2-way interaction (group by time).

 

An independent t-test was used to determine the between group differences for the percentage change from baseline to 3-month follow-up in both headache intensity and disability. Separate Mann–Whitney U tests were performed with the headache frequency, GRC, headache duration and medication intake as the dependent variable. We performed Little’s Missing Completely at Random (MCAR) test [64] to determine if missing data points associated with dropouts were missing at random or missing for systematic reasons. Intention-to-treat analysis was performed by using Expectation-Maximization whereby missing data are computed using regression equations. Planned pairwise comparisons were performed examining the difference between baseline and follow-up periods between-groups using the Bonferroni correction at an alpha level of .05.

 

We dichotomized patients as responders at the 3-month follow-up using a cut score of 2 points improvement for headache intensity as measured by the NPRS. Numbers needed to treat (NNT) and 95 % confidence intervals (CI) were also calculated at the 3 months follow-up period using each of these definitions for a successful outcome. Data analysis was performed using SPSS 21.0.

 

Results

 

Two hundred and fifty-one patients with a primary complaint of headaches were screened for possible eligibility. The reasons for ineligibility can be found in Fig. 3, the flow diagram of patient recruitment and retention. Of the 251 patients screened, 110 patients, with a mean age of 35.16 years (SD 11.48) and a mean duration of symptoms of 4.56 years (SD 6.27), satisfied the eligibility criteria, agreed to participate, and were randomized into manipulation (n = 58) and mobilization and exercise (n = 52) groups. Baseline variables for each group can be found in Table 1. Twelve therapists from 8 outpatient physical therapy clinics each treated 25, 23, 20, 14, 13, 7, 6 or 2 patients, respectively; furthermore, each of the 12 therapists treated approximately an equal proportion of patients in each group. There was no significant difference (p = 0.227) between the mean number of completed treatment sessions for the manipulation group (7.17, SD 0.96) and the mobilization and exercise group (6.90, SD 1.35). In addition, the mean number of treatment sessions that targeted the C1-2 articulation was 6.41 (SD 1.63) for the manipulation group and 6.52 (SD 2.01) for the mobilization and exercise group, and this was not significantly different (p = 0.762). One hundred seven of the 110 patients completed all outcome measures through 3 months (97 % follow-up). Little’s Missing Completely at Random (MCAR) test was not statistically significant (p = 0.281); therefore, we used the Expectation-Maximization imputation technique to replace missing values with predicted values for the missing 3-month outcomes.

 

Figure 3 Flow Diagram of Patient Recruitment and Retention | El Paso, TX Chiropractor

 

Table 1 Baseline Variables, Demographics and Outcome Measures | El Paso, TX Chiropractor

 

The overall group by time interaction for the primary outcome of headache intensity was statistically significant for the NPRS (F(3,106) = 11.196; p < 0.001; partial eta squared = 0.24). Between-group differences revealed that the manipulation group experienced statistically significant greater improvement in the NPRS at both the 1-week (2.1, 95 % CI: 1.2, 2.9), 4-week (2.3, 95 % CI: 1.5, 3.1) and 3-month (2.1, 95 % CI: 1.2, 3.0) follow-up periods (Table 2). In addition, an independent samples t-test revealed the between-group difference in percentage change in headache intensity (36.58 %, 95 % CI: 22.52, 50.64) from baseline to 3-month follow-up was statistically significant (t(108) = 5.156; p < 0.001) in favor of manipulation. See Table 3 for the percentage of subjects gaining 50, 75, and 100 % reduction in headache intensity at 3 months.

 

Table 2 Changes in Headache Intensity and Disability | El Paso, TX Chiropractor

 

Table 3 Percentage of Subjects Gaining 50, 75, and 100 Percent Reduction | El Paso, TX Chiropractor

 

For secondary outcomes a significant group by time interaction existed for the NDI (F(3,106) = 8.57; p < 0.001; partial eta squared = 0.20). At each follow-up period the manipulation group had superior outcomes in disability reduction as compared to the mobilization and exercise group. An independent samples t- test revealed the between-group mean percentage change in disability (35.56 %, 95 % CI: 24.95, 46.17) from baseline to 3 months follow-up was statistically significant (t(108) = 6.646, p < 0.001); indicating the manipulation group experienced a significantly greater percentage in disability reduction (Table 3).

 

Mann–Whitney U tests revealed that patients in the upper cervical and upper thoracic manipulation group experienced less frequent headaches at 1 week (p < 0.001; median 2.0 versus 3.0), 4 weeks (p < 0.001; median 1.0 versus 3.0) and 3 months (p < 0.001; median 1.0 versus 2.5) than patients in the mobilization and exercise group. Headache duration was significantly lower at 1 week (p = 0.005; median 2.0 versus 3.0, 4 weeks (p < 0.001; median 1.0 versus 2.0) and 3 months (p < 0.001; median 1.0 versus 2.0) in the manipulation group. Additionally, patient perceived improvement as measured by the GRC was significantly greater at 1 week (p < 0.001, 4.0 versus 1.0), 4 weeks (p < 0.001, 6.0 versus 3.0) and 3 months (p < 0.001, 6.0 versus 3.0) than patients in the mobilization and exercise group. At 3 months, patients receiving upper cervical and upper thoracic manipulation experienced significantly (p < 0.001) greater reductions in medication intake as compared to the mobilization and exercise group. Based on the cutoff score of 2 points on the NPRS, the NNT was 4.0 (95 % CI: 2.3, 7.7) in favor of the manipulation group at 3-month follow-up.

 

We did not collect any data on the occurrence of “minor” adverse events [48, 49] (transient neurological symptoms, increased stiffness, radiating pain, fatigue or other); however, no “major” adverse events [48, 49] (stroke or permanent neurological deficits) were reported for either group.

 

Discussion

 

Statement of Principal Findings

 

To our knowledge, this study is the first randomized clinical trial to directly compare the effectiveness of both cervical and thoracic manipulation to mobilization and exercise in patients with CH. The results suggest 6–8 sessions of manipulation over 4 weeks, directed mainly to both the upper cervical (C1-2) and upper thoracic (T1-2) spines, resulted in greater improvements in headache intensity, disability, headache frequency, headache duration, and medication intake than mobilization combined with exercises. The point estimates for between-group changes in headache intensity (2.1 points) and disability (6.0 points or 12.0 %) exceeded the reported MCIDs for both measures. Although the MCID for the NDI in patients with CH has not yet been investigated, it should however be noted that the lower bound estimate of the 95 % CI for disability (3.5 points) was slightly below (or approximated in two cases) the MCID that has been found to be 3.5 [65], 5 [66], and 7.5 [45] points in patients with mechanical neck pain, 8.5 [33] points in patients with cervical radiculopathy, and 3.5 [44] points in patients with mixed, non-specific neck pain. However, it should be recognized that both groups made clinical improvement. In addition, the NNT suggests for every four patients treated with manipulation, rather than mobilization, one additional patient achieves clinically important pain reduction at 3 months follow-up.

 

Strengths and Weaknesses of the Study

 

The inclusion of 12 treating physical therapists from 8 private clinics in 6 different geographical states enhances the overall generalizability of our findings. Although significant differences were recognized up to 3 months, it is not known if these benefits would have been sustained at long-term. In addition, we used high-velocity, low-amplitude manipulation techniques that employed bidirectional thrusts into rotation and translation simultaneously and Maitland based grade IV PA mobilization techniques; thus, we cannot be certain that these results are generalizable to other kinds of manual therapy techniques. Some might argue that the comparison group might have not received adequate intervention. We sought to balance internal and external validity so standardized treatment for both groups and provided a very explicit description of the techniques used which will also allow for replication. Furthermore, we did not measure minor adverse events and only asked about two potential major adverse events. Another limitation is that we included multiple secondary outcomes. Therapist preferences as to which technique they thought would be superior was not collected and potentially could impact the results.

 

Strengths and Weaknesses in Relation to Other Studies: Important Differences in Results

 

Jull et al. [11] demonstrated treatment efficacy for manipulative therapy and exercise in the management of CH; however, this treatment package included both mobilization and manipulation. The current study may provide evidence that the management of patients with CH should include some form of manipulation despite the fact it is often suggested that cervical manipulation should be avoided because of the risk of serious adverse events [67, 68]. Furthermore, it has been shown that individuals receiving spinal manipulation for neck pain and headaches are no more likely to experience a vertebrobasilar stroke than if they received treatment by their medical physician [69]. Additionally, after reviewing 134 case reports, Puentedura et al. concluded that with appropriate selection of patients by careful screening of red flags and contraindications, the majority of adverse events associated with cervical manipulation could have been prevented [70].

 

Meaning of the Study: Possible Explanations and Implications for Clinicians and Policymakers

 

Based on the results of the current study clinicians should consider incorporating spinal manipulation for individuals with CH. A recent systematic review found both mobilization and manipulation to be effective for the management of patients with CH but was unable to determine which technique was superior [8]. Additionally, clinical guidelines reported that manipulation, mobilization and exercise were all effective for the management of patients with CH; however, the guideline made no suggestions regarding the superiority of either technique. [71] The current results may assist authors of future systematic reviews and clinical guidelines in providing more specific recommendations about the use of spinal manipulation in this population.

 

Unanswered Questions and Future Research

 

The underlying mechanisms as to why manipulation may have resulted in greater improvements remains to be elucidated. It has been suggested that high-velocity displacement of vertebrae with impulse durations of less than 200 ms may alter afferent discharge rates [72] by stimulating mechanoreceptors and proprioceptors, thereby changing alpha motorneuron excitability levels and subsequent muscle activity [72–74]. Manipulation might also stimulate receptors in the deep paraspinal musculature, and mobilization might be more likely to facilitate receptors in the superficial muscles [75]. Biomechanical [76, 77], spinal or segmental [78, 79] and central descending inhibitory pain pathway [80–83] models are plausible explanations for the hypoalgesic effects observed following manipulation. Recently, the biomechanical effects of manipulation have been under scientific scrutiny [84], and it is plausible that the clinical benefits found in our study are associated with a neurophysiological response involving temporal sensory summation at the dorsal horn of the spinal cord [78]; however, this proposed model is currently supported only on findings from transient, experimentally induced pain in healthy subjects [85, 86], not patients with CH. Future studies should examine different manual therapy techniques with varying dosages and include a 1-year follow-up. Furthermore, future studies examining the neurophysiological effects of both manipulation and mobilization will be important for determining why there may or may not be a difference in clinical effects between these two treatments.

 

Conclusion

 

The results of the current study demonstrated that patients with CH who received cervical and thoracic manipulation experienced significantly greater reductions in headache intensity, disability, headache frequency, headache duration, and medication intake as compared to the group that received mobilization and exercise; furthermore, the effects were maintained at 3 months follow-up. Future studies should examine the effectiveness of different types and dosages of manipulation and include a long-term follow-up.

 

Acknowledgements

 

None of the authors received any funding for this study. The authors wish to thank all the participants of the study.

 

Footnotes

 

  • Competing interests: Dr. James Dunning is the President of the American Academy of Manipulative Therapy (AAMT). AAMT provides postgraduate training programs in spinal manipulation, spinal mobilization, dry needling, extremity manipulation, extremity mobilization, instrument-assisted soft-tissue mobilization and therapeutic exercise to licensed physical therapists, osteopaths and medical doctors. Drs. James Dunning, Raymond Butts, Thomas Perreault, and Firas Mourad are senior instructors for AAMT. The other authors declare that they have no competing interests.
  • Authors’ contributions: JRD participated in the conception, design, data acquisition, statistical analyses and drafting of the manuscript. RB and IY participated in the design, data collection, statistical analyses and revision of the manuscript. FM participated in the design, statistical analyses, data interpretation and revision of the manuscript. MH participated in the conception, design and revision of the manuscript. CF and JC were involved in the statistical analyses, interpretation of data, and critical revision of the manuscript for important intellectual content. TS, JD, DB, and TH were involved in data collection and revision of the manuscript. All authors read and approved the final manuscript.

 

Contributor Information

 

Ncbi.nlm.nih.gov/pmc/articles/PMC4744384/

 

In conclusion, head pain caused by secondary headache due to a health issue along the surrounding structures of the cervical spine, or neck, can cause painful and debilitating symptoms which can affect the patient’s quality of life. Spinal manipulation and mobilization can be safely and effectively utilized to help improve cervicogenic headache symptoms. Information referenced from the National Center for Biotechnology Information (NCBI). The scope of our information is limited to chiropractic as well as to spinal injuries and conditions. To discuss the subject matter, please feel free to ask Dr. Jimenez or contact us at 915-850-0900 .

 

Curated by Dr. Alex Jimenez

 

 

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Additional Topics: Back Pain

 

According to statistics, approximately 80% of people will experience symptoms of back pain at least once throughout their lifetimes. Back pain is a common complaint which can result due to a variety of injuries and/or conditions. Often times, the natural degeneration of the spine with age can cause back pain. Herniated discs occur when the soft, gel-like center of an intervertebral disc pushes through a tear in its surrounding, outer ring of cartilage, compressing and irritating the nerve roots. Disc herniations most commonly occur along the lower back, or lumbar spine, but they may also occur along the cervical spine, or neck. The impingement of the nerves found in the low back due to injury and/or an aggravated condition can lead to symptoms of sciatica.

 

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EXTRA IMPORTANT TOPIC: Migraine Pain Treatment

 

 

MORE TOPICS: EXTRA EXTRA: El Paso, Tx | Athletes

 

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Chiropractic Headache Treatment Guidelines in El Paso, TX

Chiropractic Headache Treatment Guidelines in El Paso, TX

Headache pain is one of the most prevalent reasons for doctor office visits. The majority of people experience them at some point in their life and they can affect anyone, regardless of age, race and gender. The International Headache Society, or IHS, categorizes headaches as primary, when they are not caused by another injury and/or condition, or secondary, when there is an underlying cause behind them. From migraines to cluster headaches and tension headaches, people who suffer from constant head pain may find it difficult to participate in their everyday activities. Many healthcare professionals treat headache pain, however, chiropractic care has become a popular alternative treatment option for a variety of health issues. The purpose of the following article is to demonstrate evidence-based guidelines for the chiropractic treatment of adults with headache.

 

Evidence-Based Guidelines for the Chiropractic Treatment of Adults with Headache

 

Abstract

 

  • Objective: The purpose of this manuscript is to provide evidence-informed practice recommendations for the chiropractic treatment of headache in adults.
  • Methods: Systematic literature searches of controlled clinical trials published through August 2009 relevant to chiropractic practice were conducted using the databases MEDLINE; EMBASE; Allied and Complementary Medicine; the Cumulative Index to Nursing and Allied Health Literature; Manual, Alternative, and Natural Therapy Index System; Alt HealthWatch; Index to Chiropractic Literature; and the Cochrane Library. The number, quality, and consistency of findings were considered to assign an overall strength of evidence (strong, moderate, limited, or conflicting) and to formulate practice recommendations.
  • Results: Twenty-one articles met inclusion criteria and were used to develop recommendations. Evidence did not exceed a moderate level. For migraine, spinal manipulation and multimodal multidisciplinary interventions including massage are recommended for management of patients with episodic or chronic migraine. For tension-type headache, spinal manipulation cannot be recommended for the management of episodic tension-type headache. A recommendation cannot be made for or against the use of spinal manipulation for patients with chronic tension-type headache. Low-load craniocervical mobilization may be beneficial for longer term management of patients with episodic or chronic tension-type headaches. For cervicogenic headache, spinal manipulation is recommended. Joint mobilization or deep neck flexor exercises may improve symptoms. There is no consistently additive benefit of combining joint mobilization and deep neck flexor exercises for patients with cervicogenic headache. Adverse events were not addressed in most clinical trials; and if they were, there were none or they were minor.
  • Conclusions: Evidence suggests that chiropractic care, including spinal manipulation, improves migraine
    and cervicogenic headaches. The type, frequency, dosage, and duration of treatment(s) should be based on guideline recommendations, clinical experience, and findings. Evidence for the use of spinal manipulation as an isolated intervention for patients with tension-type headache remains equivocal. (J Manipulative Physiol Ther 2011;34:274-289)
  • Key Indexing Terms: Spinal Manipulation; Migraine Disorders; Tension-Type Headache; Post-traumatic Headache; Practice Guideline; Chiropractic

 

Dr Jimenez White Coat

Dr. Alex Jimenez’s Insight

Headache, or head pain, including migraine and other types of headaches, is one of the most common types of pain reported among the general population. These may occur on one or both sides of the head, can be isolated to a specific location or they may radiate across the head from one point. While headache symptoms can vary depending on the type of head pain as well as due to the source of the health issue, headaches are considered to be a general complaint regardless of their severity and form. Headache, or head pain, may occur as a result of spinal misalignment, or subluxation, along the length of the spine. Through the use of spinal adjustments and manual manipulations, chiropractic care can safely and effectively realign the spine, reducing stress and pressure on the surrounding structures of the spine, to ultimately help improve migraine headache pain symptoms as well as overall health and wellness.

 

Headache is a common experience in adults. Recurring headaches negatively impact family life, social activity, and work capacity.[1,2] Worldwide, according to the World Health Organization, migraine alone is 19th among all causes of years lived with disability. Headache is third among reasons for seeking chiropractic care in North America.[3]

 

Accurate diagnosis is key to management and treatment, and a wide range of headache types are described in the International Classification of Headache Disorders 2 (International Headache Society [IHS]).[4] The categories are intended for clinical as well as research use. The most common headaches, tension-type and migraine, are considered primary headaches that are episodic or chronic in nature. Episodic migraine or tension-type headaches occur fewer than 15 days per month, whereas chronic headaches occur more than 15 days per month for at least 3 (migraine) or 6 months (tension-type headache).[4] Secondary headaches are attributed to underlying clinical problems in the head or neck that may also be episodic or chronic. Cervicogenic headaches are secondary headaches commonly treated by chiropractors and involve pain referred from a source in the neck and perceived in 1 or more regions of the head. The IHS recognizes cervicogenic headache as a distinct disorder,[4] and evidence that headache can be attributed to a neck disorder or lesion based on history and clinical features (history of neck trauma, mechanical exacerbation of pain, reduced cervical range of motion, and focal neck tenderness, excluding myofascial pain alone) is relevant to diagnosis but is not without controversy in the literature.[4,5] When myofascial pain alone is the cause, the patient should be managed as having tension-type headaches.[4]

 

Treatment modalities typically used by chiropractors to care for patients with headaches include spinal manipulation, mobilization, device-assisted spinal manipulation, education about modifiable lifestyle factors, physical therapy modalities, heat/ice, massage, advanced soft tissue therapies such as trigger point therapy, and strengthening and stretching exercises. There is a growing expectation for health professions, including chiropractic, to adopt and use research-based knowledge, taking sufficient account of the quality of available research evidence to inform clinical practice. As a result, the purpose of the Canadian Chiropractic Association (CCA) and the Canadian Federation of Chiropractic Regulatory and Educational Accrediting Boards (Federation) Clinical Practice Guidelines Project is to develop guidelines for practice based on available evidence. The purpose of this manuscript is to provide evidence-informed practice recommendations for the chiropractic treatment of headache in adults.

 

Methods

 

The Guidelines Development Committee (GDC) planned for and adapted systematic processes for literature searching, screening, review, analysis, and interpretation. Methods are consistent with criteria proposed by the “Appraisal of Guidelines Research and Evaluation” collaboration (http://www.agreecollaboration.org). This guideline is a supportive tool for practitioners. It is not intended as a standard of care. The guideline links available published evidence to clinical practice and is only 1 component of an evidence-informed approach to patient care.

 

Data Sources and Searches

 

Systematic search and evaluation of the treatment literature were conducted using methods recommended by The Cochrane Collaboration Back Review Group[6] and Oxman and Guyatt.[7] The search strategy was developed in MEDLINE by exploring MeSH terms related to chiropractic and specific interventions and later modified for other databases. The literature search strategy was intentionally broad. Chiropractic treatment was defined as including the most common therapies used by practitioners and was not restricted to treatment modalities delivered only by chiropractors. A wide net was cast to include treatments that may be administered in chiropractic care as well as those that could also be delivered in the context of care by other health care professionals in a specific research study (Appendix A). Spinal manipulation was defined as a high-velocity low-amplitude thrust delivered to the spine. Excluded therapies included invasive analgesic or neurostimulation procedures, pharmacotherapy, injections of botulinum toxin, cognitive or behavioral therapies, and acupuncture.

 

Literature searches were completed from April to May 2006, updated in 2007 (phase 1), and updated again in August 2009 (phase 2). Databases searched included MEDLINE; EMBASE; Allied and Complementary Medicine; the Cumulative Index to Nursing and Allied Health Literature; Manual, Alternative, and Natural Therapy Index System; Alt HealthWatch; Index to Chiropractic Literature; and the Cochrane Library (Appendix A). Searches included articles published in English or with English abstracts. The search strategy was limited to adults (≥18 years); although research studies with subject inclusion criteria encompassing a broad range of ages, such as adults and adolescents, were retrieved using the search strategy. Reference lists provided in systematic reviews (SRs) were also reviewed by the GDC to minimize relevant articles from being missed.

 

Evidence Selection Criteria

 

Search results were screened electronically, and multi-stage screening was applied (Appendix B): stage 1A (title), 1B (abstract); stage 2A (full text), 2B (full text-methodology, relevance); and stage 3 (full text-final GDC screening as clinical content experts). Duplicate citations were removed, and relevant articles were retrieved as electronic and/or hard copies for detailed analysis. Different assessors, using the same criteria, completed the literature screens in 2007 and 2009 due to the time span between searches.

 

Only controlled clinical trials (CCTs); randomized, controlled trials (RCTs); and systematic reviews (SRs) were selected as the evidence base for this guideline consistent with current standards for interpreting clinical findings. The GDC did not rate observational studies, case series, or case reports because of their uncontrolled nature and probable low methodological quality vs CCTs. This approach is consistent with updated methods for SRs published by the Cochrane Back Review Group.[8] If multiple SRs were published by the same authors on a given topic, only the most recent publication was counted and used for evidence synthesis. Systematic reviews of SRs were also excluded to avoid double counting of research results.

 

Literature Assessment and Interpretation

 

Quality ratings of CCTs or RCTs included 11 criteria answered by “yes (score 1)” or “no (score 0)/do not know (score 0)” (Table 1). The GDC documented 2 additional criteria of interest: (1) researchers’ use of IHS diagnostic criteria for subject enrollment and (2) evaluation of side effects (Table 1, columns L and M). Use of IHS criteria[4] was relevant to this Clinical Practice Guideline (CPG) process to confirm diagnostic specificity within and across research studies. Studies were excluded if IHS diagnostic criteria were not applied by the researchers for subject inclusion into a study (Appendix C); and if before 2004, before cervicogenic headache was included in the IHS classification, the diagnostic criteria of the Cervicogenic Headache International Study Group[9] were not used. Side effects were reviewed as a proxy for potential risk(s) with treatment. No weighting factor(s) was applied to individual criteria, and possible quality ratings ranged from 0 to 11. Both blinding of subjects and care providers were rated in the research articles by the GDC, since these items are listed in the quality rating tool.[6] The GDC’s methods did not adapt or alter the rating tool. The rationale for this approach was that certain treatment modalities (eg, transcutaneous electrical nerve stimulation [TENS], ultrasound) and trial designs may achieve patient and/or practitioner blinding.[10] The GDC did not limit the evaluation of these benchmarks of quality if indeed they were reported in clinical studies for the treatment of headache disorders. The GDC also considered it outside their scope of expertise to modify, without validation, a widely used rating tool used to assess the clinical literature.[6] New research tools for the analysis and rating of the manual therapy literature, however, are urgently needed and are noted as an area for future research in the discussion section below.

 

Table 1 Qualitative Ratings of Controlled Trials of Physical Treatments for the Management of Headache Disorders

 

Literature assessors were project contributors separate from the GDC and were unblinded as to study authors, institutions, and source journals. Three members of the GDC (MD, RR, and LS) corroborated quality rating methods by completing quality assessments on a random subset of 10 articles.[11-20] A high level of agreement was confirmed across quality ratings. Complete agreement on all items was achieved for 5 studies: in 10 of 11 items for 4 studies and 8 of 11 items for the 1 remaining study. All discrepancies were easily resolved through discussion and consensus by the GDC (Table 1). Due to heterogeneity of research methods across trials, no meta-analysis or statistical pooling of trial results was done. Trials scoring more than half of the total possible rating (ie, ≥6) were considered high quality. Trials scoring 0 through 5 were considered low quality. Studies with major methodological flaws or investigating specialized treatment techniques were excluded (eg, treatment not considered relevant by the GDC for the chiropractic care of patients with headache; Appendix Table 3).

 

Quality rating of SRs included 9 criteria answered by yes (score 1) or no (score 0)/do not know (score 0) and a qualitative response for item J “no flaws,” “minor flaws,” or “major flaws” (Table 2). Possible ratings ranged from 0 to 9. The determination of overall scientific quality of SRs with major flaws, minor flaws, or no flaws, as listed in column J (Table 2), was based on the literature raters’ answers to the previous 9 items. The following parameters were used to derive the overall scientific quality of a SR: if the no/do not know response was used, an SR was likely to have minor flaws at best. However, if “No” was used on items B, D, F, or H, the review was likely to have major flaws.[21] Systematic reviews scoring more than half of the total possible rating (ie, ≥5) with no or minor flaws were rated as high quality. Systematic reviews scoring 4 or less and/or with major flaws were excluded.

 

Table 2 Qualitative Ratings of Systematic Reviews of Physical Treatments for the Management of Headache Disorders

 

Reviews were defined as systematic if they included an explicit and repeatable method for searching and analyzing the literature and if inclusion and exclusion criteria for studies were described. Methods, inclusion criteria, methods for rating study quality, characteristics of included studies, methods for synthesizing data, and results were evaluated. Raters achieved complete agreement for all rating items for 7 SRs[22-28] and for 7 of 9 items for the 2 additional SRs.[29,30] The discrepancies were deemed minor and easily resolved through GDC review and consensus (Table 2).

 

Developing Recommendations for Practice

 

The GDC interpreted the evidence relevant to chiropractic treatment of headache patients. A detailed summary of the relevant articles will be posted to the CCA/Federation Clinical Practice Guidelines Project web site.

 

Randomized, controlled trials and their findings were appraised to inform treatment recommendations. To assign an overall strength of evidence (strong, moderate, limited, conflicting, or no evidence),[6] the GDC considered the number, quality, and consistency of research results (Table 3). Strong evidence was considered only when multiple high-quality RCTs corroborated the findings of other researchers in other settings. Only high-quality SRs were appraised in relation to the body of evidence and to inform treatment recommendations. The GDC considered treatment modalities to have proven benefit(s) when supported by a minimum of moderate level of evidence.

 

Table 3 Strength of Evidence

 

Recommendations for practice were developed in collaborative working group meetings.

 

Results

 

Table 4 Literature Summary of !uality Ratings of the Evidence for Interventions for Migraine Headache with or without Aura

 

Table 5 Literature Summary and Quality Ratings of the Evidence for Interventions for Tension-Type Headache

 

Table 6 Literature Summary and Quality Ratings of the Evidence for Interventions for Cervicogenic Headache

 

Table 7 Literature Summary and Quality Ratings of Systematic Reviews of Physical Treatments for the Management of Headache Disorders

 

Literature

 

From the literature searches, initially 6206 citations were identified. Twenty-one articles met final criteria for inclusion and were considered in developing practice recommendations (16 CCTs/RCTs[11-20,31-36] and 5 SRs[24-27,29]). Quality ratings of the included articles are provided in Tables 1 and 2. Appendix Table 3 lists articles excluded in final screening by the GDC and reason(s) for their exclusion. Absence of subject and practitioner blinding and unsatisfactory descriptions of cointerventions were commonly identified methodological limitations of the controlled trials. Headache types evaluated in these trials included migraine (Table 4), tension-type headache (Table 5), and cervicogenic headache (Table 6). Consequently, only these headache types are represented by the evidence and practice recommendations in this CPG. Evidence summaries of SRs are provided in Table 7.

 

Practice Recommendations: Treatment of Migraine

 

  • Spinal manipulation is recommended for the management of patients with episodic or chronic migraine with or without aura. This recommendation is based on studies that used a treatment frequency 1 to 2 times per week for 8 weeks (evidence level, moderate). One high-quality RCT,[20] 1 low-quality RCT,[17] and 1 high- quality SR[24] support the use of spinal manipulation for patients with episodic or chronic migraine (Tables 4 and 7).
  • Weekly massage therapy is recommended for reducing episodic migraine frequency and for improving affective symptoms potentially linked to headache pain (evidence level, moderate). One high-quality RCT[16] supports this practice recommendation (Table 4). Researchers used a 45-minute massage with focus on neuromuscular and trigger point framework of the back, shoulder, neck, and head.
  • Multimodal multidisciplinary care (exercise, relaxation, stress and nutritional counseling, massage therapy) is recommended for the management of patients with episodic or chronic migraine. Refer as appropriate (evidence level, moderate). One high-quality RCT[32] supports the effectiveness of multi-modal multidisciplinary intervention for migraine (Table 4). The intervention prioritizes a general management approach consisting of exercise, education, lifestyle change, and self-management.
  • There are insufficient clinical data to recommend for or against the use of exercise alone or exercise combined with multimodal physical therapies for the management of patients with episodic or chronic migraine (aerobic exercise, cervical range of motion [cROM], or whole body stretching). Three low-quality CCTs[13,33,34] contribute to this conclusion (Table 4).

 

Practice Recommendations: Tension-Type Headache

 

  • Low-load craniocervical mobilization (eg, Thera-Band, Resistive Exercise Systems; Hygenic Corporation, Akron, OH) is recommended for longer term (eg, 6 months) management of patients with episodic or chronic tension-type headaches (evidence level, moderate). One high-quality RCT[36] showed that low-load mobilization significantly reduced symptoms of tension-type headaches for patients during the longer term (Table 5).
  • Spinal manipulation cannot be recommended for the management of patients with episodic tension-type headache (evidence level, moderate). There is moderate-level evidence that spinal manipulation after premanipulative soft tissue therapy provides no additional benefit for patients with tension-type headaches. One high-quality RCT[12] (Table 5) and observations reported in 4 SRs[24-27] (Table 7) suggest no benefit of spinal manipulation for patients with episodic tension-type headaches.
  • A recommendation cannot be made for or against the use of spinal manipulation (2 times per week for 6 weeks) for patients with chronic tension-type headache. Authors of 1 RCT[11] rated as high quality by the quality assessment tool[6] (Table 1), and summaries of this study in 2 SRs[24,26] suggest that spinal manipulation may be effective for chronic tension-type headache. However, the GDC considers the RCT[11] difficult to interpret and inconclusive (Table 5). The trial is inadequately controlled with imbalances in the number of subject-clinician encounters between study groups (eg, 12 visits for subjects in the soft tissue therapy plus spinal manipulation group vs 2 visits for subjects in the amitriptyline group). There is no way of knowing whether a comparable level of personal attention for subjects in the amitriptyline group may have impacted the study outcomes. These considerations and interpretations from 2 other SRs[25,27]contribute to this conclusion (Table 7).
  • There is insufficient evidence to recommend for or against the use of manual traction, connective tissue manipulation, Cyriax’s mobilization, or exercise/ physical training for patients with episodic or chronic tension-type headache. Three low-quality inconclusive studies[19,31,35] (Table 5), 1 low-quality negative RCT,[14] and 1 SR[25] contribute to this conclusion (Table 7).

 

Practice Recommendations: Cervicogenic Headache

 

  • Spinal manipulation is recommended for the management of patients with cervicogenic headache. This recommendation is based on 1 study that used a treatment frequency of 2 times per week for 3 weeks (evidence level, moderate). In a high-quality RCT, Nilsson et al[18] (Table 6) showed a significantly positive effect of high-velocity, low-amplitude spinal manipulation for patients with cervicogenic headache. Evidence synthesis from 2 SRs[24,29] (Table 7) supports this practice recommendation.
  • Joint mobilization is recommended for the management of patients with cervicogenic headache (evidence level, moderate). Jull et al[15] examined the effects of Maitland joint mobilization 8 to 12 treatments for 6 weeks in a high-quality RCT (Table 6). Mobilization followed typical clinical practice, in which the choice of low-velocity and high-velocity techniques was based on initial and progressive assessments of patients’ cervical joint dysfunction. Beneficial effects were reported for headache frequency, intensity, as well as neck pain and disability. Evidence synthesis from 2 SRs[24,29] (Table 7) supports this practice recommendation.
  • Deep neck flexor exercises are recommended for the management of patients with cervicogenic headache (evidence level, moderate). This recommendation is based on a study of 2 times daily for 6 weeks. There is no consistently additive benefit of combining deep neck flexor exercises and joint mobilization for cervicogenic headache. One high-quality RCT[15] (Table 6) and observations provided in 2 SRs[24,29] (Table 7) support this practice recommendation.

 

Safety

 

Practitioners select treatment modalities in conjunction with all available clinical information for a given patient. Of the 16 CCTs/RCTS[11-20,31-36] included in the body of evidence for this CPG, only 6 studies[11,12,15,20,32,36] adequately assessed or discussed patient side effects or safety parameters (Table 1, column M). Overall, reported risks were low. Three of the trials reported safety information for spinal manipulation.[11,12,20] Boline et al[11] reported that 4.3% of subjects experienced neck stiffness after initial spinal manipulation that disappeared for all cases after the first 2 weeks of treatment. Soreness or increase in headaches after spinal manipulation (n = 2) were reasons for treatment discontinuation cited by Tuchin et al.[20] No side effects were experienced by any subjects studied by Bove et al[12] using spinal manipulation for the treatment of episodic tension-type headache. Treatment trials to evaluate efficacy outcomes may not enroll adequate numbers of subjects to assess the incidence of rare adverse events. Other research methods are required to develop a full understanding of the balance between benefits and risks.

 

Discussion

 

Spinal manipulation and other manual therapies commonly used in chiropractic have been studied in several CCTs that are heterogeneous in subject enrollment, design, and overall quality. Patient and headache types systematically represented in the evidence base are migraine, tension-type headaches, and cervicogenic headache. The primary health status outcomes reported are typically headache frequency, intensity, duration, and quality-of-life measures. The evidence is no greater than a moderate level at this time.

 

The evidence supports the use of spinal manipulation for the chiropractic management of patients with migraine or cervicogenic headaches but not tension-type headaches. For migraine, multidisciplinary care using weekly 45-minute massage therapy and multimodal care (exercise, relaxation, and stress and nutritional counseling) may also be effective. Alternatively, joint mobilization or deep neck flexor exercises are recommended for improving symptoms of cervicogenic headache. There appears to be no consistently additive benefit of combining joint mobilization and deep neck flexor exercises for patients with cervicogenic headache. Moderate evidence support the use of low-load craniocervical mobilization for longer term management of tension-type headaches.

 

Limitations

 

Shortcomings for this guideline include the quantity and quality of supporting evidence found during the searches. No recent adequately controlled high-quality research studies with reproducible clinical findings have been published for the chiropractic care of headache patients. Studies are needed to further our understanding of specific manual therapies in isolation or in well-controlled combinations for the treatment of migraine, tension-type headache, cervicogenic headache, or other headache types presenting to clinicians (eg, cluster, posttraumatic head- ache). Another shortcoming of this literature synthesis is the reliance on published research studies with small sample sizes (Tables 4-6), short-term treatment paradigms, and follow-up periods. Well-designed clinical trials with sufficient numbers of subjects, longer term treatments, and follow-up periods need to be funded to advance chiropractic care, and spinal manipulation in particular, for the management of patients with headache disorders. As with any literature review and clinical practice guideline, foundational information and published literature are evolving. Studies that may have informed this work may have been published after the conclusion of this study.[37-39]

 

Considerations for Future Research

 

The GDC consensus is that there is a need for further chiropractic studies with patients with headache disorders.

 

  • More high-quality clinical research is needed. Future research requires study designs using active comparators and nontreatment and/or placebo group(s) to enhance the evidence base for patient care. Patient blinding to physical interventions to manage expectancy results is needed and has been explored by researchers in chiropractic for other pain conditions.[10] The lack of systematically reported studies presents a practical challenge for generating evidence-based treatment recommendations. All future studies should be structured using systematic validated methods (eg, Consolidated Standards of Reporting Trials [CONSORT] and Transparent Reporting of Evaluations with Non-randomized Designs [TREND]).
  • Systematic reporting of safety data is needed in chiropractic research. All clinical trials must collect and report on potential side effects or harms even if none are observed.
  • Develop novel quantitative tools for evaluating manual therapy research. Blinding serves to control expectancy effects and nonspecific effects of subject-provider interactions across study groups. It is typically not possible to blind subjects and providers in efficacy studies of manual therapies. Despite inherent limitations, both blinding of subjects and care providers were rated in the research articles by the GDC, since these items are included in high-quality rating instruments.[6] Advanced research tools for analyzing and subsequent rating of the manual therapy literature are urgently needed.
  • To advance research on functional outcomes in the chiropractic care of headache. This guideline identified that headache studies use a variable range of measures in evaluating the effect of treatment on health outcomes. Headache frequency, intensity, and duration are the most consistently used outcomes (Tables 4-6). Serious efforts are needed to include validated patient-centered outcome measures in chiropractic research that are congruent with improvements in daily living and resumption of meaningful routines.
  • Cost-effectiveness. No research studies were retrieved on cost-effectiveness of spinal manipulation for the treatment of headache disorders. Future clinical trials of spinal manipulation should evaluate cost-effectiveness.

 

Other research methods are required to develop a full understanding of the balance between benefits and risks. This CPG does not provide a review of all chiropractic treatments. Any omissions reflect gaps in the clinical literature. The type, frequency, dosage, and duration of treatment(s) should be based on guideline recommendations, clinical experience, and knowledge of the patient until higher levels of evidence are available.

 

Conclusions

 

There is a baseline of evidence to support chiropractic care, including spinal manipulation, for the management of migraine and cervicogenic headaches. The type, frequency, dosage, and duration of treatment(s) should be based on guideline recommendations, clinical experience, and knowledge of the patient. Evidence for the use of spinal manipulation as an isolated intervention for patients with tension-type headache remains equivocal. More research is needed.
Practice guidelines link the best available evidence to good clinical practice and are only 1 component of an evidence-informed approach to providing good care. This guideline is intended to be a resource for the delivery of chiropractic care for patients with headache. It is a “living document” and subject to revision with the emergence of new data. Furthermore, it is not a substitute for a practitioner’s clinical experience and expertise. This document is not intended to serve as a standard of care. Rather, the guideline attests to the commitment of the profession to advance evidence-based practice through engaging a knowledge exchange and transfer process to support the movement of research knowledge into practice.

 

Practical Applications

 

  • This guideline is a resource for the delivery of chiropractic care for patients with headache.
  • Spinal manipulation is recommended for the management of patients with migraine or cervicogenic headaches.
  • Multimodal multidisciplinary interventions including massage may benefit patients with migraine.
  • Joint mobilization or deep neck flexor exercises may improve symptoms of cervicogenic headache.
  • Low-load craniocervical mobilization may improve tension-type headaches.

 

Acknowledgements

 

The authors thank the following for input on this guideline: Ron Brady, DC; Grayden Bridge, DC; H James Duncan; Wanda Lee MacPhee, DC; Keith Thomson, DC, ND; Dean Wright, DC; and Peter Waite (Members of the Clinical Practice Guidelines Task Force). The authors thank the following for assistance with the Phase I literature search assessment: Simon Dagenais, DC, PhD; and Thor Eglinton, MSc, RN. The authors thank the following for assistance with the Phase II additional literature search and evidence rating: Seema Bhatt, PhD; Mary-Doug Wright, MLS. The authors thank Karin Sorra, PhD for assistance with literature searches, evidence rating, and editorial support.

 

Funding Sources and Potential Conflicts of Interest

 

Funding was provided by the CCA, Canadian Chiropractic Protective Association, and provincial chiropractic contributions from all provinces except British Columbia. This work was sponsored by The CCA and the Federation. No conflicts of interest were reported for this study.

 

In conclusion, headache is one of the most common reasons people seek medical attention. Although many healthcare professionals can treat headaches, chiropractic care is a well-known alternative treatment option frequently used to treat a variety of health issues, including several types of headaches. According to the article above, evidence suggests that chiropractic care, including spinal adjustments and manual manipulations, can improve headache and migraine. Information referenced from the National Center for Biotechnology Information (NCBI). The scope of our information is limited to chiropractic as well as to spinal injuries and conditions. To discuss the subject matter, please feel free to ask Dr. Jimenez or contact us at 915-850-0900 .

 

Curated by Dr. Alex Jimenez

 

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Additional Topics: Back Pain

 

According to statistics, approximately 80% of people will experience symptoms of back pain at least once throughout their lifetimes. Back pain is a common complaint which can result due to a variety of injuries and/or conditions. Often times, the natural degeneration of the spine with age can cause back pain. Herniated discs occur when the soft, gel-like center of an intervertebral disc pushes through a tear in its surrounding, outer ring of cartilage, compressing and irritating the nerve roots. Disc herniations most commonly occur along the lower back, or lumbar spine, but they may also occur along the cervical spine, or neck. The impingement of the nerves found in the low back due to injury and/or an aggravated condition can lead to symptoms of sciatica.

 

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EXTRA IMPORTANT TOPIC: Neck Pain Treatment El Paso, TX Chiropractor

 

 

MORE TOPICS: EXTRA EXTRA: El Paso, Tx | Athletes

 

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25. Fernandez-de-Las-Penas C, Alonso-Blanco C, Cuadrado ML, Miangolarra JC, Barriga FJ, Pareja JA. Are manual therapies effective in reducing pain from tension-type headache?: a systematic review. Clin J Pain 2006;22:278-85.
26. Hurwitz EL, Aker PD, Adams AH, Meeker WC, Shekelle PG. Manipulation and mobilization of the cervical spine. A systematic review of the literature. Spine (Phila Pa 1976) 1996;21:1746-59.
27. Lenssinck ML, Damen L, Verhagen AP, Berger MY, Passchier J, Koes BW. The effectiveness of physiotherapy and manipulation in patients with tension-type headache: a systematic review. Pain 2004;112:381-8.
28. Vernon H, McDermaid CS, Hagino C. Systematic review of randomized clinical trials of complementary/alternative ther- apies in the treatment of tension-type and cervicogenic headache. Complement Ther Med 1999;7:142-55.
29. Fernandez-de-Las-Penas C, Alonso-Blanco C, Cuadrado ML, Pareja JA. Spinal manipulative therapy in the management of cervicogenic headache. Headache 2005;45:1260-3.
30. Maltby JK, Harrison DD, Harrison D, Betz J, Ferrantelli JR, Clum GW. Frequency and duration of chiropractic care for headaches, neck and upper back pain. J Vertebr Subluxat Res 2008;2008:1-12.
31. Demirturk F, Akarcali I, Akbayrak T, Cita I, Inan L. Results of two different manual therapy techniques in chronic tension- type headache. Pain Clin 2002;14:121-8.
32. Lemstra M, Stewart B, Olszynski WP. Effectiveness of multidisciplinary intervention in the treatment of migraine: a randomized clinical trial. Headache 2002;42:845-54.
33. Marcus DA, Scharff L, Mercer S, Turk DC. Nonpharmaco- logical treatment for migraine: incremental utility of physical therapy with relaxation and thermal biofeedback. Cephalalgia 1998;18:266-72.
34. Narin SO, Pinar L, Erbas D, Ozturk V, Idiman F. The effects of exercise and exercise-related changes in blood nitric oxide level on migraine headache. Clin Rehabil 2003;17:624-30.
35. Torelli P, Jensen R, Olesen J. Physiotherapy for tension-type headache: a controlled study. Cephalalgia 2004;24:29-36.
36. van Ettekoven H, Lucas C. Efficacy of physiotherapy
including a craniocervical training programme for tension- type headache; a randomized clinical trial. Cephalalgia 2006; 26:983-91.
37. Vavrek D, Haas M, Peterson D. Physical examination and self-reported pain outcomes from a randomized trial on chronic cervicogenic headache. J Manipulative Physiol Ther 2010;33:338-48.
38. Haas M, Aickin M, Vavrek D. A preliminary path analysis of expectancy and patient-provider encounter in an open-label randomized controlled trial of spinal manipulation for cervicogenic headache. J Manipulative Physiol Ther 2010; 33:5-13.
39. Toro-Velasco C, Arroyo-Morales M, Fernández-de-Las- Peñas C, Cleland JA, Barrero-Hernández FJ. Short-term effects of manual therapy on heart rate variability, mood state, and pressure pain sensitivity in patients with chronic tension-type headache: a pilot study. J Manipulative Physiol Ther 2009;32:527-35.
40. Allais G, De Lorenzo C, Quirico PE, et al. Non-pharmaco- logical approaches to chronic headaches: transcutaneous electrical nerve stimulation, lasertherapy and acupuncture in transformed migraine treatment. Neurol Sci 2003;24(Suppl 2): S138-42.
41. Nilsson N. A randomized controlled trial of the effect of spinal manipulation in the treatment of cervicogenic head- ache. J Manipulative Physiol Ther 1995;18:435-40.
42. Annal N, Soundappan SV, Palaniappan KMC, Chadrasekar S. Introduction of transcutaneous, low-voltage, non-pulsatile direct current (DC) therapy for migraine and chronic headaches. A comparison with transcutaneous electrical nerve stimulation (TENS). Headache Q 1992;3:434-7.
43. Nilsson N, Christensen HW, Hartvigsen J. Lasting changes in passive range motion after spinal manipulation: a randomized, blind, controlled trial. J Manipulative Physiol Ther 1996;19: 165-8.
44. Anderson RE, Seniscal C. A comparison of selected osteopathic treatment and relaxation for tension-type head- aches. Headache 2006;46:1273-80.
45. Ouseley BR, Parkin-Smith GF. Possible effects of chiropractic spinal manipulation and mobilization in the treatment of chronic tension-type headache: a pilot study. Eur J Chiropr 2002;50:3-13.
46. Fernandez-de-las-Penas C, Fernandez-Carnero J, Plaza Fernandez A, Lomas-Vega R, Miangolarra-Page JC. Dorsal manipulation in whiplash injury treatment: a randomized controlled trial. J Whiplash Related Disorders 2004;3:55-72.
47. Parker GB, Pryor DS, Tupling H. Why does migraine improve during a clinical trial? Further results from a trial of cervical manipulation for migraine. Aust N Z J Med 1980; 10:192-8.
48. Parker GB, Tupling H, Pryor DS. A controlled trial of cervical manipulation of migraine. Aust N Z J Med 1978;8:589-93.
49. Foster KA, Liskin J, Cen S, et al. The Trager approach in the treatment of chronic headache: a pilot study. Altern Ther Health Med 2004;10:40-6.
50. Haas M, Groupp E, Aickin M, et al. Dose response for chiropractic care of chronic cervicogenic headache and associated neck pain: a randomized pilot study. J Manipula- tive Physiol Ther 2004;27:547-53.
51. Sjogren T, Nissinen KJ, Jarvenpaa SK, Ojanen MT, Vanharanta H, Malkia EA. Effects of a workplace physical exercise intervention on the intensity of headache and neck and shoulder symptoms and upper extremity muscular strength of office workers: a cluster randomized controlled cross-over trial. Pain 2005;116:119-28.
52. Hanten WP, Olson SL, Hodson JL, Imler VL, Knab VM, Magee JL. The effectiveness of CV-4 and resting position techniques on subjects with tension-type headaches. J Manual Manipulative Ther 1999;7:64-70.
53. Solomon S, Elkind A, Freitag F, Gallagher RM, Moore K, Swerdlow B, et al. Safety and effectiveness of cranial electrotherapy in the treatment of tension headache. Headache 1989;29:445-50.
54. Hall T, Chan HT, Christensen L, Odenthal B, Wells C, Robinson K. Efficacy of a C1-C2 self-sustained natural apophyseal glide (SNAG) in the management of cervicogenic headache. J Orthop Sports Phys Ther 2007;37:100-7.
55. Solomon S, Guglielmo KM. Treatment of headache by transcutaneous electrical stimulation. Headache 1985;25: 12-5.
56. Hoyt WH, Shaffer F, Bard DA, Benesler ES, Blankenhorn GD, Gray JH, et al. Osteopathic manipulation in the treatment of muscle-contraction headache. J Am Osteopath Assoc 1979;78:322-5.
57. Vernon H, Jansz G, Goldsmith CH, McDermaid C. A randomized, placebo-controlled clinical trial of chiropractic and medical prophylactic treatment of adults with tension-type headache: results from a stopped trial. J Manipulative Physiol Ther 2009;32:344-51.
58. Mongini F, Ciccone G, Rota E, Ferrero L, Ugolini A, Evangelista A, et al. Effectiveness of an educational and physical programme in reducing headache, neck and shoulder pain: a workplace controlled trial. Cephalalgia 2008;28: 541-52.
59. Fernandez-de-las-Penas C, Alonso-Blanco C, San-Roman J, Miangolarra-Page JC. Methodological quality of randomized controlled trials of spinal manipulation and mobilization in tension-type headache, migraine, and cervicogenic headache. J Orthop Sports Phys Ther 2006;36:160-9.
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Migraine Headache Pain Chiropractic Therapy in El Paso, TX

Migraine Headache Pain Chiropractic Therapy in El Paso, TX

Migraine headaches have been considered to be one of the most frustrating ailments when compared to other common health issues. Generally triggered by stress, the symptoms of migraines, including the debilitating head pain, sensitivity to light and sound as well as the nausea, can tremendously affect a migraineur’s quality of life. However, research studies have found that chiropractic care can help reduce the frequency and the severity of your migraine pain. Many healthcare professionals have demonstrated that a spinal misalignment, or subluxation, may be the source of migraine headache pain. The purpose of the article below is to demonstrate the outcome measures of chiropractic spinal manipulative therapy for migraine.

 

Chiropractic Spinal Manipulative Therapy for Migraine: a Three‐Armed, Single‐Blinded, Placebo, Randomized Controlled Trial

 

Abstract

 

  • Background and purpose: To investigate the efficacy of chiropractic spinal manipulative therapy (CSMT) for migraineurs.
  • Methods: This was a prospective three‐armed, single‐blinded, placebo, randomized controlled trial (RCT) of 17 months duration including 104 migraineurs with at least one migraine attack per month. The RCT was conducted at Akershus University Hospital, Oslo, Norway. Active treatment consisted of CSMT, whereas placebo was a sham push manoeuvre of the lateral edge of the scapula and/or the gluteal region. The control group continued their usual pharmacological management. The RCT consisted of a 1‐month run‐in, 3 months intervention and outcome measures at the end of the intervention and at 3, 6 and 12 months follow‐up. The primary end‐point was the number of migraine days per month, whereas secondary end‐points were migraine duration, migraine intensity and headache index, and medicine consumption.
  • Results: Migraine days were significantly reduced within all three groups from baseline to post‐treatment (P < 0.001). The effect continued in the CSMT and placebo group at all follow‐up time points, whereas the control group returned to baseline. The reduction in migraine days was not significantly different between the groups (P > 0.025 for interaction). Migraine duration and headache index were reduced significantly more in the CSMT than the control group towards the end of follow‐up (P = 0.02 and P = 0.04 for interaction, respectively). Adverse events were few, mild and transient. Blinding was strongly sustained throughout the RCT.
  • Conclusions: It is possible to conduct a manual‐therapy RCT with concealed placebo. The effect of CSMT observed in our study is probably due to a placebo response.
  • Keywords: chiropractic, headache, migraine, randomized controlled trial, spinal manipulative therapy

 

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Dr. Alex Jimenez’s Insight

Neck pain and headaches are the third most common reason people seek chiropractic care. Many research studies have demonstrated that chiropractic spinal manipulative therapy is a safe and effective alternative treatment option for migraines. Chiropractic care can carefully correct any spinal misalignment, or subluxation, found along the length of the spine, which has been shown to be a source for migraine headaches. In addition, spinal adjustments and manual manipulations can help reduce stress and muscle tension by decreasing the amount of pressure being placed against the complex structures of the spine as a result of a spinal misalignment, or subluxation. By realigning the spine as well as reducing stress and muscle tension, chiropractic care can improve migraine symptoms and decrease their frequency.

 

Introduction

 

The socio‐economic costs of migraine are enormous due to its high prevalence and disability during attacks [1, 2, 3]. Acute pharmacological treatment is usually the first treatment option for migraine in adults. Migraineurs with frequent attacks, insufficient effect and/or contraindication to acute medication are potential candidates for prophylactic treatment. Migraine prophylactic treatment is often pharmacological, but manual therapy is not unusual, especially if pharmacological treatment fails or if the patient wishes to avoid medicine [4]. Research has suggested that spinal manipulative therapy may stimulate neural inhibitory systems at different spinal cord levels because it might activate various central descending inhibitory pathways [5, 6, 7, 8, 9, 10].

 

Pharmacological randomized controlled trials (RCTs) are usually double‐blinded, but this is not possible in manual‐therapy RCTs, as the interventional therapist cannot be blinded. At present there is no consensus on a sham procedure in manual‐therapy RCTs that mimics placebo in pharmacological RCTs [11]. Lack of a proper sham procedure is a major limitation in all previous manual‐therapy RCTs [12, 13]. Recently, we developed a sham chiropractic spinal manipulative therapy (CSMT) procedure, where participants with migraine were unable to distinguish between real and sham CSMT evaluated after each of 12 individual interventions over a 3‐month period [14].

 

The first objective of this study was to conduct a manual‐therapy three‐armed, single‐blinded, placebo RCT for migraineurs with a methodological standard similar to that of pharmacological RCTs.

 

The second objective was to assess the efficacy of CSMT versus sham manipulation (placebo) and CSMT versus controls, i.e. participants who continued their usual pharmacological management.

 

Methods

 

Study Design

 

The study was a three‐armed, single‐blinded, placebo RCT over 17 months. The RCT consisted of a 1‐month baseline, 12 treatment sessions over 3 months with follow‐up measures at the end of intervention, 3, 6 and 12 months later.

 

Participants were, before baseline, randomized equally into three groups: CSMT, placebo (sham manipulation) and control (continued their usual pharmacological management).

 

The design of the study conformed to the recommendations of the International Headache Society (IHS) and CONSORT (Appendix S1) [1, 15, 16]. The Norwegian Regional Committee for Medical Research Ethics and the Norwegian Social Science Data Services approved the project. The RCT was registered at ClinicalTrials.gov (ID no: NCT01741714). The full trial protocol has been published previously [17].

 

Participants

 

Participants were recruited from January to September 2013 primarily through the Department of Neurology, Akershus University Hospital. Some participants were also recruited through General Practitioners from Akershus and Oslo Counties or media advertisement. All participants received posted information about the project followed by a telephone interview.

 

Eligible participants were migraineurs of 18–70 years old with at least one migraine attack per month and were allowed to have concomitant tension‐type headache but no other primary headaches. All participants were diagnosed by a chiropractor with experience in headache diagnostics during the interview and according to the International Classification of Headache Disorders‐II (ICHD‐II) 2. A neurologist had diagnosed all migraineurs from Akershus University Hospital.

 

Exclusion criteria were contraindication to spinal manipulative therapy, spinal radiculopathy, pregnancy, depression and CSMT within the previous 12 months. Participants who received manual therapy [18], changed their prophylactic migraine medicine or became pregnant during the RCT were informed that they would be withdrawn from the study at that time and regarded as drop‐outs. Participants were allowed to continue and change acute migraine medication throughout the study period.

 

Eligible participants were invited to an interview and physical assessment including meticulous spinal column investigation by a chiropractor (A.C.). Participants randomized to the CSMT or the placebo group had a full spine radiographic examination.

 

Randomization and Masking

 

After written consent was obtained, participants were equally randomized into one of the three study arms by drawing one single lot. Numbered sealed lots with the three study arms were each subdivided into four subgroups by age and gender, i.e. 18–39 or 40–70 years, and men or women.

 

After each treatment session, the participants in the CSMT and the placebo group completed a questionnaire on whether they believed CSMT treatment was received, and how certain they were that active treatment was received on a 0–10 numeric rating scale, where 10 represented absolute certainty [14].

 

Both the block randomization and the blinding questionnaire were exclusively administered by a single external party.

 

Interventions

 

The CSMT group received spinal manipulative therapy using the Gonstead method, a specific contact, high‐velocity, low‐amplitude, short‐lever spinal with no post‐adjustment recoil that was directed to spinal biomechanical dysfunction (full spine approach) as diagnosed by standard chiropractic tests at each individual treatment session [19].

 

The placebo group received sham manipulation, a broad non‐specific contact, low‐velocity, low‐amplitude sham push manoeuvre in a non‐intentional and non‐therapeutic directional line of the lateral edge of the scapula and/or the gluteal region [14]. All of the non‐therapeutic contacts were performed outside the spinal column with adequate joint slack and without soft tissue pre‐tension so that no joint cavitations occurred. The sham manipulation alternatives were pre‐set and equally interchanged among the placebo participants according to protocol during the 12‐week treatment period to strengthen the study validity. The placebo procedure is described in detail in the available trial protocol [17].

 

Each intervention session lasted for 15 min and both groups underwent the same structural and motion assessments prior to and after each intervention. No other intervention or advice was given to participants during the trial period. Both groups received interventions at Akershus University Hospital by a single experienced chiropractor (A.C.).

 

The control group continued their usual pharmacological management without receiving manual intervention by the clinical investigator.

 

Outcomes

 

The participants filled in a validated diagnostic headache diary throughout the study and returned them on a monthly basis [20]. In the case of unreturned diaries or missing data, the participants were contacted by phone to secure compliance.

 

The primary end‐point was number of migraine days per month (30 days/month). At least 25% reduction of migraine days from baseline to end of intervention, with the same level maintained at 3, 6 and 12 months follow‐up was expected in the CSMT group.

 

Secondary end‐points were migraine duration, migraine intensity and headache index (HI), and medicine consumption. At least 25% reduction in duration, intensity and HI, and at least 50% reduction in medicine consumption were expected from baseline to end of intervention, with the same level maintained at 3, 6 and 12 months follow‐up in the CSMT group.

 

No change was expected for primary and secondary end‐point in the placebo and the control group.

 

A migraine day was defined as a day on which migraine with aura, migraine without aura or probable migraine occurred. Migraine attacks lasting for >24 h were calculated as one attack unless pain‐free intervals of ≥48 h had occurred [21]. If a patient fell asleep during a migraine attack and woke up without a migraine, in accordance with the ICHD‐III β, the duration of the attack was recorded as persisting until the time of awakening [22]. The minimum duration of a migraine attack was 4 h unless a triptan or drug containing ergotamine was used, in which case we specified no minimum duration. HI was calculated as mean migraine days per month (30 days) × mean migraine duration (h/day) × mean intensity (0–10 numeric rating scale).

 

The primary and secondary end‐points were chosen based on the Task Force of the IHS Clinical Trial Subcommittee’s clinical trial guidelines [1, 15]. Based on previous reviews on migraine, a 25% reduction was considered to be a conservative estimate [12, 13].

 

The outcome analyses were calculated during the 30 days after the last intervention session and 30 days after the follow‐up time points, i.e. 3, 6 and 12 months, respectively.

 

All adverse events (AEs) were recorded after each intervention in accordance with the recommendations of CONSORT and the IHS Task Force on AEs in migraine trials [16, 23].

 

Statistical Analysis

 

We based the power calculation on a recent study of topiramate in migraineurs [24]. We hypothesized the average difference in reduction of number of migraine days per month between the active and the placebo, and between the active and the control groups of 2.5 days, with SD of 2.5 for reduction in each group. As primary analysis includes two group comparisons, the significance level was set at 0.025. For the power of 80%, a sample size of 20 patients was required in each group to detect a significant difference in reduction of 2.5 days.

 

Patient characteristics at baseline were presented as means and SD or frequencies and percentages in each group and compared by independent samples t‐test and χ 2 test.

 

Time profiles of all end‐points were compared between the groups. Due to repeated measurements for each patient, linear mixed models accounting for the intra‐individual variations were estimated for all end‐points. Fixed effects for (non‐linear) time, group allocation and interaction between the two were included. Random effects for patients and slopes were entered into the model. As the residuals were skewed, the bootstrap inference based on 1000 cluster samples was used. Pairwise comparisons were performed by deriving individual time point contrasts within each group at each time point with the corresponding P‐values and 95% confidence intervals. Medicine consumption within groups was reported by mean doses with SD, and groups were compared by an independent samples median test. A dose was defined as a single administration of a triptan or ergotamine; paracetamol 1000 mg ± codeine; non‐steroidal anti‐inflammatory drugs (tolfenamic acid, 200 mg; diclofenac, 50 mg; aspirin, 1000 mg; ibuprofen, 600 mg; naproxen, 500 mg); and morphinomimetics (tramadol, 50 mg). None of the patients changed study arm and none of the drop‐outs filled in headache diaries after withdrawal from the study. Hence, only per protocol analysis was relevant.

 

The analyses were blinded to treatment allocation and conducted in SPSS v22 (IBM Corporation, Armonk, NY, USA) and STATA v14 (JSB) (StataCorp LP, College Station, TX, USA). A significance level of 0.025 was applied for the primary end‐point, whereas elsewhere a level of 0.05 was used.

 

Ethics

 

Good clinical practice guidelines were followed [25]. Oral and written information about the project was provided in advance of inclusion and group allocation. Written consent was obtained from all participants. Participants in the placebo and control group were promised CSMT treatment after the RCT, if the active intervention was found to be effective. Insurance was provided through the Norwegian System of Compensation to Patients (Patient Injury Compensation), an independent national body that compensates patients injured by treatments provided by the Norwegian health service. A stopping rule was defined for withdrawing participants from this study in accordance with the recommendations in the CONSORT extension for Better Reporting of Harms [26]. All AEs were monitored during the intervention period and acted on as they occurred according to the recommendations of CONSORT and the IHS Task Force on AEs in migraine trials [16, 23]. In case of severe AE, the participant would be withdrawn from the study and referred to the General Practitioner or hospital emergency department depending on the event. The investigator (A.C.) was available by mobile phone at any time throughout the study treatment period.

 

Results

 

Figure ​1 shows a flow chart of the 104 migraineurs included in the study. Baseline and demographic characteristics were similar across the three groups (Table 1).

 

Figure 1 Study Flow Chart

Figure 1: Study flow chart.

 

Table 1 Baseline Demographic and Clinical Characteristics

 

Outcome Measures

 

The results on all end‐points are presented in Fig. ​2a–d and Tables 2, 3, 4.

 

Figure 2

Figure 2: (a) Headache days; (b) headache duration; (c) headache intensity; (d) headache index. Time profiles in primary and secondary end‐points, means and error bars represent 95% confidence intervals. BL, baseline; control, control group (×); CSMT, chiropractic spinal manipulative therapy (●); placebo, sham manipulation (□); PT, post‐treatment; 3 m, 3‐month follow‐up; 6 m, 6‐month follow‐up; 12 m, 12‐month follow‐up; VAS, visual analogue scale.

 

Table 2 Regression Coefficients and SE

 

Table 3 Means and SD

 

Table 4 Mean SD Doses of Medications

 

Primary end‐point. Migraine days were significantly reduced within all groups from baseline to post‐treatment (P < 0.001). The effect continued in the CSMT and the placebo groups at 3, 6 and 12 months follow‐up, whereas migraine days reverted to baseline level in the control group (Fig. ​2a). The linear mixed model showed no overall significant differences in change in migraine days between the CSMT and the placebo groups (P = 0.04) or between the CSMT and the control group (P = 0.06; Table 2). However, the pairwise comparisons at individual time points showed significant differences between the CSMT and the control group at all time points starting at post‐treatment (Table 3).

 

Secondary end‐points. There was a significant reduction from baseline to post‐treatment in migraine duration, intensity and HI in the CSMT (P = 0.003, P = 0.002 and P < 0.001, respectively) and the placebo (P < 0.001, P = 0.001 and P < 0.001, respectively) groups, and the effect continued at 3, 6 and 12 months follow‐up.

 

The only significant differences between the CSMT and control groups were change in migraine duration (P = 0.02) and in HI (P = 0.04; Table 2).

 

At 12 months follow‐up, change in consumption of paracetamol was significantly lower in the CSMT group as compared with the placebo (P = 0.04) and control (P = 0.03) groups (Table 4).

 

Blinding. After each of the 12 intervention sessions, >80% of the participants believed they had received CSMT regardless of group allocation. The odds ratio for believing that CSMT treatment was received was >10 at all treatment sessions in both groups (all P < 0.001).

 

Adverse effects. A total of 703 of the potential 770 intervention sessions were assessed for AEs (355 in the CSMT group and 348 in the placebo group). Reasons for missed AE assessment were drop‐out or missed intervention sessions. AEs were significantly more frequent in the CSMT than the placebo intervention sessions (83/355 vs. 32/348; P < 0.001). Local tenderness was the most common AE reported by 11.3% (95% CI, 8.4–15.0) in the CSMT group and 6.9% (95% CI, 4.7–10.1) in the placebo group, whereas tiredness on the intervention day and neck pain were reported by 8.5% and 2.0% (95% CI, 6.0–11.8 and 1.0–4.0), and 1.4% and 0.3% (95% CI, 0.6–3.3 and 0.1–1.9), respectively. All other AEs (lower back pain, face numbness, nausea, provoked migraine attack and fatigue in arms) were rare (<1%). No severe or serious AEs were reported.

 

Discussion

 

To our knowledge, this is the first manual‐therapy RCT with a documented successful blinding. Our three‐armed, single‐blinded, placebo RCT evaluated the efficacy of CSMT in the treatment of migraine versus placebo (sham chiropractic) and control (usual pharmacological treatment). The results showed that migraine days were significantly reduced within all three groups from baseline to post‐treatment. The effect continued in the CSMT and placebo groups at all follow‐up time points, whereas the control group returned to baseline. AEs were mild and transient, which is in accordance with previous studies.

 

The study design adhered to the recommendations for pharmacological RCTs as given by the IHS and CONSORT [1, 15, 16]. Manual‐therapy RCTs have three major obstacles as compared with pharmacological RCTs. Firstly, it is impossible to blind the investigator in relation to the applied treatment. Secondly, consensus on an inert placebo treatment is lacking [11]. Thirdly, previous attempts to include a placebo group have omitted validating the blinding, thus, it remains unknown whether active and placebo treatment were concealed [27]. Due to these challenges we decided to conduct a three‐armed, single‐blinded RCT, which also included a control group that continued usual pharmacological treatment in order to obtain an indication of the magnitude of the placebo response.

 

It has been suggested that, in pharmacological double‐blind placebo RCTs, only 50% will believe that they receive active treatment in each group, if the blinding is perfect. However, this may not be true in manual‐therapy RCTs, because the active and placebo physical stimulus might be more convincing than a tablet [28]. A single investigator reduces inter‐investigator variability by providing similar information to all participants and it is generally recommended that the placebo intervention should resemble the active treatment in terms of procedure, treatment frequency and time spent with the investigator to allow for similar expectations in both groups [28]. The importance of our successful blinding is emphasized by the fact that all previous manual‐therapy RCTs on headache lack placebo. Thus, we believe that our results discussed below are valid at the same level as a pharmacological RCT [14].

 

Prospective data are more reliable than retrospective data in terms of recall bias; however, non‐compliance can be a challenge, especially at the end of the study. We believe the frequent contact between participants and the investigator, including monthly contact in the follow‐up period, probably maintained high compliance throughout our study.

 

Although our study sample ended with 104 participants in the three groups, the power calculation assumption and the high completion rate support the data achieved being valid for the investigated population. The Gonstead method is used by 59% of chiropractors [19] and, thus, the results are generalizable for the profession. Diagnostic certainty is one of our major strengths as nearly all of the participants had been diagnosed by a neurologist according to the ICHD‐II [2]. In contrast to previous chiropractic migraine RCTs that recruited participants through media such as newspapers and radio advertisement [12], the majority of our participants were recruited from the Department of Neurology, Akershus University Hospital, indicating that the migraineurs may have more frequent/severe attacks that are difficult to treat than the general population, as they were referred by their General Practitioner and/or practicing neurologist. Thus, our study is representative of primarily the tertiary clinic population, and the outcome might have been different if participants had been recruited from the general population. The percentage of neck pain has been found to be high in patients with migraine [29] and, thus, the high percentage of non‐radicular spinal pain in our study might be a confounder for which effect was seen on migraine days.

 

Three pragmatic chiropractic manual‐therapy RCTs using the diversified technique have previously been conducted for migraineurs [12, 30, 31, 32]. An Australian RCT showed within‐group reduction in migraine frequency, duration and intensity of 40%, 43% and 36%, respectively, at 2 months follow‐up [30]. An American study found migraine frequency and intensity to reduce within‐group by 33% and 42%, respectively, at 1 month follow‐up [31]. Another Australian study, which was the only RCT to include a control group, i.e. detuned ultrasound, found a within‐group reduction of migraine frequency and duration of 35% and 40%, respectively, at 2 months follow‐up in the CSMT group, as compared with a within‐group reduction of 17% and 20% in the control group, respectively [32]. The reduction in migraine days was similar to ours (40%) in the CSMT group from baseline to 3 months follow‐up, whereas migraine duration and intensity were less reduced at 3 months follow‐up, i.e. 21% and 14%, respectively. Long‐term follow‐up comparisons are impossible as neither of the previous studies included a sufficient follow‐up period. Our study design including strong internal validity allows us to interpret the effect seen as a placebo response.

 

Our RCT had fewer AEs as compared with previous manual‐therapy studies, but of similar transient and mild character [33, 34, 35, 36, 37, 38, 39]. However, it was not sufficiently powered to detect uncommon serious AEs. In comparison, AEs in pharmacological migraine prophylactic placebo RCTs are common including non‐mild and non‐transient AEs [40, 41].

 

Conclusion

 

The blinding was strongly sustained throughout the RCT, AEs were few and mild, and the effect in the CSMT and placebo group was probably a placebo response. Because some migraineurs do not tolerate medication because of AEs or co‐morbid disorders, CSMT might be considered in situations where other therapeutic options are ineffective or poorly tolerated.

 

Disclosure of Conflicts of Interest

 

All authors have completed the International Committee of Medical Journal Editors uniform disclosure form and declare no financial or other conflicts of interest.

 

Supporting Information

 

Ncbi.nlm.nih.gov/pmc/articles/PMC5214068/#ene13166-tbl-0001

 

Acknowledgements

 

The authors want to express their sincere gratitude to Akershus University Hospital, which kindly provided the research facilities, and Chiropractor Clinic 1, Oslo, Norway, which performed all x‐ray assessments. This study was supported by grants from Extrastiftelsen, the Norwegian Chiropractic Association, Akershus University Hospital and University of Oslo in Norway.

 

In conclusion, the debilitating symptoms of migraines, including the severe head pain and the sensitivity to light and sound as well as the nausea, can affect an individual’s quality of life, fortunately, chiropractic care has been demonstrated to be a safe and effective treatment option for migraine headache pain. Furthermore, the article above demonstrated that migraineurs experienced reduced symptoms and migraine days as a result of chiropractic care. Information referenced from the National Center for Biotechnology Information (NCBI). The scope of our information is limited to chiropractic as well as to spinal injuries and conditions. To discuss the subject matter, please feel free to ask Dr. Jimenez or contact us at 915-850-0900 .

 

Curated by Dr. Alex Jimenez

 

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Additional Topics: Back Pain

 

According to statistics, approximately 80% of people will experience symptoms of back pain at least once throughout their lifetimes. Back pain is a common complaint which can result due to a variety of injuries and/or conditions. Often times, the natural degeneration of the spine with age can cause back pain. Herniated discs occur when the soft, gel-like center of an intervertebral disc pushes through a tear in its surrounding, outer ring of cartilage, compressing and irritating the nerve roots. Disc herniations most commonly occur along the lower back, or lumbar spine, but they may also occur along the cervical spine, or neck. The impingement of the nerves found in the low back due to injury and/or an aggravated condition can lead to symptoms of sciatica.

 

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EXTRA IMPORTANT TOPIC: Neck Pain Treatment El Paso, TX Chiropractor

 

 

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References
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2. Headache Classification Subcommittee of the International Headache Society . The International Classification of Headache Disorders: 2nd editionCephalalgia 2004; 24(Suppl. 1): 9–160. [PubMed]
3. Vos T, Flaxman AD, Naghavi M, et al Years lived with disability (YLDs) for 1160 sequelae of 289 diseases and injuries 1990–2010: a systematic analysis for the Global Burden of Disease Study 2010Lancet 2012; 380: 2163–2196. [PubMed]
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7. Vicenzino B, Paungmali A, Buratowski S, Wright A. Specific manipulative therapy treatment for chronic lateral epicondylalgia produces uniquely characteristic hypoalgesiaMan Ther 2001; 6: 205–212.[PubMed]
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10. De Camargo VM, Alburquerque‐Sendin F, Berzin F, Stefanelli VC, de Souza DP, Fernandez‐de‐las‐Penas C. Immediate effects on electromyographic activity and pressure pain thresholds after a cervical manipulation in mechanical neck pain: a randomized controlled trialJ Manipulative Physiol Ther 2011; 34: 211–220. [PubMed]
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12. Chaibi A, Tuchin PJ, Russell MB. Manual therapies for migraine: a systematic reviewJ Headache Pain2011; 12: 127–133. [PubMed]
13. Chaibi A, Russell MB. Manual therapies for primary chronic headaches: a systematic review of randomized controlled trialsJ Headache Pain 2014; 15: 67. [PubMed]
14. Chaibi A, Saltyte Benth J, Bjorn Russell M. Validation of placebo in a manual therapy randomized controlled trialSci Rep 2015; 5: 11774. [PubMed]
15. Silberstein S, Tfelt‐Hansen P, Dodick DW, et al Task force of the International Headache Society Clinical Trial Subcommittee. Guidelines for controlled trials of prophylactic treatment of chronic migraine in adultsCephalalgia 2008; 28: 484–495. [PubMed]
16. Moher D, Hopewell S, Schulz KF, et al CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trialsBMJ 2010; 340: c869. [PubMed]
17. Chaibi A, Saltyte Benth J, Tuchin PJ, Russell MB. Chiropractic spinal manipulative therapy for migraine: a study protocol of a single‐blinded placebo‐controlled randomised clinical trialBMJ Open2015; 5: e008095. [PMC free article] [PubMed]
18. French HP, Brennan A, White B, Cusack T. Manual therapy for osteoarthritis of the hip or knee ‐ a systematic reviewMan Ther 2011; 16: 109–117. [PubMed]
19. Cooperstein R. Gonstead chiropractic technique (GCT)J Chiropr Med 2003; 2: 16–24. [PubMed]
20. Russell MB, Rasmussen BK, Brennum J, Iversen HK, Jensen RA, Olesen J. Presentation of a new instrument: the diagnostic headache diaryCephalalgia 1992; 12: 369–374. [PubMed]
21. Tfelt‐Hansen P, Pascual J, Ramadan N, et al Guidelines for controlled trials of drugs in migraine: third edition. A guide for investigatorsCephalalgia 2012; 32: 6–38. [PubMed]
22. Headache Classification Subcommittee of the International Headache Society . The International Classification of Headache Disorders, 3rd edition (beta version)Cephalalgia 2013; 33: 629–808.[PubMed]
23. Tfelt‐Hansen P, Bjarnason NH, Dahlof C, Derry S, Loder E, Massiou H. Evaluation and registration of adverse events in clinical drug trials in migraineCephalalgia 2008; 28: 683–688. [PubMed]
24. Silberstein SD, Neto W, Schmitt J, Jacobs D. Topiramate in migraine prevention: results of a large controlled trialArch Neurol 2004; 61: 490–495. [PubMed]
25. Dixon JR. The International Conference on Harmonization Good Clinical Practice guidelineQual Assur 1998; 6: 65–74. [PubMed]
26. Ioannidis JP, Evans SJ, Gotzsche PC, et al Better reporting of harms in randomized trials: an extension of the CONSORT statementAnn Intern Med 2004; 141: 781–788. [PubMed]
27. Scholten‐Peeters GG, Thoomes E, Konings S, et al Is manipulative therapy more effective than sham manipulation in adults: a systematic review and meta‐analysisChiropr Man Therap 2013; 21: 34. [PMC free article] [PubMed]
28. Meissner K, Fassler M, Rucker G, et al Differential effectiveness of placebo treatments: a systematic review of migraine prophylaxisJAMA Intern Med 2013; 173: 10. [PubMed]
29. Ashina S, Bendtsen L, Lyngberg AC, Lipton RB, Hajiyeva N, Jensen R. Prevalence of neck pain in migraine and tension‐type headache: a population studyCephalalgia 2015; 35: 211–219. [PubMed]
30. Parker GB, Tupling H, Pryor DS. A controlled trial of cervical manipulation of migraineAust NZ J Med 1978; 8: 589–593. [PubMed]
31. Nelson CF, Bronfort G, Evans R, Boline P, Goldsmith C, Anderson AV. The efficacy of spinal manipulation, amitriptyline and the combination of both therapies for the prophylaxis of migraine headacheJ Manipulative Physiol Ther 1998; 21: 511–519. [PubMed]
32. Tuchin PJ, Pollard H, Bonello R. A randomized controlled trial of chiropractic spinal manipulative therapy for migraineJ Manipulative Physiol Ther 2000; 23: 91–95. [PubMed]
33. Cagnie B, Vinck E, Beernaert A, Cambier D. How common are side effects of spinal manipulation and can these side effects be predicted? Man Ther 2004; 9: 151–156. [PubMed]
34. Hurwitz EL, Morgenstern H, Vassilaki M, Chiang LM. Adverse reactions to chiropractic treatment and their effects on satisfaction and clinical outcomes among patients enrolled in the UCLA Neck Pain StudyJ Manipulative Physiol Ther 2004; 27: 16–25. [PubMed]
35. Thiel HW, Bolton JE, Docherty S, Portlock JC. Safety of chiropractic manipulation of the cervical spine: a prospective national surveySpine (Phila Pa 1976) 2007; 32: 2375–2378. [PubMed]
36. Rubinstein SM, Leboeuf‐Yde C, Knol DL, de Koekkoek TE, Pfeifle CE, van Tulder MW. The benefits outweigh the risks for patients undergoing chiropractic care for neck pain: a prospective, multicenter, cohort studyJ Manipulative Physiol Ther 2007; 30: 408–418. [PubMed]
37. Eriksen K, Rochester RP, Hurwitz EL. Symptomatic reactions, clinical outcomes and patient satisfaction associated with upper cervical chiropractic care: a prospective, multicenter, cohort studyBMC Musculoskelet Disord 2011; 12: 219. [PubMed]
38. Walker BF, Hebert JJ, Stomski NJ, et al Outcomes of usual chiropractic. The OUCH randomized controlled trial of adverse eventsSpine 2013; 38: 1723–1729. [PubMed]
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41. Ferrari MD, Roon KI, Lipton RB, Goadsby PJ. Oral triptans (serotonin 5‐HT(1B/1D) agonists) in acute migraine treatment: a meta‐analysis of 53 trialsLancet 2001; 358: 1668–1675. [PubMed]
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Psychology, Headache, Back Pain, Chronic Pain and Chiropractic in El Paso, TX

Psychology, Headache, Back Pain, Chronic Pain and Chiropractic in El Paso, TX

Everyone experiences pain from time to time. Pain is a physical feeling of discomfort caused by injury or illness. When you pull a muscle or cut your finger, for instance, a signal is sent through the nerve roots to the brain, signaling you that something is wrong in the body. Pain may be different for everyone and there are several ways of feeling and describing pain. After an injury or illness heals, the pain will subside, however, what happens if the pain continues even after you’ve healed?

 

Chronic pain is often defined as any pain which lasts more than 12 weeks. Chronic pain can range from mild to severe and it can be the result of previous injury or surgery, migraine and headache, arthritis, nerve damage, infection and fibromyalgia. Chronic pain can affect an individual’s emotional and mental disposition, making it more difficult to relieve the symptoms. Research studies have demonstrated that psychological interventions can assist the chronic pain recovery process. Several healthcare professionals, like a doctor of chiropractic, can provide chiropractic care together with psychological interventions to help restore the overall health and wellness of their patients. The purpose of the following article is to demonstrate the role of psychological interventions in the management of patients with chronic pain, including headache and back pain.

 

 

The Role of Psychological Interventions in the Management of Patients with Chronic Pain

 

Abstract

 

Chronic pain can be best understood from a biopsychosocial perspective through which pain is viewed as a complex, multifaceted experience emerging from the dynamic interplay of a patient’s physiological state, thoughts, emotions, behaviors, and sociocultural influences. A biopsychosocial perspective focuses on viewing chronic pain as an illness rather than disease, thus recognizing that it is a subjective experience and that treatment approaches are aimed at the management, rather than the cure, of chronic pain. Current psychological approaches to the management of chronic pain include interventions that aim to achieve increased self-management, behavioral change, and cognitive change rather than directly eliminate the locus of pain. Benefits of including psychological treatments in multidisciplinary approaches to the management of chronic pain include, but are not limited to, increased self-management of pain, improved pain-coping resources, reduced pain-related disability, and reduced emotional distress – improvements that are effected via a variety of effective self-regulatory, behavioral, and cognitive techniques. Through implementation of these changes, psychologists can effectively help patients feel more in command of their pain control and enable them to live as normal a life as possible despite pain. Moreover, the skills learned through psychological interventions empower and enable patients to become active participants in the management of their illness and instill valuable skills that patients can employ throughout their lives.

 

Keywords: chronic pain management, psychology, multidisciplinary pain treatment, cognitive behavioral therapy for pain

 

Dr Jimenez White Coat

Dr. Alex Jimenez’s Insight

Chronic pain has previously been determined to affect the psychological health of those with persistent symptoms, ultimately altering their overall mental and emotional disposition. In addition, patients with overlapping conditions, including stress, anxiety and depression, can make treatment a challenge. The role of chiropractic care is to restore as well as maintain and improve the original alignment of the spine through the use of spinal adjustments and manual manipulations. Chiropractic care allows the body to naturally heal itself without the need for drugs/medications and surgical interventions, although these can be referred to by a chiropractor if needed. However, chiropractic care focuses on the body as a whole, rather than on a single injury and/or condition and its symptoms. Spinal adjustments and manual manipulations, among other treatment methods and techniques commonly used by a chiropractor, require awareness of the patient’s mental and emotional disposition in order to effectively provide them with overall health and wellness. Patients who visit my clinic with emotional distress from their chronic pain are often more susceptible to experience psychological issues as a result. Therefore, chiropractic care can be a fundamental psychological intervention for chronic pain management, along with those demonstrated below.

 

Introduction

 

Pain is a ubiquitous human experience. It is estimated that approximately 20%–35% of adults experience chronic pain.[1,2] The National Institute of Nursing Research reports that pain affects more Americans than diabetes, heart disease, and cancer combined.[3] Pain has been cited as the primary reason to seek medical care in the United States.[4] Furthermore, pain relievers are the second most commonly prescribed medications in physicians’ offices and emergency rooms.[5] Further solidifying the importance of adequate assessment of pain, the Joint Commission on the Accreditation of Healthcare Organizations issued a mandate requiring that pain be evaluated as the fifth vital sign during medical visits.[6]

 

The International Association for the Study of Pain (IASP) defines pain as “an unpleasant sensory and emotional experience associated with actual or potential tissue damage, or described in terms of such damage”.[7] The IASP’s definition highlights the multidimensional and subjective nature of pain, a complex experience that is unique to each individual. Chronic pain is typically differentiated from acute pain based on its chronicity or persistence, its physiological maintenance mechanisms, and/or its detrimental impact on an individual’s life. Generally, it is accepted that pain that persists beyond the expected period of time for tissue healing following an injury or surgery is considered chronic pain. However, the specific timeframe constituting an expected healing period is variable and often difficult to ascertain. For ease of classification, certain guidelines suggest that pain persisting beyond a 3–6 month time window is considered chronic pain.[7] Nevertheless, classification of pain based solely on duration is a strictly practical and, in some instances, arbitrary criterion. More commonly, additional factors such as etiology, pain intensity, and impact are considered alongside duration when classifying chronic pain. An alternative way to characterize chronic pain has been based on its physiological maintenance mechanism; that is, pain that is thought to emerge as a result of peripheral and central reorganization. Common chronic pain conditions include musculoskeletal disorders, neuropathic pain conditions, headache pain, cancer pain, and visceral pain. More broadly, pain conditions may be primarily nociceptive (producing mechanical or chemical pain), neuropathic (resulting from nerve damage), or central (resulting from dysfunction in the neurons of the central nervous system).[8]

 

Unfortunately, the experience of pain is frequently characterized by undue physical, psychological, social, and financial suffering. Chronic pain has been recognized as the leading cause of long-term disability in the working- age American population.[9] Because chronic pain affects the individual at multiple domains of his/her existence it also constitutes an enormous financial burden to our society. The combined direct and indirect costs of pain have been estimated to range from $125 billion to $215 billion, annually.[10,11] The widespread implications of chronic pain include increased reports of emotional distress (eg, depression, anxiety, and frustration), increased rates of pain-related disability, pain-related alterations in cognition, and reduced quality of life. Thus, chronic pain can be best understood from a biopsychosocial perspective through which pain is viewed as a complex, multifaceted experience emerging from the dynamic interplay of a patient’s physiological state, thoughts, emotions, behaviors, and sociocultural influences.

 

Pain Management

 

Given the widespread prevalence of pain and its multi-dimensional nature, an ideal pain management regimen will be comprehensive, integrative, and interdisciplinary. Current approaches to the management of chronic pain have increasingly transcended the reductionist and strictly surgical, physical, or pharmacological approach to treatment. Current approaches recognize the value of a multidisciplinary treatment framework that targets not only nociceptive aspects of pain but also cognitive-evaluative, and motivational-affective aspects alongside equally unpleasant and impacting sequelae. The interdisciplinary management of chronic pain typically includes multimodal treatments such as combinations of analgesics, physical therapy, behavioral therapy, and psychological therapy. The multimodal approach more adequately and comprehensively addresses pain management at the molecular, behavioral, cognitive-affective, and functional levels. These approaches have been shown to lead to superior and long-lasting subjective and objective outcomes including pain reports, mood, restoration of daily functioning, work status, and medication or health care use; multimodal approaches have also been shown to be more cost-effective than unimodal approaches.[12,13] The focus of this review will be specifically on elucidating the benefits of psychology in the management of chronic pain.

 

Dr. Jimenez performing physical therapy on a patient.

 

Patients will typically initially present to a physician’s office in the pursuit of a cure or treatment for their ailment/acute pain. For many patients, depending on the etiology and pathology of their pain alongside biopsychosocial influences on the pain experience, acute pain will resolve with the passage of time, or following treatments aimed at targeting the presumed cause of pain or its transmission. Nonetheless, some patients will not achieve resolution of their pain despite numerous medical and complementary interventions and will transition from an acute pain state to a state of chronic, intractable pain. For instance, research has demonstrated that approximately 30% of patients presenting to their primary-care physician for complaints related to acute back pain will continue to experience pain and, for many others, severe activity limitations and suffering 12 months later.[14] As pain and its consequences continue to develop and manifest in diverse aspects of life, chronic pain may become primarily a biopsychosocial problem, whereby numerous biopsychosocial aspects may serve to perpetuate and maintain pain, thus continuing to negatively impact the affected individual’s life. It is at this point that the original treatment regimen may diversify to include other therapeutic components, including psychological approaches to pain management.

 

Psychological approaches for the management of chronic pain initially gained popularity in the late 1960s with the emergence of Melzack and Wall’s “gate-control theory of pain”[15] and the subsequent “neuromatrix theory of pain”.[16] Briefly, these theories posit that psychosocial and physiological processes interact to affect perception, transmission, and evaluation of pain, and recognize the influence of these processes as maintenance factors involved in the states of chronic or prolonged pain. Namely, these theories served as integral catalysts for instituting change in the dominant and unimodal approach to the treatment of pain, one heavily dominated by strictly biological perspectives. Clinicians and patients alike gained an increasing recognition and appreciation for the complexity of pain processing and maintenance; consequently, the acceptance of and preference for multidimensional conceptualizations of pain were established. Currently, the biopsychosocial model of pain is, perhaps, the most widely accepted heuristic approach to understanding pain.[17] A biopsychosocial perspective focuses on viewing chronic pain as an illness rather than disease, thus recognizing that it is a subjective experience and that treatment approaches are aimed at the management, rather than the cure, of chronic pain.[17] As the utility of a broader and more comprehensive approach to the management of chronic pain has become evident, psychologically-based interventions have witnessed a remarkable rise in popularity and recognition as adjunct treatments. The types of psychological interventions employed as part of a multidisciplinary pain treatment program vary according to therapist orientation, pain etiology, and patient characteristics. Likewise, research on the effectiveness of psychologically based interventions for chronic pain has shown variable, albeit promising, results on key variables studied. This overview will briefly describe frequently employed psychologically based treatment options and their respective effectiveness on key outcomes.

 

Current psychological approaches to the management of chronic pain include interventions that aim to achieve increased self-management, behavioral change, and cognitive change rather than directly eliminate the locus of pain. As such, they target the frequently overlooked behavioral, emotional, and cognitive components of chronic pain and factors contributing to its maintenance. Informed by the framework offered by Hoffman et al[18] and Kerns et al,[19] the following frequently employed psychologically-based treatment domains are reviewed: psychophysiological techniques, behavioral approaches to treatment, cognitive behavioral therapy, and acceptance-based interventions.

 

Psychophysiological Techniques

 

Biofeedback

 

Biofeedback is a learning technique through which patients learn to interpret feedback (in the form of physiological data) regarding certain physiological functions. For instance, a patient may use biofeedback equipment to learn to recognize areas of tension in their body and subsequently learn to relax those areas to reduce muscular tension. Feedback is provided by a variety of measurement instruments that can yield information about brain electrical activity, blood pressure, blood flow, muscle tone, electrodermal activity, heart rate, and skin temperature, among other physiological functions in a rapid manner. The goal of biofeedback approaches is for the patient to learn how to initiate physiological self-regulatory processes by achieving voluntary control over certain physiological responses to ultimately increase physiological flexibility through greater awareness and specific training. Thus a patient will use specific self-regulatory skills in an attempt to reduce an undesired event (eg, pain) or maladaptive physiological reactions to an undesired event (eg, stress response). Many psychologists are trained in biofeedback techniques and provide these services as part of therapy. Biofeedback has been designated as an efficacious treatment for pain associated with headache and temporomandibular disorders (TMD).[20] A meta-analysis of 55 studies revealed that biofeedback interventions (including various biofeedback modalities) yielded significant improvements with regard to frequency of migraine attacks and perceptions of headache management self-efficacy when compared to control conditions.[21] Studies have provided empirical support for biofeedback for TMD, albeit more robust improvements with regard to pain and pain-related disability have been found for protocols that combine biofeedback with cognitive behavioral skills training, under the assumption that a combined treatment approach more comprehensively addresses the gamut of biopsychosocial problems that may be encountered as a result of TMD.[22]

 

Behavioral Approaches

 

Relaxation Training

 

It is generally accepted that stress is a key factor involved in the exacerbation and maintenance of chronic pain.[16,23] Stress can be predominantly of an environmental, physical, or psychological/emotional basis, though typically these mechanisms are intricately intertwined. The focus of relaxation training is to reduce tension levels (physical and mental) through activation of the parasympathetic nervous system and through attainment of greater awareness of physiological and psychological states, thereby achieving reductions in pain and increasing control over pain. Patients can be taught several relaxation techniques and practice them individually or in conjunction with one another, as well as adjuvant components to other behavioral and cognitive pain management techniques. The following are brief descriptions of relaxation techniques commonly taught by psychologists specializing in the management of chronic pain.

 

Diaphragmatic breathing. Diaphragmatic breathing is a basic relaxation technique whereby patients are instructed to use the muscles of their diaphragm as opposed to the muscles of their chest to engage in deep breathing exercises. Breathing by contracting the diaphragm allows the lungs to expand down (marked by expansion of abdomen during inhalation) and thus increase oxygen intake.[24]

 

Progressive muscle relaxation (PMR). PMR is characterized by engaging in a combination of muscle tension and relaxation exercises of specific muscles or muscle groups throughout the body.[25] The patient is typically instructed to engage in the tension/relaxation exercises in a sequential manner until all areas of the body have been addressed.

 

Autogenic training (AT). AT is a self-regulatory relaxation technique in which a patient repeats a phrase in conjunction with visualization to induce a state of relaxation.[26,27] This method combines passive concentration, visualization, and deep breathing techniques.

 

Visualization/Guided imagery. This technique encourages patients to use all of their senses in imagining a vivid, serene, and safe environment to achieve a sense of relaxation and distraction from their pain and pain-related thoughts and sensations.[27]

 

Collectively, relaxation techniques have generally been found to be beneficial in the management of a variety of types of acute and chronic pain conditions as well as in the management of important pain sequelae (eg, health-related quality of life).[28–31] Relaxation techniques are usually practiced in conjunction with other pain management modalities, and there is considerable overlap in the presumed mechanisms of relaxation and biofeedback, for instance.

 

Operant Behavior Therapy

 

Operant behavior therapy for chronic pain is guided by the original operant conditioning principles proposed by Skinner[32] and refined by Fordyce[33] to be applicable to pain management. The main tenets of the operant conditioning model as it relates to pain hold that pain behavior can eventually evolve into and be maintained as chronic pain manifestations as a result of positive or negative reinforcement of a given pain behavior as well as punishment of more adaptive, non-pain behavior. If reinforcement and the ensuing consequences occur with sufficient frequency, they can serve to condition the behavior, thus increasing the likelihood of repeating the behavior in the future. Therefore, conditioned behaviors occur as a product of learning of the consequences (actual or anticipated) of engaging in the given behavior. An example of a conditioned behavior is continued use of medication – a behavior that results from learning through repeated associations that taking medication is followed by removal of an aversive sensation (pain). Likewise, pain behaviors (eg, verbal expressions of pain, low activity levels) can be become conditioned behaviors that serve to perpetuate chronic pain and its sequelae. Treatments that are guided by operant behavior principles aim to extinguish maladaptive pain behaviors through the same learning principles that these may have been established by. In general, treatment components of operant behavior therapy include graded activation, time contingent medication schedules, and use of reinforcement principles to increase well behaviors and decrease maladaptive pain behaviors.

 

Graded activation. Psychologists can implement graded activity programs for chronic pain patients who have vastly reduced their activity levels (increasing likelihood of physical deconditioning) and subsequently experience high levels of pain upon engaging in activity. Patients are instructed to safely break the cycle of inactivity and deconditioning by engaging in activity in a controlled and time-limited fashion. In this manner, patients can gradually increase the length of time and intensity of activity to improve functioning. Psychologists can oversee progress and provide appropriate reinforcement for compliance, correction of misperceptions or misinterpretations of pain resulting from activity, where appropriate, and problem-solve barriers to adherence. This approach is frequently embedded within cognitive-behavioral pain management treatments.

 

Time-contingent medication schedules. A psychologist can be an important adjunct healthcare provider in overseeing the management of pain medications. In some cases, psychologists have the opportunity for more frequent and in-depth contact with patients than physicians and thus can serve as valuable collaborators of an integrated multidisciplinary treatment approach. Psychologists can institute time-contingent medication schedules to reduce the likelihood of dependence on pain medications for attaining adequate control over pain. Furthermore, psychologists are well equipped to engage patients in important conversations regarding the importance of proper adherence to medications and medical recommendations and problem-solve perceived barriers to safe adherence.

 

Fear-avoidance. The fear-avoidance model of chronic pain is a heuristic most frequently applied in the context of chronic low back pain (LBP).[34] This model draws largely from the operant behavior principles described previously. In essence, the fear-avoidance model posits that when acute pain states are repeatedly misinterpreted as danger signals or signs of serious injury, patients may be at risk of engaging in fear-driven avoidance behaviors and cognitions that further reinforce the belief that pain is a danger signal and perpetuate physical deconditioning. As the cycle continues, avoidance may generalize to broader types of activity and result in hypervigilance of physical sensations characterized by misinformed catastrophic interpretations of physical sensations. Research has shown that a high degree of pain catastrophizing is associated with maintenance of the cycle.[35] Treatments aimed at breaking the fear-avoidance cycle employ systematic graded exposure to feared activities to disconfirm the feared, often catastrophic, consequences of engaging in activities. Graded exposure is typically supplemented with psychoeducation about pain and cognitive restructuring elements that target maladaptive cognitions and expectations about activity and pain. Psychologists are in an excellent position to execute these types of interventions that closely mimic exposure treatments traditionally used in the treatment of some anxiety disorders.

 

Though specific graded exposure treatments have been shown to be effective in the treatment of complex regional pain syndrome type I (CRPS-1)[36] and LBP[37] in single-case designs, a larger-scale randomized controlled trial comparing systematic graded exposure treatment combined with multidisciplinary pain program treatment with multidisciplinary pain program treatment alone and with a wait-list control group found that the two active treatments resulted in significant improvements on outcome measures of pain intensity, fear of movement/injury, pain self-efficacy, depression, and activity level.[38] Results from this trial suggest that both interventions were associated with significant treatment effectiveness such that the graded exposure treatment did not appear to result in additional treatment gains.[38] A cautionary note in the interpretation of these results highlights that the randomized controlled trial (RCT) included a variety of chronic pain conditions that extended beyond LBP and CRPS-1 and did not exclusively include patients with high levels of pain-related fear; the interventions were also delivered in group formats rather than individual formats. Although in-vivo exposure treatments are superior at reducing pain catastrophizing and perceptions of harmfulness of activities, exposure treatments seem to be as effective as graded activity interventions in improving functional disability and chief complaints.[39] Another clinical trial compared the effectiveness of treatment-based classification (TBC) physical therapy alone to TBC augmented with graded activity or graded exposure for patients with acute and sub-acute LBP.[40] Outcomes revealed that there were no differences in 4-week and 6-month outcomes for reduction of disability, pain intensity, pain catastrophizing, and physical impairment among treatment groups, although graded exposure and TBC yielded larger reductions in fear-avoidance beliefs at 6 months.[40] Findings from this clinical trial suggest that enhancing TBC with graded activity or graded exposure does not lead to improved outcomes with regard to measures associated with the development of chronic LBP beyond improvements achieved with TBC alone.[40]

 

Cognitive-Behavioral Approaches

 

Cognitive-behavioral therapy (CBT) interventions for chronic pain utilize psychological principles to effect adaptive changes in the patient’s behaviors, cognitions or evaluations, and emotions. These interventions are generally comprised of basic psychoeducation about pain and the patient’s particular pain syndrome, several behavioral components, coping skills training, problem-solving approaches, and a cognitive restructuring component, though the exact treatment components vary according to the clinician. Behavioral components may include a variety of relaxation skills (as reviewed in the behavioral approaches section), activity pacing instructions/graded activation, behavioral activation strategies, and promotion of resumption of physical activity if there is a significant history of activity avoidance and subsequent deconditioning. The primary aim in coping skills training is to identify current maladaptive coping strategies (eg, catastrophizing, avoidance) that the patient is engaging in alongside their use of adaptive coping strategies (eg, use of positive self-statements, social support). As a cautionary note, the degree to which a strategy is adaptive or maladaptive and the perceived effectiveness of particular coping strategies varies from individual to individual.[41] Throughout treatment, problem-solving techniques are honed to aid patients in their adherence efforts and to help them increase their self-efficacy. Cognitive restructuring entails recognition of current maladaptive cognitions the patient is engaging in, challenging of the identified negative cognitions, and reformulation of thoughts to generate balanced, adaptive alternative thoughts. Through cognitive restructuring exercises, patients become increasingly adept at recognizing how their emotions, cognitions, and interpretations modulate their pain in positive and negative directions. As a result, it is presumed that the patients will attain a greater perception of control over their pain, be better able to manage their behavior and thoughts as they relate to pain, and be able to more adaptively evaluate the meaning they ascribe to their pain. Additional components sometimes included in a CBT intervention include social skills training, communication training, and broader approaches to stress management. Via a pain-oriented CBT intervention, many patients profit from improvements with regard to their emotional and functional well-being, and ultimately their global perceived health-related quality of life.

 

Dr. Alex Jimenez engaging in fitness exercise and physical activity.

 

CBT interventions are delivered within a supportive and empathetic environment that strives to understand the patient’s pain from a biopsychosocial perspective and in an integrated manner. Therapists see their role as “teachers” or “coaches” and the message communicated to patients is that of learning to better manage their pain and improve their daily function and quality of life as opposed to aiming to cure or eradicate the pain. The overarching goal is to increase the patients’ understanding of their pain and their efforts to manage pain and its sequelae in a safe and adaptive manner; therefore, teaching patients to self-monitor their behavior, thoughts, and emotions is an integral component of therapy and a useful strategy to enhance self-efficacy. Additionally, the therapist endeavors to foster an optimistic, realistic, and encouraging environment in which the patient can become increasingly skilled at recognizing and learning from their successes and learning from and improving upon unsuccessful attempts. In this manner, therapists and patients work together to identify patient successes, barriers to adherence, and to develop maintenance and relapse-prevention plans in a constructive, collaborative, and trustworthy atmosphere. An appealing feature of the cognitive behavioral approach is its endorsement of the patient as an active participant of his/her pain rehabilitation or management program.

 

Research has found CBT to be an effective treatment for chronic pain and its sequelae as marked by significant changes in various domains (ie, measures of pain experience, mood/affect, cognitive coping and appraisal, pain behavior and activity level, and social role function) when compared with wait-list control conditions.[42] When compared with other active treatments or control conditions, CBT has resulted in notable improvements, albeit smaller effects (effect size ~ 0.50), with regard to pain experience, cognitive coping and appraisal, and social role function.[42] A more recent meta-analysis of 52 published studies compared behavior therapy (BT) and CBT against treatment as usual control conditions and active control conditions at various time-points.[43] This meta-analysis concluded that their data did not lend support for BT beyond improvements in pain immediately following treatment when compared with treatment as usual control conditions.[43] With regard to CBT, they concluded that CBT has limited positive effects for pain disability, and mood; nonetheless, there are insufficient data available to investigate the specific influence of treatment content on selected outcomes.[43] Overall, it appears that CBT and BT are effective treatment approaches to improve mood; outcomes that remain robust at follow-up data points. However, as highlighted by several reviews and meta-analyses, a critical factor to consider in evaluating the effectiveness of CBT for the management of chronic pain is centered on issues of effective delivery, lack of uniform treatment components, differences in delivery across clinicians and treatment populations, and variability in outcome variables of interest across research trials.[13] Further complicating the interpretation of effectiveness findings are patient characteristics and additional variables that may independently affect treatment outcome.

 

Acceptance-Based Approaches

 

Acceptance-based approaches are frequently identified as third-wave cognitive-behavioral therapies. Acceptance and commitment therapy (ACT) is the most common of the acceptance-based psychotherapies. ACT emphasizes the importance of facilitating the client’s progress toward attaining a more valued and fulfilling life by increasing psychological flexibility rather than strictly focusing on restructuring cognitions.[44] In the context of chronic pain, ACT targets ineffective control strategies and experiential avoidance by fostering techniques that establish psychological flexibility. The six core processes of ACT include: acceptance, cognitive defusion, being present, self as context, values, and committed action.[45] Briefly, acceptance encourages chronic pain patients to actively embrace pain and its sequelae rather than attempt to change it, in doing so encouraging the patient to cease a futile fight directed at the eradication of their pain. Cognitive defusion (deliteralization) techniques are employed to modify the function of thoughts rather than to reduce their frequency or restructure their content. In this manner, cognitive defusion may simply alter the undesirable meaning or function of negative thoughts and thus decrease the attachment and subsequent emotional and behavioral response to such thoughts. The core process of being present emphasizes a non-judgmental interaction between the self and private thoughts and events. Values are utilized as guides for electing behaviors and interpretations that are characterized by those values an individual strives to instantiate in everyday life. Finally, through committed action, patients can realize behavior changes aligned with individual values. Thus, ACT utilizes the six core principles in conjunction with one another to take a holistic approach toward increasing psychological flexibility and decreasing suffering. Patients are encouraged to view pain as inevitable and accept it in a nonjudgmental manner so that they can continue to derive meaning from life despite the presence of pain. The interrelated core processes exemplify mindfulness and acceptance processes and commitment and behavior change processes.[45]

 

Results of research on the effectiveness of ACT-based approaches for the management of chronic pain are promising, albeit still warranting further evaluation. A RCT comparing ACT with a waitlist control condition reported significant improvements in pain catastrophizing, pain-related disability, life satisfaction, fear of movements, and psychological distress that were maintained at the 7 month follow-up.[46] A larger trial reported significant improvements for pain, depression, pain-related anxiety, disability, medical visits, work status, and physical performance.[47] A recent meta-analysis evaluating acceptance-based interventions (ACT and mindfulness-based stress reduction) in patients with chronic pain found that, in general, acceptance-based therapies lead to favorable outcomes for patients with chronic pain.[48] Specifically, the meta-analysis revealed small to medium effect sizes for pain intensity, depression, anxiety, physical wellbeing, and quality of life, with smaller effects found when controlled clinical trials were excluded and only RCTs were included in the analyses.[48] Other acceptance-based interventions include contextual cognitive-behavioral therapy and mindfulness-based cognitive therapy, though empirical research on the effectiveness of these therapies for the management of chronic pain is still in its infancy.

 

Expectations

 

An important and vastly overlooked common underlying element of all treatment approaches is consideration of the patient’s expectation for treatment success. Despite the numerous advances in the formulation and delivery of effective multidisciplinary treatments for chronic pain, relatively little emphasis has been placed on recognizing the importance of expectations for success and on focusing efforts on enhancement of patients’ expectations. The recognition that placebo for pain is characterized by active properties leading to reliable, observable, and quantifiable changes with neurobiological underpinnings is currently at the vanguard of pain research. Numerous studies have confirmed that, when induced in a manner that optimizes expectations (via manipulation of explicit expectations and/or conditioning), analgesic placebos can result in observable and measurable changes in pain perception at a conscious self-reported level as well as a neurological pain-processing level.[49,50] Analgesic placebos have been broadly defined as simulated treatments or procedures that occur within a psychosocial context and exert effects on an individual’s experience and/or physiology.[51] The current conceptualization of placebo emphasizes the importance of the psychosocial context within which placebos are embedded. Underlying the psychosocial context and ritual of treatment are patients’ expectations. Therefore, it is not surprising that the placebo effect is intricately embedded in virtually every treatment; as such, clinicians and patients alike will likely benefit from recognition that therein lies an additional avenue by which current treatment approaches to pain can be enhanced.

 

It has been proposed that outcome expectancies are core influences driving the positive changes attained through the various modes of relaxation training, hypnosis, exposure treatments, and many cognitive-oriented therapeutic approaches. Thus, a sensible approach to the management of chronic pain capitalizes on the power of patients’ expectations for success. Regrettably, too often, health care providers neglect to directly address and emphasize the importance of patients’ expectations as integral factors contributing to successful management of chronic pain. The zeitgeist in our society is that of mounting medicalization of ailments fueling the general expectation that pain (even chronic pain) ought to be eradicated through medical advancements. These all too commonly held expectations leave many patients disillusioned with current treatment outcomes and contribute to an incessant search for the “cure”. Finding the “cure” is the exception rather than the rule with respect to chronic pain conditions. In our current climate, where chronic pain afflicts millions of Americans annually, it is in our best interest to instill and continue to advocate a conceptual shift that instead focuses on effective management of chronic pain. A viable and promising route to achieving this is to make the most of patients’ positive (realistic) expectations and educate pain patients as well as the lay public (20% of whom will at some future point become pain patients) on what constitutes realistic expectations regarding the management of pain. Perhaps, this can occur initially through current, evidence-based education regarding placebo and nonspecific treatment effects such that patients can correct misinformed beliefs they may have previously held. Subsequently clinicians can aim to enhance patients’ expectations within treatment contexts (in a realistic fashion) and minimize pessimistic expectations that deter from treatment success, therefore, learning to enhance their current multidisciplinary treatments through efforts guided at capitalizing on the improvements placebo can yield, even within an “active treatment”. Psychologists can readily address these issues with their patients and help them become advocates of their own treatment success.

 

Emotional Concomitants of Pain

 

An often challenging aspect of the management of chronic pain is the unequivocally high prevalence of comorbid emotional distress. Research has demonstrated that depression and anxiety disorders are upward to three times more prevalent among chronic pain patients than among the general population.[52,53] Frequently, pain patients with psychiatric comorbidities are labeled “difficult patients” by healthcare providers, possibly diminishing the quality of care they will receive. Patients with depression have poorer outcomes for both depression and pain treatments, compared with patients with single diagnoses of pain or depression.[54,55] Psychologists are remarkably suited to address most of the psychiatric comorbidities typically encountered in chronic pain populations and thus improve pain treatment outcomes and decrease the emotional suffering of patients. Psychologists can address key symptoms (eg, anhedonia, low motivation, problem-solving barriers) of depression that readily interfere with treatment participation and emotional distress. Moreover, irrespective of a psychiatric comorbidity, psychologists can help chronic pain patients process important role transitions they may undergo (eg, loss of job, disability), interpersonal difficulties they may be encountering (eg, sense of isolation brought about by pain), and emotional suffering (eg, anxiety, anger, sadness, disappointment) implicated in their experience. Thus, psychologists can positively impact the treatment course by reducing the influence of emotional concomitants that are addressed as part of therapy.

 

Conclusion

 

Benefits of including psychological treatments in multidisciplinary approaches to the management of chronic pain are abundant. These include, but are not limited to, increased self-management of pain, improved pain-coping resources, reduced pain-related disability, and reduced emotional distress-improvements that are effected via a variety of effective self-regulatory, behavioral, and cognitive techniques. Through implementation of these changes, a psychologist can effectively help patients feel more in command of their pain control and enable them to live as normal a life as possible despite pain. Moreover, the skills learned through psychological interventions empower and enable patients to become active participants in the management of their illness and instill valuable skills that patients can employ throughout their lives. Additional benefits of an integrated and holistic approach to the management of chronic pain may include increased rates of return to work, reductions in health care costs, and increased health-related quality of life for millions of patients throughout the world.

 

Image of a trainer providing training advice to a patient.

 

Footnotes

 

Disclosure: No conflicts of interest were declared in relation to this paper.

 

In conclusion, psychological interventions can be effectively used to help relieve symptoms of chronic pain along with the use of other treatment modalities, such as chiropractic care. Furthermore, the research study above demonstrated how specific psychological interventions can improve the outcome measures of chronic pain management. Information referenced from the National Center for Biotechnology Information (NCBI). The scope of our information is limited to chiropractic as well as to spinal injuries and conditions. To discuss the subject matter, please feel free to ask Dr. Jimenez or contact us at 915-850-0900 .

 

Curated by Dr. Alex Jimenez

 

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Additional Topics: Back Pain

 

According to statistics, approximately 80% of people will experience symptoms of back pain at least once throughout their lifetimes. Back pain is a common complaint which can result due to a variety of injuries and/or conditions. Often times, the natural degeneration of the spine with age can cause back pain. Herniated discs occur when the soft, gel-like center of an intervertebral disc pushes through a tear in its surrounding, outer ring of cartilage, compressing and irritating the nerve roots. Disc herniations most commonly occur along the lower back, or lumbar spine, but they may also occur along the cervical spine, or neck. The impingement of the nerves found in the low back due to injury and/or an aggravated condition can lead to symptoms of sciatica.

 

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EXTRA IMPORTANT TOPIC: Managing Workplace Stress

 

 

MORE IMPORTANT TOPICS: EXTRA EXTRA: Car Accident Injury Treatment El Paso, TX Chiropractor

 

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Mindfulness Interventions for Chronic Headache in El Paso, TX

Mindfulness Interventions for Chronic Headache in El Paso, TX

If you’ve experienced a headache, you’re not alone. Approximately 9 out of 10 individuals in the United States suffer from headaches. While some are intermittent, some frequent, some are dull and throbbing, and some cause debilitating pain and nausea, getting rid of the head pain is an immediate response for many. But, how can you most effectively relieve a headache?

 

Research studies have demonstrated that chiropractic care is an effective alternative treatment option for many types of headaches. A 2014 report in the Journal of Manipulative and Physiological Therapeutics (JMPT) discovered that spinal adjustments and manual manipulations used in chiropractic care improved outcome measures for the treatment of chronic and acute neck pain as well as improved the benefits of a variety of treatment approaches for neck pain. Furthermore, a 2011 JMPT study found that chiropractic care can improve and reduce the frequency of migraine and cervicogenic headaches.

 

How Does Chiropractic Care Treat Headaches?

 

Chiropractic care focuses on the treatment of a variety of injuries and/or conditions of the musculoskeletal and nervous system, including headache. A chiropractor utilizes spinal adjustments and manual manipulations to carefully correct the alignment of the spine. A subluxation, or a spinal misalignment, has been demonstrated to cause symptoms, such as neck and back pain, and headache and migraine. A balanced spine can improve spine function as well as alleviate structural stress. In addition, a doctor of chiropractic can help treat headaches and other painful symptoms by supplying nutritional advice, offering posture and ergonomics advice and recommending stress management and exercise advice. Chiropractic care can ultimately ease muscle tension along the surrounding structures of the spine, restoring the spine’s original function.

 

Dr. Alex Jimenez performs a chiropractic adjustment on a patient.

 

Dr. Alex Jimenez offers fitness advice to patient.

 

Furthermore, chiropractic care can safely and effectively treat other spinal health issues, including symptoms of neck and lower back pain due to cervical and lumbar herniated discs, among other injuries and/or conditions. A chiropractor understands how a spinal misalignment, or subluxation, can affect different areas of the body and they will treat the body as a whole rather than focusing on the symptom alone. Chiropractic treatment can help the human body naturally restore its original health and wellness.

 

Trainer and patient interaction at rehabilitation center.

 

It is well-known that chiropractic care is effective for a variety of injuries and/or conditions, however, over the last few years, research studies have found that chiropractic can enhance our well-being by managing our stress. A number of these recent research studies demonstrated that chiropractic care can alter immune function, affect heart rate, and also reduce blood pressure. A 2011 research from Japan indicated that chiropractic may have a much bigger influence on your body than you believe.

 

Stress is an essential indicator of health, and chronic pain symptoms can tremendously affect wellness. Researchers in Japan sought to check whether chiropractic could alter stress levels in 12 men and women with neck pain and headache. But scientists at Japan wanted to find a more objective picture of how chiropractic spinal adjustments and manual manipulations affect the nervous system, so they used PET scans to monitor brain activity and salvia trials to monitor hormone changes.

 

After chiropractic care, patients had altered brain activity in the areas of the brain responsible for pain processing and stress reactions. They also had significantly reduced cortisol levels, indicating decreased stress. Participants also reported lower pain scores and a greater quality of life after treatment. Mindfulness interventions, such as chiropractic care, are fundamental stress management methods and techniques. Chronic stress can lead to a variety of health issues, including neck and back pain as well as headache and migraine. Other mindfulness interventions can also safely and effectively help improve symptoms. The purpose of the following article is to demonstrate the effectiveness of another mindfulness intervention, known as mindfulness-based stress reduction, on perceived pain intensity and quality of life in patients previously diagnosed with chronic headache.

 

The Effectiveness of Mindfulness-Based Stress Reduction on Perceived Pain Intensity and Quality of Life in Patients With Chronic Headache

 

Abstract

 

The aim of this study was to determine the effectiveness of Mindfulness-Based Stress reduction (MBSR) on perceived pain intensity and quality of life in patients with chronic headache. Thus, forty patients based on the diagnosis of a neurologist and diagnostic criteria of the International Headache Society (IHS) for migraine and chronic tension-type headache were selected and randomly assigned to the intervention group and control group, respectively. The participants completed the Pain and quality of life (SF-36) questionnaire. The intervention group enrolled in an eight-week MBSR program that incorporated meditation and daily home practice, per week, session of 90-minutes. Results of covariance analysis with the elimination of the pre-test showed significantly improvement of pain and quality of life in the intervention group compared with the control group. The findings from this study revealed that MBSR can be used non-pharmacological intervention for improvement the quality of life and development of strategies to cope with pain in patients with chronic headache. And can be used in combination with other therapies such as pharmacotherapy.

 

Keywords: chronic pain, migraine headache, mindfulness, quality of life, tension headache

 

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Dr. Alex Jimenez’s Insight

Chronic headache is a debilitating symptoms which affects many people. There are many different types of headaches, however, a majority of them often share a common trigger. Chronic stress can cause a variety of health issues of not properly managed, including muscle tension, which may lead to spinal misalignment, or subluxation, as well as other symptoms, such as neck and back pain, headaches and migraines. Stress management methods and techniques can ultimately help improve and manage stress associated symptoms. Mindfulness interventions like chiropractic care and mindfulness-based stress reduction have been determined to effectively help reduce stress and alleviate chronic headache symptoms.

 

Introduction

 

Headache is one of the most common complaints investigated in adult and pediatric neurological clinics. The vast majority of these headaches are migraine and tension-type headaches (Kurt & Kaplan, 2008). Headaches are classified into two categories of main or primary and secondary headaches. Ninety percent of headaches are primary headaches, among which migraine and tension headaches are the most common types (International Headache Society [IHS], 2013). According to the definition, migraine headache is usually unilateral and pulsating in nature and lasts from 4 to 72 hours. The associated symptoms include nausea, vomiting, increased sensitivity to light, sound and pain, and it generally increases with increasing physical activity. Also, tension headache is characterized by bilateral, non-pulsating pain, pressure or tightness, blunt pain, like a bandage or a hat, and a continuum of mild to moderate pain, preventing daily life activities (IHS, 2013).

 

Stovner et al. (2007) using the IHS diagnostic criteria, estimated the percentages of the adult population with an active headache disorder about 46% for headache in general, 42% for tension-type headache. This suggests that the incidence and the prevalence of tension-type headache are much higher than it was predicted. It is estimated that about 12 to 18 percent of the people have migraines (Stovner & Andree, 2010). Women are more likely to experience migraines compared to men, migraine prevalence is about 6% for men and 18% for women (Tozer et al., 2006).

 

Migraine and tension-type headaches are common and well-documented responses to psychological and physiological stressors (Menken, Munsat, & Toole, 2000). Migraine is a periodic and debilitating chronic pain and has a negative impact on quality of life, relationships and productivity. The World Health Organization (WHO) has announced the severe migraine as one of the most debilitating diseases with the nineteenth rank (IHS, 2013; Menken et al., 2000).

 

Despite the development of many medications for treatment and prevention of migraine attacks, a number of patients find them ineffective and some other find them inappropriate because of their side effects and side-effects often times lead to early discontinuation of treatment. As a result, a great interest in the development of non-pharmacologic treatments can be observed (Mulleners, Haan, Dekker, & Ferrari, 2010).

 

Biological factors alone cannot explain vulnerability to the experience of the headache, the onset of the attack and its course, intensified attacks of headache, headache-related disability and also the quality of life in patients with chronic headache. Negative life events are (as psychosocial factor) often known as a key factor in the development and exacerbation of headache (Nash & Thebarge, 2006).

 

The program of Mindfulness-Based Stress reduction (MBSR) is among the treatments, which have been studied in the past two decades on a variety of chronic pain. MBSR developed by Kabat-Zinn and used in a wide range of population with stress-related disorders and chronic pain (Kabat-Zinn, 1990). Especially in recent years, many studies have been conducted to examine the therapeutic effects of MBSR. Most studies have shown the significant effects of MBSR on different psychological conditions including the reduction of psychological symptoms of distress, anxiety, rumination, anxiety and depression (Bohlmeijer, Prenger, Taal, & Cuijpers, 2010; Carlson, Speca, Patel, & Goodey, 2003; Grossman, Niemann, Schmidt, & Walach, 2004; Jain et al., 2007; Kabat-Zinn, 1982; Kabat-Zinn, Lipworth, & Burney, 1985; Kabat-Zinn et al., 1992; Teasdale et al., 2002), pain (Flugel et al., 2010; Kabat-Zinn, 1982; Kabat-Zinn et al., 1985; La Cour & Petersen, 2015; Rosenzweig et al., 2010; Zeidan, Gordon, Merchant, & Goolkasian, 2010) and quality of life (Brown & Ryan, 2003; Carlson et al., 2003; Flugel et al., 2010; Kabat-Zinn, 1982; La Cour & Petersen, 2015; Morgan, Ransford, Morgan, Driban, & Wang, 2013; Rosenzweig et al., 2010).

 

Bohlmeijer et al. (2010) conducted a meta-analysis of eight randomized controlled studies on the effects of MBSR program, concluded that MBSR has small effects on depression, anxiety and psychological distress in people with chronic medical diseases. Also Grossman et al. (2004) in a meta-analysis of 20 controlled and uncontrolled studies on the effects of the MBSR program on physical and mental health of medical and non-medical samples, found an effect size of moderate for controlled studies on mental health. No effect sizes for specific symptoms such as depression and anxiety were reported. The most recent review includes 16 studies controlled and uncontrolled, This review reports that MBSR intervention decrease pain intensity, and most controlled trial studies (6 of 8) show higher reductions in pain intensity for intervention group compared with control group (Reiner, Tibi, & Lipsitz, 2013).

 

In another study, researchers found significant effect sizes for some subscales of quality of life for example vitality scale and bodily pain, nonsignificant effect sizes for pain and significant medium to large size effects for lower general anxiety and depression (La Cour & Petersen, 2015). Also in a study by Rosenzweig et al. (2010) on patients with chronic pain including those suffering from migraine, there were significant differences in pain intensity, pain-related functional limitations between patients. However, those suffering from migraine experienced the lowest improvement in pain and different aspects of quality of life. In general, different groups of chronic pain showed significant improvements in pain intensity and pain-related functional limitations in this study. Two other studies were conducted by Kabat-Zinn and using MBSR methods for treating patients with chronic pain, including a number of patients with chronic headaches. Statistical analysis showed a significant reduction in pain, pain interference with daily activities, medical and psychiatric signs and symptoms, anxiety and depression, negative body image, pain interference with daily activities, use of the drug and also increase in confidence (Kabat-Zinn, 1982; Kabat-Zinn et al., 1985).

 

Due to pain and loss of function and reduced work productivity and increased use of health care, chronic headache impose costs on individual and society, it seems that the chronic headache is a major health problem and finding ways to control and treat this problem could be of great importance. The main objective of this study was to evaluate the effectiveness of MBSR in addition to conventional pharmacotherapy in a clinical population sample of patients with chronic headache to show the effectiveness of this technique as a method of pain management and enhancement of the quality of life in patients with chronic headaches.

 

Methods

 

Participants and Procedure

 

This is a randomized controlled trial two- group ‘pretest-posttest’ study design. Also an approval was obtained from the Ethics Committee of Zahedan University of Medical Sciences. The participants selected through convenience sampling method from patients with chronic migraine and tension-type headache, diagnosed by a neurologist and a psychiatrist using IHS diagnostic criteria-referred to university hospitals of Zahedan University of Medical Sciences, Zahedan-Iran.

 

After evaluating each patient for meeting the inclusion and exclusion criteria and taking an initial interview, 40 out of eighty-seven primary patients with chronic headache were selected and randomly assigned into two equal groups of intervention and control. Both the control and intervention groups received common pharmacotherapy under the supervision of the neurologist. During therapy sessions three subjects, due to the lack of a regular presence or exclusion criteria, opted out or were excluded from the study.

 

Inclusion Criteria

 

  • (1) Informed consent to participate in the sessions.
  • (2) Minimum age of 18 years.
  • (3) Minimum educational qualification of middle-school degree.
  • (4) The diagnosis of chronic headache (primary chronic migraine and tension-type headache) by the neurologist and according to IHS diagnostic criteria.
  • (5) 15 or more days per month for more than 3 months and least six months history of migraines and tension-type headache

 

Exclusion Criteria

 

  • (1) Subjects who were not willing to continue the participation in the study or leave the study for any reason.
  • (2) Other chronic pain problems.
  • (3) Psychosis, delirium and cognitive disorders.
  • (4) Cases of interpersonal difficulties interfering with teamwork.
  • (5) Drug and substance abuse.
  • (6) Mood disorder

 

Intervention Groups

 

Therapy sessions (MBSR) were held for 1.5 to 2 hours a week for the members of the intervention group (drug plus MBSR); While no MBSR was performed for the control group (only common drugs used) until the end of the research. The MBSR was carried out for 8 weeks. In this study, the 8-session MBSR program (Chaskalon, 2011) has been used. To do the meditation homework while training participants in sessions, the necessary measures have been provided in a CD and a booklet. If any one of subjects did not participate in a session or sessions, at the beginning of the next session the therapist would provide written notes of the sessions to the subjects, in addition to repeat the previous session summaries. MBSR program and discussions were presented to the patients in the eight sessions including: understanding pain and its aetiology, discuss about relationship stress, anger and emotion with pain, Understanding negative automatic thoughts, identyfying thoughts and feelings, introducing the concept of Acceptance, breathing space, three-minute breathing space, breath focus exercise, pleasant and unpleasant events daily, behavioral activation, mindfulness of routine activity, body scan practice, Seeing and hearing exercise, sitting meditation, mindful walking, reading poems related to mindfulness and also discuss how to keep up what has been developed over the whole course, discuss plans and positive reasons for maintaining the practice. Patients also received information about learning how to detect any future relapses as well as strategies and plans on which to base early detection of symptom pain attacks and for being self-directed towards new situations.

 

Control Group

 

Patients who were randomized in the control group were continuing usual pharmacotherapy(including specific and nonspecific drugs) by their neurologist until the end of the research.

 

Instruments

 

Two main tools were used in the pre-test and post-test to collect data, in addition to demographic data form. Headache log was used to determine the perceived intensity of pain using three parts: (1) 10-point likert-scale ratings, (2) the number of hours of pain per day and (3) pain frequency during the month. Each part is scored from 0 to 100, the highest level being 100. Since each patient rates their perceived pain intensity in the questionnaire, validity and reliability are not considered. And the other was a short-form 36 questionnaire (SF-36). The questionnaire is applicable in the various age groups and different diseases. The reliability and validity of the questionnaire was approved by Ware et al (Ware, Osinski, Dewey, & Gandek, 2000). The SF-36 assesses the perception of the quality of life in 8 subscales include: physical functioning (PF), role limitations due to physical health (RP), bodily pain (PB), general health (GH), energy and vitality (VT), social functioning (SF), role limitations due to emotional problems (RE) and affect health (AH). The tool has also two summary scales for Physical Component Summary (PCS) and Mental Component Summary (MCS) scores. Each scale is scored from 0 to 100, the highest functional status level being 100. The validity and reliability of the SF-36 were examined in an Iranian population. Internal consistency coefficients were between 0.70 and 0.85 for the 8 subscales and test-retest coefficients were between 0.49 and 0.79 with an interval of one week (Montazeri, Goshtasebi, Vahdaninia, & Gandek, 2005).

 

Data Analysis

 

For analyzing the data, in addition to the use of descriptive indicators, to compare the results of the intervention and control groups, the analysis of covariance was used to determine the effectiveness and the removal of the pre-test results at 95% confidence level.

 

Drop-Out

 

During therapy sessions three subjects, due to the lack of a regular presence or exclusion criteria, opted out or were excluded from the study. Thirty-seven out of 40 patients completed current study and the gathered data were then analyzed.

 

Results

 

Analysis for comparison of demographic distribution between the two groups was performed using chi-square and independent t-test. Demographic data of both groups are shown in Table 1. Distribution of age, educational years, gender and marital status were the same in each group.

 

Table 1 Demographic Characteristics of Participants

Table 1: Demographic characteristics of participants.

 

Table 2 shows the results of analysis of covariance (ANCOVA). Levene’s test was non-significant, F (1, 35) = 2.78, P = 0.105, indicating that the assumption of homogeneity of variance had been approved. This finding shows that the variances across groups are equal and no difference was observed between two groups.

 

Table 2 The Results of Covarice Analysis

Table 2: The results of covariance analysis for the effectiveness of MBSR on pain intensity.

 

The main effect of MBSR intervention was significant, F (1, 34) = 30.68, P = 0.001, partial η2 = 0.47, indicating that the pain intensity was lower after MBSR intervention (Mean = 53.89, SD.E = 2.40) than control group (Mean = 71.94, SD.E = 2.20). The covariate (pre-test of pain) was also significant, F (1, 34) = 73.41, P = 0.001, partial η2 = 0.68, indicating that level of pain intensity before MBSR intervention had a significant effect on level of pain intensity. In other words, there was a positive relationship in the pain scores between pre-test and post-test. Therefore, the first research hypothesis is confirmed and MBSR treatment on perceived intensity was effective in patients with chronic headache and could reduce the intensity of perceived pain in these patients. All significant values are reported at p<0.05.

 

The second hypothesis of this study is the effectiveness of MBSR technique on quality of life in patients with chronic headache. To evaluate the effectiveness of MBSR technique on quality of life in patients with chronic headaches and eliminating the confounding variables and the effect of pre-test, for the analysis of data, multivariate covariance analysis (MANCOVA) of the dimensions of quality of life is used that Table 3 shows the results of analysis in the intervention group.

 

Table 3 The Results of Covariance Analysis

Table 3: The results of covariance analysis for the effectiveness of MBSR on quality of life.

 

The Table 3 shows the results of analysis of covariance (MANCOVA). The following information is needed to understand the results presented in Table 3.

 

The box’s test was non- significant, F = 1.08, P = 0.320, indicating that the variance–covariance matrices are the same in two groups and therefore the assumption of homogeneity is met. Also F (10, 16) = 3.153, P = 0.020, Wilks’ Lambda = 0.33, partial η2 = 0.66, indicating was a significant difference between the pre-test of the groups in the dependent variables.

 

Levene’s test was non-significant in some of dependent variables including [PF: F (1, 35) = 3.19, P = 0.083; RF: F (1, 35) = 1.92, P = 0.174; BP: F (1, 35) = 0.784, P = 0.382; GH: F (1, 35) = 0.659, P = 0.422; PCS: F (1, 35) = 2.371, P = 0.133; VT: F (1, 35) = 4.52, P = 0.141; AH: F (1, 35) = 1.03, P = 0.318], indicating that the assumption of homogeneity of variance had been approved in subscales of quality of life and Levene’s test was significant in some of dependent variables including [RE: F (1, 35) = 4.27, P = 0.046; SF: F (1, 35) = 4.82, P = 0.035; MCS: F (1, 35) = 11.69, P = 0.002], showing that the assumption of homogeneity of variance had been broken in subscales of quality of life.

 

The main effect of MBSR intervention was significant for some of dependent variables including [RP: F (1, 25) = 5.67, P = 0.025, partial η2 = 0.18; BP: F (1, 25) = 12.62, P = 0.002, partial η2 = 0.34; GH: F (1, 25) = 9.44, P = 0.005, partial η2 = 0.28; PCS: F (1, 25) = 9.80, P = 0.004, partial η2 = 0.28; VT: F (1, 25) = 12.60, P = 0.002, partial η2 = 0.34; AH: F (1, 25) = 39.85, P = 0.001, partial η2 = 0.61; MCS: F (1, 25) = 12.49, P = 0.002, partial η2 = 0.33], these results indicating that subscales of RP, BP, GH, PCS, VT, AH, and MCS were higher after MBSR intervention [RP: Mean = 61.62, SD.E = 6.18; BP: Mean = 48.97, SD.E = 2.98; GH: Mean = 48.77, SD.E = 2.85; PCS: Mean = 58.52, SD.E = 2.72; VT: Mean = 44.99, SD.E = 2.81; AH: Mean = 52.60, SD.E = 1.97; MCS: Mean = 44.82, SD.E = 2.43] than control group [RP: Mean = 40.24, SD.E = 5.62; BP: Mean = 33.58, SD.E = 2.71; GH: Mean = 36.05, SD.E = 2.59; PCS: Mean = 46.13, SD.E = 2.48; VT: Mean = 30.50, SD.E = 2.56; AH: Mean = 34.49, SD.E = 1.80; MCS: Mean = 32.32, SD.E = 2.21].

 

Nonetheless, the main effect of MBSR intervention was non-significant for some of dependent variables including [PF: F (1, 25) = 1.05, P = 0.314, partial η2 = 0.04; RE: F (1, 25) = 1.74, P = 0.199, partial η2 = 0.06; SF: F (1, 25) = 2.35, P = 0.138, partial η2 = 0.09]. These results indicating, although the means in these subscales of quality of life were higher [PF: Mean = 75.43, SD.E = 1.54; RE: Mean = 29.65, SD.E = 6.02; SF: Mean = 51.96, SD.E = 2.63] than the control group [PF: Mean = 73.43, SD.E = 1.40; RE: Mean = 18.08, SD.E = 5.48; SF: Mean = 46.09, SD.E = 2.40], But Mean difference was non-significant.

 

In summary, Covariance analysis (MANCOVA) results in Table 3 indicate a statistically significant difference in the scores of subscales of role limitation due to physical health (RP), bodily pain (BP), general health (GH), energy and vitality (VT), Affect health (AH) and sum of physical health dimensions (PCS) and mental health (MCS). And also indicates that there was not a statistically significant difference in subscale scores of physical functioning (PF), role limitations due to emotional problems (RE) and social functioning (SF) in the intervention group. All significant values are reported at p<0.05.

 

Discussion

 

This study aimed to evaluate the effectiveness of MBSR on perceived pain intensity and quality of life in patients with chronic headache. The results showed that MBSR treatment was significantly effective on reduction of pain intensity perception. The results of current study are consistent with the results of other researchers who had used the same method for chronic pain (e.g. Flugel et al., 2010; Kabat-Zinn, 1982; Kabat-Zinn et al., 1985; La Cour & Petersen, 2015; Reibel, Greeson, Brainard, & Rosenzweig, 2001; Reiner et al., 2013; Rosenzweig et al., 2010; zeidan et al., 2010). For example, in two studies conducted by Kabat-Zinn, where the MBSR program was used for treating patients with chronic pain by physicians, a number of patients with chronic headache were also included. The first study of the two studies, showed a significant reduction in pain, pain interference with daily activities, medical signs and psychiatric disorders, including anxiety and depression (Kabat-Zinn, 1982). The results of second study showed significant reduction in pain, negative body image, anxiety, depression, pain interference with daily activities, medical symptoms, medication use, and also showed an increase in self-confidence (Kabat-Zinn et al., 1985).

 

Also, the findings of the current study are consistent with the results of Rosenzweig et al. (2010), their results suggest that MBSR program is effective for reduction, physical pain, quality of life and psychological well-being of patients with various chronic pains and mindfulness is effective on emotional and sensory components of pain perception by self-regulation of attention through meditation activities. Although the results of Rosenzweig et al. (2010) showed that among patients with chronic pain the minimal impact on the reduction in bodily pain and improvement in quality of life was related to patients with fibromyalgia, chronic headache. In another study conducted by Flugel et al. (2010), although positive changes were observed in the frequency and the intensity of pain, the pain reduction was not statistically significant.

 

In another study, pain severity significantly reduced after the intervention in patients with tension headache. In addition, the MBSR group showed higher scores in mindful awareness in comparison with the control group (Omidi & Zargar, 2014). In a pilot study by Wells et al. (2014), their results showed that MBSR with pharmacological treatment was possible for patients with migraines. Although the small sample size of this pilot study did not provide power to detect a significant difference in the pain severity and migraine frequency, results demonstrated this intervention had a beneficial effect on headache duration, disability, self-efficacy.

 

In explaining the results of the effectiveness of mindfulness based therapies for pain it can be said, psychological models of chronic pain such as fear-avoidance model showed that the ways by which people interpret their feelings of pain and respond to them are important determinants in the experience of pain (Schutze, Rees, Preece, & Schutze, 2010). Pain catastrophizing is significantly associated with fear and anxiety caused by pain, the cognitive paths through which the fear of pain can be caused and also the pain-related disability is associated and also because the negative cognitive assessment of pain explains 7 to 31% of the variance of the pain intensity. Therefore, any mechanism that can reduce pain catastrophizing or make changes in its process can reduce the perception of pain intensity and the disability caused by that. Schutz et al. (2010) argue that the little mindfulness is the primer of pain catastrophizing. In fact, it seems that the tendency of the individual to engage in the automatic processing processes rather than knowledge-based processes with attention of insufficient flexibility, and lack of awareness of the present moment (Kabat-Zinn, 1990), will cause people to think more about the pain and thus overestimate the resulting risk of it. Thus, little mindfulness allows for the development of negative cognitive evaluation of the pain (Kabat-Zinn, 1990).

 

Another possible reason may be that the pain acceptance and readiness for change increase positive emotions, leading to a reduction in pain intensity through effects on the endocrine system and the production of endogenous opioids and reduction in pain-related disability or preparing individuals for the use of effective strategies to deal with pain (Kratz, Davis, & Zautra, 2007). Another possible reason to explain the results of the present study in its effectiveness on pain reduction can be the fact that chronic pain is developed due to an overactive stress response system (Chrousos & Gold, 1992). The result is the disturbing of the physical and mental processes. Mindfulness can allow for the access to the frontal cortex and improve it, brain areas that integrate physical and mental functions (Shapiro et al., 1995). The result is the creation of a little stimulation that reduces the intensity and the experience of physical and mental pain. Thus, pain impulses are experienced as feeling of the real pain rather than a negative recognition. The result is the closing of the pain channels that can reduce pain (Astin, 2004).

 

Mindfulness meditation Reduces Pain Through several Brain Mechanisms and various pathways such as changing of attention in meditation practices might impress both sensory and affective components of pain perception. On the other hand, mindfulness reduces the reactivity to distressing thoughts and feelings that accompany pain perception and strengthen the pain. Also, mindfulness reduces psychological symptoms such as comorbid anxiety and depression and increases parasympathetic activity, which can promote deep muscle relaxation that may reduce pain. Finally, mindfulness may decrease stress and mood dysfunction-related psychophysiologic activation by strengthening reframing negative situation and self-regulation skills. Higher level of mindfulness predicted lower levels of anxiety, depression, catastrophic thinking and disability. Other research has showed that mindfulness has an important role in cognitive and emotional control, and may be useful in reframing negative situations (Zeidan et al., 2011; Zeidan, Grant, Brown, McHaffie, & Coghill, 2012).

 

The second aim of this study was to determine the effectiveness of the MBSR program on quality of life in patients with chronic headache. This study showed that this treatment was significantly effective on quality of life dimensions, including role limitations due to health status, bodily pain, general health, energy and vitality, emotional health and overall physical and mental health scales. However, the MBSR program could not significantly increase the quality of life in physical functioning, role limitations due to emotional problems and social functioning. It seems apparent from previous and current studies and as well as from the present study that MBSR no effect on physical and social functions. This is likely because that the effects on pain levels in patients with headache are small, and that change is slow. On the other hand, patients with chronic pain have often learned to ignore pain in order to function normally (La Cour & Petersen, 2015). Although, the changes have been in the desired direction and increased the mean scores of the intervention group compared with the control group. These findings are consistent with previous findings (Brown & Ryan, 2003; Carlson et al., 2003; Flugel et al., 2010; Kabat-Zinn, 1982; La Cour & Petersen, 2015; Morgan et al., 2013; Reibel et al., 2001; Rosenzweig et al., 2010).

 

With regard to the content of the MBSR sessions, this program emphasizes the application of techniques to reduce stress, deal with pain and the awareness of the situation. Giving up the fight and accepting the present situation, without judgment, is the main concept of the program (Flugel et al., 2010). In fact, changes in acceptance without judgment are associated with improvement in quality of life (Rosenzweig et al., 2010). MBSR is aimed to increase awareness of the present moment. The treatment plan is a new and personal way to deal with stress to the individual. External stressors are part of life and cannot be changed, but coping skills and how to respond to the stress can be changed (Flugel et al., 2010). McCracken and velleman (2010) showed that cognitive flexibility and higher mindfulness is associated with less suffering and disability in patients. Patients with chronic pain with higher levels of mindfulness reported less depression, stress, anxiety and pain and also improvement in the self-efficacy and quality of life. Morgan et al. (2013) studying arthritis patients achieved similar results, so that patients with higher levels of mindfulness reported lower stress, depression and higher self-efficacy and quality of life. As noted above it was expected that pain reduction in patients leads to reduced fear and anxiety associated with pain and thereby reduces the resulting functioning limitations. Also, the results of the several studies (Cho, Heiby, McCracken, Lee, & Moon, 2010; McCracken, Gauntlett-Gilbert, & Vowles, 2007; Rosenzweig et al., 2010; Schutz et al., 2010) confirm this finding.

 

Several studies have been done to evaluate the effectiveness of different types of mindfulness-based treatments on chronic pain, including patients with headache. Unlike other research that examined heterogeneous sets of patients with chronic pain, the advantage of this study is that, it has been only performed on patients with chronic headache.

 

In the end, it should be acknowledged that there are some limitations in this study such as small sample size, lack of a long-term follow-up program, participants’ medication use and arbitrary treatments; and despite the efforts of researchers, the lack of fully similar pharmacotherapy for all participants can confound the test results and make it difficult to generalize the results. Since the present study is the first of its type in patients with chronic headache in Iran, it is suggested that similar studies should be carry out in this field, with larger sample sizes as possible. And further studies investigate the stability of the treatment results in long-term follow-up periods of time.

 

Conclusion

 

According to the findings of this study it can be concluded that MBSR methods generally are effective on perceived pain intensity and quality of life of patients with chronic headache. Although there was no statistically significant difference in some aspects of quality of life, such as physical functioning, role limitations due to emotional problems and social functioning, but overall changes in mean were desired to the study. Thus the integrating of MBSR treatment with conventional medical therapy in the treatment protocol for patients with chronic headache can be advised. The researcher also believes that despite the shortcomings and deficiencies of current research, this study could be a new approach to the treatment of chronic headache and could provide a new horizon in this field of treatment.

 

Acknowledgements

 

This research was supported (as a thesis) in part by Zahedan University of Medical Sciences. We would like to thank all participants in the study, local healers, the staff of hospitals- Ali -ebn-abitaleb, Khatam-al-anbia and Ali asghar- for their support and help.

 

In conclusion, chiropractic care is a safe and effective alternative treatment option utilized to help improve as well as manage chronic headache symptoms by carefully and gently realigning the spine as well as providing stress management methods and techniques. Because stress has been associated with a variety of health issues, including subluxation, or misalignment of the spine, and chronic headache, mindfulness interventions like chiropractic care and mindfulness-based stress reduction (MBSR) are fundamental towards chronic headache. Finally, the article above demonstrated that MBSR can be effectively used as a mindfulness intervention for chronic headache and to improve overall health and wellness. Information referenced from the National Center for Biotechnology Information (NCBI). The scope of our information is limited to chiropractic as well as to spinal injuries and conditions. To discuss the subject matter, please feel free to ask Dr. Jimenez or contact us at 915-850-0900 .

 

Curated by Dr. Alex Jimenez

 

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Additional Topics: Back Pain

 

According to statistics, approximately 80% of people will experience symptoms of back pain at least once throughout their lifetimes. Back pain is a common complaint which can result due to a variety of injuries and/or conditions. Often times, the natural degeneration of the spine with age can cause back pain. Herniated discs occur when the soft, gel-like center of an intervertebral disc pushes through a tear in its surrounding, outer ring of cartilage, compressing and irritating the nerve roots. Disc herniations most commonly occur along the lower back, or lumbar spine, but they may also occur along the cervical spine, or neck. The impingement of the nerves found in the low back due to injury and/or an aggravated condition can lead to symptoms of sciatica.

 

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EXTRA IMPORTANT TOPIC: Managing Workplace Stress

 

 

MORE IMPORTANT TOPICS: EXTRA EXTRA: Car Accident Injury Treatment El Paso, TX Chiropractor

 

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14. Kabat-Zinn J, Lipworth L, Burney R. The clinical use of mindfulness meditation for the self-regulation of chronic pain. J Behav Med. 1985;8(2):163–190. http://dx.doi.org/10.1007/BF00845519 . [PubMed] 15. Kabat-Zinn J, Massion A. O, Kristeller J, Peterson L. G, Fletcher K. E, Pbert L, Santorelli S. F. Effectiveness of a meditation-based stress reduction program in the treatment of anxiety disorders. Am J Psychiatry. 1992;149(7):936–943. http://dx.doi.org/10.1176/ajp.149.7.936 . [PubMed] 16. Kratz A. L, Davis M. C, Zautra A. J. Pain acceptance moderates the relation between pain and negative affect in female osteoarthritis and fibromyalgia patients. Ann Behav Med. 2007;33(3):291–301. http://dx.doi.org/10.1080/08836610701359860 . [PMC free article] [PubMed] 17. Kurt S, Kaplan Y. Epidemiological and clinical characteristics of headache in university students. Clin Neurol Neurosurg. 2008;110(1):46–50. http://dx.doi.org/10.1016/j.clineuro.2007.09.001 . [PubMed] 18. La Cour P, Petersen M. Effects of mindfulness meditation on chronic pain: a randomized controlled trial. Pain Med. 2015;16(4):641–652. http://dx.doi.org/10.1111/pme.12605 . [PubMed] 19. McCracken L. M, Gauntlett-Gilbert J, Vowles K. E. The role of mindfulness in a contextual cognitive-behavioral analysis of chronic pain-related suffering and disability. Pain. 2007;131(1-2):63–69. http://dx.doi.org/10.1016/j.pain.2006.12.013 . [PubMed] 20. McCracken L. M, Velleman S. C. Psychological flexibility in adults with chronic pain: a study of acceptance, mindfulness, and values-based action in primary care. Pain. 2010;148(1):141–147. http://dx.doi.org/10.1016/j.pain.2009.10.034 . [PubMed] 21. Menken M, Munsat T. L, Toole J. F. The global burden of disease study: implications for neurology. Arch Neurol. 2000;57(3):418–420. http://dx.doi.org/10.1001/archneur.57.3.418 . [PubMed] 22. Montazeri A, Goshtasebi A, Vahdaninia M, Gandek B. The Short Form Health Survey (SF-36): translation and validation study of the Iranian version. Qual Life Res. 2005;14(3):875–882. http://dx.doi.org/10.1007/s11136-004-1014-5 . [PubMed] 23. Morgan N. L, Ransford G. L, Morgan L. P, Driban J. B, Wang C. Mindfulness is associated with psychological symptoms, self-efficacy, and quality of life among patients with symptomatic knee osteoarthritis. Osteoarthritis and Cartilage. 2013;21(Supplement):S257–S258. http://dx.doi.org/10.1016/j.joca.2013.02.535 .
24. Mulleners W. M, Haan J, Dekker F, Ferrari M. D. Preventive treatment for migraine. Ned Tijdschr Geneeskd. 2010;154:A1512. [PubMed] 25. Nash J. M, Thebarge R. W. Understanding psychological stress, its biological processes, and impact on primary headache. Headache. 2006;46(9):1377–1386. http://dx.doi.org/10.1111/j.1526-4610.2006.00580.x . [PubMed] 26. Omidi A, Zargar F. Effect of mindfulness-based stress reduction on pain severity and mindful awareness in patients with tension headache: a randomized controlled clinical trial. Nurs Midwifery Stud. 2014;3(3):e21136. [PMC free article] [PubMed] 27. Reibel D. K, Greeson J. M, Brainard G. C, Rosenzweig S. Mindfulness-based stress reduction and health-related quality of life in a heterogeneous patient population. Gen Hosp Psychiatry. 2001;23(4):183–192. http://dx.doi.org/10.1016/S0163-8343(01)00149-9 . [PubMed] 28. Reiner K, Tibi L, Lipsitz J. D. Do mindfulness-based interventions reduce pain intensity? A critical review of the literature. Pain Med. 2013;14(2):230–242. http://dx.doi.org/10.1111/pme.12006 . [PubMed] 29. Rosenzweig S, Greeson J. M, Reibel D. K, Green J. S, Jasser S. A, Beasley D. Mindfulness-based stress reduction for chronic pain conditions: variation in treatment outcomes and role of home meditation practice. J Psychosom Res. 2010;68(1):29–36. http://dx.doi.org/10.1016/j.jpsychores.2009.03.010 . [PubMed] 30. Schutze R, Rees C, Preece M, Schutze M. Low mindfulness predicts pain catastrophizing in a fear-avoidance model of chronic pain. Pain. 2010;148(1):120–127. http://dx.doi.org/10.1016/j.pain.2009.10.030 . [PubMed] 31. Shapiro D. H, Wu J, Hong C, Buchsbaum M. S, Gottschalk L, Thompson V. E, Hillyard D, Hetu M, Friedman G. Exploring the relationship between having control and losing control to functional neuroanatomy within the sleeping state. Psychologia. 1995;38:133–145.
32. Stovner L, Hagen K, Jensen R, Katsarava Z, Lipton R, Scher A, Zwart J. A. The global burden of headache: a documentation of headache prevalence and disability worldwide. Cephalalgia. 2007;27(3):193–210. http://dx.doi.org/10.1111/j.1468-2982.2007.01288.x . [PubMed] 33. Stovner L. J, Andree C. Prevalence of headache in Europe: a review for the Eurolight project. J Headache Pain. 2010;11(4):289–299. http://dx.doi.org/10.1007/s10194-010-0217-0 . [PMC free article] [PubMed] 34. Teasdale J. D, Moore R. G, Hayhurst H, Pope M, Williams S, Segal Z. V. Metacognitive awareness and prevention of relapse in depression: empirical evidence. J Consult Clin Psychol. 2002;70(2):275–287. http://dx.doi.org/10.1037/0022-006X.70.2.275 . [PubMed] 35. Tozer B. S, Boatwright E. A, David P. S, Verma D. P, Blair J. E, Mayer A. P, Files J. A. Prevention of migraine in women throughout the life span. Mayo Clin Proc. 2006;81(8):1086–1091. quiz 1092. http://dx.doi.org/10.4065/81.8.1086 . [PubMed] 36. Ware J. E, Kosinski M, Dewey J. E, Gandek B. SF-36 health survey: manual and interpretation guide. Quality Metric Inc; 2000.
37. Wells R. E, Burch R, Paulsen R. H, Wayne P. M, Houle T. T, Loder E. Meditation for migraines: a pilot randomized controlled trial. Headache. 2014;54(9):1484–1495. http://dx.doi.org/10.1111/head.12420 . [PubMed] 38. Zeidan F, Gordon N. S, Merchant J, Goolkasian P. The effects of brief mindfulness meditation training on experimentally induced pain. J Pain. 2010;11(3):199–209. http://dx.doi.org/10.1016/j.jpain.2009.07.015 . [PubMed] 39. Zeidan F, Grant J. A, Brown C. A, McHaffie J. G, Coghill R. C. Mindfulness meditation-related pain relief: evidence for unique brain mechanisms in the regulation of pain. Neurosci Lett. 2012;520(2):165–173. http://dx.doi.org/10.1016/j.neulet.2012.03.082 . [PMC free article] [PubMed] 40. Zeidan F, Martucci K. T, Kraft R. A, Gordon N. S, McHaffie J. G, Coghill R. C. Brain mechanisms supporting the modulation of pain by mindfulness meditation. The Journal of Neuroscience. 2011;31(14):5540–5548. http://dx.doi.org/10.1523/JNEUROSCI.5791-10.2011 . [PMC free article] [PubMed]

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Mindfulness for Headache and Cervical Disc Herniation in El Paso, TX

Mindfulness for Headache and Cervical Disc Herniation in El Paso, TX

Stress is a result of the human body’s “fight or flight” response, a prehistoric defense mechanism triggered by the sympathetic nervous system (SNS). Stress is an essential component of survival. When stressors activate the fight or flight response, a mixture of chemicals and hormones are secreted into the blood flow, which prepare the body for perceived danger. Although short-term stress is helpful, however, long-term stress can lead to a variety of health issues. Furthermore, stressors in modern society have changed and it’s become more difficult for people to manage their stress and maintain mindfulness.

 

How Does Stress Affect the Body?

 

Stress can be experienced through three different channels: emotion; body and environment. Emotional stress involves adverse situations which affect our mind and decision making. Bodily stress includes improper nutrition and a lack of sleep. And finally, environmental stress occurs based on external experiences. When you experience any of these types of stressors, the sympathetic nervous system will trigger the “fight or flight” response, releasing adrenaline and cortisol to increase heart rate and heighten our senses to make us more alert in order to face the situation ahead of us.

 

However, if perceived stressors are always present, the SNS’s fight or flight response can remain active. Chronic stress can then lead to a variety of health issues, such as anxiety, depression, muscle tension, neck and back pain, digestive problems, weight gain and sleep problems as well as impaired memory and concentration. In addition, muscle tension along the spine due to stress can cause a spinal misalignment, or subluxation, which may in turn lead to disc herniation.

 

Headache and Disc Herniation from Stress

 

A herniated disc occurs when the soft, gel-like center of an intervertebral disc pushes through a tear in its outer, cartilage ring, irritating and compressing the spinal cord and/or the nerve roots. Disc herniation commonly occurs in the cervical spine, or neck, and in the lumbar spine, or low back. Symptoms of herniated discs depend on the location of the compression along the spine. Neck pain and back pain accompanied by numbness, tingling sensations and weakness along the upper and lower extremities are some of the most common symptoms associated with disc herniation. Headache and migraine are also common symptoms associated with stress and herniated discs along the cervical spine, as a result of muscle tension and spinal misalignment.

 

Mindfulness Interventions for Stress Management

 

Stress management is essential towards improving as well as maintaining overall health and wellness. According to research studies, mindfulness interventions, such as chiropractic care and mindfulness-based stress reduction (MBSR), among others, can safely and effectively help reduce stress. Chiropractic care utilizes spinal adjustments and manual manipulations to carefully restore the original alignment of the spine, relieving pain and discomfort as well as easing muscle tension. Additionally, a chiropractor may include lifestyle modifications to help further improve symptoms of stress. A balanced spine can help the nervous system respond to stress more effectively. MBSR can also help reduce stress, anxiety and depression.

 

Contact Us Today

 

If you are experiencing symptoms of stress with headache or migraine as well as neck and back pain associated with disc herniation, mindfulness interventions such as chiropractic care can be a safe and effective treatment for your stress. Dr. Alex Jimenez’s stress management services can help you achieve overall health and wellness. Seeking the proper mindfulness interventions can get you the relief you deserve. The purpose of the following article is to demonstrate the effects of mindfulness-based stress reduction in patients with tension headache. Don’t just treat the symptoms, get to the source of the issue.

 

Effects of Mindfulness-Based Stress Reduction on Perceived Stress and Psychological Health in Patients with Tension Headache

 

Abstract

 

Background: Programs for improving health status of patients with illness related to pain, such as headache, are often still in their infancy. Mindfulness-based stress reduction (MBSR) is a new psychotherapy that appears to be effective in treating chronic pain and stress. This study evaluated efficacy of MBSR in treatment of perceived stress and mental health of client who has tension headache.

 

Materials and Methods: This study is a randomized clinical trial. Sixty patients with tension type headache according to the International Headache Classification Subcommittee were randomly assigned to the Treatment As Usual (TAU) group or experimental group (MBSR). The MBSR group received eight weekly classmates with 12-min sessions. The sessions were based on MBSR protocol. The Brief Symptom Inventory (BSI) and Perceived Stress Scale (PSS) were administered in the pre- and posttreatment period and at 3 months follow-up for both the groups.

 

Results: The mean of total score of the BSI (global severity index; GSI) in MBSR group was 1.63 ± 0.56 before the intervention that was significantly reduced to 0.73 ± 0.46 and 0.93 ± 0.34 after the intervention and at the follow-up sessions, respectively (P < 0.001). In addition, the MBSR group showed lower scores in perceived stress in comparison with the control group at posttest evaluation. The mean of perceived stress before the intervention was 16.96 ± 2.53 and was changed to 12.7 ± 2.69 and 13.5 ± 2.33 after the intervention and at the follow-up sessions, respectively (P < 0.001). On the other hand, the mean of GSI in the TAU group was 1.77 ± 0.50 at pretest that was significantly reduced to 1.59 ± 0.52 and 1.78 ± 0.47 at posttest and follow-up, respectively (P < 0.001). Also, the mean of perceived stress in the TAU group at pretest was 15.9 ± 2.86 and that was changed to 16.13 ± 2.44 and 15.76 ± 2.22 at posttest and follow-up, respectively (P < 0.001).

 

Conclusion: MBSR could reduce stress and improve general mental health in patients with tension headache.

 

Keywords: Mental health, tension headache, mindfulness-based stress reduction (MBSR), perceived stress, treatment as usual (TAU)

 

Dr Jimenez White Coat

Dr. Alex Jimenez’s Insight

Chiropractic care is an effective stress management treatment because it focuses on the spine, which is the base of the nervous system. Chiropractic utilizes spinal adjustments and manual manipulations to carefully restore the alignment of the spine in order to allow the body to naturally heal itself. A spinal misalignment, or subluxation, can create muscle tension along the spine and lead to a variety of health issues, including headache and migraine, as well as disc herniation and sciatica. Chiropractic care can also include lifestyle modifications, such as nutritional advice and exercise recommendations, to further enhance its effects. Mindfulness-based stress reduction can also effectively help with stress management and symptoms.

 

Introduction

 

Tension headache constitutes 90% of total headaches. About 3% of the population are suffering from chronic tension headache.[1] Tension headaches are often associated with lower quality of life and high levels of psychological discomforts.[2] In recent years, several meta-analyses evaluating the established pain treatments used today have shown that medical treatments, which may be effective in acute pain, are not effective with chronic pain and may, in fact, be causing further problems. Most of the pain treatments are designed for and useful for acute pain but if used in the long run may create more problems such as substance abuse and avoidance of important activities.[3] A common element in most of the pain treatments is that they emphasize on either avoiding pain or fighting to reduce pain. The pain in tension headache can be intolerable. Painkillers and pain management strategies can increase intolerance and sensitivity to pain. Therefore, the treatments that increase acceptance and tolerance to pain, especially chronic pain, are effective. Mindfulness-based stress reduction (MBSR) is a new psychotherapy that appears to be effective in improving physical performance and psychological well-being in patients with chronic pain.[4,5,6,7,8] In the past two decades, Kabat-Zinn et al. in the US successfully used mindfulness for the relief of pain and illness related to pain.[9] Recent studies on acceptance-based methods, such as mindfulness, show improved performance in patients with chronic pain. Mindfulness modulates the pain using nonelaborative awareness of thoughts, feelings and sensations, and an emotionally distanced relationship with internal and external experience.[10] Studies found that MBSR program can significantly alleviate medical illness related to chronic pains such as fibromyalgia, rheumatoid arthritis, chronic musculoskeletal pain, chronic low back pain, and multiple sclerosis.[7,11,12,13] MBSR has significant changes in pain intensity, anxiety, depression, somatic complaints, well-being, adaptation, quality of sleep, fatigue, and physical functioning.[6,14,15,16,17] But the programs for improving health status of patients with illness related to pain, such as tension headache, are often still in their infancy. Therefore, the study was conducted to assess the effects of MBSR on perceived stress and general mental health in patients with tension headache.

 

Materials and Methods

 

This randomized controlled clinical trial was performed in 2012 in Shahid Beheshti Hospital in Kashan City. The Research Ethics Committee of the Kashan University of Medical Sciences approved this study (IRCT No: 2014061618106N1). The participants of the study included adults with tension headache who were referred by the psychiatrists and neurologists in Kashan. The inclusion criteria were as follows: Having tension headache according to the International Headache Classification Subcommittee, willing to participate in the study, not having a medical diagnosis of organic brain disorder or psychotic disorder, and not having a history of psychological treatment during the preceding 6 months. The patients who did not complete the intervention and missed more than two sessions were excluded from the study. The participants, who signed an informed consent form, completed the measures as a pretest. For estimating the sample size, we referred to another study in which changes in mean of scores of fatigue was 62 ± 9.5 in the pretreatment period and 54.5 ± 11.5 in the posttreatment period.[18] Then, by utilizing the sample size calculation, 33 participants (with attrition risk) in each group with α = 0.95 and 1 – β = 0.9 were segregated. After sample size calculation, 66 patients with tension headache were selected via convenient sampling according to the inclusion criteria. Then, the patients were called and invited to participate in the study. If a patient agreed to participate, then he/she was invited to attend the study-briefing session and if not another patient was selected similarly. Then using a random number table, they were assigned either to the experimental group (MBSR) or to the control group that treated as usual. Finally, 3 patients were excluded from each group and 60 patients were included (30 patients in each group). The TAU group was treated only by antidepressant medication and clinical management. The MBSR group received MBSR training in addition to TAU. The patients in MBSR group were trained for 8 weeks by a clinical psychologist with PhD degree. The Brief Symptom Inventory (BSI) and Perceived Stress Scale (PSS) were administered before the first treatment session in the MBSR group, after the eighth session (posttest), and 3 months after the test (follow-up) in both groups. The TAU group was invited to Shahid Beheshti Hospital to fill out the questionnaires. Figure 1 shows a Consolidated Standards of Reporting Trials (CONSORT) diagram depicting the flow of study participants.

 

Figure 1 CONSORT Diagram Depicting Flow of Study Participants

Figure 1: CONSORT diagram depicting flow of study participants.

 

Intervention

 

The intervention group (MBSR) was trained in Shahid Beheshti Hospital. The eight weekly sessions (120 min) were held according to the standard MBSR protocol as developed by Kabat-Zinn.[11] Additional sessions were held for the participants who had missed one or two sessions. At the end of the training and 3 months later (follow-up), both MBSR and TAU groups were invited to Shahid Beheshti Hospital (the place of MBSR trial) and were instructed to complete the questionnaires. During the MBSR sessions, the participants were trained to be aware of their thoughts, feelings, and physical sensations nonjudgmentally. Mindfulness exercises are taught as two forms of meditation practices — formal and informal. Formal type exercises include trained sitting meditation, body scan, and mindful yoga. In informal meditation, attention and awareness are focused not only on daily activities, but also on thoughts, feelings, and physical sensation even they are problematic and painful. The overall content of the sessions were mentioned in Table 1.

 

Table 1 Agendas for Sessions of MBSR

Table 1: Agendas for sessions of mindfulness-based stress reduction.

 

Measurement Tools

 

International Headache Classification Subcommittee Diary Scale for Headache

 

Headache was measured by diary scale for headache.[19] The patients were asked to record the pain severity diary on a 0-10 rating scale. Absence of pain and the most intense disabling headache were characterized by 0 and 10, respectively. The mean of headache severity in a week was calculated by dividing the sum of the severity scores by 7. Moreover, the mean of headache severity in a month was calculated by dividing the sum of the severity scores by 30. The minimum and maximum scores of headache severity were 0 and 10, respectively. Headache diary was given to five patients and a neurologist and a psychiatrist confirmed the content validity of the instrument.[20] The reliability coefficient of Persian version of this scale was calculated as 0.88.[20]

 

Brief symptom Inventory (BSI)

 

Psychological symptoms were assessed with the BSI.[21] The inventory consist 53 items and 9 subscales that assess psychological symptoms. Each item scores between 0 and 4 (for example: I have nausea or upset in my stomach). BSI has a global severity index (GSI) achieved a total score of 53 items. The reliability of the test has reported a score of 0.89.[22] In our study, GSI test–retest estimate was .90 based on a sample of 60 patients with tension headache who completed the BSI.

 

Perceived Stress Scale (PSS)

 

Perceived stress was assessed using the PSS,[21,23] a 10-item scale that assesses the degree of uncontrollable and unpredictable situations of life during the past month (for example: Felt that you were unable to control the important things in your life?). Respondents report the prevalence of an item within the last month on a 5-point scale, ranging from 0 (never) to 4 (very often). Scoring is completed by reverse scoring of four positively worded items[4,5,7,8] and summing all item scores. The scale scores range from 0-40. Higher scores indicate higher levels of stress. It assumes that people depending on their coping resources evaluate level of threatening or challenging events. A higher score indicates a greater degree of perceived stress. Adequate test–retest reliability and convergent and discriminate validity have also been reported.[19] In our study, Cronbach’s alpha coefficients for assessing internal consistency of this scale were calculated to be 0.88.

 

The repeated measures analysis of variance was performed to compare the MBSR and TAU groups on measures of perceived stress and GSI at pretreatment, posttreatment, and 3-month follow-up. Also, Chi-square test was used to compare the demographics in the two groups. P value less than 0.05 was considered significant in all tests.

 

Results

 

Among 66 subjects, 2 participants from the MBSR group were excluded because of missing more than 2 sessions. Also, three participants were excluded because of did not complete the questionnaires in post-test or follow-up who one of them were from MBSR group and three participants from TAU group. Table 2 showed demographic characteristics of the subjects and results of the randomization check. The results of t-test for differences between the MBSR and TAU groups in age variable and Chi-square test in other variables showed that there was no significant difference between demographic variables in two groups and the subjects were randomly assigned to two groups.

 

Table 2 Demographic Characteristics of the Subjects

Table 2: Demographic characteristics of the subjects a,b.

 

Table 3 provides the mean scores and standard deviations of the dependent variables (perceived stress and GSI) and comparison of outcome measures at pretreatment period, post-treatment period, and 3-month follow-up.

 

Table 3 Means, Standard Deviations and Comparison of Outcome Measures

Table 3: Means, standard deviations, and comparison of outcome measures at pretreatment, posttreatment, and follow-up stages in the MBSR and TAU groups a,b.

 

Table 3 shows the more reduction in received stress and GSI in the intervention group (MBSR) compared to TAU group, while the reduction in received stress and GSI were not observed in the TAU group. The results revealed the significant effect of time and interaction between time and type of treatment on the changes of scores (P < 0.001).

 

Figures ​2 and ​3 present mean received stress and GSI scores for MBSR and TAU groups at posttest and follow-up stages.

 

Figure 2 CONSORT Diagram Depicting Flow of Study Participants

Figure 2: CONSORT diagram depicting flow of study participants.

 

Figure 3 Mean of Perceived Stress in MBSR and Control Groups

Figure 3: Mean of perceived stress in MBSR and control groups in pretest, posttest, and follow-up.

 

Discussion

 

This study compared efficacy of MBSR and Treatment As Usual (TAU) in perceived stress and mental health of patients with tension headache. Although MBSR is recognized as an effective treatment for stress symptoms and pain, there is a need to examine its efficacy for the treatment of mental health problems in patients with tension headache, which is one of the common complaints in the population.

 

The findings of our study demonstrate enhanced general mental health in the GSI index of BSI. In some study, significant improvements by MBSR intervention were reported on all indexes of the 36-item Short Form Health Survey (SF-36).[20,24] Studies showed significant reduction in psychological problems in the Symptom Checklist-90-Revised (SCL-90-R) subscale such as anxiety and depression by MBSR after intervention and 1-year follow-up.[5] Reibel et al. showed MBSR in patients with chronic pain reported a decrease in medical symptoms such as anxiety, depression, and pain.[5] It has been shown that tension headache and anxiety are accompanied with deficits in controlled cognitive processing such as sustained attention and working memory.[25] Negative emotions may amplify suffering associated with pain perception.

 

MBSR implements the following mechanisms to improve the patient’s mental status: First, mindfulness leads to increased awareness for what is happening in each moment, with an accepting attitude, without getting caught up in habitual thoughts, emotions, and behavior patterns. The increased awareness then gives rise to new ways to respond and cope in relation to oneself and the world around.[3] Mindfulness establishes a sense of self that is greater than one’s thoughts, feelings, and bodily sensation such as pain. Mindfulness exercises, learned clients develop an “observer–self”. With this ability, they can observe their thoughts and feelings in a nonreactive and nonjudgmental way that previously avoided, that previously avoided thoughts and feelings be observed in a nonreactive and nonjudgmental way. The clients learn to notice thoughts without necessarily acting on them, being controlled by them, or believing them.[3]

 

Second, mindfulness helps the client develop persistence in taking steps in valued directions that are important to them. Most clients with chronic pain want to become pain free rather than living the vital lives of their choice. But the MBSR program trained them to engage in valued action despite the the pain. Studies have shown attention and emotional reaction to pain has an important role in becoming persistent the pain.[26] Emotional and cognitive components can modulate attention to pain and worry about it that could intensify pain and disrupt the patients activities.[27,28]

 

Third, findings from some studies indicate that MBSR can alter the function of the brain that is responsible for affect regulation and the areas that govern how we react to stressful impulses, and this in turn may normalize body functions such as breathing, heart rate, and immune function.[29,30] Mindfulness practice reduces reactivity to distressing thoughts and feelings that comorbid and strengthen pain perception.[31] Also mindfulness may lessen psychophysiological activation related to stress and mood dysfunction by strengthening positive reappraisal and emotion regulation skills.[32]

 

The strength of this study is the use of a new effective psychotherapy in reducing the stress on a complaint that is less studied, but it is a common medical problem. The implications of our study are using a simple psychotherapy that does not make too much cognitive demand and is readily usable as a coping skill for the patient with tension headache. Therefore, the health-care professionals related to this complaint and the patient will be able to use this treatment. Also, MBSR will change the patient’s lifestyle who would be exacerbated by his/her problem. The main limitation of this study was the lack of comparison between MBSR and the gold standard psychotherapies such as cognitive behavior therapy (CBT). It is suggested that future studies need to compare the efficacy of MBSR and other traditional and newer cognitive behavioral therapies in patients with tension headache.

 

Conclusion

 

Our study supports the hypothesis that patients suffering from tension headache can enhance their general mental health by participating in the MBSR program. In summary, the results of the present study suggest that MBSR can reduce pain-related anxiety and interference in daily activities in the short term. The unique features of mindfulness exercises are easy training and no need to complex cognitive abilities.

 

Financial support and sponsorship: Nil.

 

Conflicts of interest: There are no conflicts of interest.

 

Author’s Contribution

 

AO contributed in the conception of the work, conducting the study, and agreed for all aspects of the work. FZ contributed in the conception of the work, revising the draft, approval of the final version of the manuscript and agreed for all aspects of the work.

 

Acknowledgments

 

Authors are grateful to the staff of Shahid Beheshti Hospital and participants. Authors also express their gratitude to Kabat-Zinn from the Center for Mindfulness (CFM) at the University of Massachusetts who graciously provided electronic copies of the MBSR guidelines.

 

In conclusion, while short-term stress is helpful, long-term stress can eventually lead to a variety of health issues, including anxiety and depression as well as neck and back pain, headache and disc herniation. Fortunately, mindfulness interventions, such as chiropractic care and mindfulness-based stress reduction (MBSR) are safe and effective stress management alternative treatment options. Finally, the article above demonstrated evidence-based results that MBSR could reduce stress and improve general mental health in patients with tension headache. Information referenced from the National Center for Biotechnology Information (NCBI). The scope of our information is limited to chiropractic as well as to spinal injuries and conditions. To discuss the subject matter, please feel free to ask Dr. Jimenez or contact us at 915-850-0900 .

 

Curated by Dr. Alex Jimenez

 

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Additional Topics: Back Pain

 

According to statistics, approximately 80% of people will experience symptoms of back pain at least once throughout their lifetimes. Back pain is a common complaint which can result due to a variety of injuries and/or conditions. Often times, the natural degeneration of the spine with age can cause back pain. Herniated discs occur when the soft, gel-like center of an intervertebral disc pushes through a tear in its surrounding, outer ring of cartilage, compressing and irritating the nerve roots. Disc herniations most commonly occur along the lower back, or lumbar spine, but they may also occur along the cervical spine, or neck. The impingement of the nerves found in the low back due to injury and/or an aggravated condition can lead to symptoms of sciatica.

 

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EXTRA IMPORTANT TOPIC: Managing Workplace Stress

 

 

MORE IMPORTANT TOPICS: EXTRA EXTRA: Car Accident Injury Treatment El Paso, TX Chiropractor

 

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Cognitive-Behavioral Therapy for Auto Accident Injuries in El Paso, TX

Cognitive-Behavioral Therapy for Auto Accident Injuries in El Paso, TX

Being involved in an automobile accident is an undesirable situation which can result in a variety of physical trauma or injury as well as lead to the development of a number of aggravating conditions. Auto accident injuries, such as whiplash, can be characterized by painful symptoms, including chronic neck pain, however, recent research studies have found that emotional distress resulting from an auto collision could manifest into physical symptoms. Stress, anxiety, depression and post traumatic stress disorder, or PTSD, are common psychological issues which may occur as a result of an automobile accident.

 

The researchers of the research studies also determined that cognitive-behavioral therapy may be an effective treatment for emotional distress and psychological issues which may have developed as a result of the auto accident injuries. Additionally, auto accident injuries may also cause stress, anxiety, depression and even PTSD if left untreated for an extended amount of time. The purpose of the article below is to demonstrate the effects of cognitive-behavioral therapy, together with alternative treatment options like chiropractic care and physical therapy. for auto accident injuries, such as whiplash.

 

Neck Exercises, Physical and Cognitive Behavioural-Graded Activity as a Treatment for Adult Whiplash Patients with Chronic Neck Pain: Design of a Randomised Controlled Trial

 

Abstract

 

Background

 

Many patients suffer from chronic neck pain following a whiplash injury. A combination of cognitive, behavioural therapy with physiotherapy interventions has been indicated to be effective in the management of patients with chronic whiplash-associated disorders. The objective is to present the design of a randomised controlled trial (RCT) aimed at evaluating the effectiveness of a combined individual physical and cognitive behavioural-graded activity program on self-reported general physical function, in addition to neck function, pain, disability and quality of life in patients with chronic neck pain following whiplash injury compared with a matched control group measured at baseline and 4 and 12 months after baseline.

 

Methods/Design

 

The design is a two-centre, RCT-study with a parallel group design. Included are whiplash patients with chronic neck pain for more than 6 months, recruited from physiotherapy clinics and an out-patient hospital department in Denmark. Patients will be randomised to either a pain management (control) group or a combined pain management and training (intervention)group. The control group will receive four educational sessions on pain management, whereas the intervention group will receive the same educational sessions on pain management plus 8 individual training sessions for 4 months, including guidance in specific neck exercises and an aerobic training programme. Patients and physiotherapists are aware of the allocation and the treatment, while outcome assessors and data analysts are blinded. The primary outcome measures will be Medical Outcomes Study Short Form 36 (SF36), Physical Component Summary (PCS). Secondary outcomes will be Global Perceived Effect (-5 to +5), Neck Disability Index (0-50), Patient Specific Functioning Scale (0-10), numeric rating scale for pain bothersomeness (0-10), SF-36 Mental Component Summary (MCS), TAMPA scale of Kinesiophobia (17-68), Impact of Event Scale (0-45), EuroQol (0-1), craniocervical flexion test (22 mmHg – 30 mmHg), joint position error test and cervical range of movement. The SF36 scales are scored using norm-based methods with PCS and MCS having a mean score of 50 with a standard deviation of 10.

 

Discussion

 

The perspectives of this study are discussed, in addition to the strengths and weaknesses.

 

Trial registration

 

The study is registered in http://www.ClinicalTrials.gov identifier NCT01431261.

 

Background

 

The Danish National Board of Health estimates that 5-6,000 subjects per year in Denmark are involved in a traffic accident evoking whiplash-induced neck pain. About 43% of those will still have physical impairment and symptoms 6 months after the accident [1]. For Swedish society, including Swedish insurance companies, the economic burden is approximately 320 million Euros [2], and this burden is likely to be comparable to that of Denmark. Most studies suggest that patients with Whiplash-Associated Disorders (WAD) report chronic neck symptoms one year after the injury [3]. The main problems in whiplash patients with chronic neck pain are cervical dysfunction and abnormal sensory processing, reduced neck mobility and stability, impaired cervicocephalic kinaesthetic sense, in addition to local and possibly generalised pain [4,5]. Cervical dysfunction is characterised by reduced function of the deep stabilising muscles of the neck.

 

Besides chronic neck pain, patients with WAD may suffer from physical inactivity as a consequence of prolonged pain [6,7]. This influences physical function and general health and can result in a poor quality of life. In addition, WAD patients may develop chronic pain followed by sensitisation of the nervous system [8,9], a lowering of the threshold for different sensory inputs (pressure, cold, warm, vibration and electrical impulses) [10]. This can be caused by an impaired central pain inhibition [11] – a cortical reorganisation [12]. Besides central sensitisation, the group with WAD may have poorer coping strategies and cognitive functions, compared with patients with chronic neck pain in general [13-15].

 

Studies have shown that physical training, including specific exercises targeting the deep postural muscles of the cervical spine, is effective in reducing neck pain [16-18] for patients with chronic neck pain, albeit there is a variability in the response to training with not every patient showing a major change. Physical behavioural-graded activity is a treatment approach with a focus on increasing general physical fitness, reducing fear of movement and increasing psychological function [19,20]. There is insufficient evidence for the long-term effect of treatment of physical and cognitive behavioural-graded activity, especially in chronic neck pain patients. Educational sessions, where the focus is on understanding complex chronic pain mechanisms and development of appropriate pain coping and/or cognitive behavioural strategies, have shown reduced general pain [6,21-26]. A review indicated that interventions with a combination of cognitive, behavioural therapy with physiotherapy including neck exercises is effective in the management of WAD patients with chronic neck pain [27], as also recommended by the Dutch clinical guidelines for WAD [28]. However, the conclusions regarding the guidelines are largely based on studies performed on patients with either acute or sub-acute WAD [29]. A more strict conclusion was drawn for WAD patients with chronic pain in the Bone and Joint Decade 2000-2010 Task Force, stating, that ‘because of conflicting evidence and few high-quality studies, no firm conclusions could be drawn about the most effective non-invasive interventions for patients with chronic WAD” [29,30]. The concept of combined treatment for WAD patients with chronic pain has been used in a former randomised controlled trial [31]. The results indicated that a combination of non-specific aerobic exercises and advice containing standardised pain education and reassurance and encouragement to resume light activity, produced better outcomes than advice alone for patients with WAD 3 months after the accident. The patients showed improvements in pain intensity, pain bothersomeness and functions in daily activities in the group receiving exercise and advice, compared with advice alone. However, the improvements were small and only apparent in the short term.

 

This project is formulated on the expectation that rehabilitation of WAD patients with chronic neck pain must target cervical dysfunctions, training of physical function and the understanding and management of chronic pain in a combined therapy approach. Each single intervention is based upon former studies that have shown effectiveness [6,18,20,32]. This study is the first to also include the long-term effect of the combined approach in patients with chronic neck pain after whiplash trauma. As illustrated in Figure ​Figure1,1, the conceptual model in this study is based upon the hypothesis that training (including both individually-guided specific neck exercises and graded aerobic training) and education in pain management (based on a cognitive behavioural approach) is better for increasing the patients’ physical quality of life, compared with education in pain management alone. Increasing the physical quality of life includes increasing the general physical function and level of physical activity, decreasing fear of movement, reducing post-traumatic stress symptoms, reducing neck pain and increasing neck function. The effect is anticipated to be found immediately after the treatment (i.e. 4 months; short-term effect) as well as after one year (long-term effect).

 

Figure 1 Hypothesis of the Intervention Effect

Figure 1: Hypothesis of the intervention effect for patients with chronic neck pain after a whiplash accident.

 

Using a randomised controlled trial (RCT) design, the aim of this study is to evaluate the effectiveness of: graded physical training, including specific neck exercises and general aerobic training, combined with education in pain management (based on a cognitive behavioural approach) versus education in pain management (based on a cognitive behavioural approach), measured on physical quality of life’, physical function, neck pain and neck functions, fear of movement, post-traumatic symptoms and mental quality of life, in patients with chronic neck pain after whiplash injury.

 

Methods/Design

 

Trial Design

 

The study is conducted in Denmark as an RCT with a parallel group design. It will be a two-centre study, stratified by recruitment location. Patients will be randomised to either the Pain Management group (control) or the Pain Management and Training group (intervention). As illustrated in Figure ​Figure2,2, the study is designed to include a secondary data assessment 12 months after baseline; the primary outcome assessment will be performed immediately after the intervention program 4 months after baseline. The study utilises an allocation concealment process, ensuring that the group to which the patient is allocated is not known before the patient is entered into the study. The outcome assessors and data analysts will be kept blinded to the allocation to intervention or control group.

 

Figure 2 Flowchart of the Patients in the Study

Figure 2: Flowchart of the patients in the study.

 

Settings

 

The participants will be recruited from physiotherapy clinics in Denmark and from The Spine Centre of Southern Denmark, Hospital Lillebælt via an announcement at the clinics and the Hospital. Using physiotherapy clinics spread across Denmark, the patients will receive the intervention locally. The physiotherapy clinics in Denmark receive patients via referral from their general practitioners. The Spine Centre, a unit specialising in treating patients with musculoskeletal dysfunctions and only treating out-patients, receives patients referred from general practitioners and/or chiropractors.

 

Study Population

 

Two hundred adults with a minimum age of 18 years, receiving physiotherapy treatment or having been referred for physiotherapy treatment will be recruited. For patients to be eligible, they must have: chronic neck pain for at least 6 months following a whiplash injury, reduced physical neck function (Neck Disability Index score, NDI, of a minimum of 10), pain primarily in the neck region, finished any medical /radiological examinations, the ability to read and understand Danish and the ability to participate in the exercise program. The exclusion criteria include: neuropathies/ radiculopathies (clinically tested by: positive Spurling, cervical traction and plexus brachialis tests) [33], neurological deficits (tested as in normal clinical practice through a process of examining for unknown pathology), engagement in experimental medical treatment, being in an unstable social and/or working situation, pregnancy, known fractures, depression according to the Beck Depression Index (score > 29) [18,34,35], or other known coexisting medical conditions which could severely restrict participation in the exercise program. The participants will be asked not to seek other physiotherapy or cognitive treatment during the study period.

 

Intervention

 

Control

 

The Pain Management (control) group will receive education in pain management strategies. There will be 4 sessions of 11/2 hours, covering topics regarding pain mechanisms, acceptance of pain, coping strategies, and goal-setting, based upon pain management and cognitive therapy concepts [21,26,36].

 

Intervention

 

The Pain Management plus Training (intervention) group will receive the same education in pain management as those in the control group plus 8 treatment sessions (instruction in neck exercises and aerobic training) with the same period of 4 months length. If the treating physiotherapist estimates additional treatments are needed, the treatment can be extended with 2 more sessions. Neck training: The treatment of neck-specific exercises will be progressed through different phases, which are defined by set levels of neck function. At the first treatment session, patients are tested for cervical neuromuscular function to identify the specific level at which to start neck training. A specific individually tailored exercise program will be used to target the neck flexor and extensor muscles. The ability to activate the deep cervical neck flexor muscles of the upper cervical region to increase their strength, endurance and stability function is trained progressively via the craniocervical training method using a biopressure feedback transducer [18,37]. Exercises for neck-eye coordination, neck joint positioning, balance and endurance training of the neck muscles will be included as well, since it has been shown to reduce pain and improve sensorimotor control in patients with insidious neck pain [17,38]. Aerobic training: The large trunk and leg muscles will be trained with a gradually increasing physical training program. Patients will be allowed to select activities such as walking, cycling, stick walking, swimming, and jogging. The baseline for training duration is set by exercising 3 times at a comfortable level, that does not exacerbate pain and aims at a rated perceived exertion (RPE) level of between 11 and 14 on a Borg scale [39]. The initial duration of training is set 20% below the average time of the three trials. Training sessions are carried out every second day with a prerequisite that pain is not worsened, and that RPE is between 9 and 14. A training diary is used. If patients do not experience a relapse, and report an average RPE value of 14 or less, the exercise duration for the following period (1 or 2 weeks) is increased by 2-5 minutes, up to a maximum of 30 minutes. If the RPE level is 15 or higher, the exercise duration will be reduced to an average RPE score of 11 to 14 every fortnight [20,40]. By using these pacing principles, the training will be graded individually by the patient, with a focus on perceived exertion – with the aim of increasing the patient’ s general physical activity level and fitness.

 

Patients’ compliance will be administered by registration of their participation in the control and intervention group. The patients in the control group will be considered to have completed the pain management if they have attended 3 out of 4 sessions. The patiesnts in the intervention group will be considered to have completed if the patient has attended a minimum of 3 out of 4 pain management sessions and a minimum of 5 out of 8 trainings sessions. Each patient’s home training with neck exercises and aerobic training will be registered by him/her in a logbook. Compliance with 75% of the planned home training will be considered as having completed the intervention.

 

Physiotherapists

 

The participating physiotherapists will be recruited via an announcement in the Danish Physiotherapy Journal. The inclusion criteria consist of: being a qualified physiotherapist, working at a clinic and having at least two years of working experience as a physiotherapist, having attended a course in the described intervention and passed the related exam.

 

Outcome Measures

 

At baseline the participants’ information on age, gender, height and weight, type of accident, medication, development of symptoms over the last two months (status quo, improving, worsening), expectation of treatment, employment and educational status will be registered. As a primary outcome measure, Medical Outcomes Study Short Form 36 (SF36) – Physical Component Summary (PCS) will be used [41,42]. The PCS scales are scored using norm-based methods [43,44] with a mean score of 50 with a standard deviation of 10. The primary outcome with respect to having an effect, will be calculated as a change from baseline [45]. Secondary outcomes contain data on both clinical tests and patient-reported outcomes. Table ​Table11 presents clinical tests for measuring the intervention effect on neuromuscular control of the cervical muscles, cervical function and mechanical allodynia. Table ​Table22 presents the patient-related outcomes from questionnaires used to test for perceived effect of the treatment, neck pain and function, pain bothersomeness, fear of movement, post-traumatic stress and quality of life and potential treatment modifiers.

 

Table 1 Clinical Outcomes Used for Measurement of Treatment Effect

Table 1: Clinical outcomes used for measurement of treatment effect on muscle strategy, function and treatment modifiers.

 

Table 2 Patient Reported Outcomes Used for Measured of Treatment Effect

Table 2: Patient reported outcomes used for measured of treatment effect on pain and function.

 

Patients will be tested at baseline, 4 and 12 months after baseline, except for GPE, which will only be measured 4 and 12 months after baseline.

 

Power and Sample Size Estimation

 

The power and sample size calculation is based on the primary outcome, being SF36-PCS 4 months after baseline. For a two-sample pooled t-test of a normal mean difference with a two-sided significance level of 0.05, assuming a common SD of 10, a sample size of 86 per group is required to obtain a power of at least 90% to detect a group mean difference of 5 PCS points [45]; the actual power is 90.3%, and the fractional sample size that achieves a power of exactly 90% is 85.03 per group. In order to adjust for an estimated 15% withdrawal during the study period of 4 months, we will include 100 patients in each group. For sensitivity, three scenarios were applied: firstly, anticipating that all 2 × 100 patients complete the trial, we will have sufficient power (> 80%) to detect a group mean difference as low as 4 PCS points; secondly, we will be able to detect a statistically significant group mean difference of 5 PCS points with sufficient power (> 80%) even with a pooled SD of 12 PCS points. Thirdly and finally, if we aim for a group mean difference of 5 PCS points, with a pooled SD of 10, we will have sufficient power (> 80%) with only 64 patients in each group. However, for logistical reasons, new patients will no longer be included in the study 24 months after the first patient has been included.

 

Randomisation, Allocation and Blinding Procedures

 

After the baseline assessment, the participants are randomly assigned to either the control group or the intervention group. The randomisation sequence is created using SAS (SAS 9.2 TS level 1 M0) statistical software and is stratified by centre with a 1:1 allocation using random block sizes of 2, 4, and 6. The allocation sequence will be concealed from the researcher enrolling and assessing participants in sequentially numbered, opaque, sealed and stapled envelopes. Aluminium foil inside the envelope will be used to render the envelope impermeable to intense light. After revealing the content of the envelope, both patients and physiotherapists are aware of the allocation and the corresponding treatment. Outcome assessors and data analysts are however kept blinded. Prior to the outcome assessments, the patients will be asked by the research assistant not to mention the treatment to which they have been allocated.

 

Statistical Analysis

 

All the primary data analyses will be carried out according to a pre-established analysis plan; all analyses will be done applying SAS software (v. 9.2 Service Pack 4; SAS Institute Inc., Cary, NC, USA). All descriptive statistics and tests are reported in accordance with the recommendations of the ‘Enhancing the QUAlity and Transparency Of health Research’ (EQUATOR) network; i.e., various forms of the CONSORT statement [46]. Data will be analysed using a two-factor Analysis of Covariance (ANCOVA), with a factor for Group and a factor for Gender, using the baseline value as covariate to reduce the random variation, and increase the statistical power. Unless stated otherwise, results will be expressed as the difference between the group means with 95% confidence intervals (CIs) and associated p-values, based on a General Linear Model (GLM) procedure. All the analyses will be performed using the Statistical Package for Social Sciences (version 19.0.0, IBM, USA) as well as the SAS system (v. 9.2; SAS Institute Inc., Cary, NC, USA). A two-way analysis of variance (ANOVA) with repeated measures (Mixed model) will be performed to test the difference over time between the intervention and the control groups; interaction: Group × Time. An alpha-level of 0.05 will be considered as being statistically significant (p < 0.05, two- sided). The data analysts will be blinded to the allocated interventions for primary analyses.

 

The baseline scores for the primary and secondary outcomes will be used to compare the control and intervention groups. The statistical analyses will be performed on the basis of the intention-to-treat principle, i.e. patients will be analysed in the treatment group to which they were randomly allocated. In the primary analyses, missing data will be replaced with the feasible and transparent ‘Baseline Observation Carried Forward’ (BOCF) technique, and for sensitivity also a multiple imputation technique will apply.

 

Secondarily, to relate the results to compliance, a ‘per protocol’ analysis will be used as well. The ‘per protocol’ population he patients who have ‘completed’ the intervention to which they were allocated, according to the principles described in the intervention section above.

 

Ethical Considerations

 

The Regional Scientific Ethical Committee of Southern Denmark approved the study (S-20100069). The study conformed to The Declaration of Helsinki 2008 [47] by fulfilling all general ethical recommendations.

 

All subjects will receive information about the purpose and content of the project and give their oral and written consent to participate, with the possibility to drop out of the project at any time.

 

Dr Jimenez White Coat

Dr. Alex Jimenez’s Insight

Managing stress, anxiety, depression and symptoms of post traumatic stress disorder, or PTSD, after being involved in an automobile accident can be difficult, especially if the incident caused physical trauma and injuries or aggravated a previously existing condition. In many cases, the emotional distress and the psychological issues caused by the incident may be the source of the painful symptoms. In El Paso, TX, many veterans with PTSD visit my clinic after manifesting worsening symptoms from a previous auto accident injury. Chiropractic care can provide patients the proper stress management environment they need to improve their physical and emotional symptoms. Chiropractic care can also treat a variety of auto accident injuries, including whiplash, head and neck injuries, herniated disc and back injuries.

 

Discussion

 

This study will contribute to a better understanding of treating patients with chronic neck pain following a whiplash accident. The knowledge from this study can be implemented into clinical practice, as the study is based on a multimodal approach, mirroring the approach, which in spite of the current lack of evidence, is often used in a clinical physiotherapy setting. The study may also be included in systematic reviews thereby contributing to updating the knowledge about this population and to enhancing evidence-based treatment.

 

Publishing the design of a study before the study is performed and the results obtained has several advantages. It allows the design to be finalised without its being influenced by the outcomes. This can assist in preventing bias as deviations from the original design can be identified. Other research projects will have the opportunity to follow a similar approach with respect to population, interventions, controls and outcome measurements. The challenges of this study are related to standardising the interventions, treating a non-homogeneous population, defining and standardising relevant outcome measures on a population with long-lasting symptoms and having a population from two different clinical settings. Standardisation of the interventions is obtained by teaching the involved physiotherapists in an instructional course. Population homogeneity will be handled by strict inclusion and exclusion criteria and by monitoring the baseline characteristics of the patients, and differences between groups based on other influences than the intervention/control will be possible to analyse statistically. This research design is composed as an ‘add-on’ design: both groups receive pain education; the intervention group receives additional physical training, including specific neck exercises and general training. Today there is insufficient evidence for the effect of treatment for patients with chronic neck pain following a whiplash accident. All participating patients will be referred for a treatment (control or intervention), as we consider it unethical not to offer some form of treatment, i.e. randomising the control group to a waiting list. The add-on design is chosen as a pragmatic workable solution in such a situation [48].

 

For whiplash patients with chronic pain, the most responsive disability measures (for the individual patient, not for the group as a whole) are considered to be the Patient Specific Functional Scale and the numerical rating scale of pain bothersomeness [49]. By using these and NDI (the most often used neck disability measure) as secondary outcome measures, it is anticipated that patient-relevant changes in pain and disability can be evaluated. The population will be recruited from and treated at two different clinical settings: the out-patient clinic of The Spine Centre, Hospital Lillebælt and several private physiotherapy clinics. To avoid any influence of the different settings on the outcome measures, the population will be block randomised related to the settings, securing equal distribution of participants from each setting to the two intervention groups.

 

Competing Interests

 

The authors declare that they have no competing interests.

 

Authors’ Contributions

 

IRH drafted the manuscript. IRH, BJK and KS participated in the design of the study. All contributed to the design. RC, IRH; BJK and KS participated in the power and sample size calculation and in describing the statistical analysis as well as the allocation and randomization procedure. All authors read and approved the final manuscript. Suzanne Capell provided writing assistance and linguistic corrections.

 

Pre-Publication History

 

The pre-publication history for this paper can be accessed here: http://www.biomedcentral.com/1471-2474/12/274/prepub

 

Acknowledgements

 

This study has received funding from the Research Fund for the Region of Southern Denmark, the Danish Rheumatism Association, the Research Foundation of the Danish Association of Physiotherapy, the Fund for Physiotherapy in Private Practice, and the Danish Society of Polio and Accident Victims (PTU). The Musculoskeletal Statistics Unit at the Parker Institute is supported by grants from the Oak Foundation. Suzanne Capell provided writing assistance and linguistic correction.

 

The trial is registered in http://www.ClinicalTrials.gov identifier NCT01431261.

 

A Randomized Controlled Trial of Cognitive-Behavioral Therapy for the Treatment of PTSD in the context of Chronic Whiplash

 

Abstract

 

Objectives

 

Whiplash-associated disorders (WAD) are common and involve both physical and psychological impairments. Research has shown that persistent posttraumatic stress symptoms are associated with poorer functional recovery and physical therapy outcomes. Trauma-focused cognitive-behavioral therapy (TF-CBT) has shown moderate effectiveness in chronic pain samples. However, to date, there have been no clinical trials within WAD. Thus, this study will report on the effectiveness of TF-CBT in individuals meeting the criteria for current chronic WAD and posttraumatic stress disorder (PTSD).

 

Method

 

Twenty-six participants were randomly assigned to either TF-CBT or a waitlist control, and treatment effects were evaluated at posttreatment and 6-month follow-up using a structured clinical interview, self-report questionnaires, and measures of physiological arousal and sensory pain thresholds.

 

Results

 

Clinically significant reductions in PTSD symptoms were found in the TF-CBT group compared with the waitlist at postassessment, with further gains noted at the follow-up. The treatment of PTSD was also associated with clinically significant improvements in neck disability, physical, emotional, and social functioning and physiological reactivity to trauma cues, whereas limited changes were found in sensory pain thresholds.

 

Discussion

 

This study provides support for the effectiveness of TF-CBT to target PTSD symptoms within chronic WAD. The finding that treatment of PTSD resulted in improvements in neck disability and quality of life and changes in cold pain thresholds highlights the complex and interrelating mechanisms that underlie both WAD and PTSD. Clinical implications of the findings and future research directions are discussed.

 

In conclusion, being involved in an automobile accident is an undesirable situation which can result in a variety of physical trauma or injury as well as lead to the development of a number of aggravating conditions. However, stress, anxiety, depression and post traumatic stress disorder, or PTSD, are common psychological issues which may occur as a result of an automobile accident. According to research studies, physical symptoms and emotional distress may be closely connected and treating both physical and emotional injuries could help patients achieve overall health and wellness. Information referenced from the National Center for Biotechnology Information (NCBI). The scope of our information is limited to chiropractic as well as to spinal injuries and conditions. To discuss the subject matter, please feel free to ask Dr. Jimenez or contact us at 915-850-0900 .

 

Curated by Dr. Alex Jimenez

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Additional Topics: Back Pain

 

According to statistics, approximately 80% of people will experience symptoms of back pain at least once throughout their lifetimes. Back pain is a common complaint which can result due to a variety of injuries and/or conditions. Often times, the natural degeneration of the spine with age can cause back pain. Herniated discs occur when the soft, gel-like center of an intervertebral disc pushes through a tear in its surrounding, outer ring of cartilage, compressing and irritating the nerve roots. Disc herniations most commonly occur along the lower back, or lumbar spine, but they may also occur along the cervical spine, or neck. The impingement of the nerves found in the low back due to injury and/or an aggravated condition can lead to symptoms of sciatica.

 

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EXTRA IMPORTANT TOPIC: Managing Workplace Stress

 

 

MORE IMPORTANT TOPICS: EXTRA EXTRA: Car Accident Injury Treatment El Paso, TX Chiropractor

 

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References

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30. Hurwitz EL, Carragee EJ, van dV, Carroll LJ, Nordin M, Guzman J, Peloso PM, Holm LW, Cote P, Hogg-Johnson S. et al. Treatment of neck pain: noninvasive interventions: results of the Bone and Joint Decade 2000-2010 Task Force on Neck Pain and Its Associated Disorders. Spine. 2008;12(4 Suppl):S123–S152. [PubMed] 31. Stewart MJ, Maher CG, Refshauge KM, Herbert RD, Bogduk N, Nicholas M. Randomized controlled trial of exercise for chronic whiplash-associated disorders. Pain. 2007;12(1-2):59–68. doi: 10.1016/j.pain.2006.08.030. [PubMed] [Cross Ref] 32. Ask T, Strand LI, Sture SJ. The effect of two exercise regimes; motor control versus endurance/strength training for patients with whiplash-associated disorders: a randomized controlled pilot study. ClinRehabil. 2009;12(9):812–823. [PubMed] 33. Rubinstein SM, Pool JJ, van Tulder MW, Riphagen II, de Vet HC. A systematic review of the diagnostic accuracy of provocative tests of the neck for diagnosing cervical radiculopathy. EurSpine J. 2007;12(3):307–319. [PMC free article] [PubMed] 34. Peolsson M, Borsbo B, Gerdle B. Generalized pain is associated with more negative consequences than local or regional pain: a study of chronic whiplash-associated disorders7. JRehabilMed. 2007;12(3):260–268. [PubMed] 35. Beck AT, Ward CH, Mendelson M, Mock J, Erbaugh J. An inventory for measuring depression. ArchGenPsychiatry. 1961;12:561–571. [PubMed] 36. Wicksell RK, Ahlqvist J, Bring A, Melin L, Olsson GL. Can exposure and acceptance strategies improve functioning and life satisfaction in people with chronic pain and whiplash-associated disorders (WAD)? A randomized controlled trial. Cogn BehavTher. 2008;12(3):169–182. [PubMed] 37. Falla D, Jull G, Dall’Alba P, Rainoldi A, Merletti R. An electromyographic analysis of the deep cervical flexor muscles in performance of craniocervical flexion. PhysTher. 2003;12(10):899–906. [PubMed] 38. Palmgren PJ, Sandstrom PJ, Lundqvist FJ, Heikkila H. Improvement after chiropractic care in cervicocephalic kinesthetic sensibility and subjective pain intensity in patients with nontraumatic chronic neck pain. JManipulative Physiol Ther. 2006;12(2):100–106. doi: 10.1016/j.jmpt.2005.12.002. [PubMed] [Cross Ref] 39. Borg G. Psychophysical scaling with applications in physical work and the perception of exertion. ScandJWork EnvironHealth. 1990;12(Suppl 1):55–58. [PubMed] 40. Wallman KE, Morton AR, Goodman C, Grove R. Exercise prescription for individuals with chronic fatigue syndrome. MedJAust. 2005;12(3):142–143. [PubMed] 41. McCarthy MJ, Grevitt MP, Silcocks P, Hobbs G. The reliability of the Vernon and Mior neck disability index, and its validity compared with the short form-36 health survey questionnaire. EurSpine J. 2007;12(12):2111–2117. [PMC free article] [PubMed] 42. Bjorner JB, Damsgaard MT, Watt T, Groenvold M. Tests of data quality, scaling assumptions, and reliability of the Danish SF-36. JClinEpidemiol. 1998;12(11):1001–1011. [PubMed] 43. Ware JE Jr, Kosinski M, Bayliss MS, McHorney CA, Rogers WH, Raczek A. Comparison of methods for the scoring and statistical analysis of SF-36 health profile and summary measures: summary of results from the Medical Outcomes Study. MedCare. 1995;12(4 Suppl):AS264–AS279. [PubMed] 44. Ware JE Jr. SF-36 health survey update. Spine (Phila Pa 1976) 2000;12(24):3130–3139. doi: 10.1097/00007632-200012150-00008. [PubMed] [Cross Ref] 45. Carreon LY, Glassman SD, Campbell MJ, Anderson PA. Neck Disability Index, short form-36 physical component summary, and pain scales for neck and arm pain: the minimum clinically important difference and substantial clinical benefit after cervical spine fusion. Spine J. 2010;12(6):469–474. doi: 10.1016/j.spinee.2010.02.007. [PubMed] [Cross Ref] 46. Moher D, Hopewell S, Schulz KF, Montori V, Gotzsche PC, Devereaux PJ, Elbourne D, Egger M, Altman DG. CONSORT 2010 Explanation and Elaboration: Updated guidelines for reporting parallel group randomised trials. JClinEpidemiol. 2010;12(8):e1–37. [PubMed] 47. Subjects WDoH-EPfMRIH. WORLD MEDICAL ASSOCIATION DECLARATION OF HELSINKI. WMA Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects. 2008.
48. Dworkin RH, Turk DC, Peirce-Sandner S, Baron R, Bellamy N, Burke LB, Chappell A, Chartier K, Cleeland CS, Costello A. et al. Research design considerations for confirmatory chronic pain clinical trials: IMMPACT recommendations. Pain. 2010;12(2):177–193. doi: 10.1016/j.pain.2010.02.018. [PubMed] [Cross Ref] 49. Stewart M, Maher CG, Refshauge KM, Bogduk N, Nicholas M. Responsiveness of pain and disability measures for chronic whiplash. Spine (Phila Pa 1976) 2007;12(5):580–585. doi: 10.1097/01.brs.0000256380.71056.6d. [PubMed] [Cross Ref] 50. Jull GA, O’Leary SP, Falla DL. Clinical assessment of the deep cervical flexor muscles: the craniocervical flexion test. JManipulative Physiol Ther. 2008;12(7):525–533. doi: 10.1016/j.jmpt.2008.08.003. [PubMed] [Cross Ref] 51. Revel M, Minguet M, Gregoy P, Vaillant J, Manuel JL. Changes in cervicocephalic kinesthesia after a proprioceptive rehabilitation program in patients with neck pain: a randomized controlled study. ArchPhysMedRehabil. 1994;12(8):895–899. [PubMed] 52. Heikkila HV, Wenngren BI. Cervicocephalic kinesthetic sensibility, active range of cervical motion, and oculomotor function in patients with whiplash injury. ArchPhysMedRehabil. 1998;12(9):1089–1094. [PubMed] 53. Treleaven J, Jull G, Grip H. Head eye co-ordination and gaze stability in subjects with persistent whiplash associated disorders. Man Ther. 2010. [PubMed] 54. Williams MA, McCarthy CJ, Chorti A, Cooke MW, Gates S. A systematic review of reliability and validity studies of methods for measuring active and passive cervical range of motion. JManipulative Physiol Ther. 2010;12(2):138–155. doi: 10.1016/j.jmpt.2009.12.009. [PubMed] [Cross Ref] 55. Kasch H, Qerama E, Kongsted A, Bach FW, Bendix T, Jensen TS. Deep muscle pain, tender points and recovery in acute whiplash patients: a 1-year follow-up study. Pain. 2008;12(1):65–73. doi: 10.1016/j.pain.2008.07.008. [PubMed] [Cross Ref] 56. Sterling M. Testing for sensory hypersensitivity or central hyperexcitability associated with cervical spine pain. JManipulative Physiol Ther. 2008;12(7):534–539. doi: 10.1016/j.jmpt.2008.08.002. [PubMed] [Cross Ref] 57. Ettlin T, Schuster C, Stoffel R, Bruderlin A, Kischka U. A distinct pattern of myofascial findings in patients after whiplash injury. ArchPhysMedRehabil. 2008;12(7):1290–1293. [PubMed] 58. Vernon H, Mior S. The Neck Disability Index: a study of reliability and validity. JManipulative Physiol Ther. 1991;12(7):409–415. [PubMed] 59. Vernon H. The Neck Disability Index: state-of-the-art, 1991-2008. JManipulative Physiol Ther. 2008;12(7):491–502. doi: 10.1016/j.jmpt.2008.08.006. [PubMed] [Cross Ref] 60. Vernon H, Guerriero R, Kavanaugh S, Soave D, Moreton J. Psychological factors in the use of the neck disability index in chronic whiplash patients. Spine (Phila Pa 1976) 2010;12(1):E16–E21. doi: 10.1097/BRS.0b013e3181b135aa. [PubMed] [Cross Ref] 61. Sterling M, Kenardy J, Jull G, Vicenzino B. The development of psychological changes following whiplash injury. Pain. 2003;12(3):481–489. doi: 10.1016/j.pain.2003.09.013. [PubMed] [Cross Ref] 62. Stalnacke BM. Relationship between symptoms and psychological factors five years after whiplash injury. JRehabilMed. 2009;12(5):353–359. [PubMed] 63. Rabin R, de CF. EQ-5D: a measure of health status from the EuroQol Group. AnnMed. 2001;12(5):337–343. [PubMed] 64. Borsbo B, Peolsson M, Gerdle B. Catastrophizing, depression, and pain: correlation with and influence on quality of life and health – a study of chronic whiplash-associated disorders4. JRehabilMed. 2008;12(7):562–569. [PubMed]

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Mindfulness Interventions for Auto Accident Injuries in El Paso, TX

Mindfulness Interventions for Auto Accident Injuries in El Paso, TX

When you’ve been involved in a car crash, the auto accident injuries resulting from the incident may not always have a physical cause. The emotional distress due to trauma or injury from the impact of an automobile accident may often be so immense, it can lead to a variety of painful symptoms. If such stress is not treated immediately, it could result in the development of psychological conditions. Stress, anxiety, depression and in severe cases, PTSD, or post traumatic stress disorder, are some of the most common psychological issues you may end up encountering after a traumatic auto accident.

 

Anxiety and Irrational Fears

 

In several cases, the victim of an automobile accident may develop irrational fears as a result of the incident. As a matter of fact, many of these individuals report experiencing anxiety about getting behind the wheel again. For them, the fear of being in another accident may ultimately cause them to avoid driving altogether. For many other individuals still, the irrational fear of suffering a panic attack while on the road may be the cause for them to avert driving entirely. If the anxiety and irrational fears caused by the emotional distress of an auto accident worsen, it may permanently discourage a person from driving again.

 

Depression

 

It is also possible for people who’ve been involved in an auto accident to develop depression following the incident. In the end, you wind up experiencing psychological trauma as a result of physical trauma. There are numerous symptoms of depression which you might readily recognize. These include problems with sleep, losing your appetite, and headaches. As it becomes worse, however, you might end up feeling sad or hopeless all of the time, which could lead to worsening symptoms.

 

Post Traumatic Stress Disorder (PTSD)

 

It’s highly possible for individuals involved in an automobile accident to suffer from post traumatic stress disorder, or PTSD. According to the National Center For PTSD, as much as 9 percent of people who experience auto accident injuries end up suffering from PTSD. Moreover, at least 14 percent of car crash survivors who seek mental health care are experiencing PTSD.

 

A new research study demonstrated that mindfulness interventions might be just as essential to your health as traditional treatment, especially if you’ve got post traumatic stress disorder, or PTSD. Researchers have demonstrated that chiropractic care can lead to a substantial advancement in the mind-body stress component of a patient’s overall health and wellness.

 

 

Chiropractic Care for Auto Accident Injuries

 

Addressing automobile accident injuries, such as whiplash, which also result in anxiety and irrational fears, depression and especially PTSD, demands a multi-disciplinary strategy. Chiropractic is an alternative treatment option which focuses on injuries and/or conditions of the musculoskeletal and nervous system. A chiropractor commonly utilizes spinal adjustments and manual manipulations to carefully correct spinal misalignments, or subluxations, which could be causing pain and discomfort. By releasing pressure and muscle tension, a doctor of chiropractic, or chiropractor, can help reduce stress and emotional distress which could be causing the individual’s anxiety, irrational fears, depression and PTSD. If further help is required, the chiropractor can recommend patients to the best healthcare specialist to help them with their symptoms. The purpose of the following article is to demonstrate the prevalence of PTSD on individuals involved in a traffic collision as well as to show how mindfulness interventions can ultimately help improve as well as manage the stress symptoms people may experience after a car crash.

 

Prediction of Post Traumatic Stress Disorder by Immediate Reactions to Trauma: a Prospective Study in Road Traffic Accident Victims

 

Abstract

 

Road traffic accidents often cause serious physical and psychological sequelae. Specialists of various medical faculties are involved in the treatment of accident victims. Little is known about the factors which might predict psychiatric disorders, e.g. Posttraumatic Stress Disorder (PTSD) after accidents and how psychological problems influence physical treatment. In a prospective study 179 unselected, consecutively admitted road traffic accident victims were assessed a few days after the accident for psychiatric diagnoses, severity of injury and psychopathology. All were inpatients and had to be treated for bone fractures. At 6-months follow-up assessment 152 (85%) of the patients were interviewed again. Of the patients, 18.4% fulfilled the criteria for Posttraumatic Stress Disorder (DSM-III-R) within 6 months after the accident. Patients who developed PTSD were injured more severely and showed more symptoms of anxiety, depression and PTSD a few days after the accident than patients with no psychiatric diagnosis. Patients with PTSD stayed significantly longer in the hospital than the other patients. Multiple regression analysis revealed that the length of hospitalization was due mainly to a diversity of factors such as severity of injury, severity of accident, premorbid personality and psychopathology. Posttraumatic stress disorder is common after road traffic accidents. Patients with PTSD at follow-up can be identified by findings from early assessment. Untreated psychological sequelae such as PTSD cause longer hospitalization and therefore more costs than in non-PTSD patients.

 

 

Trauma-Focused Cognitive Behavior Therapy and Exercise for Chronic Whiplash: Protocol of a Randomized Controlled Trial

 

Abstract

 

  • Introduction: As a consequence of a road traffic crash, persistent pain and disability following whiplash injury are common and incur substantial personal and economic costs. Up to 50% of people who experience a whiplash injury will never fully recover and up to 30% will remain moderately to severely disabled by the condition. The reason as to why symptoms persist past the acute to sub-acute stage and become chronic is unclear, but likely results from complex interactions between structural injury, physical impairments, and psychological and psychosocial factors. Psychological responses related to the traumatic event itself are becoming an increasingly recognised factor in the whiplash condition. Despite this recognition, there is limited knowledge regarding the effectiveness of psychological interventions, either delivered alone or in combination with physiotherapy, in reducing the physical and pain-related psychological factors of chronic whiplash. Pilot study results have shown positive results for the use of trauma-focused cognitive behaviour therapy to treat psychological factors, pain and disability in individuals with chronic whiplash. The results have indicated that a combined approach could not only reduce psychological symptoms, but also pain and disability.
  • Aims: The primary aim of this randomised, controlled trial is to investigate the effectiveness of combined trauma-focused cognitive behavioural therapy, delivered by a psychologist, and physiotherapy exercise to decrease pain and disability of individuals with chronic whiplash and post-traumatic stress disorder (PTSD). The trial also aims to investigate the effectiveness of the combined therapy in decreasing post-traumatic stress symptoms, anxiety and depression.
  • Participants and Setting: A total of 108 participants with chronic whiplash-associated disorder (WAD) grade II of > 3 months and < 5 years duration and PTSD (diagnosed with the Clinician Administered PTSD Scale (CAPS) according to the DSM-5) will be recruited for the study. Participants will be assessed via phone screening and in person at a university research laboratory. Interventions will take place in southeast Queensland, Australia and southern Denmark.
  • Intervention: Psychological therapy will be delivered once a week over 10 weeks, with participants randomly assigned to either trauma-focused cognitive behavioural therapy or supportive therapy, both delivered by a clinical psychologist. Participants will then receive ten sessions of evidence-based physiotherapy exercise delivered over a 6-week period.
  • Outcome Measures: The primary outcome measure is neck disability (Neck Disability Index). Secondary outcomes focus on: pain intensity; presence and severity of PTSD (CAPS V and PTSD Checklist 5); psychological distress (Depression, Anxiety Stress Scale 21); patient perceived functionality (SF-12, Tampa Scale of Kinesiophobia, and Patient-Specific Functional Scale); and pain-specific self-efficacy and catastrophising (Pain Self-Efficacy Questionnaire and Pain Catastrophizing Scale). After psychotherapy (10 weeks after randomisation) and physiotherapy (16 weeks after randomisation), as well as at the 6-month and 12-month follow-ups, a blind assessor will measure the outcomes.
  • Analysis: All analyses will be conducted on an intention-to-treat basis. The primary and secondary outcomes that are measured will be analysed using linear mixed and logistic regression models. Any effect of site (Australia or Denmark) will be evaluated by including a site-by-treatment group-by-time interaction term in the mixed models analyses. Effect modification will only be assessed for the primary outcome of the Neck Disability Index.
  • Discussion: This study will provide a definitive evaluation of the effects of adding trauma-focused cognitive behaviour therapy to physiotherapy exercise for individuals with chronic WAD and PTSD. This study is likely to influence the clinical management of whiplash injury and will have immediate clinical applicability in Australia, Denmark and the wider international community. The study will also have implications for both health and insurance policy makers in their decision-making regarding treatment options and funding.

 

Introduction

 

Persistent pain and disability following whiplash injury as a consequence of a road traffic crash (RTC) is common and incurs substantial personal and economic costs. Up to 50% of people who experience a whiplash injury will never fully recover and up to 30% will remain moderately to severely disabled by the condition [1-3]. Less recognised are the mental health issues that accompany this condition. The prevalence of psychiatric disorders has been shown to be 25% for PTSD, 31% for Major Depressive Episode and 20% for Generalised Anxiety Disorder [4-6]. Whiplash injury accounts for the vast majority of any submitted claims as well as the greatest incurred costs in Queensland compulsory third party scheme [7]. In Australia, Whiplash injuries comprise approximately 75% of all survivable RTC injuries [8] with total costs of more than $950 M per annum [9], exceeding costs for both spinal cord and traumatic brain injury [7]. In Denmark, whiplash costs an estimated 300 million USD per annum if loss of work is included [10].

 

Neck pain is the cardinal symptom of individuals following whiplash injury. It is now generally accepted that there is an initial peripheral injury of some kind to the neck [11] although the specific injured structure in individual patients is difficult to clinically identify with current imaging techniques. The reason as to why symptoms persist past the acute to sub-acute stage and become chronic is not clear but likely results from complex interactions between structural injury, physical impairments, psychological and psychosocial factors [12]. However it is clear that chronic WAD is a heterogeneous and complex condition involving physical impairments such as movement loss, disturbed movement patterns and sensory disturbances [13] as well as pain related psychological responses such as catastrophizing [14, 15], kinesiophobia [16], activity avoidance and poor self-efficacy for pain control [17]. In addition recent studies have shown that posttraumatic stress symptoms or event related distress is common [18-20]. Thus it would seem logical that interventions targeting both the physical and psychological manifestations of the whiplash condition would be of benefit.

 

In contrast to many common musculoskeletal pain conditions (e.g. low back pain, non-specific neck pain) whiplash related neck pain usually occurs following a traumatic event, namely a motor vehicle crash. Psychological responses related to the traumatic event itself, posttraumatic stress symptoms, are emerging as an important additional psychological factor in the whiplash condition. Recent data indicates that post-traumatic stress symptoms are prevalent in individuals who have sustained whiplash injuries following motor vehicle accidents [18, 20, 21]. The early presence of posttraumatic stress symptoms have been shown to be associated with poor functional recovery from the injury [13, 18]. Recent data from our laboratory have shown that following whiplash injury 17% of individuals will follow a trajectory of initial moderate/severe posttraumatic stress symptoms that persist for at least 12 months and 43% will follow a trajectory of moderate initial symptoms that decrease but remain at mild to moderate (sub-clinical) levels for at least 12 months (the duration of the study) [4]. See Figure 1. These figures are significant as they are similar to the prevalence of PTSD in individuals admitted to hospital following ‘more severe’ motor vehicle injuries [22].

 

Figure 1 Data from Whiplash Injured Participants

Figure 1: Data from 155 whiplash injured participants measured at 1, 3, 6 & 12 months post-accident. The Posttraumatic Stress Diagnostic Scale (PDS) was measured at each time point. Group based trajectory modelling identified 3 distinct clinical pathways (trajectories). 1. Chronic moderate/severe (17%) 2. Recovering: initial moderate levels of posttraumatic stress decreasing to mild/ moderate levels. 3. Resilient: negligible symptoms throughout2. PDS symptom score Cut-offs: 1–10 mild, 11–20 moderate, 21–35.

 

Although chronic WAD is a considerable health problem the number of published randomized controlled trials (RCTs) is very limited [23]. A recent systematic review concluded that there is evidence to suggest that exercise programs are modestly effective in relieving whiplash-related pain, at least over the short term [23]. For example, Stewart et al [24] showed only a 2 point (on a 10 point scale) decrease in pain levels immediately after a 6 week functional exercise management intervention that adhered to pain-related CBT principals but with no significant sustained effects at more long term follow-ups of 6 and 12 months. In a preliminary RCT conducted in our laboratory (published in 2007), a more neck specific exercise approach also delivered only modest effects, in that pain and disability scores decreased by just clinically relevant amounts (8±14% on the Neck disability Index) when compared to a single advice session [25].

 

The systematic review also concluded that there is conflicting evidence regarding the effectiveness of psychological interventions either delivered alone or in combination with physiotherapy [23]. The studies included in the review were of variable quality and mostly utilized CBT in some format to address pain related cognitions and distress [26, 27]. No study specifically targeted PTSD symptoms.

 

Thus the seemingly logical proposal of interventions to target the physical and pain–related psychological factors of chronic WAD is not working as well as would be anticipated. This expectation is based on more favourable outcomes with such approaches for other musculoskeletal pain conditions such as low back [28].

 

In an endeavour to understand why exercise rehabilitation approaches are not very effective for chronic WAD, we undertook a NHMRC (570884) funded randomized controlled trial that included effect modifiers of PTSD symptoms and sensory disturbances. In this larger (n=186) multicentre trial, preliminary analysis indicate that only 30% of patients with chronic WAD and a PTSD diagnosis had a clinically relevant change in Neck Disability Index scores (>10% change) compared to 70% of WAD patients without PTSD following an exercise rehabilitation program. All included participants reported moderate or greater levels of pain and disability indicating that the co-morbid presence of PTSD prevents a good response to physical rehabilitation. We could find no modifying effect of any sensory changes. The results of this study lead us to propose that first treating PTSD and then instituting physical rehabilitation will be a more effective intervention to improve health outcomes for chronic WAD.

 

Trauma-focused CBT is a highly effective treatment for PTSD symptoms [29] and the Australian Guidelines for Treatment of Acute Stress Disorder and PTSD recommend that individually delivered trauma-focused CBT should be provided to people with these conditions [30]. There is data available to indicate that trauma-focused CBT may potentially have an effect not only on PTSD symptoms but also on pain and disability. The results of a recent empirical examination explored directional relationships between PTSD and chronic pain in 323 survivors of accidents [31]. The results indicated a mutual maintenance of pain intensity and posttraumatic stress symptoms at 5 days post injury but by 6 months post injury (chronic stage), PTSD symptoms impacted significantly on pain but not vice versa. Whilst this study did not specifically focus on whiplash injury, it provides indication that addressing PTSD symptoms in the chronic stage of WAD may allow for a decrease in levels of pain thus facilitating the potential effects of more pain/disability focused approaches to management such as exercise and pain-focused CBT.

 

Based on our findings of the co-occurrence of PTSD and WAD, we conducted a small pilot study with the aim being to test the effects of trauma-focused CBT on psychological factors, pain and disability in individuals with chronic WAD [32]. Twenty-six participants with chronic WAD and a diagnosis of PTSD were randomly assigned to treatment (n = 13) or no-Intervention (n = 13) control. The treatment group underwent 10 weekly sessions of trauma-focused CBT for PTSD. Assessments of PTSD diagnosis, psychological symptoms, disability, and pain symptoms were made at baseline and post-assessment (10-12 weeks). Following the treatment intervention, there was not only a significant reduction in psychological symptoms (PTSD symptom severity; numbers meeting the diagnostic criteria for PTSD; depression, anxiety and stress scores) but also a significant decrease in pain and disability and improvements in physical function, bodily pain and role physical items of the SF36 (Table 1).

 

Table 1. Results of pilot randomised control trial

Trauma-focused CBT No-intervention Control
Neck Disability Index (0-100)*
Baseline 43.7 (15) 42.8 (14.3)
Post intervention 38.7 (12.6) 43.9 (12.9)
SF-36 Physical Function §
Baseline 55.8 (25.9) 55.4 (28.2)
Post intervention 61.5 (20.1) 51.1 (26.3)
SF -36 Bodily Pain §
Baseline 31.2 (17.2) 22.6 (15.5)
Post intervention 41.8 (18) 28.2 (15.8)
Posttraumatic Stress Disorder Diagnosis (SCID-IV)
Baseline N= 13 (100%) N= 13 (100%)
Post intervention N= 5 (39.5%) N= 12 (92.3%)

* higher score=worse; §higher scores=better

 

The results of this study indicate that trauma-focused CBT provided to individuals with chronic WAD has positive effects, not only on psychological status but also on pain and disability the cardinal symptoms of this condition. Whilst the mean change of 5% was marginal in terms of a clinical relevance [33], the effect size for change of the NDI was moderate (d=0.4) and shows promise for a greater effect in a larger sample size [34]. Nevertheless our pilot trial findings suggest that trauma-focused CBT alone will not be enough for successful management of chronic WAD and for this reason our proposed trial will combine this approach with exercise. These findings are potentially ground breaking in the area of whiplash management and it is imperative that they are now tested in a full randomised controlled design.

 

In summary, we have already shown that individuals with chronic WAD and moderate PTSD symptoms do not respond as well to a physical rehabilitation based intervention as those without PTSD symptoms [25]. Our recent pilot study indicates that trauma-focused CBT has a beneficial effect on both psychological status and pain and disability. We propose that by pre-treating the PTSD, PTSD symptoms and pain related disability will decrease allowing the exercise intervention to be more effective than has been seen to date [24, 25]. Therefore our proposed research will address this identified gap in knowledge by being the first to evaluate the efficacy of a combined trauma-focused CBT intervention followed by exercise for chronic WAD.

 

The primary aim of this project is to investigate the effectiveness of combined trauma-focused CBT and exercise to decrease pain and disability of individuals with chronic whiplash and PTSD. The secondary aims are to investigate the effectiveness of combined trauma-focused CBT and exercise to decrease posttraumatic stress symptoms, anxiety and depression, and to investigate the effectiveness of trauma-focused CBT alone on posttraumatic stress symptoms and pain/disability.

 

This trial is expected to commence in June 2015 and completed by December 2018.

 

Design

 

This study will be a randomised controlled multi-centre trial evaluating 10 weeks of trauma-focused CBT compared with 10 weeks of supported therapy, each followed by a 6 week exercise program. Outcomes will be measured at 10 weeks, 16 weeks, 6 and 12 months post randomisation. A total of 108 people with chronic whiplash disorder (>3 months, <5 years duration) and PTSD (DSM-5 diagnosed with CAPS) will be enrolled in the study. The assessors measuring outcomes will be blinded to the assigned treatment group allocation. The protocol conforms to CONSORT guidelines.

 

Figure 2 Study Design

 

Methods

 

Participants

 

A total of 108 participants with chronic whiplash associated disorder (WAD) grade II (symptom duration >3 months and <5 years) and PTSD will be recruited from Southeast Queensland and Zealand, Denmark. Participants will be recruited via:

 

  1. Advertisements (the Danish national health register, newspaper, newsletter and internet): potential participants will be invited to make contact with project staff.
  2. Physiotherapy and General Medical Practices: the study will be promoted in physiotherapy and medical clinics where project staff already have a relationship. Patients deemed to be appropriate for inclusion will be given an information sheet about the project and invited to contact project staff directly.

 

There is a two-step process to determining inclusion to this study: initial online/telephone interview followed by a screening clinical examination. The initial interview will identify duration of whiplash injury (inclusion criteria) and moderate pain based on NDI scores, and potential exclusion criteria. Likelihood of PTSD will be based on conservative PCL-5 scores, requiring at least one moderate score per symptom and a minimum score of 30 overall. A description of the project will be provided to all volunteers at the point of initial contact. Volunteers deemed likely to be eligible will be invited to attend a screening clinical examination. If more than four weeks passes between the phone interview and clinical screening than the NDI and PCL-5 measures are to be re-administered.

 

Prior to undertaking the screening clinical examination, volunteers will be provided with participant information and asked to complete informed consent documentation. During the screening examination, participants who have significant co-morbidity such as serious spinal pathology will be identified and excluded from participation. To screen for serious pathology, a diagnostic triage will be conducted following the Motor Accident Authority of NSW Whiplash Guidelines [35]. The screening examination will also include a clinical interview by a research assistant who will administer the Clinician Administered PTSD scale 5 (CAPS 5) to determine the presence and severity of PTSD [36]. The research assistant will also confirm the absence of exclusion criteria such as past history or current presentation of psychosis, bipolar disorder, organic brain disorder and severe depression substance abuse. If participants report a diagnosis of an exclusion criteria the relevant section of SCID-I will be utilised to clarify diagnosis.

 

During the initial screen or during treatment, if a participant is identified as being at high risk of self-harm or suicide, they will be referred to appropriate care in accordance with the professional standards of psychologists. Participants who meet the inclusion criteria (NDI >30% and PTSD diagnosis) will then be evaluated on all outcome measures for baseline results. It is possible that volunteers invited to attend the screening clinical examination will not meet the inclusion criteria (NDI >30% and PTSD diagnosis) and will therefore be excluded from further participation. Volunteers will be informed of this possibility during the telephone interview and also during the informed consent process. The Interview will be recorded and a random selection will be assessed for consistency

 

Inclusion Criteria

 

  • Chronic WAD Grade II (no neurological deficit or fracture) [37] of at least 3 months duration but less than 5 years duration
  • At least moderate pain and disability (>30% on the NDI)
  • A diagnosis of PTSD (DSM-5, APA, 2013) using the CAPS 5
  • Aged between 18 and 70 years old
  • Proficient in written English or Danish (depending on country of participation)

 

Exclusion Criteria

 

  • Known or suspected serious spinal pathology (e.g. metastatic, inflammatory or infective diseases of the spine)
  • Confirmed fracture or dislocation at the time of injury (WAD Grade IV)
  • Nerve root compromise (at least 2 of the following signs: weakness/reflex changes/sensory loss associated with the same spinal nerve)
  • Spinal surgery in the last 12 months
  • A history or current presentation of psychosis, bipolar disorder, organic brain disorder or severe depression.

 

Sample Size

 

We are interested in detecting a clinically important difference between the two interventions, given that baseline values for each group are statistically equivalent as a result of the randomisation. Based on a two-sided t-test a sample of 86 (43 per group) will provide 80% power to detect a significant difference at alpha 0.05 between the group means of 10 points on the 100 point NDI (assuming a SD of 16, based on our pilot data and data from recent trials ). Effects smaller than this are unlikely to be considered clinically worthwhile. Allowing for a 20% loss to follow up by 12 months, we would require 54 participants per treatment group.

 

Intervention

 

Randomisation

 

Participants will be randomly allocated to treatment group. The randomisation schedule will be generated by the study biostatistician. Randomisation will be by random permuted blocks of 4 to 8. Consecutively numbered, sealed, opaque envelopes will be used to conceal randomisation. Group allocation will be performed immediately following completion of baseline measures by an independent (non-blinded) research assistant . This same research assistant will arrange all appointment times with the treating practitioners and the blinded assessor for all outcome measures. Participants will be instructed not to reveal details about their treatment to the examiner in order to assist with blinding. Patients will be scheduled to receive their first treatment within one week of randomisation.

 

Intervention group – Trauma-focused Cognitive-behavioural therapy (CBT)

 

A psychological intervention that targets PTSD symptoms will consist of 10 weekly 60-90 minute sessions of individually delivered trauma-focused CBT based on the Australian Guidelines for the treatment of Adults with Acute Stress Disorder and PTSD [38] (see Table 2). Session one will focus on providing psycho-education regarding the common symptoms of PTSD, maintaining factors and providing a rationale for various treatment components. Sessions two and three will continue to develop patient’s knowledge of PTSD symptoms and teach anxiety management strategies including deep breathing and progressive muscle relaxation. Cognitive restructuring which involves challenging unhelpful and irrational thoughts and beliefs will commence in session three and continue throughout treatment. Participants will start prolonged exposure in session four which will be paired with relaxation and cognitive challenging. Session six will introduce graded in-vivo exposure. Relapse prevention will also be included in the final two sessions [12]. Participants will be asked to complete a home practice over the course of their sessions which will be recorded and brought to the next session. Treatment will be delivered by registered psychologists with postgraduate clinical training and experience delivering trauma-focused CBT interventions.

 

Table 2. Overview of CBT program

Session Overview
1 Introduction and rationale
2 Relaxation training
3 Relaxation training and cognitive challenging
4 and 5 Cognitive challenging and prolonged exposure
6 Prolonged exposure and in vivo exposure
7 and 8 Prolonged exposure and in-vivo exposure
9 Relapse prevention
10 Relapse prevention and end of treatment

 

 

Control group – Supportive Therapy

 

The first session will involve education about trauma and an explanation of the nature of supportive therapy. The following sessions will include discussions of current problems and general problem-solving skills. Home practice will involve diary keeping of current problems and mood states. Supportive therapy will specifically avoid exposure, cognitive restructuring or anxiety management techniques. If the results of the trial are favourable and participants randomised to this intervention still have a PTSD diagnosis at the 12 month follow-up, they will be offered a referral to a clinical psychologist.

 

Exercise Program

 

Following the 10 week psychological therapy sessions (intervention or control), All participants will participate in the same exercise program. The 6-week exercise program will be carried out under supervision from a physiotherapist (2 sessions in each of the first four weeks; and 1 session in week 5 and week 6) and will comprise specific exercises to improve the movement and control of the neck and shoulder girdles as well as proprioceptive and co-ordination exercises (see Table 3). The exercises will be tailored by the physiotherapist for each individual participant.

 

The program begins with a clinical examination of the cervical muscles and the axio-scapular-girdle muscles and includes tests that assess ability to recruit the muscles in a coordinated manner, tests of balance, cervical kinaesthesia and eye movement control and tests of muscle endurance at low levels of maximum voluntary contraction. The specific impairments that are identified are then addressed with an exercise program that is supervised and progressed by the physiotherapist. This specific treatment program has been described in detail [15] and focuses on activating and improving the co-ordination and endurance capacity of the neck flexor, extensor and scapular muscles in specific exercises and functional tasks, and a graded program directed to the postural control system, including balance exercises, head relocation exercises and exercises for eye movement control.

 

Participants will also perform the exercises at home, once a day. A log book will be completed by participants to record compliance with the exercises. At the same time, the physiotherapist will guide the subject’s return to normal activities.

 

Physiotherapists will adhere to cognitive-behavioural principles during training and supervision of all exercises [26]. The cognitive behavioural therapy principles include the encouragement of skill acquisition by modelling, setting progressive goals, self-monitoring of progress, and positive reinforcement of progress. Self-reliance will be fostered by encouraging subjects to engage in problem-solving to deal with difficulties rather than seeking reassurance and advice, by encouraging relevant and realistic activity goals, and by encouraging self-reinforcement. Daily physical activity at home will be encouraged and monitored using a diary. Written and illustrated exercise instructions will be provided.

 

Table 3. Overview of the exercise program

Week Sessions per week Components
1 2 ·       Baseline & follow-up assessments to guide initial prescription & progression of program

·       Exercise to improve cervical and scapular muscle control, kinaesthesia & balance

·       Education and advice

·       Daily home program including exercise & graded increase of physical activities

·       CBT principles such as goal setting, reinforcement used by physiotherapists

·       Discharge session to reinforce progress and plan for continued activity

2 2
3 2
4 2
5 1
6 1

 

 

Outcome Measures

 

At the baseline assessment, personal characteristics such as age, gender, level of education, compensation status, accident date and information about symptoms of whiplash will be collected. The following outcome measures will be assessed by a blind assessor at baseline, 10 weeks, 16 weeks, 6 months and 12 months post randomisation.

 

The Neck Disability Index (NDI) will be the primary outcome measure [21]. The NDI is a valid measure and reliable measure of neck pain related disability [21] and is recommended for use by the Bone and Joint Decade Neck Pain Task Force [7] and at the recent International Whiplash Summit [11, 16].

 

Secondary outcome measures include:

 

  1. Average pain intensity over last week (0-10 scale) [39]
  2. Average pain intensity over last 24 hours (0-10 scale) [39]
  3. Patient’s global impression of recovery (-5 to +5 scale) [39]
  4. Clinician administered PTSD scale 5 (CAPS 5) [40].
  5. The PTSD Checklist (PCL-5) [41]
  6. Depression Anxiety Stress Scale-21 (DASS-21) [42]
  7. Generic measure of health status (SF-12) [43]
  8. Patient-generated measure of disability (Patient-Specific Functional Scale) [44]
  9. Physical measures (cervical range of movement, pressure pain threshold, cold pain threshold)
  10. Pain Catastrophizing Scale (PCS) [45]
  11. Pain Self Efficacy Questionnaire (PSEQ) [46]
  12. Tampa Scale of Kinesiophobia (TSK) [47]

 

Expectations of a beneficial treatment effect will be measured with the Credibility Expectancy Questionnaire (CEQ) [48] at the first and last week of each treatment. Working alliance as reported by the client and the therapist (psych or physio) will also be measured at the first and last week of each treatment using the Working Alliance Inventory (WAI) [49].

 

Monitoring of Treatment Sites

 

Treatment sites will be located in areas easily accessible by public transport. Attempts will be made to have both the psychology and exercise sessions held at the same site. Prior to commencement of the trial, psychologists and physiotherapists at each treatment site will be provided with the appropriate therapist protocol. Psychologists will be trained to implement the CBT program and the supported therapy by senior investigators at a one day workshops. Physiotherapists will be trained by senior investigators to implement the exercise program at a one day workshop.

 

Prior to starting the trial, the different treatment provider sites and therapists will be provided with a copy of the trial and treatment protocols. Both psychological therapies will be conducted according to a procedural manual. Therapists will be required to record each session as well as complete a checklist of adherence to the protocol. A random sample of these recordings and checklists will be evaluated and ongoing supervision provided by a psychologist on the research team. Physiotherapy exercises will be based on a previous exercise trial for chronic WAD [25]. An audit of the physiotherapy sessions will be conducted twice during the intervention by a senior investigator expert in this area. A handover will occur between psychologist and physiotherapist to maintain continuity of care.

 

Adverse Events

 

Apart from the usual ethics committee based provisions for reporting of adverse effects, practitioners will be requested to report any adverse event to the Chief Investigators. Also at the 16 week follow-up, information about adverse effects of treatment will be sought from all subjects using open-ended questioning. At 6 and 12 months follow-up, data relating to the number of recurrences of neck pain, and the number of health care contacts will also be collected.

 

Statistical Analysis

 

The study biostatistician will analyse the data in a blinded manner. All analyses will be conducted on an intention to treat basis. The primary and secondary outcomes measured at 10 weeks, 16 weeks, 6 months, and 12 months will be analysed using linear mixed and logistic regression models that will include their respective baseline scores as a covariate, subjects as a random effect and treatment conditions as fixed factors. Diagnostics will be used to examine assumptions, including homogeneity of variances. Effect sizes will be calculated for all measures with an effect size of 0.2 considered small, 0.5 medium and 0.8 large. Alpha will be set at 0.05. Any effect of site (Qld or Denmark) will be evaluated by including a site-by-treatment group-by-time interaction term to the mixed models analyses. Effect modification will only be assessed for the primary outcome of NDI.

 

Funding

 

  • The trial is funded by a NHMRC Project grant 1059310.
  • The Council of the Danish Victims Fund Project grant 14-910-00013

 

Potential Significance

 

This project addresses a problem of major importance to human health. Whiplash is an enormous health burden for both Australia and all countries where there are motor vehicles. Current conservative approaches to the management of chronic WAD have been shown to be only marginally effective. One reason for this may be due to the lack of attention of current practice to the psychological status of whiplash injured patients. This study will provide a definitive evaluation of the effects of adding trauma-focused CBT to exercise for individuals with chronic WAD and PTSD.

 

This study is likely to influence the clinical management of whiplash injury and will have immediate clinical applicability. Any intervention that may improve health outcomes for individuals with chronic whiplash will have far reaching effects in both Australia and internationally. Our study will also have implications for both health and insurance policy makers in their decision making regarding treatment options and funding. A search of the WHO International Clinical Trials Registry Platform Search Portal on 2/3/13 revealed no planned or completed trial that would duplicate our work.

 

Conflict of Interest Declaration

 

The authors declare no conflict of interest.

 

Role of Psychosocial Stress in Recovery from Common Whiplash

 

Abstract

 

It is widely accepted that psychosocial factors are related to illness behaviour and there is some evidence that they may influence the rate of recovery from post-traumatic disorders. The abilities of psychosocial stress, somatic symptoms, and subjectively assessed cognitive impairment to predict delayed recovery from common whiplash were investigated in a follow-up study. 78 consecutive patients referred 7.2 (SD 4.5) days after they had sustained common whiplash in car accidents were assessed for psychosocial stress, negative affectivity, personality traits, somatic complaints, and cognitive impairment by semistructured interview and by several standardised tests. On examination 6 months later 57 patients were fully recovered and 21 had persisting symptoms. The groups’ scores for the independent variables assessed at the baseline examination were compared. Stepwise regression analysis showed that psychosocial factors, negative affectivity, and personality traits were not significant in predicting the outcome. However, initial neck pain intensity, injury-related cognitive impairment, and age were significant factors predicting illness behaviour. This study, which was based on a random sample and which considered many other possible predictive factors as well as psychosocial status, does not support previous findings that psychosocial factors predict illness behaviour in post-trauma patients.

 

Dr Jimenez White Coat

Dr. Alex Jimenez’s Insight

Being involved in an automobile accident can be a traumatic experience for anyone. From physical injuries and financial problems, to emotional distress, an auto accident can place a heavy burden on those individuals who’ve experienced it, especially if the auto accident injuries begin to take a toll on the mind. Many patients visit my chiropractic office with anxiety, irrational fears, depression and PTSD after being involved in an automobile accident. Learning to trust again to receive chiropractic care can be challenging, but through careful and effective spinal adjustments and manual manipulations, our staff can provide patients with the sense of safety they need to continue treatment and achieve overall health and wellness.

 

In conclusion, automobile accidents can cause a variety of physical injuries and conditions, such as whiplash, back pain and headaches, as well as financial issues, however, auto accident injuries and complications can also lead to emotional distress. According to evidence-based research studies, like the one above, emotional distress has been connected to chronic pain symptoms. Fortunately, researchers have conducted numerous research studies to demonstrate how mindfulness interventions, like chiropractic care, can help reduce emotional distress and improve painful symptoms. Information referenced from the National Center for Biotechnology Information (NCBI). The scope of our information is limited to chiropractic as well as to spinal injuries and conditions. To discuss the subject matter, please feel free to ask Dr. Jimenez or contact us at 915-850-0900 .

 

Curated by Dr. Alex Jimenez

 

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Additional Topics: Back Pain

 

According to statistics, approximately 80% of people will experience symptoms of back pain at least once throughout their lifetimes. Back pain is a common complaint which can result due to a variety of injuries and/or conditions. Often times, the natural degeneration of the spine with age can cause back pain. Herniated discs occur when the soft, gel-like center of an intervertebral disc pushes through a tear in its surrounding, outer ring of cartilage, compressing and irritating the nerve roots. Disc herniations most commonly occur along the lower back, or lumbar spine, but they may also occur along the cervical spine, or neck. The impingement of the nerves found in the low back due to injury and/or an aggravated condition can lead to symptoms of sciatica.

 

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EXTRA IMPORTANT TOPIC: Managing Workplace Stress

 

 

MORE IMPORTANT TOPICS: EXTRA EXTRA: Car Accident Injury Treatment El Paso, TX Chiropractor

 

 

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  38. ACPMH, Australian guidelines for the treatment of adults with acute stress disorder and post-traumatic stress disorder. 2007, Melbourne, VIC: Australian Centre for Posttraumatic Mental Health.
  39. Pengel, L.H.M.M., K.M.P. Refshauge, and C.G.P. Maher, Responsiveness of Pain, Disability, and Physical Impairment Outcomes in Patients With Low Back Pain. Spine, 2004. 29(8): p. 879-883.
  40. Weathers, F.W., T.M. Keane, and J.R.T. Davidson, Clinician-administered PTSD scale: A review of the first ten years of research. Depression and Anxiety, 2001. 13(3): p. 132-156.
  41. Weathers, F., et al., The PTSD Checklist for DSM-5 (PCL-5). Scale available from the National Center for PTSD. www.​ ptsd.​ va.​ gov, 2013.
  42. Lovibond, S. and P. Lovibond, Manual for the Depression Anxiety Stress Scales. 2nd ed. 1995, Sydney: Psychological Foundation.
  43. Ware, J., et al., User’s manual for the SF-12v2® Health Survey with a supplement documenting SF-12® Health Survey. 2002, Lincoln, Rhode Island: QualityMetric Incorporated
  44. Westaway, M., P. Stratford, and J. Binkley, The Patient-Specific Functional Scale: Validation of Its Use in Persons With Neck Dysfunction. Journal of Orthopaedic & Sports Physical Therapy, 1998. 27(5): p. 331-338.
  45. Sullivan, M.J.L., S.R. Bishop, and J. Pivik, The Pain Catastrophizing Scale: Development and validation. Psychological Assessment, 1995. 7(4): p. 524-532.
  46. Nicholas, M.K., The pain self-efficacy questionnaire: Taking pain into account. European Journal of Pain, 2007. 11(2): p. 153-163.
  47. Miller, R., S. Kori, and D. Todd, The Tampa Scale for Kinesiophobia. Tampa, FL. Unpublished report, 1991.
  48. Devilly, G.J. and T.D. Borkovec, Psychometric properties of the credibility/expectancy questionnaire. Journal of Behavior Therapy and Experimental Psychiatry, 2000. 31(2): p. 73-86.
  49. Horvath, A.O. and L.S. Greenberg, Development and validation of the Working Alliance Inventory. Journal of Counseling Psychology, 1989. 36(2): p. 223-233.
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Effectiveness of Mindfulness on Herniated Discs & Sciatica in El Paso, TX

Effectiveness of Mindfulness on Herniated Discs & Sciatica in El Paso, TX

Chronic low back pain is the second most common cause of disability in the United States. Approximately 80 percent of the population will experience back pain at least once throughout their lifetime. The most prevalent causes of chronic low back pain include: herniated discs, sciatica, injuries from lifting heavy objects or any other non-specific spine injury. However, people will often react differently to their symptoms. These differing responses are due to people’s psychological attitudes and outlooks.

 

Chronic Low Back Pain and the Mind

 

Stress has been associated with increased pain but your own personal health beliefs and coping strategies can influence your own perception of pain as well. That’s because psychological vulnerabilities can alter your brain and intensify the pain. Additionally, the pain itself can rewire the brain. When pain first occurs, it impacts the pain-sensitivity brain circuits. When pain becomes persistent, the associated brain activity switches from the pain circuits to circuits that process emotions. That’s why it’s believed that stress, anxiety and depression can cause as well as worsen chronic low back pain.

 

Managing the Scourge of Chronic Low Back Pain

 

Fortunately, several stress management methods and techniques can help improve chronic low back pain. Mindfulness is the most common treatment with the best supporting evidence towards improving and managing chronic pain. A recent study demonstrated that mindfulness-based stress reduction, or MBSR, including mindfulness meditation and other mindfulness interventions, can help reduce back pain and enhance psychological control by increasing brain blood flow to the frontal lobe. Practicing mindfulness involves activating a brain relaxation pathway by intentionally ignoring mental “chatter” and focusing on your breathing. Cognitive behavioral therapy, or CBT can also be helpful for chronic low back pain. Cognitive behavioral therapy can prevent an acute injury from progressing to chronic low back pain. Hypnosis may also help relieve chronic low back pain. However, CBT and hypnosis have weaker evidence to support their effectiveness on back pain.

 

Mind Over Matter

 

So while it may seem that chronic low back pain is all “in your head”, research studies have demonstrated that stress can influence painful symptoms. “Mind” includes “matter,” especially when you consider that the physical “matter” of the brain plays a major role in mindset changes. This is especially true when it comes to the brain-based changes related to low back pain. The purpose of the article below is to demonstrate the effectiveness of mindfulness meditation on chronic low back pain.

 

Effectiveness of Mindfulness Meditation on Pain and Quality of Life of Patients with Chronic Low Back Pain

 

Abstract

 

  • Background and aim: Recovery of patients with chronic low back pain (LBP) is depended on several physical and psychological factors. Therefore, the authors aimed to examine the efficacy of mindfulness based stress reduction (MBSR) as a mind-body intervention on quality of life and pain severity of female patients with nonspecific chronic LBP (NSCLBP).
  • Methods: Eighty-eight patients diagnosed as NSCLBP by physician and randomly assigned to experimental (MBSR+ usual medical care) and the control group (usual medical care only). The subjects assessed in 3 times frames; before, after and 4 weeks after intervention by Mac Gil pain and standard brief quality of life scales. Data obtained from the final sample analyzed by ANCOVA using SPSS software.
  • Results: The findings showed MBSR was effective in reduction of pain severity and the patients who practiced 8 sessions meditation reported significantly lower pain than patients who only received usual medical care. There was a significant effect of the between subject factor group (F [1, 45] = 16.45, P < 0.001) and (F [1, 45] = 21.51, P < 0.001) for physical quality of life and (F [1, 45] = 13.80, P < 0.001) and (F [1, 45] = 25.07, P < 0.001) mental quality of life respectively.
  • Conclusion: MBSR as a mind-body therapy including body scan, sitting and walking meditation was effective intervention on reduction of pain severity and improvement of physical and mental quality of life of female patients with NSCLBP.
  • Keywords: Chronic low back pain, mindfulness based stress reduction, pain, quality of life, SF-12

 

Introduction

 

In nonspecific low back pain (NSLBP) the pain is not related to conditions such as fractures, spondylitis, direct trauma, or neoplastic, infectious, vascular, metabolic, or endocrine-related although it is a cause of limitation in daily activities due to actual pain or fear of pain.[1] Unfortunately, the majority of LBP patients (80–90%) suffers from nonspecific LBP which leads to considerable pain-related disability and limitation in daily activities.[1,2] Chronic LBP is not only prevalent, but is also a source of great physical disability, role impairment, and diminished psychological well-being and quality of life.[1]

 

Prior to the current accepted biopsychosocial model, the biomedical model dominated all illness conceptualizations for almost 300 years and still dominates in the popular imagination. First proposed by Engel (1977) the biopsychosocial model acknowledges biological processes but also highlights the importance of experiential and psychological factors in pain. The famous gate control theory of pain[3] also proposed that the brain plays a dynamic role in pain perception as opposed to being a passive recipient of pain signals. They suggested psychological factors can inhibit or enhance sensory flow of pain signals and thus influence the way brain ultimately responds to painful stimulation.[4] If mind processes can change the way the brain processes pain then this holds tremendous potential for psychological intervention to produce reduced pain signals from the brain.

 

Kabat-Zinn’s et al. (1986) described the process of pain reduction in his paper on mindfulness and meditation. The process of pain reduction occurred by “an attitude of detached observation toward a sensation when it becomes prominent in the field of awareness and to observe with similar detachment the accompanying but independent cognitive processes which lead to evaluation and labeling of the sensation as painful, as hurt.” Thus, by “uncoupling” the physical sensation, from the emotional and cognitive experience of pain, the patient is able to reduce the pain.[5] The patients’ descriptions of distraction from pain, identifying maladaptive coping strategies toward pain and heightened awareness of pain sensation leading to behavioral changes are examples of how pain is unassociated with emotion, cognition, and sensation [Figure 1]. Therefore recently these theories attracted several researchers who are working on pain.

 

Figure 1 Consort Diagram

Figure 1: Consort diagram.

 

Mindfulness meditation has roots in Buddhist Vipassana philosophy and practice and has been independently adopted within clinical psychology in Western societies.[6,7,8,9] Recently in Netherlands Veehof et al. conducted a systematic review of controlled and noncontrolled studies on effectiveness of acceptance-based interventions such as mindfulness-based stress reduction program, acceptance and commitment therapy for chronic pain. Primary outcomes measured were pain intensity and depression. Secondary outcomes measured were anxiety, physical well-being and quality of life.[10] Twenty-two studies randomized controlled studies clinical controlled studies without randomization and noncontrolled studies were included totaling 1235 patients with chronic pain. An effect size on pain of (0.37) was found in the controlled studies. The effect on depression was (0.32). The authors concluded that ACT and mindfulness interventions had similar effects to other cognitive-behavioral therapy interventions and that these types of interventions may be a useful alternative or adjunct to current therapies. Chiesa and Serretti also conducted another systematic review on 10 mindfulness interventions.[11] The main findings were that these interventions produced small nonspecific effects in terms of reducing chronic pain and symptoms of depression. When compared to active control groups (support and education) no additional significant effects were noted.

 

In summary, there is a need for further studies into the specific effects of mindfulness studies on chronic pain. Regarding as the researcher knowledge efficacy of mindfulness has not been explored on quality of life of chronic pain patients in Iran. The authors aimed to examine the impact of mindfulness based stress reduction (MBSR) protocol designed for pain management on quality of life and pain of a homogeneous sample of females with nonspecific chronic LBP (NSCLBP) in comparison of the usual medical care group.

 

Methods

 

Sampling

 

Out of initial female samples aged 30–45 (n = 155) who diagnosed as chronic NSLBP by physicians in physiotherapy centers of Ardebil-Iran at least 6 months before. Only 88 met inclusion criteria and gave consent to participate in the research program. Patients were randomly assigned in small groups to receive MBSR plus medical usual care (experimental group) and medical usual care (control group). Some patients dropped during and after the treatment. The final sample of the study comprised of 48 females.

 

Inclusion Criteria

 

  • Age 30–45 years
  • Being under medical treatments like physiotherapy and medicine
  • Medical problem-history of NSCLBP and persisting pain for at least 6 months
  • Language – Persian
  • Gender – female
  • Qualification – educated at least up to high school
  • Consent and willingness to alternative and complementary therapies for pain management.

 

Exclusion Criteria

 

  • History of spine surgery
  • Combination with other chronic disease
  • Psychotherapy in the last 2 years excluded
  • Unavailability in next 3 months.

 

The proposal of study approved by the scientific committee of “Panjab University,” psychology department and all patients signed consent to participate in the present study. The study approved in India (in the university which researcher done her PhD), but conducted in Iran because researcher is from Iran originally and there was language and culture difference problem. Approval from Institutional Ethics Committee of physiotherapy center of Ardebil was obtained in Iran also to carry out the research.

 

Design

 

The study made use of the pre-post quasi time series experimental design to assess the efficacy of MBSR in 3 times frames (before-after-4 weeks after the program). A MBSR program administered one session per week for explaining techniques, practice, and feedback and share their experience for 8 weeks beside 30–45 min’ daily home practice [Table 1]. The intervention was conducted in three groups included 7–9 participants in each group. The process of framing the program was based on the quid lines provided by Kabat-Zinn, Morone (2008a, 2008b and 2007)[6,12,13,14] and some adaptation done for the patients involved in the study. The control group was not offered any type of intervention in the research project. Consequently, they underwent the normal routines in healthcare including physiotherapy and medicine.

 

Table 1 Content of MBSR Sessions

Table 1: Content of MBSR sessions.

 

Intervention

 

The sessions conducted in a private physiatrist clinic near to physiotherapy centers. Sessions took 8 weeks, and each session lasted for 90 min. Meditation transformed the patients’ awareness through the techniques of breathing and mindfulness. The intervention was conducted in small groups included 7–9 participants in each group. Table 1 for details of session’s content which prepared according books and previous studies.[6,12,13,14]

 

Assessments

 

The questionnaire completed by patients before the intervention, after intervention and 4 weeks after the interventions. The receptor of physiotherapy centers conducted the assessment. The receptors trained before conducting the assessment, and they were blind for the hypothesis of the study. The following are used for assessment of participants:

 

McGill Pain Questionnaire

 

The main component of this scale consists of 15 descriptive adjectives, 11 sensory including: Throbbing, Shooting, Stabbing, Sharp, Cramping, Gnawing, Hot-burning, Aching, Heavy, Tender, Splitting, and four affective including: Tiring-exhausting, Sickening, Fearful, Punishing-cruel, which are rated by the patients according to their severity on a four point scale (0 = none, 1 = mild, 2 = moderate, 3 = severe), yielding three scores. The sensory and affective scores are calculated by adding sensory and affective item values separately, and the total score is the sum of the two above-mentioned scores. In this study, we just used pain rating index with total scores. Adelmanesh et al.,[15] translated and validated Iran version of this questionnaire.

 

Quality of Life (SF-12)

 

The quality of life assessed by the validated SF-12 Health Survey.[16] It was developed as a shorter, quicker-to-complete alternative to the SF-36v2 Health Survey and measures the same eight health constructs. The constructs are: Physical functioning; role physical; bodily pain; general health; vitality; social functioning; role emotional; and mental health. Items have five response choices (for example: All of the time, most of the time, some of the time, a little of the time, none of the time), apart from two questions for which there are three response choices (for the physical functioning domain). Four items are reverse scored. Summed raw scores in the eight domains are transformed to convert the lowest possible score to zero and the highest possible score to 100. Higher scores represent better health and well-being. The standard form SF-12 uses a time frame of the past 4 weeks.[16]

 

The Iranian version of SF-12 in Montazeri et al. (2011) study showed satisfactory internal consistency for both summary measures, that are the Physical Component Summary (PCS) and the Mental Component Summary (MCS); Cronbach’s α for PCS-12 and MCS-12 was 0.73 and 0.72, respectively. The known – group comparison showed that the SF-12 discriminated well between men and women and those who differed in age and educational status (P < 0.001) 2.5.[17]

 

Statistical Analysis

 

The SPSS 20 (Armonk, NY: IBM Corp) was used to analysis of data. For descriptive analysis mean, standard deviation (SD) used. For performing ANCOVA, the pretest scores were used as covariates.

 

Results

 

The mean age was 40.3, SD = 8.2. 45% of females were working and the rest were a house wife. 38% had two children, 55% one child and the rest did have children. All were married and from middle-income families. 9.8% of patients reported very low physical quality of life, and the rest were low (54.8%) and moderate (36.4%). This was 12.4%, 40% and 47.6% very low, low and medium levels of mental quality of life in patients participated in our study (n = 48). The mean and SD of patients in MBSR and control group showed a decrease in pain and increase in mental and physical quality of life [Table 2].

 

Table 2 Mean and SD of Patients

Table 2: Mean and SD of patients in pain, mental and physical quality of life in baseline, after intervention and 4 weeks after intervention.

 

Comparative Results

 

Pain. The results indicated that after adjusting for pretest scores, there was a significant effect of the between subject factor group (F [1, 45] =110.4, P < 0.001) and (F [1, 45] =115.8, P < 0.001). Adjusted post-test scores suggest that the intervention had an effect on increasing the pain scores of the NSCLBP patients who received the MBSR as compared to those who were in the control group and did not receive any mind-body therapy [Table 3].

 

Table 3 The Result of Comparison of Pain and Quality of Life

Table 3: The result of comparison of pain and quality of life of MBSR and control group after intervention (time 1) and 4 weeks after intervention (time 2).

 

Quality of life. The results shows that after adjusting for pretest scores, there was a significant effect of the between subject factor group (F [1, 45] =16.45, P < 0.001) and (F [1, 45] =21.51, P < 0.001). Adjusted post-test scores suggest that the intervention had an effect on increasing the physical quality of life scores of the NSCLBP patients who received the MBSR as compared to those who were in the control group and did not receive any mind-body therapy [Table 3].

 

The results also showed that after adjusting for pretest scores, there was a significant effect of the between subject factor group (F [1, 45] =13.80, P < 0.001) and (F [1, 45] =25.07, P < 0.001). Adjusted post-test scores suggest that the intervention had an effect on increasing the mental quality of life scores of the NSCLBP patients who received the MBSR as compared to those who were in the control group and did not receive any psychological therapy [Table 3].

 

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Dr. Alex Jimenez’s Insight

Mindfulness is the psychological process which involves activating a brain relaxation pathway by intentionally ignoring mental “chatter”, bringing one’s attention to experiences occurring in the present moment and focusing on your breathing. Mindfulness can commonly be achieved through the practice of meditation and stress management methods and techniques. According to research studies, mindfulness is an effective treatment option which can help decrease chronic low back pain. Researchers have previously compared mindfulness-based stress reduction, or MBSR, with cognitive behavioral therapy to determine whether these mindfulness interventions could improve chronic low back pain. The following article was also conducted to determine if mindfulness meditation is an effective treatment option for chronic low back pain. The results of both research studies were promising, demonstrating that mindfulness can be more effective for chronic low back pain than traditional treatment options as well as the use of drugs and/or medication.

 

Discussion

 

The results showed that the experimental group who were subjected to the MBSR showed a significant improvement in their overall pain severity, physical and mental quality of life scores due to the training received as compared to the control group who received only usual medical care. The program reduced pain perception and enhanced both physical and mental quality of life and impacted on the experimental group clearly in comparison of the usual medical care. Baranoff et al., 2013,[18] Nyklícek and Kuijpers, 2008,[19] and Morone (2) et al., 2008[20] reported the same results.

 

Kabat-Zinn et al. believed the process of pain reduction occurred by “uncoupling” the physical sensation, from the emotional and cognitive experience of pain, the patient is able to reduce the pain.[21] In the current study, the participants uncoupled the different components of the experience of pain. Breathing exercise distract their mind from pain to breathing and mindful living made them aware about maladaptive coping strategies.

 

In the first session, information given about the fundamentals of mindfulness, describing the mindfulness supporting attitudes included being nonjudgmental toward thought, emotions or sensations as they arise, patience, nonstriving, compassion, acceptance and curiosity gave them a wisdom and believe that they are suffering from painful thoughts more than the pain itself.

 

Furthermore, during body scan practice they learned to see their real body conditions, as it truly was, without trying to change the reality. Accepting their chronic illness condition helped them see the other possible abilities in their social and emotional roles. In fact the body scan practice helped them change the relationship with their body and pain. Through direct experience in body scan, one realizes the interconnection between the state of the mind and the body, and thereby increases patients’ self-control over their life. Mindful living techniques also improved their quality of life by teaching them to pay more attention to their daily life necessities, which led to the experience of subtle positive emotions, like peace and joy, self-esteem and confidence. Furthermore, they appreciated positive things. Once they learned to see the persistent pain objectively and observe other sensations in their body, they applied the same principles through mindful living techniques in their everyday life. As a result, they learned how to manage their health and began to engage in their duties mindfully.

 

A number of research studies such as Plews-Ogan et al.,[22] Grossman et al.,[23] and Sephton et al., (2007)[24] showed effectiveness of mindfulness meditation program on quality of life of patients with chronic pain conditions.

 

Conclusion

 

All together the result of this study and previous studies highlighted the effectiveness of complementary and alternative treatment for patients with chronic LBP. Regarding the considerable role of quality of life in professional and personal life designing the effective psychotherapies especially for enhancement of quality of life of patients with chronic LBP strongly suggested by the authors.

 

This study involved with several limitations such as ununiformed usual care received by patients. The provided physiotherapy sessions or methods and medicine prescribed by different physicians in slightly different manner. Although some patients commonly dose not completed physiotherapy sessions. The sample size was small and it was only limited to three centers. This is suggested for future researchers to conduct study with considering physiologic variables such as MRI, NMR and neurologic signals to test the efficacy of MBSR to decrease pain sufferer.

 

In conclusion, more evidence-based larger scale researches with longer-term follow-up need to be done to increase the therapeutic weight and value of MBSR as a part of complementary alternative medicine being preventive and rehabilitation method among CLBP patients.

 

Acknowledgement

 

We are thankful from patients who were corporate with us. Dr. Afzalifard and staff of physiotherapy centers of Ardebil.

 

Footnotes

 

  • Source of support: Nil.
  • Conflict of interest: None declared.

 

In conclusion, mindfulness is the most prevalent treatment with the best supporting evidence towards improving and managing chronic low back pain. Mindfulness interventions, such as mindfulness-based stress reduction and cognitive behavioral therapy, have demonstrated to be effective for chronic low back pain. Furthermore, mindfulness meditation was also demonstrated to effectively help improve as well as manage chronic low back pain caused by stress. However, further research studies are still required to determine a solid outcome measure for mindfulness interventions and chronic pain. Information referenced from the National Center for Biotechnology Information (NCBI). The scope of our information is limited to chiropractic as well as to spinal injuries and conditions. To discuss the subject matter, please feel free to ask Dr. Jimenez or contact us at 915-850-0900 .

 

Curated by Dr. Alex Jimenez

 

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Additional Topics: Back Pain

 

According to statistics, approximately 80% of people will experience symptoms of back pain at least once throughout their lifetimes. Back pain is a common complaint which can result due to a variety of injuries and/or conditions. Often times, the natural degeneration of the spine with age can cause back pain. Herniated discs occur when the soft, gel-like center of an intervertebral disc pushes through a tear in its surrounding, outer ring of cartilage, compressing and irritating the nerve roots. Disc herniations most commonly occur along the lower back, or lumbar spine, but they may also occur along the cervical spine, or neck. The impingement of the nerves found in the low back due to injury and/or an aggravated condition can lead to symptoms of sciatica.

 

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EXTRA IMPORTANT TOPIC: Managing Workplace Stress

 

 

MORE IMPORTANT TOPICS: EXTRA EXTRA: Choosing Chiropractic? | Familia Dominguez | Patients | El Paso, TX Chiropractor

 

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References
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2. Kovacs FM, Abraira V, Zamora J, Fernández C. Spanish Back Pain Research Network. The transition from acute to subacute and chronic low back pain: A study based on determinants of quality of life and prediction of chronic disability. Spine (Phila Pa 1976) 2005;30:1786–92. [PubMed]
3. Melzack R, Wall PD. Pain mechanisms: A new theory. Science. 1965;150:971–9. [PubMed]
4. Beverly ET. USA: The Guilford Press; 2010. Cognitive Therapy for Chronic Pain: A Step-by-Step Guide.
5. Kabat-Zinn J, Lipworth L, Burney R, Sellers W. Four-Year Follow-up of a meditation-based program for the self-regulation of chronic pain: Treatment outcomes and compliance. Clin J Pain. 1986;2:159–73.
6. Wetherell JL, Afari N, Rutledge T, Sorrell JT, Stoddard JA, Petkus AJ, et al. A randomized, controlled trial of acceptance and commitment therapy and cognitive-behavioral therapy for chronic pain. Pain. 2011;152:2098–107. [PubMed]
7. Baer RA. Mindfulness training as a clinical intervention: A conceptual and empirical review. Clin Psychol Sci Pract. 2003;10:125–43.
8. Kabat-Zinn J. An outpatient program in behavioral medicine for chronic pain patients based on the practice of mindfulness meditation: Theoretical considerations and preliminary results. Gen Hosp Psychiatry. 1982;4:33–47. [PubMed]
9. Glombiewski JA, Hartwich-Tersek J, Rief W. Two psychological interventions are effective in severely disabled, chronic back pain patients: A randomised controlled trial. Int J Behav Med. 2010;17:97–107.[PubMed]
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11. Chiesa A, Serretti A. Mindfulness-based interventions for chronic pain: A systematic review of the evidence. J Altern Complement Med. 2011;17:83–93. [PubMed]
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13. Kabat-Zinn J. New York: Dell Publishing; 1990. Full Catastrophe Living: Using the Wisdom of Your Body and Mind to Face Stress, Pain and Illness.
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15. Adelmanesh F, Arvantaj A, Rashki H, Ketabchi S, Montazeri A, Raissi G. Results from the translation and adaptation of the Iranian Short-Form McGill Pain Questionnaire (I-SF-MPQ): Preliminary evidence of its reliability, construct validity and sensitivity in an Iranian pain population. Sports Med Arthrosc Rehabil Ther Technol. 2011;3:27. [PMC free article] [PubMed]
16. Ware JE, Jr, Kosinski M, Turner-Bowker DM, Gandek B. Lincoln, RI: Quality Metric Incorporated; 2002. How to Score Version 2 of the SF-12® Health Survey (With a Supplement Documenting Version 1)
17. Montazeri A, Vahdaninia M, Mousavi SJ, Omidvari S. The Iranian version of 12-item short form health survey (SF-12): A population-based validation study from Tehran, Iran. Health Qual Life Outcomes. 2011;9:12. [PMC free article] [PubMed]
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Effects of Stress Management Treatment for Low Back Pain in El Paso, TX

Effects of Stress Management Treatment for Low Back Pain in El Paso, TX

Chiropractic care is a well-known alternative treatment option commonly used for a variety of injuries and/or conditions, including low back pain and sciatica. Of course, not all pain is physical nor does it always have a physical cause. Stress, anxiety and depression affects millions of people each year. While many patients require prescription drug therapy to treat their mental health issues, others may be able to control and treat they symptoms with a holistic approach. Chiropractic care is an effective stress management treatment which can help reduce symptoms associated with stress, such as low back pain and sciatica.

 

How Does Stress Affect the Body?

 

There are 3 major categories of stress: bodily, environmental and emotional.

 

  • Bodily stress: Caused by lack of sleep, disease, trauma or injury, and an improper nutrition.
  • Environmental stress: Caused by loud noises (sudden or sustained), pollution and world events, such as war and politics.
  • Emotional stress: Caused by a variety of life events, such as moving homes, starting a new job and regular personal interactions. In contrast to the other two categories of stress, however, people can have some control over their emotional stress. Such can depend on the individual’s own attitude.

 

Stress can affect the human body in a variety of ways, both positively and negatively, physically and emotionally. Although short-term stress can be helpful, long-term stress can cause many cumulative health issues on both the mind and body. Stress activates the “fight or flight” response, a defense mechanism triggered by the sympathetic nervous system to prepare the body for perceived danger by increasing heart rate and breathing as well as the senses, by way of instance, eyesight can become more acute. Once the stressor goes away, the central nervous system relays the message to the body and the vitals return to normal.

 

In several instances, the central nervous system can fail to relay the signal to the body when it is time to return to its relaxed state. Many people also experience persistent, recurrent stress, referred to as chronic stress. Either occurrence takes a toll on the human body. This type of stress can often lead to pain, anxiety, irritability and depression.

 

Managing Your Stress

 

Chronic stress can cause painful symptoms, such as low back pain and sciatica, which can then cause more stress. Pain generally contributes to mood issues, such as anxiety and depression, clouded thought processes, and an inability to concentrate. Individuals with chronic stress who experience painful symptoms may feel unable to perform and engage in regular activities.

 

Stress management treatment can help people improve as well as manage their chronic stress and its associated symptoms. Chiropractic care can help reduce pain and muscle tension, further decreasing stress. The central nervous system can also benefit from the effects of chiropractic treatment. The central nervous system, or CNS, helps regulate mood, as well as full-body health and wellness, meaning that a balanced central nervous system can help enhance overall well-being.

 

Benefits of Chiropractic Care

 

Chiropractic care is a holistic treatment approach, designed to return the body to the original state it needs to maintain the muscles and joints functioning properly. Chronic stress can cause muscle tension along the back, which can eventually lead to spinal misalignments. A misalignment of the spine, or a subluxation, can contribute to a variety of symptoms, including nausea and vomiting, headaches and migraines, stress and digestive issues. A chiropractor utilized spinal adjustments and manual manipulations to release pressure and decrease the inflammation around the spine to improve nerve function and allow the body to heal itself naturally. Alleviating pain can ultimately help decrease stress and enhance overall health and wellness. Chiropractic care can also include massage as well as counseling to help control stress, anxiety and depression.

 

A Holistic Care Approach

 

Most chiropractors will utilize other treatment methods and techniques, such as physical therapy, exercise, and nutrition advice, to further increase the stress management effects of chiropractic care. These lifestyle changes affect every area of your well-being. Furthermore, the purpose of the article below is to demonstrate the effects of mindfulness-based stress reduction compared to cognitive-behavioral therapy and usual care on stress with associated symptoms of chronic low back pain and sciatica.

 

Effects of Mindfulness-Based Stress Reduction vs Cognitive-Behavioral Therapy and Usual Care on Back Pain and Functional Limitations among Adults with Chronic Low Back Pain: A Randomized Clinical Trial

 

Abstract

 

Importance

 

Mindfulness-based stress reduction (MBSR) has not been rigorously evaluated for young and middle-aged adults with chronic low back pain.

 

Objective

 

To evaluate the effectiveness for chronic low back pain of MBSR versus usual care (UC) and cognitive-behavioral therapy (CBT).

 

Design, Setting, and Participants

 

Randomized, interviewer-blind, controlled trial in integrated healthcare system in Washington State of 342 adults aged 20–70 years with CLBP enrolled between September 2012 and April 2014 and randomly assigned to MBSR (n = 116), CBT (n = 113), or UC (n = 113).

 

Interventions

 

CBT (training to change pain-related thoughts and behaviors) and MBSR (training in mindfulness meditation and yoga) were delivered in 8 weekly 2-hour groups. UC included whatever care participants received.

 

Main Outcomes and Measures

 

Co-primary outcomes were the percentages of participants with clinically meaningful (≥30%) improvement from baseline in functional limitations (modified Roland Disability Questionnaire [RDQ]; range 0 to 23) and in self-reported back pain bothersomeness (0 to 10 scale) at 26 weeks. Outcomes were also assessed at 4, 8, and 52 weeks.

 

Results

 

Among 342 randomized participants (mean age, 49 (range, 20–70); 225 (66%) women; mean duration of back pain, 7.3 years (range 3 months to 50 years), <60% attended 6 or more of the 8 sessions, 294 (86.0%) completed the study at 26 weeks and 290 (84.8%) completed the study 52weeks. In intent-to-treat analyses, at 26 weeks, the percentage of participants with clinically meaningful improvement on the RDQ was higher for MBSR (61%) and CBT (58%) than for UC (44%) (overall P = 0.04; MBSR versus UC: RR [95% CI] = 1.37 [1.06 to 1.77]; MBSR versus CBT: 0.95 [0.77 to 1.18]; CBT versus UC: 1.31 [1.01 to 1.69]. The percentage of participants with clinically meaningful improvement in pain bothersomeness was 44% in MBSR and 45% in CBT, versus 27% in UC (overall P = 0.01; MBSR versus UC: 1.64 [1.15 to 2.34]; MBSR versus CBT: 1.03 [0.78 to 1.36]; CBT versus UC: 1.69 [1.18 to 2.41]). Findings for MBSR persisted with little change at 52 weeks for both primary outcomes.

 

Conclusions and Relevance

 

Among adults with chronic low back pain, treatment with MBSR and CBT, compared with UC, resulted in greater improvement in back pain and functional limitations at 26 weeks, with no significant differences in outcomes between MBSR and CBT. These findings suggest that MBSR may be an effective treatment option for patients with chronic low back pain.

 

Introduction

 

Low back pain is a leading cause of disability in the U.S. [1]. Despite numerous treatment options and greatly increased medical care resources devoted to this problem, the functional status of persons with back pain in the U.S. has deteriorated [2, 3]. There is need for treatments with demonstrated effectiveness that are low-risk and have potential for widespread availability.

 

Psychosocial factors play important roles in pain and associated physical and psychosocial disability [4]. In fact, 4 of the 8 non-pharmacologic treatments recommended for persistent back pain include “mind-body” components [4]. One of these, cognitive-behavioral therapy (CBT), has demonstrated effectiveness for various chronic pain conditions [5–8] and is widely recommended for patients with chronic low back pain (CLBP). However, patient access to CBT is limited. Mindfulness-Based Stress Reduction (MBSR) [9], another “mind-body” approach, focuses on increasing awareness and acceptance of moment-to-moment experiences, including physical discomfort and difficult emotions. MBSR is becoming increasingly popular and available in the U.S. Thus, if demonstrated beneficial for CLBP, MBSR could offer another psychosocial treatment option for the large number of Americans with this condition. MBSR and other mindfulness-based interventions have been found helpful for a range of conditions, including chronic pain [10–12]. However, only one large randomized clinical trial (RCT) has evaluated MBSR for CLBP [13], and that trial was limited to older adults.

 

This RCT compared MBSR with CBT and usual care (UC). We hypothesized that adults with CLBP randomized to MBSR would show greater short- and long-term improvement in back pain-related functional limitations, back pain bothersomeness, and other outcomes, as compared with those randomized to UC. We also hypothesized that MBSR would be superior to CBT because it includes yoga, which has been found effective for CLBP [14].

 

Methods

 

Study Design, Setting, and Participants

 

We previously published the Mind-Body Approaches to Pain (MAP) trial protocol [15]. The primary source of participants was Group Health (GH), a large integrated healthcare system in Washington State. Letters describing the trial and inviting participation were mailed to GH members who met the electronic medical record (EMR) inclusion/exclusion criteria, and to random samples of residents in communities served by GH. Individuals who responded to the invitations were screened and enrolled by telephone (Figure 1). Potential participants were told that they would be randomized to one of “two different widely-used pain self-management programs that have been found helpful for reducing pain and making it easier to carry out daily activities” or to continued usual care plus $50. Those assigned to MBSR or CBT were not informed of their treatment allocation until they attended the first session. We recruited participants from 6 cities in 10 separate waves.

 

Figure 1 Flow of Participants Through Trial

Figure 1: Flow of participants through trial comparing mindfulness-based stress reduction with cognitive-behavioral therapy and usual care for chronic low back pain.

 

We recruited individuals 20 to 70 years of age with non-specific low back pain persisting at least 3 months. Persons with back pain associated with a specific diagnosis (e.g., spinal stenosis), with compensation or litigation issues, who would have difficulty participating (e.g., unable to speak English, unable to attend classes at the scheduled time and location), or who rated pain bothersomeness <4 and/or pain interference with activities <3 on 0–10 scales were excluded. Inclusion and exclusion criteria were assessed using EMR data for the previous year (for GH enrollees) and screening interviews. Participants were enrolled between September 2012 and April 2014. Due to slow enrollment, after 99 participants were enrolled, we stopped excluding persons 64–70 years old, GH members without recent visits for back pain, and patients with sciatica. The trial protocol was approved by the GH Human Subjects Review Committee. All participants gave informed consent.

 

Randomization

 

Immediately after providing consent and completing the baseline assessment, participants were randomized in equal proportions to MBSR, CBT, or UC. Randomization was stratified by the baseline score (≤12 versus ≥13, 0–23 scale) of one of the primary outcome measures, the modified Roland Disability Questionnaire (RDQ) [16]. Participants were randomized within these strata in blocks of 3, 6, or 9. The stratified randomization sequence was generated by the study biostatistician using R statistical software [17], and the sequence was stored in the study recruitment database and concealed from study staff until randomization.

 

Interventions

 

All participants received any medical care they would normally receive. Those randomized to UC received $50 but no MBSR training or CBT as part of the study and were free to seek whatever treatment, if any, they desired.

 

The interventions were comparable in format (group), duration (2 hours/week for 8 weeks, although the MBSR program also included an optional 6-hour retreat), frequency (weekly), and number of participants per group [See reference 15 for intervention details]. Each intervention was delivered according to a manualized protocol in which all instructors were trained. Participants in both interventions were given workbooks, audio CDs, and instructions for home practice (e.g., meditation, body scan, and yoga in MBSR; relaxation and imagery in CBT). MBSR was delivered by 8 instructors with 5 to 29 years of MBSR experience. Six of the instructors had received training from the Center for Mindfulness at the University of Massachusetts Medical School. CBT was delivered by 4 licensed Ph.D.-level psychologists experienced in group and individual CBT for chronic pain. Checklists of treatment protocol components were completed by a research assistant at each session and reviewed weekly by a study investigator to ensure all treatment components were delivered. In addition, sessions were audio-recorded and a study investigator monitored instructors’ adherence to the protocol in person or via audio-recording for at least one session per group.

 

MBSR was modelled closely after the original MBSR program [9], with adaptation of the 2009 MBSR instructor’s manual [18] by a senior MBSR instructor. The MBSR program does not focus specifically on a particular condition such as pain. All classes included didactic content and mindfulness practice (body scan, yoga, meditation [attention to thoughts, emotions, and sensations in the present moment without trying to change them, sitting meditation with awareness of breathing, walking meditation]). The CBT protocol included CBT techniques most commonly applied and studied for CLBP [8, 19–22]. The intervention included (1) education about chronic pain, relationships between thoughts and emotional and physical reactions, sleep hygiene, relapse prevention, and maintenance of gains; and (2) instruction and practice in changing dysfunctional thoughts, setting and working towards behavioral goals, relaxation skills (abdominal breathing, progressive muscle relaxation, guided imagery), activity pacing, and pain coping strategies. Between-session activities included reading chapters of The Pain Survival Guide [21]. Mindfulness, meditation, and yoga techniques were proscribed in CBT; methods to challenge dysfunctional thoughts were proscribed in MBSR.

 

Follow-Up

 

Trained interviewers masked to treatment group collected data by telephone at baseline (before randomization) and 4 (mid-treatment), 8 (post-treatment), 26 (primary endpoint), and 52 weeks post-randomization. Participants were compensated $20 for each interview.

 

Measures

 

Sociodemographic and back pain information was obtained at baseline (Table 1). All primary outcome measures were administered at each time-point; secondary outcomes were assessed at all time-points except 4 weeks.

 

Table 1 Baseline Characteristics of Participants

Table 1: Baseline characteristics of participants by treatment group.

 

Co–primary Outcomes

 

Back pain-related functional limitation was assessed by the RDQ [16], modified to 23 (versus the original 24) items and to ask about the past week rather than today only. Higher scores (range 0–23) indicate greater functional limitation. The original RDQ has demonstrated reliability, validity, and sensitivity to clinical change [23]. Back pain bothersomeness in the past week was measured by a 0–10 scale (0 = “not at all bothersome,” 10 = “extremely bothersome”). Our primary analyses examined the percentages of participants with clinically meaningful improvement (≥30% improvement from baseline) [24] on each measure. Secondary analyses compared the adjusted mean change from baseline between groups.

 

Secondary Outcomes

 

Depressive symptoms were assessed by the Patient Health Questionnaire-8 (PHQ-8; range, 0–24; higher scores indicate greater severity) [25]. Anxiety was measured using the 2-item Generalized Anxiety Disorder scale (GAD-2; range, 0–6; higher scores indicate greater severity) [26]. Characteristic pain intensity was assessed as the mean of three 0–10 ratings (current back pain and worst and average back pain in the previous month; range, 0–10; higher scores indicate greater intensity) from the Graded Chronic Pain Scale [27]. The Patient Global Impression of Change scale [28] asked participants to rate their improvement in pain on a 7-point scale (“completely gone, much better, somewhat better, a little better, about the same, a little worse, and much worse”). Physical and mental general health status were assessed with the 12-item Short-Form Health Survey (SF-12) (0–100 scale; lower scores indicate poorer health status) [29]. Participants were also asked about their use of medications and exercise for back pain during the previous week.

 

Adverse Experiences

 

Adverse experiences were identified during intervention sessions and by follow-up interview questions about significant discomfort, pain, or harm caused by the intervention.

 

Sample Size

 

A sample size of 264 participants (88 in each group) was chosen to provide adequate power to detect meaningful differences between MBSR and CBT and UC at 26 weeks. Sample size calculations were based on the outcome of clinically meaningful improvement (≥30% from baseline) on the RDQ [24]. Estimates of clinically meaningful improvement in the intervention and UC groups were based on unpublished analyses of data from our previous trial of massage for CLBP in a similar population [30]. This sample size provided adequate power for both co-primary outcomes. The planned sample size provided 90% power to detect a 25% difference between MBSR and UC in the proportion with meaningful improvement on the RDQ, and ≥80% power to detect a 20% difference between MBSR and CBT, assuming 30% of UC participants and 55% of CBT participants showed meaningful improvement. For meaningful improvement in pain bothersomeness, the planned sample size provided ≥80% power to detect a 21.8% difference between MBSR and UC, and a 16.7% difference between MBSR and CBT, assuming 47.5% in UC and 69.3% in CBT showed meaningful improvement.

 

Allowing for an 11% loss to follow-up, we planned to recruit 297 participants (99 per group). Because observed follow-up rates were lower than expected, an additional wave was recruited. A total of 342 participants were randomized to achieve a target sample size of 264 with complete outcome data at 26 weeks.

 

Statistical Analysis

 

Following the pre-specified analysis plan [15], differences among the three groups on each primary outcome were assessed by fitting a regression model that included outcome measures from all four time-points after baseline (4, 8, 26, and 52 weeks). A separate model was fit for each co-primary outcome (RDQ and bothersomeness). Indicators for time-point, randomization group, and the interactions between these variables were included in each model to estimate intervention effects at each time-point. Models were fit using generalized estimating equations (GEE) [31], which accounted for possible correlation within individuals. For binary primary outcomes, we used a modified Poisson regression model with a log link and robust sandwich variance estimator [32] to estimate relative risks. For continuous measures, we used linear regression models to estimate mean change from baseline. Models adjusted for age, sex, education, pain duration (<1 year versus ≥1 year since experiencing a week without back pain), and the baseline score on the outcome measure. Evaluation of secondary outcomes followed a similar analytic approach, although models did not include 4-week scores because secondary outcomes were not assessed at 4 weeks.

 

We evaluated the statistical significance of intervention effects at each time-point separately. We decided a priori to consider MBSR successful only if group differences were significant at the 26-week primary endpoint. To protect against multiple comparisons, we used the Fisher protected least-significant difference approach [33], which requires that pairwise treatment comparisons are made only if the overall omnibus test is statistically significant.

 

Because our observed follow-up rates differed across intervention groups and were lower than anticipated (Figure 1), we used an imputation method for non-ignorable nonresponse as our primary analysis to account for possible non-response bias. The imputation method used a pattern mixture model framework using a 2-step GEE approach [34]. The first step estimated the GEE model previously outlined with observed outcome data adjusting for covariates, but further adjusting for patterns of non-response. We included the following missing pattern indicator variables: missing one outcome, missing one outcome and assigned CBT, missing one outcome and assigned MBSR, and missing ≥2 outcomes (no further interaction with group was included because very few UC participants missed ≥2 follow-up time-points). The second step estimated the GEE model previously outlined, but included imputed outcomes from step 1 for those with missing follow-up times. We adjusted the variance estimates to account for using imputed outcome measures for unobserved outcomes.

 

All analyses followed an intention-to-treat approach. Participants were included in the analysis by randomization assignment, regardless of level of intervention participation. All tests and confidence intervals were 2-sided and statistical significance was defined as a P-value ≤ 0.05. All analyses were performed using the statistical package R version 3.0.2 [17].

 

Results

 

Figure 1 depicts participant flow through the study. Among 1,767 individuals expressing interest in study participation and screened for eligibility, 342 were enrolled and randomized. The main reasons for exclusion were inability to attend treatment sessions, pain lasting <3 months, and minimal pain bothersomeness or interference with activities. All but 7 participants were recruited from GH. Almost 90% of participants randomized to MBSR and CBT attended at least 1 session, but only 51% in MBSR and 57% in CBT attended at least 6 sessions. Only 26% of those randomized to MBSR attended the 6-hour retreat. Overall follow-up response rates ranged from 89.2% at 4 weeks to 84.8% at 52 weeks, and were higher in the UC group.

 

At baseline, treatment groups were similar in sociodemographic and pain characteristics except for more women in UC and fewer college graduates in MBSR (Table 1). Over 75% reported at least one year since a week without back pain and most reported pain on at least 160 of the previous 180 days. The mean RDQ score (11.4) and pain bothersomeness rating (6.0) indicated moderate levels of severity. Eleven percent reported using opioids for their pain in the past week. Seventeen percent had at least moderate levels of depression (PHQ-8 scores ≥10) and 18% had at least moderate levels of anxiety (GAD-2 scores ≥3).

 

Co-Primary Outcomes

 

At the 26-week primary endpoint, the groups differed significantly (P = 0.04) in percent with clinically meaningful improvement on the RDQ (MBSR 61%, UC 44%, CBT 58%; Table 2a). Participants randomized to MBSR were more likely than those randomized to UC to show meaningful improvement on the RDQ (RR = 1.37; 95% CI, 1.06–1.77), but did not differ significantly from those randomized to CBT. The overall difference among groups in clinically meaningful improvement in pain bothersomeness at 26 weeks was also statistically significant (MBSR 44%, UC 27%, CBT 45%; P = 0.01). Participants randomized to MBSR were more likely to show meaningful improvement when compared with UC (RR = 1.64; 95% CI, 1.15–2.34), but not when compared with CBT (RR = 1.03; 95% CI, 0.78–1.36). The significant differences between MBSR and UC, and non-significant differences between MBSR and CBT, in percent with meaningful function and pain improvement persisted at 52 weeks, with relative risks similar to those at 26 weeks (Table 2a). CBT was superior to UC for both primary outcomes at 26, but not 52, weeks. Treatment effects were not apparent before end of treatment (8 weeks). Generally similar results were found when the primary outcomes were analyzed as continuous variables, although more differences were statistically significant at 8 weeks and the CBT group improved more than the UC group at 52 weeks (Table 2b).

 

Table 2A Co-Primary Outcomes

Table 2A: Co-primary outcomes: Percentage of participants with clinically meaningful improvement in chronic low back pain by treatment group and relative risks comparing treatment groups (Adjusted Imputed Analyses).

 

Table 2B Co-Primary Outcomes

Table 2B: Co-primary outcomes: Mean (95% CI) change in chronic low back pain by treatment group and mean (95% CI) differences between treatment groups (Adjusted Imputed Analyses).

 

Secondary Outcomes

 

Mental health outcomes (depression, anxiety, SF-12 Mental Component) differed significantly across groups at 8 and 26, but not 52, weeks (Table 3). Among these measures and time-points, participants randomized to MBSR improved more than those randomized to UC only on the depression and SF-12 Mental Component measures at 8 weeks. Participants randomized to CBT improved more than those randomized to MBSR on depression at 8 weeks and anxiety at 26 weeks, and more than the UC group at 8 and 26 weeks on all three measures.

 

Table 3 Secondary Outcomes

Table 3: Secondary outcomes by treatment group and between-group comparisons (Adjusted Imputed Analyses).

 

The groups differed significantly in improvement in characteristic pain intensity at all three time-points, with greater improvement in MBSR and CBT than in UC and no significant difference between MBSR and CBT. No overall differences in treatment effects were observed for the SF-12 Physical Component score or self-reported use of medications for back pain. Groups differed at 26 and 52 weeks in self-reported global improvement, with both the MBSR and CBT groups reporting greater improvement than the UC group, but not differing significantly from each other.

 

Adverse Experiences

 

Thirty of the 103 (29%) participants attending at least 1 MBSR session reported an adverse experience (mostly temporarily increased pain with yoga). Ten of the 100 (10%) participants who attended at least one CBT session reported an adverse experience (mostly temporarily increased pain with progressive muscle relaxation). No serious adverse events were reported.

 

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Dr. Alex Jimenez’s Insight

Stress management treatment includes a combination of stress management methods and techniques as well as lifestyle changes to help improve and manage stress and its associated symptoms. Because every person responds to stress in a wide variety of ways, treatment for stress will often vary greatly depending on the specific symptoms the individual is experiencing and according to their grade of severity. Chiropractic care is an effective stress management treatment which helps reduce chronic stress and its associated symptoms by reducing pain and muscle tension on the structures surrounding the spine. A spinal misalignment, or subluxation, can create stress and other symptoms, such as low back pain and sciatica. Furthermore, the results of the article above demonstrated that mindfulness-based stress reduction, or MBSR, is an effective stress management treatment for adults with chronic low back pain.

 

Discussion

 

Among adults with CLBP, both MBSR and CBT resulted in greater improvement in back pain and functional limitations at 26 and 52 weeks, as compared with UC. There were no meaningful differences in outcomes between MBSR and CBT. The effects were moderate in size, which has been typical of evidence-based treatments recommended for CLBP [4]. These benefits are remarkable given that only 51% of those randomized to MBSR and 57% of those randomized to CBT attended ≥6 of the 8 sessions.

 

Our findings are consistent with the conclusions of a 2011 systematic review [35] that “acceptance-based” interventions such as MBSR have beneficial effects on the physical and mental health of patients with chronic pain, comparable to those of CBT. They are only partially consistent with the only other large RCT of MBSR for CLBP [13], which found that MBSR, as compared with a time- and attention-matched health education control group, provided benefits for function at post-treatment (but not at 6-month follow-up) and for average pain at 6-month follow-up (but not post-treatment). Several differences between our trial and theirs (which was limited to adults ≥65 years and had a different comparison condition) could be responsible for differences in findings.

 

Although our trial lacked a condition controlling for nonspecific effects of instructor attention and group participation, CBT and MBSR have been shown to be more effective than control and active interventions for pain conditions. In addition to the trial of older adults with CLBP [14] that found MBSR to be more effective than a health education control condition, a recent systematic review of CBT for nonspecific low back pain found CBT to be more effective than guideline-based active treatments in improving pain and disability at short- and long-term follow-ups [7]. Further research is needed to identify moderators and mediators of the effects of MBSR on function and pain, evaluate benefits of MBSR beyond one year, and determine its cost-effectiveness. Research is also needed to identify reasons for session non-attendance and ways to increase attendance, and to determine the minimum number of sessions required.

 

Our finding of increased effectiveness of MBSR at 26–52 weeks relative to post-treatment for both primary outcomes contrasts with findings of our previous studies of acupuncture, massage, and yoga conducted in the same population as the current trial [30, 36, 37]. In those studies, treatment effects decreased between the end of treatment (8 to 12 weeks) and long-term follow-up (26 to 52 weeks). Long-lasting effects of CBT for CLBP have been reported [7, 38, 39]. This suggests that mind-body treatments such as MBSR and CBT may provide patients with long-lasting skills effective for managing pain.

 

There were more differences between CBT and UC than between MBSR and UC on measures of psychological distress. CBT was superior to MBSR on the depression measure at 8 weeks, but the mean difference between groups was small. Because our sample was not very distressed at baseline, further research is needed to compare MBSR to CBT in a more distressed patient population.

 

Limitations of this study must be acknowledged. Study participants were enrolled in a single healthcare system and generally highly educated. The generalizability of findings to other settings and populations is unknown. About 20% of participants randomized to MBSR and CBT were lost to follow-up. We attempted to correct for bias from missing data in our analyses by using imputation methods. Finally, the generalizability of our findings to CBT delivered in an individual rather than group format is unknown; CBT may be more effective when delivered individually [40]. Study strengths include a large sample with adequate statistical power to detect clinically meaningful effects, close matching of the MBSR and CBT interventions in format, and long-term follow-up.

 

Conclusions

 

Among adults with chronic low back pain, treatment with MBSR and CBT, compared with UC, resulted in greater improvement in back pain and functional limitations at 26 weeks, with no significant differences in outcomes between MBSR and CBT. These findings suggest that MBSR may be an effective treatment option for patients with chronic low back pain.

 

Acknowledgments

 

Funding/Support: Research reported in this publication was supported by the National Center for Complementary & Integrative Health of the National Institutes of Health under Award Number R01AT006226. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

 

Role of sponsor: The study funder had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; or decision to submit the manuscript for publication.

 

Footnotes

 

Ncbi.nlm.nih.gov/pmc/articles/PMC4914381/

 

Contributor Information

 

  • Daniel C. Cherkin, Group Health Research Institute; Departments of Health Services and Family Medicine, University of Washington.
  • Karen J. Sherman, Group Health Research Institute; Department of Epidemiology, University of Washington.
  • Benjamin H. Balderson, Group Health Research Institute, University of Washington.
  • Andrea J. Cook, Group Health Research Institute; Department of Biostatistics, University of Washington.
  • Melissa L. Anderson, Group Health Research Institute, University of Washington.
  • Rene J. Hawkes, Group Health Research Institute, University of Washington.
  • Kelly E. Hansen, Group Health Research Institute, University of Washington.
  • Judith A. Turner, Departments of Psychiatry and Behavioral Sciences and Rehabilitation Medicine, University of Washington.

 

In conclusion, chiropractic care is recognized as an effective stress management treatment for low back pain and sciatica. Because chronic stress can cause a variety of health issues over time, improving as well as managing stress accordingly is essential towards achieving overall health and wellness. Additionally, as demonstrated in the article above comparing the effects of mindfulness-based stress reduction with cognitive-behavioral therapy and usual care for stress with associated chronic low back pain, mindfulness-based stress reduction, or MBSR, is effective as a stress management treatment. Information referenced from the National Center for Biotechnology Information (NCBI). The scope of our information is limited to chiropractic as well as to spinal injuries and conditions. To discuss the subject matter, please feel free to ask Dr. Jimenez or contact us at 915-850-0900 .

 

Curated by Dr. Alex Jimenez

 

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Additional Topics: Back Pain

 

According to statistics, approximately 80% of people will experience symptoms of back pain at least once throughout their lifetimes. Back pain is a common complaint which can result due to a variety of injuries and/or conditions. Often times, the natural degeneration of the spine with age can cause back pain. Herniated discs occur when the soft, gel-like center of an intervertebral disc pushes through a tear in its surrounding, outer ring of cartilage, compressing and irritating the nerve roots. Disc herniations most commonly occur along the lower back, or lumbar spine, but they may also occur along the cervical spine, or neck. The impingement of the nerves found in the low back due to injury and/or an aggravated condition can lead to symptoms of sciatica.

 

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EXTRA IMPORTANT TOPIC: Managing Workplace Stress

 

 

MORE IMPORTANT TOPICS: EXTRA EXTRA: Choosing Chiropractic? | Familia Dominguez | Patients | El Paso, TX Chiropractor

 

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15. Cherkin DC, Sherman KJ, Balderson BH, et al. Comparison of complementary and alternative medicine with conventional mind-body therapies for chronic back pain: protocol for the Mind-body Approaches to Pain (MAP) randomized controlled trial. Trials. 2014;15:211. doi: 10.1186/1745-6215-15-211. [PMC free article] [PubMed] [Cross Ref]
16. Patrick DL, Deyo RA, Atlas SJ, Singer DE, Chapin A, Keller RB. Assessing health-related quality of life in patients with sciatica. Spine (Phila Pa 1976) 1995;20:1899–1908. [PubMed]
17. R Core Team. R: A language and environment for statistical computing. Vienna, Austria: R Foundation for Statistical Computing; 2013. http://www.R-project.org/
18. Blacker M, Meleo-Meyer F, Kabat-Zinn J, Santorelli SF. Stress Reduction Clinic Mindfulness-Based Stress Reduction (MBSR) Curriculum Guide. Worcester, MA: Center for Mindfulness in Medicine, Health Care, and Society, Division of Preventive and Behavioral Medicine, Department of Medicine, University of Massachusetts Medical School; 2009.
19. Turner JA, Romano JM. Cognitive-behavioral therapy for chronic pain. In: Loeser JD, Butler SH, Chapman CR, Turk DC, editors. Bonica’s Management of Pain. 3rd. Philadelphia, PA: Lippincott Williams & Wilkins; 2001. pp. 1751–1758.
20. Lamb SE, Hansen Z, Lall R, et al. Back Skills Training Trial investigators: Group cognitive behavioural treatment for low-back pain in primary care: a randomised controlled trial and cost-effectiveness analysis. Lancet. 2010;375:916–923. [PubMed]
21. Turk DC, Winter F. The Pain Survival Guide: How to Reclaim Your Life. Washington, DC: American Psychological Association; 2005.
22. Otis JD. Managing Chronic Pain: A Cognitive-Behavioral Therapy Approach (Therapist Guide) New York, NY: Oxford University Press; 2007.
23. Roland M, Fairbank J. The Roland-Morris Disability Questionnaire and the Oswestry Disability Questionnaire. Spine (Phila Pa 1976) 2000;25:3115–3124. A published erratum appears in Spine (Phila Pa 1976) 2001;26:847. [PubMed]
24. Ostelo RW, Deyo RA, Stratford P, et al. Interpreting change scores for pain and functional status in low back pain: towards international consensus regarding minimal important change. Spine (Phila Pa 1976) 2008;33:90–94. [PubMed]
25. Kroenke K, Strine TW, Spitzer RL, Williams JB, Berry JT, Mokdad AH. The PHQ-8 as a measure of current depression in the general population. J Affect Disord. 2009;114:163–173. [PubMed]
26. Skapinakis P. The 2-item Generalized Anxiety Disorder scale had high sensitivity and specificity for detecting GAD in primary care. Evid Based Med. 2007;12:149. [PubMed]
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28. Guy W, National Institute of Mental Health (US). Psychopharmacology Research Branch. Early Clinical Drug Evaluation Program . ECDEU Assessment Manual for Psychopharmacology. Rockville, MD: US Department of Health, Education, and Welfare, Public Health Service, Alcohol, Drug Abuse, and Mental Health Administration, National Institute of Mental Health, Psychopharmacology Research Branch, Division of Extramural Research Programs; 1976. Revised 1976.
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31. Liang KY, Zeger SL. Longitudinal data analysis using generalized linear models. Biometrika. 1986;73(1):13–22.
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34. Wang M, Fitzmaurice GM. A simple imputation method for longitudinal studies with non-ignorable non-responses. Biom J. 2006;48:302–318. [PubMed]
35. Veehof MM, Oskam MJ, Schreurs KM, Bohlmeijer ET. Acceptance-based interventions for the treatment of chronic pain: a systematic review and meta-analysis. Pain. 2011;152(3):533–42. doi: 10.1016/j.pain.2010.11.002. [PubMed] [Cross Ref]
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Stress Management Techniques for Chronic Pain in El Paso, TX

Stress Management Techniques for Chronic Pain in El Paso, TX

In the modern world, it’s easy to find circumstances to stress about. Whether it involves work, financial issues, health emergencies, relationship problems, media stimulation and/or other factors, stress can begin to weigh in on our overall health and wellness if not managed properly. Also, we often tend to create stress ourselves through poor nutrition and a lack of sleep.

 

In fact, more than three-fourths of the population in the United States experiences stress on a regular basis, where one-third of those individuals characterize their stress levels as “extreme”. Although short-term stress can be helpful, long-term stress can lead to a variety of health issues. Stress has been considered the cause of so many diseases, healthcare professionals estimate it accounts for half of the country’s healthcare-related expenses, according to the U.S. News & World Report.

 

How Stress Affects the Body

 

Stress signals the sympathetic nervous system to trigger the “fight or flight” response, a defense mechanism which prepares the body for perceived danger by causing the heart rate, blood volume and blood pressure to rise. This diverts blood away from the digestive system and limbs. The adrenal glands also secrete a special mixture of hormones and chemicals, including adrenaline, epinephrine and norepinephrine, which could affect an individual’s well-being if they’re constantly being secreted into the body.

 

Also, chronic stress can cause muscle tension. Excess muscle tension along the neck and back may result in the misalignment of the spine, known as a subluxation, ultimately interfering with the proper function of the nervous system and causing symptoms of back pain and sciatica. Fortunately, a variety of stress management techniques, including chiropractic care and mindfulness meditation, can help reduce chronic pain, commonly associated with chronic stress.

 

Chiropractic Care for Stress

 

Chiropractic care is a well-known, alternative treatment option utilized to treat a variety of injuries and conditions associated with the musculoskeletal and nervous system. Correcting spinal misalignments is the first step for reducing stress. If there is a subluxation in the spine, the nervous system may often not be able to properly send signals throughout the rest of the body. By using spinal adjustments and manual manipulations, a doctor of chiropractic can carefully realign the spine, releasing muscle tension, soothing irritated spinal nerves and improving blood flow, changes which could will alert the brain to switch off the “fight or flight” response so that the body can return to a more relaxed state.

 

Furthermore, a chiropractor can also recommend lifestyle modifications, together with spinal adjustments and manual manipulations, to help reduce stress. Nutritional supplementation, rehabilitative exercises, deep-tissue massage, relaxation techniques and posture changes recommended by a chiropractor are several stress management techniques which can help improve symptoms of chronic pain associated with stress. The following article is a systematic review and meta-analysis demonstrating the use of mindfulness medication for chronic pain, including back pain and sciatica.

 

Mindfulness Meditation for Chronic Pain: Systematic Review and Meta-analysis

 

Abstract

 

  • Background: Chronic pain patients increasingly seek treatment through mindfulness meditation.
  • Purpose: This study aims to synthesize evidence on efficacy and safety of mindfulness meditation interventions for the treatment of chronic pain in adults.
  • Method: We conducted a systematic review on randomized controlled trials (RCTs) with meta-analyses using the Hartung-Knapp-Sidik-Jonkman method for random-effects models. Quality of evidence was assessed using the GRADE approach. Outcomes included pain, depression, quality of life, and analgesic use.
  • Results: Thirty-eight RCTs met inclusion criteria; seven reported on safety. We found low-quality evidence that mindfulness meditation is associated with a small decrease in pain compared with all types of controls in 30 RCTs. Statistically significant effects were also found for depression symptoms and quality of life.
  • Conclusions: While mindfulness meditation improves pain and depression symptoms and quality of life, additional well-designed, rigorous, and large-scale RCTs are needed to decisively provide estimates of the efficacy of mindfulness meditation for chronic pain.
  • Electronic supplementary material: The online version of this article (doi:10.1007/s12160-016-9844-2) contains supplementary material, which is available to authorized users.
  • Keywords: Chronic pain, Mindfulness, Meditation, Systematic review

 

Introduction

 

Chronic pain, often defined as pain lasting longer than 3 months or past the normal time for tissue healing [1], can lead to significant medical, social, and economic consequences, relationship issues, lost productivity, and larger health care costs. The Institute of Medicine recognizes pain as a significant public health problem that costs our nation at least $560–635 billion annually, including costs of health care and lost productivity [2]. Further, chronic pain is frequently accompanied by psychiatric disorders such as pain medication addiction and depression that make treatment complicated [3]. The high prevalence and refractory nature of chronic pain, in conjunction with the negative consequences of pain medication dependence, has led to increased interest in treatment plans that include adjunctive therapy or alternatives to medication [4]. One such modality that pain patients are using is mindfulness meditation. Based on ancient Eastern meditation practices, mindfulness facilitates an attentional stance of detached observation. It is characterized by paying attention to the present moment with openness, curiosity, and acceptance [5, 6]. Mindfulness meditation is thought to work by refocusing the mind on the present and increasing awareness of one’s external surroundings and inner sensations, allowing the individual to step back and reframe experiences. Current research using neuroimaging to elucidate neurological mechanisms underlying effects of mindfulness has focused on brain structures such as the posterior cingulate cortex, which appear to be involved in self-referential processing [7, 8]. Clinical uses of mindfulness include applications in substance abuse [9], tobacco cessation [10], stress reduction [11], and treatment of chronic pain [12–14].

 

Early mindfulness studies in pain patients showed promising outcomes on pain symptoms, mood disturbance, anxiety, and depression, as well as pain-related drug utilization [5]. Numerous systematic reviews on the effects of mindfulness meditation have been published in recent years. Of those that report pain outcomes, several have focused on specific types of pain such as low back pain [13], fibromyalgia [15], or somatization disorder [16]. Others were not limited to RCTs [14, 17]. There have been several comprehensive reviews focused on controlled trials of mindfulness interventions for chronic pain including a review [4] that showed improvements in depressive symptoms and coping, another review [18] on mindfulness for chronic back pain, fibromyalgia, and musculoskeletal pain that showed small positive effects for pain, and the most recent review [19] on various pain conditions which found improvements in pain, pain acceptance, quality of life, and functional status. Authors of these reviews echoed concerns that there is limited evidence for efficacy of mindfulness-based interventions for patients with chronic pain because of methodological issues. They have concluded that additional high-quality research was needed before a recommendation for the use of mindfulness meditation for chronic pain symptoms could be made.

 

The purpose of this study was to conduct a systematic review and meta-analysis of the effects and safety of mindfulness meditation, as an adjunctive or monotherapy to treat individuals with chronic pain due to migraine, headache, back pain, osteoarthritis, or neuralgic pain compared with treatment as usual, waitlists, no treatment, or other active treatments. Pain was the primary outcome, and secondary outcomes included depression, quality of life, and analgesic use. The systematic review protocol is registered in an international registry for systematic reviews (PROSPERO 2015:CRD42015025052).

 

Methods

 

Search Strategy

 

We searched the electronic databases PubMed, Cumulative Index to Nursing and Allied Health Literature (CINAHL), PsycINFO, and Cochrane Central Register of Controlled Trials (CENTRAL) for English-language-randomized controlled trials from inception through June 2016. We combined pain conditions and design terms with the following mindfulness search terms: “Mindfulness” [Mesh]) or “Meditation” [Mesh] or mindfulness* or mindfulness-based or MBSR or MBCT or M-BCT or meditation or meditat* or Vipassana or satipaṭṭhāna or anapanasati or Zen or Pranayama or Sudarshan or Kriya or zazen or shambhala or buddhis*.” In addition to this search and the reference mining of all included studies identified through it, we reference mined prior systematic reviews and retrieved all studies included therein.

 

Eligibility Criteria

 

Parallel group, individual or cluster RCTs of adults who report chronic pain were included. Studies where the author defined chronic pain and studies in patients reporting pain for a minimum of 3 months were included. Studies were required to involve mindfulness meditation, either as an adjunctive or monotherapy; studies testing other meditation interventions such as yoga, tai chi, qigong, and transcendental meditation techniques without reference to mindfulness were excluded. Mindfulness interventions that did not require formal meditation, such as acceptance and commitment therapy (ACT) were also excluded. Only studies that reported pain measures or change in analgesic use were included. Dissertations and conference abstracts were excluded.

 

Procedures

 

Two independent reviewers screened titles and abstracts of retrieved citations—following a pilot session to ensure similar interpretation of the inclusion and exclusion criteria. Citations judged as potentially eligible by one or both reviewers were obtained as full text. The full text publications were then dually screened against the specified inclusion criteria. The flow of citations throughout this process was documented in an electronic database, and reasons for exclusion of full-text publications were recorded. Data abstraction was also conducted in dual. Risk of bias was assessed using the Cochrane Risk of Bias tool [20]. Other biases related to the US Preventive Services Task Force’s (USPSTF) criteria for internal validity of included studies were assessed [21, 22]. These criteria were used to rate the quality of evidence as good, fair, or poor for each included study.

 

Meta-Analytic Techniques

 

When sufficient data were available and statistical heterogeneity was below agreed thresholds [20], we performed meta-analysis to pool efficacy results across included studies for the outcomes of interest and present a forest plot for the main meta-analysis. We used the Hartung-Knapp-Sidik-Jonkman method for random effects meta-analysis using unadjusted means and measures of dispersion [23–25]. For studies reporting multiple pain outcomes, we used specific pain measures, such as the McGill Pain Questionnaire (MPQ) for the main meta-analysis rather than the pain subscale of the SF-36, and average or general pain measures rather than situational measures such as pain at the time of assessment. Due to the small number of adverse events reported, quantitative analysis was not conducted. We conducted subgroup analyses and meta-regressions to address whether there were differences in effect sizes between different interventions types, populations, or when used as monotherapy versus an adjunctive therapy. The quality of the body of evidence was assessed using the GRADE approach [22, 26] by which a determination of high, moderate, low, or very low was made for each major outcome [27].

 

Results

 

Description of Included Studies

 

We identified 744 citations through searches of electronic databases and 11 additional records identified through other sources (see Figure 1). Full texts were obtained for 125 citations identified as potentially eligible by two independent reviewers; 38 RCTs met inclusion criteria. Details of study characteristics are displayed in Table ​1 and effects for individual studies are displayed in Table ​2.

 

 

Table 1 Characteristics of Included Studies

Table 1: Characteristics of included studies.

 

Table 2 Effects for Individual Studies

Table 2: Effects for individual studies.

 

In total, studies assigned 3536 participants; sample sizes ranged from 19 to 342. Fifteen studies reported an a priori power calculation with targeted sample size achieved, ten studies did not report information about a power calculation, and three studies were unclear in the reporting of a power calculation. Ten studies noted there was insufficient power; the authors considered these pilot studies. The majority of the studies were conducted in North America or Europe. The mean age of participants ranged from 30 (SD, 9.08) to 78 years (SD, 7.1. Eight studies included only female participants.

 

Medical conditions reported included fibromyalgia in eight studies and back pain in eight studies. (Categories are not mutually exclusive; some studies included patients with different conditions.) Osteoarthritis was reported in two studies and rheumatoid arthritis in three. Migraine headache was reported in three studies and another type of headache in five studies. Three studies reported irritable bowel syndrome (IBS). Eight studies reported other causes of pain and three studies did not specify a medical condition or source of chronic pain.

 

The total length of the interventions ranged from 3 to 12 weeks; the majority of interventions (29 studies) were 8 weeks in length. Twenty-one studies were conducted on mindfulness-based stress reduction (MBSR) and six on mindfulness-based cognitive therapy (MBCT). Eleven additional studies reported results on other types of mindfulness training. Thirteen RCTs provided the mindfulness intervention as monotherapy, and eighteen utilized a mindfulness intervention as adjunctive therapy, specifying that all participants received this in addition to other treatment such as medication. Seven of the studies were unclear as to whether the mindfulness intervention was monotherapy or adjunctive therapy. Nineteen RCTs used treatment as usual as comparators, thirteen used passive comparators, and ten used education/support groups as comparators. Beyond these common comparators, one study each used stress management, massage, a multidisciplinary pain intervention, relaxation/stretching, and nutritional information/food diaries as comparators; two studies used cognitive-behavioral therapy. Several studies had two comparison arms.

 

Study Quality and Risk of Bias

 

The study quality for each included study is displayed in Table ​1. Eleven studies obtained a “good” quality rating [28–38]. Fourteen studies were judged to be of fair quality, primarily due to being unclear in some aspects of the methods [39–52]. Thirteen studies were judged to be poor; ten primarily due to issues with completeness of reporting outcome data such as inadequate or missing intention to treat (ITT) analysis and/or less than 80 % follow-up [53–62] and three due to unclear methods [63–65]. Details of the quality ratings and risk of bias for each included study is displayed in Electronic Supplementary Material 1.

 

Measures

 

Studies reported patient pain measures such as the Visual Analog Scale, the SF-36 pain subscale, and McGill Pain Questionnaire. Secondary outcome measures included depression symptoms (e.g., Beck Depression Inventory, Patient Health Questionnaire), physical and mental health-related quality of life (e.g., SF-36 mental and physical components), and functional impairment/disability (e.g., Roland-Morris Disability Questionnaire, Sheehan Disability Scale).

 

Chronic Pain Treatment Response

 

Thirty RCTs reported continuous outcome data on scales assessing chronic pain [29, 31–33, 36, 39–49, 51–60, 62–64, 66].

 

Eight studies met screening inclusion criteria but did not contribute to the meta-analysis because they did not report poolable data [28, 30, 34, 35, 38, 50, 61, 65]. Their study characteristics are displayed in Table ​1, and study level effects along with the reasons they were not in pooled analyses are displayed in Table ​2.

 

Pain scales and comparators varied from study to study. The median follow-up time was 12 weeks, with a range of 4 to 60 weeks. Figure ​2 displays the results of meta-analysis using data at the longest follow-up for each study. The pooled analysis indicates a statistically significant effect of mindfulness meditation compared with treatment as usual, passive controls, and education/support groups (SMD, 0.32; 95 % CI, 0.09, 0.54; 30 RCTs). Substantial heterogeneity was detected (I 2 = 77.6 %). There was no evidence of publication bias (Begg’s p = 0.26; Egger’s test p = 0.09). To investigate whether the treatment estimate is robust when excluding poor-quality studies and to explore the possible source of the substantial heterogeneity, we conducted a sensitivity analysis including only fair or good quality studies. The improvement remained significant, the effect size was smaller (SMD, 0.19; 95 % CI, 0.03, 0.34; 19 RCTs), and there was less heterogeneity (I 2 = 50.5 %). Meta-regressions showed that changes in pain outcomes in good- (p = 0.42) and fair-quality (p = 0.13) studies were not significantly different from changes in poor-quality studies.

 

Figure 2 Mindfulness Meditation Effects on Chronic Pain

Figure 2: Mindfulness meditation effects on chronic pain.

 

In subgroup analyses, the effect was not statistically significant at 12 weeks or less (SMD, 0.25; 95 % CI, −0.13, 0.63; 15 RCTs; I 2 = 82.6 %) but was significant for follow-up periods beyond 12 weeks (SMD, 0.31; 95 % CI, 0.04, 0.59; 14 RCTs, I 2 = 69.0 %). Begg’s test was not statistically significant (p = 0.16) but Egger’s test showed evidence of publication bias (p = 0.04). The quality of evidence that mindfulness meditation is associated with a decrease in chronic pain compared with control is low overall and for both short- and long-term follow-up due to inconsistency, heterogeneity, and possible publication bias. A detailed table displays the quality of evidence for findings for each major outcome in Electronic Supplementary Material 2.

 

In order to present clinically meaningful results, we calculated the percent change in pain symptoms from baseline to follow-up for mindfulness meditation and comparison groups for each study and displayed findings in Table ​2. We then calculated the overall weighted mean percent change for mindfulness meditation groups versus comparison groups for effects of meditation for pain at longest follow-up. The mean percent change in pain for meditation groups was −0.19 % (SD, 0.91; min, −0.48; max, 0.10) while the mean percent change in pain for control groups was −0.08 % (SD, 0.74; min, −0.35; max, 0.11). The p value for the difference between groups was significant (p = 0.0031).

 

Depression

 

Depression outcomes were reported in 12 RCTs [29, 31, 33, 34, 45, 46, 48, 49, 51–53, 56]. Overall, meditation significantly lowered depression scores as compared with treatment as usual, support, education, stress management, and waitlist control groups (SMD, 0.15; 95 % CI, 0.03, 0.26; 12 RCTs; I 2 = 0 %). No heterogeneity was detected. The quality of evidence was rated as high due to lack of heterogeneity, consistent study results, and precision of effect (small confidence intervals).

 

Quality of Life

 

Sixteen studies reported mental health-related quality of life; the effect of mindfulness meditation was significant in the pooled analysis as compared with treatment as usual, support groups, education, stress management, and waitlist controls (SMD, 0.49; 95 % CI, 0.22, 0.76; I 2, 74.9 %). [32–34, 45–49, 52, 54, 56, 59, 60, 62–64]. Sixteen studies measured physical health-related quality of life [32–34, 36, 45–49, 52, 54, 56, 60, 62–64]. Pooled analyses showed a significant effect of mindfulness meditation as compared with treatment as usual, support groups, education, stress management, and waitlist controls (SMD, 0.34; 95 % CI, 0.03, 0.65; I 2, 79.2 %). Both quality-of-life analyses detected substantial heterogeneity, and the quality of evidence was rated as moderate for mental health (small confidence intervals, more consistent results) and low for physical health-related quality of life.

 

Functional Impairment (Disability Measures)

 

Four studies reported poolable disability scores from the Roland-Morris Disability Questionnaire and the Sheehan Disability Scale [33, 36, 47, 55]. The difference between the mindfulness and comparison groups in follow-up was not statistically significant (SMD, 0.30; 95 % CI, −0.02, 0.62; I 2 = 1.7 %), although the results approached significance. No heterogeneity was detected. The quality of evidence was rated low due to imprecision and small total sample size.

 

Analgesic Use

 

Only four studies reported use of analgesics as an outcome. In a study of MBSR for treatment of chronic pain due to failed back surgery syndrome [55], at 12-week follow-up, the analgesic medication logs of the intervention group documented a decrease in analgesic use compared with those in the control group (−1.5 (SD = 1.8) vs. 0.4 (SD = 1.1), p = <0.001). A study of mindfulness meditation and cognitive-behavioral therapy vs. usual care for low back pain [35] reported that the mean morphine equivalent dose (mg/day) of opioids was not significantly different between groups at both 8 and 26 weeks. Likewise, a trial of MBSR for back pain [38] found no significant difference between groups in self-reported use of pain medication. Finally, a trial of mindfulness-oriented recovery enhancement (MORE) for chronic pain of various etiologies [44] found intervention participants significantly more likely to no longer meet criteria for opioid use disorder immediately following treatment (p = 0.05); however, these effects were not sustained at 3-month follow-up.

 

Adverse Events

 

Only 7 of the 38 included RCTs reported on adverse events. Four stated no adverse events occurred [36, 47, 50, 57]; one described that two participants experienced temporary strong feelings of anger toward their pain condition and two of the participants experienced greater anxiety [46]; two studies recorded mild side effects from yoga and progressive muscle relaxation [35, 38].

 

Study Characteristic Moderators

 

Meta-regressions were run to determine if changes in pain outcomes systematically differed by several subcategories. There was no difference in effect on pain between MBSR (16 studies) and MBCT (4 studies; p = 0.68) or other types of mindfulness interventions (10 studies; p = 0.68). When comparing MBSR (16 studies) to all other interventions (14 studies), there was also no difference in effect (p = 0.45). As stated in more detail above, medical conditions reported included fibromyalgia, back pain, arthritis, headache, and irritable bowel syndrome (IBS). Meta-regressions did not suggest differences between headache (six studies) and other conditions (p = 0.93), back pain (eight studies) and other conditions (p = 0.15), and fibromyalgia (eight studies) and other conditions (p = 0.29). Gender composition (% male) had no association with effect on pain (p = 0.26). The total length of the intervention program ranged from 3 to 12 weeks (mean was 8 weeks). Meta-regression did not suggest differences between high-frequency interventions and medium- (p = 0.16) or low-frequency (p = 0.44) interventions. No systematic difference in effect on pain between adjunctive therapy and monotherapy (p = 0.62) or between adjunctive therapy and interventions where this was unclear (p = 0.10) was found. Finally, there was no systematic difference in effect whether the comparator was treatment as usual, waitlist, or another intervention (p = 0.21).

 

Dr Jimenez White Coat

Dr. Alex Jimenez’s Insight

Chronic stress is a massive issue in the United States and it has had a detrimental impact on the overall health and wellness of the American population. Stress can affect different areas of the body. Stress can increase heart rate and cause rapid breathing, or hyperventilation, as well as muscle tension. Additionally, stress triggers the “fight or flight” response, which causes the sympathetic nervous system to release a mixture of hormones and chemicals into the body. Fortunately, chiropractic care can help with stress management. Chiropractic treatment activates the parasympathetic system which calms the “fight or flight” response. Furthermore, chiropractic care can help reduce muscle tension, improving chronic pain symptoms.

 

Discussion

 

In sum, mindfulness meditation was associated with a small effect of improved pain symptoms compared with treatment as usual, passive controls, and education/support groups in a meta-analysis of 30 randomized controlled trials. However, there was evidence of substantial heterogeneity among studies and possible publication bias resulting in a low quality of evidence. The efficacy of mindfulness meditation on pain did not differ systematically by type of intervention, medical condition, or by length or frequency of intervention. Mindfulness meditation was associated with statistically significant improvement in depression, physical health-related quality of life, and mental health-related quality of life. Quality of evidence was high for depression, moderate for mental health-related quality of life, and low for physical health-related quality of life. Only four studies reported on change in analgesic use; results were mixed. Adverse events in the included RCTs were rare and not serious, but the vast majority of studies did not collect adverse events data.

 

This review has several methodological strengths: an a priori research design, duplicate study selection and data abstraction of study information, a comprehensive search of electronic databases, risk of bias assessments, and comprehensive quality of evidence assessments used to formulate review conclusions. One limitation is that we did not contact individual study authors; results reported in the review are based on published data. We excluded conference abstracts which do not contain enough data to evaluate study quality. In addition, we included only studies published in English.

 

The included studies had many limitations. Thirteen of the thirty-eight studies were rated as poor quality, primarily due to lack of ITT, poor follow-up, or poor reporting of methods for randomization and concealment of allocation. The authors of ten studies reported inadequate statistical power to detect differences in pain outcomes between mindfulness meditation and the comparator; the authors considered these pilot studies. Ten other studies did not report a power calculation. Sample sizes were small; 15 studies randomized fewer than 50 participants.

 

More well-designed, rigorous, and large RCTs are needed in order to develop an evidence base that can more decisively provide estimates of its effectiveness. Studies should enroll samples large enough to detect statistical differences in outcomes and should follow-up with participants for 6 to 12 months in order to assess the long-term effects of meditation. Adherence to mindfulness practice and simultaneous use of other therapies should be monitored frequently. Intervention characteristics, including the optimal dose, have also not yet conclusively been established. In order to detect intervention specific effects, studies need to have attention-matched controls. Smaller trials may be conducted to answer these questions. Other outcomes that were outside the scope of this review may be important to explore. As the impact of mindfulness may be related to the appraisal of the pain, it may be useful for future trials to focus primary outcomes on symptoms associated with pain such as quality of life, pain-related interference, pain tolerance, analgesic, and related issues such as opioid craving. Future publications on RCTs of mindfulness meditation should adhere to Consolidated Standards of Reporting Trials (CONSORT) standards.

 

Only three RCTs attributed minor adverse events to mindfulness meditation. However, only 7 of the 38 included RCTs mentioned whether adverse events were monitored and collected. Thus quality of evidence for adverse events reported in RCTs is inadequate for a comprehensive assessment. Given published reports of adverse events during meditation, including psychosis [67], future trials should actively collect adverse events data. In addition, a systematic review of observational studies and case reports would shed additional light on adverse events during mindfulness meditation.

 

Further research examining the effect of mindfulness meditation on chronic pain should also focus on better understanding whether there is a minimum frequency or duration of meditation practice for it to be effective. While recent studies have yielded similar positive effects of mindfulness for pain, these effects tend to be small to medium and based on a body of evidence that is, at best, of moderate quality. A potential way to advance research on chronic pain would be to improve intervention and control group descriptions, identify different effects of various components of complex interventions, and work toward a standard criterion for assessing therapeutic gain [68]. Head-to-head trials that compare mindfulness interventions of a similar category but with variations in components or dose may be helpful to tease out the most effective elements of these interventions [69].

 

Similar to previous reviews in this area, we conclude that while mindfulness meditation interventions showed significant improvements for chronic pain, depression, and quality of life, the weaknesses in the body of evidence prevent strong conclusions. The available evidence did not yield consistent effects for pain outcomes, and few studies were available for forms of mindfulness meditation other than MBSR. Quality of evidence for the efficacy of mindfulness interventions in reducing chronic pain is low. There was higher quality evidence of the efficacy of mindfulness meditation on depression and mental health-related quality-of-life outcomes. This review is consistent with previous reviews concluding that more well-designed, rigorous, and large RCTs are needed in order to develop an evidence base that can more decisively provide estimates of the efficacy of mindfulness meditation for chronic pain. In the meantime, chronic pain continues to pose a tremendous burden on society and individuals. A novel therapeutic approach for chronic pain management such as mindfulness meditation would likely be welcomed by patients suffering from pain.

 

Electronic Supplementary Material

 

Ncbi.nlm.nih.gov/pmc/articles/PMC5368208/

 

Compliance with Ethical Standards

 

Funding and Disclaimer

 

The systematic review was sponsored by the Department of Defense Centers of Excellence for Psychological Health and Traumatic Brain Injury (contract number 14-539.2). The findings and conclusions in this manuscript are those of the authors and do not necessarily represent the views of the Department of Defense Centers of Excellence for Psychological Health and Traumatic Brain Injury.

 

Authors Statement of Conflict of Interest and Adherence to Ethical Standards Authors

Authors Hilton, Hempel, Ewing, Apaydin, Xenakis, Newberry, Colaiaco, Maher, Shanman, Sorbero, and Maglione declare that they have no conflict of interest. All procedures, including the informed consent process, were conducted in accordance with the ethical standards of the responsible committee on human experimentation (institutional and national) and with the Helsinki Declaration of 1975, as revised in 2000.

 

In conclusion, stress can ultimately affect our overall health and wellness if not managed properly. Fortunately, several stress management techniques, including chiropractic care and mindfulness meditation, can help reduce stress as well as improve chronic pain associated with stress. Chiropractic treatment is an important stress management technique because it can calm the “fight or flight” response associated with chronic stress. The article above also demonstrated how mindfulness meditation can be a fundamental stress management technique for improving overall health and wellness. Information referenced from the National Center for Biotechnology Information (NCBI). The scope of our information is limited to chiropractic as well as to spinal injuries and conditions. To discuss the subject matter, please feel free to ask Dr. Jimenez or contact us at 915-850-0900 .

 

Curated by Dr. Alex Jimenez

 

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Additional Topics: Back Pain

 

According to statistics, approximately 80% of people will experience symptoms of back pain at least once throughout their lifetimes. Back pain is a common complaint which can result due to a variety of injuries and/or conditions. Often times, the natural degeneration of the spine with age can cause back pain. Herniated discs occur when the soft, gel-like center of an intervertebral disc pushes through a tear in its surrounding, outer ring of cartilage, compressing and irritating the nerve roots. Disc herniations most commonly occur along the lower back, or lumbar spine, but they may also occur along the cervical spine, or neck. The impingement of the nerves found in the low back due to injury and/or an aggravated condition can lead to symptoms of sciatica.

 

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EXTRA IMPORTANT TOPIC: Managing Workplace Stress

 

 

MORE IMPORTANT TOPICS: EXTRA EXTRA: Choosing Chiropractic? | Familia Dominguez | Patients | El Paso, TX Chiropractor

 

 

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Chiropractic & Stress Management for Back Pain in El Paso, TX

Chiropractic & Stress Management for Back Pain in El Paso, TX

Stress is a reality of contemporary living. In a society where work hours are increasing and the media is constantly overloading our senses with the most regent tragedy, it’s no wonder why so many people experience higher levels of stress on a regular basis. Fortunately, more healthcare professionals are implementing stress management methods and techniques as a part of a patient’s treatment. While stress is a natural response which helps prepare the body for danger, constant stress can have negative effects on the body, causing symptoms of back pain and sciatica. But, why does too much stress negatively affect the human body?

 

First, it’s important to understand how the body perceives stress. There are three basic “channels” through which we perceive stress: environment, body, and emotions. Environmental stress is rather self-explanatory; if you’re walking down a quiet road and you hear a loud bang nearby, your body will perceive that as an immediate danger. That is an environmental stressor. Pollution could be another example of environmental stress because it externally affects the body the more one is exposed to it.

 

Stress through the body includes disease, lack of sleep and/or improper nutrition. Emotional stress is a little different, since it involves the way our brains interpret certain things. For instance, if someone you work with is being passive-aggressive, you might become stressed. Thoughts such as, “is he mad at me for some reason” or “they must be having a tough morning”, could be perceived as emotional stress. What is unique about emotional stress, however, is that we have control on just how much of it we experience, much more so than environmental or body stressors.

 

Now that we understand how the body can perceive stress in a variety of ways, we can discuss what effects constant stress can have on our overall health and wellness. When the body is placed under stress, through any of the above mentioned channels, the body’s fight or flight response is triggered. The sympathetic nervous system, or SNS, becomes stimulated, which in turn makes the heart beats faster and all of the body’s senses become more intense. This is a leftover defense mechanism from prehistoric times; that is the reason we’ve survived to today, instead of all becoming lunch for hungry predators out in the wild.

 

Unfortunately, the real issue is that in contemporary society, people often become overstressed and the human body is unable to differentiate between an immediate threat and a simple societal issue. Over the years many research studies have been conducted to estimate the effect of chronic stress on the human body, with such effects as hypertension, increased risk for heart disease and damage to muscle tissue as well as symptoms of back pain and sciatica.

 

According to several other research studies, combining stress management methods and techniques with a variety of treatment options can help more effectively improve symptoms and can promote a faster recovery. Chiropractic care is a well-known alternative treatment option utilized to treat a variety of injuries and/or conditions of the musculoskeletal and nervous systems. Because chiropractic treatment focuses on the spine, the root of the nervous system, chiropractic can also help with stress. Among the effects of stress is strain, which may consequently lead to subluxation or misalignment of the spine. Spinal adjustment and manual manipulations can help ease muscle tension, which in turn eases the strain on specific areas of the spine and helps ease subluxation. A balanced spine is a crucial element of handling personal stress. As mentioned before, proper nutrition and sufficient sleep is also a crucial part of stress management, which is chiropractic care offers lifestyle modification advice to further improve the patient’s stress levels as well as decrease their symptoms.

 

The purpose of the article below is to demonstrate the research study process developed to compare complementary and alternative medicine with conventional mind-body therapies for chronic back pain. The randomized controlled trial was carefully conducted and the details behind the research study have been recorded below. As with other research studies, further evidence-based information may be required to effectively determine the effect of stress management with treatment for back pain.

 

Comparison of Complementary and Alternative Medicine with Conventional Mind–Body Therapies for Chronic Back Pain: Protocol for the Mind–Body Approaches to Pain (MAP) Randomized Controlled Trial

 

Abstract

 

Background

 

The self-reported health and functional status of persons with back pain in the United States have declined in recent years, despite greatly increased medical expenditures due to this problem. Although patient psychosocial factors such as pain-related beliefs, thoughts and coping behaviors have been demonstrated to affect how well patients respond to treatments for back pain, few patients receive treatments that address these factors. Cognitive-behavioral therapy (CBT), which addresses psychosocial factors, has been found to be effective for back pain, but access to qualified therapists is limited. Another treatment option with potential for addressing psychosocial issues, mindfulness-based stress reduction (MBSR), is increasingly available. MBSR has been found to be helpful for various mental and physical conditions, but it has not been well-studied for application with chronic back pain patients. In this trial, we will seek to determine whether MBSR is an effective and cost-effective treatment option for persons with chronic back pain, compare its effectiveness and cost-effectiveness compared with CBT and explore the psychosocial variables that may mediate the effects of MBSR and CBT on patient outcomes.

 

Methods/Design

 

In this trial, we will randomize 397 adults with nonspecific chronic back pain to CBT, MBSR or usual care arms (99 per group). Both interventions will consist of eight weekly 2-hour group sessions supplemented by home practice. The MBSR protocol also includes an optional 6-hour retreat. Interviewers masked to treatment assignments will assess outcomes 5, 10, 26 and 52 weeks postrandomization. The primary outcomes will be pain-related functional limitations (based on the Roland Disability Questionnaire) and symptom bothersomeness (rated on a 0 to 10 numerical rating scale) at 26 weeks.

 

Discussion

 

If MBSR is found to be an effective and cost-effective treatment option for patients with chronic back pain, it will become a valuable addition to the limited treatment options available to patients with significant psychosocial contributors to their pain.

 

Trial Registration

 

Clinicaltrials.gov Identifier: NCT01467843.

 

Keywords: Back pain, Cognitive-behavioral therapy, Mindfulness meditation

 

Background

 

Identifying cost-effective treatments for chronic low back pain (CLBP) remains a challenge for clinicians, researchers, payers and patients. About $26 billion is spent annually in the United States in direct costs of medical care for back pain [1]. In 2002, the estimated costs of lost worker productivity due to back pain were $19.8 billion [2]. Despite numerous options for evaluating and treating back pain, as well as the greatly increased medical care resources devoted to this problem, the health and functional status of persons with back pain in the United States has deteriorated [3]. Furthermore, both providers and patients are dissatisfied with the status quo [4-6] and continue to search for better treatment options.

 

There is substantial evidence that patient psychosocial factors, such as pain-related beliefs, thoughts and coping behaviors, can have a significant impact on the experience of pain and its effects on functioning [7]. This evidence highlights the potential value of treatments for back pain that address both the mind and the body. In fact, four of the eight nonpharmacologic treatments recommended by the American College of Physicians and the American Pain Society guidelines for persistent back pain include “mind–body” components [8]. One of these treatments, cognitive-behavioral therapy (CBT), includes mind–body components such as relaxation training and has been found to be effective for a variety of chronic pain problems, including back pain [9-13]. CBT has become the most widely applied psychosocial treatment for patients with chronic back pain. Another mind–body therapy, mindfulness-based stress reduction (MBSR) [14,15], focuses on teaching techniques to increase mindfulness. MBSR and related mindfulness-based interventions have been found to be helpful for a broad range of mental and physical health conditions, including chronic pain [14-19], but they have not been well-studied for chronic back pain [20-24]. Only a few small pilot trials have evaluated the effectiveness of MBSR for back pain [25,26] and all reported improvements in pain intensity [27] or patients’ acceptance of pain [28,29].

 

Further research on the comparative effectiveness and cost-effectiveness of mind–body therapies should be a priority in back pain research for the following reasons: (1) the large personal and societal impact of chronic back pain, (2) the modest effectiveness of current treatments, (3) the positive results of the few trials in which researchers have evaluated mind–body therapies for back pain and (4) the growing popularity and safety, as well as the relatively low cost, of mind–body therapies. To help fill this knowledge gap, we are conducting a randomized trial to evaluate the effectiveness, comparative effectiveness and cost-effectiveness of MBSR and group CBT, compared with usual medical care only, for patients with chronic back pain.

 

Specific Aims

 

Our specific aims and their corresponding hypotheses are outlined below.

 

  • 1. To determine whether MBSR is an effective adjunct to usual medical care for persons with CLBP
  • Hypothesis 1: Individuals randomized to the MBSR course will show greater short-term (8 and 26 weeks) and long-term (52 weeks) improvement in pain-related activity limitations, pain bothersomeness and other health-related outcomes than those randomized to continued usual care alone.
  • 2. To compare the effectiveness of MBSR and group CBT in decreasing back pain–related activity limitations and pain bothersomeness
  • Hypothesis 2: MBSR will be more effective than group CBT in decreasing pain-related activity limitations and pain bothersomeness in both the short term and long term. The rationale for this hypothesis is based on (1) the modest effectiveness of CBT for chronic back pain found in past studies, (2) the positive results of the limited initial research evaluating MBSR for chronic back pain and (3) growing evidence that an integral part of MBSR training (but not CBT training)—yoga—is effective for chronic back pain.
  • 3. To identify the mediators of any observed effects of MBSR and group CBT on pain-related activity limitations and pain bothersomeness
  • Hypothesis 3a: The effects of MBSR on activity limitations and pain bothersomeness will be mediated by increases in mindfulness and acceptance of pain.
  • Hypothesis 3b: The effects of CBT on activity limitations and pain bothersomeness will be mediated by changes in pain-related cognition (decreases in catastrophizing, beliefs that one is disabled by pain and beliefs that pain signals harm, as well as increases in perceived control over pain and self-efficacy for managing pain) and changes in coping behaviors (increased use of relaxation, task persistence and coping self-statements and decreased use of rest).
  • 4. To compare the cost-effectiveness of MBSR and group CBT as adjuncts to usual care for persons with chronic back pain
  • Hypothesis 4: Both MBSR and group CBT will be cost-effective adjuncts to usual care.

 

We will also explore whether certain patient characteristics predict or moderate treatment effects. For example, we will explore whether patients with higher levels of depression are less likely to improve with both CBT and MBSR or whether such patients are more likely to benefit from CBT than from MBSR (that is, whether depression level is a moderator of treatment effects).

 

Methods/Design

 

Overview

 

We are conducting a randomized clinical trial in which individuals with CLBP are randomly assigned to group CBT, a group MBSR course or usual care alone (Figure 1). Participants will be followed for 52 weeks after randomization. Telephone interviewers masked to participants’ treatment assignments will assess outcomes 4, 8, 26 and 52 weeks postrandomization. The primary outcomes we will assess are pain-related activity limitations and pain bothersomeness. Participants will be informed that the study researchers are comparing “two different widely used pain self-management programs that have been found helpful for reducing pain and making it easier to carry out daily activities”.

 

Figure 1 Flowchart of the Trial Protocol

Figure 1: Flowchart of the trial protocol. CBT, Cognitive-behavioral therapy; MBSR, Mindfulness-based stress reduction.

 

The protocol for this trial has been approved by the Human Subjects Review Committee of the Group Health Cooperative (250681-22). All participants will be required to give their informed consent before enrollment in this study.

 

Study Sample and Setting

 

The primary source of participants for this trial will be the Group Health Cooperative (GHC), a group-model, not-for-profit health-care organization that serves over 600,000 enrollees through its own primary care facilities in Washington state. As needed to achieve recruitment goals, direct mailings will be sent to persons 20 to 70 years of age living in the areas served by the GHC.

 

Inclusion and Exclusion Criteria

 

We are recruiting individuals from 20 to 70 years of age whose back pain has persisted for at least 3 months. The inclusion and exclusion criteria were developed to maximize the enrollment of appropriate patients while screening out patients who have low back pain of a specific nature (for example, spinal stenosis) or a complicated nature or who would have difficulty completing the study measures or interventions (for example, psychosis). Reasons for exclusion of GHC members were identified on the basis of (1) automated data recorded (using the International Classification of Diseases, Ninth Revision coding system), during all visits over the course of the previous year and (2) eligibility interviews conducted by telephone. For non-GHC members, reasons for exclusion were identified on the basis of telephone interviews. Tables 1 and ​2 list the inclusion and exclusion criteria, respectively, as well as the rationale for each criterion and the information sources.

 

Table 1 Inclusion Criteria

 

Table 2 Exclusion Criteria

 

In addition, we require that participants be willing and able to attend the CBT or MBSR classes during the 8-week intervention period if assigned to one of those treatments, and to respond to the four follow-up questionnaires so that we can assess outcomes.

 

Recruitment Procedures

 

Because the study intervention involves classes, we are recruiting participants in ten cohorts consisting of up to forty-five individuals each. We are recruiting participants from three main sources: (1) GHC members who have made visits to their primary care providers for low back pain and whose pain has persisted for at least 3 months, (2) GHC members who have not made a visit to their primary care provider for back pain but who are between the ages of 20 and 70 years and who respond to our nontargeted GHC mailing or our ad in GHC’s twice-yearly magazine and (3) community residents between the ages of 20 and 70 years who respond to a direct mail recruitment postcard.

 

For the targeted GHC population, a programmer will use GHC’s administrative and clinical electronic databases to identify potentially eligible members with a visit in the previous 3 to 15 months to a provider that resulted in a diagnosis consistent with nonspecific low back pain. These GHC members are mailed a letter and consent checklist that explains the study and eligibility requirements. Members interested in participating sign and return a statement indicating their willingness to be contacted. A research specialist then calls the potential participant to ask questions; determine eligibility; clarify risks, benefits and expected commitment to the study; and request informed consent. After informed consent has been obtained from the individual, the baseline telephone assessment is conducted.

 

For the nontargeted GHC population (that is, GHC members without visits with back pain diagnoses received within the previous 3 to 15 months but who could possibly have low back pain), a programmer uses administrative and clinical electronic databases to identify potentially eligible members who were not included in the targeted sample described in the preceding paragraph. This population also includes GHC members who respond to an ad in the GHC magazine. The same methods used for the targeted population are then used to contact and screen the potential participants, obtain their informed consent and collect baseline data.

 

With regard to community residents, we have purchased lists of the names and addresses of a randomly selected sample of people living within our recruitment area who are between 20 and 70 years of age. The people on the list are sent direct mail postcards describing the study including information regarding how to contact study staff if interested in participating. Once an interested person has contacted the research team the same process detailed above is followed.

 

To ensure that all initially screened study participants remain eligible at the time the classes begin, those who consent more than 14 days prior to the start of the intervention classes will be recontacted approximately 0 to 14 days prior to the first class to reconfirm their eligibility. The primary concern is to exclude persons who no longer have at least moderate baseline ratings of pain bothersomeness and pain-related interference with activities. Those individuals who remain eligible and give their final informed consent will be administered the baseline questionnaire.

 

Randomization

 

After completing the baseline assessment, participants will be randomized in equal proportions to the MBSR, CBT or usual care group. Those randomized to the MBSR or CBT group will not be informed of their type of treatment until they arrive at the first classes, which will occur simultaneously in the same building. The intervention group will be assigned on the basis of a computer-generated sequence of random numbers using a program which ensures that allocation cannot be changed after randomization. To ensure balance on a key baseline prognostic factor, randomization will be stratified based on our primary outcome measurement instrument: the modified version of the Roland Disability Questionnaire (RDQ) [30,31]. We will stratify participants into two activity limitations groups: moderate (RDQ score ≤12 on a 0 to 23 scale) and high (RDQ scores ≥13). Participants will be randomized within these strata in blocks of varying size (three, six or nine) to ensure a balanced but unpredictable assignment of participants. During recruitment, the study biostatistician will receive aggregated counts of participants randomized to each group to assure that the preprogrammed randomization algorithm is functioning properly.

 

Study Treatments

 

Both the group CBT and MBSR class series consist of eight weekly 2-hour sessions supplemented by home activities.

 

Mindfulness-Based Stress Reduction

 

Mindfulness-based stress reduction, a 30-year-old treatment program developed by Jon Kabat-Zinn, is well-described in the literature [32-34]. The authors of a recent meta-analysis found that MBSR had moderate effect sizes for improving the physical and mental well-being of patients with a variety of health conditions [16]. Our MBSR program is closely modeled on the original one and includes eight weekly 2-hour classes (summarized in Table 3), a 6-hour retreat between weeks 6 and 7 and up to 45 minutes per day of home practice. Our MBSR protocol was adapted by a senior MBSR instructor from the 2009 MBSR instructor’s manual used at the University of Massachusetts [35]. This manual permits latitude in how instructors introduce mindfulness and its practice to participants. The handouts and home practice materials are standardized for this study.

 

Table 3 Content of CBT and MBSR Class Sessions

Table 3: Content of cognitive-behavioral therapy and mindfulness-based stress reduction class sessions.

 

Participants will be given a packet of information during the first class that includes a course outline and instructor contact information; information about mindfulness, meditation, communication skills and effects of stress on the body, emotions and behavior; homework assignments; poems; and a bibliography. All sessions will include mindfulness exercises, and all but the first will include yoga or other forms of mindful movement. Participants will be given audio recordings of the mindfulness and yoga techniques, which will have been recorded by their own instructors. Participants will be asked to practice the techniques discussed in each class daily for up to 45 minutes throughout the intervention period and after classes end. They will also be assigned readings to complete before each class. Time will be devoted in each class to a review of challenges that participants have had in practicing what they learned in previous classes and with their homework. An optional day of practice on the Saturday between the sixth and seventh classes will be offered. This 6-hour “retreat” will be held with the participants in silence and only the instructor speaking. This will provide participants an opportunity to deepen what they have learned in class.

 

Cognitive-Behavioral Therapy

 

CBT for chronic pain is well-described in the literature and has been found to be modestly to moderately effective in improving chronic pain problems [9-13]. There is no single, standardized CBT intervention for chronic pain, although all CBT interventions are based on the assumption that both cognition and behavior influence adaptation to chronic pain and that maladaptive cognition and behavior can be identified and changed to improve patient functioning [36]. CBT emphasizes active, structured techniques to teach patients how to identify, monitor and change maladaptive thoughts, feelings and behaviors, with a focus on helping patients to acquire skills that they can apply to a variety of problems and collaboration between the patient and therapist. A variety of techniques are taught, including training in pain coping skills (for example, use of positive coping self-statements, distraction, relaxation and problem-solving). CBT also promotes setting and working toward behavioral goals.

 

Both individual and group formats have been used in CBT. Group CBT is often an important component of multidisciplinary pain treatment programs. We will use a group CBT format because it has been found to be efficacious [37-40], is more resource-efficient than individual therapy and provides patients with the potential benefits deriving from contact with, and support and encouragement from, others with similar experiences and problems. In addition, using group formats for both MBSR and CBT will eliminate intervention format as a possible explanation for any differences observed between the two therapies.

 

For this study, we developed a detailed therapist’s manual with content specific for each session, as well as a participant’s workbook containing materials for use in each session. We developed the therapist’s manual and participant’s workbooks based on existing published resources as well as on materials we have used in prior studies [39-47].

 

The CBT intervention (Table 3) will consist of eight weekly 2-hour sessions that will provide (1) education about the role of maladaptive automatic thoughts (for example, catastrophizing) and beliefs (for example, one’s ability to control pain, hurt equals harm) common in people with depression, anxiety and/or chronic pain and (2) instruction and practice in identifying and challenging negative thoughts, the use of thought-stopping techniques, the use of positive coping self-statements and goal-setting, relaxation techniques and coping with pain flare-ups. The intervention will also include education about activity pacing and scheduling and about relapse prevention and maintenance of gains. Participants will be given audio recordings of relaxation and imagery exercises and asked to set goals regarding their relaxation practice. During each session, participants will complete a personal action plan for activities to be completed between sessions. These plans will be used as logs for setting specific home practice goals and checking off activities completed during the week to be reviewed at the next week’s session.

 

Usual Care

 

The usual care group will receive whatever medical care they would normally receive during the study period. To minimize possible disappointment with not being randomized to a mind–body treatment, participants in this group will receive $50 compensation.

 

Class Sites

 

The CBT and MBSR classes will be held in facilities close to concentrations of GHC members in Washington state (Bellevue, Bellingham, Olympia, Seattle, Spokane and Tacoma).

 

Instructors

 

All MBSR instructors will have received either formal training in teaching MBSR from the Center for Mindfulness at the University of Massachusetts or equivalent training. They will themselves be practitioners of both mindfulness and a body-oriented discipline (for example, yoga), will have taught MBSR previously and will have made mindfulness a core component of their lives. The CBT intervention will be conducted by doctorate-level clinical psychologists with previous experience in providing CBT to patients with chronic pain.

 

Training and Monitoring of Instructors

 

All CBT instructors will be trained in the study protocol for the CBT intervention by the study’s clinical psychologist investigators (BHB and JAT), who are very experienced in administering CBT to patients with chronic pain. BHB will supervise the CBT instructors. One of the investigators (KJS) will train the MBSR instructors in the adapted MBSR protocol and supervise them. Each instructor will attend weekly supervision sessions, which will include discussion of positive experiences, adverse events, concerns raised by the instructor or participants and protocol fidelity. Treatment fidelity checklists highlighting the essential components for each session were created for both the CBT and MBSR arms. A trained research specialist will use the fidelity checklist during live observation of every session. The research specialist will provide feedback to the supervisor to facilitate weekly supervision of the instructors. In addition, all sessions will be audio-recorded. The supervisors will listen to a random sample and requested portions of sessions and will monitor them using the fidelity checklist. Feedback will be provided to the instructors during their weekly supervision sessions. Treatment fidelity will be monitored in both intervention groups by KJS and BHB with assistance from research specialists. In addition, they will review and rate on the fidelity checklist a random sample of the recorded sessions.

 

Participant Retention and Adherence to Home Practice

 

Participants will receive a reminder call before the first class and whenever they miss a class. They will be asked to record their daily home practice on weekly logs. Questions about their home practice during the prior week will also be included in all follow-up interviews. To maintain interviewer blinding, adherence questions will be asked after all outcome data have been recorded.

 

Measures

 

We will assess a variety of participant baseline characteristics, including sociodemographic characteristics, back pain history and expectations of the helpfulness of the mind–body treatments for back pain (Table 4).

 

Table 4 Baseline and Follow-Up Measures

 

We will assess a core set of outcomes for patients with spinal disorders (back-related function, pain, general health status, work disability and patient satisfaction) [48] that are consistent with the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials recommendations for clinical trials of chronic pain treatment efficacy and effectiveness [49]. We will measure both short-term outcomes (8 and 26 weeks) and long-term outcomes (52 weeks). We will also include a brief, 4-week, midtreatment assessment to permit analyses of the hypothesized mediators of the effects of MBSR and CBT on the primary outcomes. The primary study endpoint is 26 weeks. Participants will be paid $20 for each follow-up interview completed to maximize response rates.

 

Co–Primary Outcome Measures

 

The co–primary outcome measures will be back-related activity limitations and back pain bothersomeness.

 

Back-related activity limitations will be measured with the modified RDQ, which asks whether 23 specific activities have been limited due to back pain (yes or no) [30]. We have further modified the RDQ to ask a question about the previous week rather than just “today”. The original RDQ has been found to be reliable, valid and sensitive to clinical changes [31,48,50-53], and it is appropriate for telephone administration and use with patients with moderate activity limitations [50].

 

Back pain bothersomeness will be measured by asking participants to rate how bothersome their back pain has been during the previous week on a 0 to 10 scale (0 = “not at all bothersome” and 10 = “extremely bothersome”). On the basis of data compiled from a similar group of GHC members with back pain, we found this bothersomeness measure to be highly correlated with a 0 to 10 measure of pain intensity (r = 0.8 to 0.9; unpublished data (DCC and KJS) and with measures of function and other outcome measures [54]. The validity of numerical rating scales of pain has been well-documented, and such scales have demonstrated sensitivity in detecting changes in pain after treatment [55].

 

We will analyze and report these co–primary outcomes in two ways. First, for our primary endpoint analyses, we will compare the percentages of participants in the three treatment groups who achieve clinically meaningful improvement (≥30% improvement from baseline) [56,57] at each time point (with 26-week follow-up being the primary endpoint). We will then examine, in a secondary outcome analysis, the adjusted mean differences between groups on these measures at the time of follow-up.

 

Secondary Outcome Measures

 

The secondary outcomes that we will measure are depressive symptoms, anxiety, pain-related activity interference, global improvement with treatment, use of medications for back pain, general health status and qualitative outcomes.

 

Depressive symptoms will be assessed with the Patient Health Questionnaire-8 (PHQ-8) [58]. With the exception of the elimination of a question about suicidal ideation, the PHQ-8 is identical to the PHQ-9, which has been found to be reliable, valid and responsive to change [59,60].

 

Anxiety will be measured with the 2-item Generalized Anxiety Disorder scale (GAD-2), which has demonstrated high sensitivity and specificity in detecting generalized anxiety disorder in primary care populations [61,62].

 

Pain-related activity interference with daily activities will be assessed using three items from the Graded Chronic Pain Scale (GCPS). The GCPS has been validated and shown to have good psychometric properties in a large population survey and in large samples of primary care patients with pain [63,64]. Participants will be asked to rate the following three items on a 0 to 10 scale: their current back pain (back pain “right now”), their worst back pain in the previous month and their average pain level over the previous month.

 

Global improvement with treatment will be measured with the Patient Global Impression of Change scale [65]. This single question asks participants to rate their improvement with treatment on a 7-point scale that ranges from “very much improved” to “very much worse,” with “no change” used as the midpoint. Global ratings of improvement with treatment provide a measure of overall clinical benefit from treatment and are considered one of the core outcome domains in pain clinical trials [49].

 

Use of medications and exercise for back pain during the previous week will be assessed with the 8-, 26- and 52-week questionnaires.

 

General health status will be assessed with the 12-item Short Form Health Survey (SF-12) [66], a widely used instrument that yields summary scores for physical and mental health status. The SF-12 will also be used to calculate quality-adjusted life-years (QALYs) using the Short Form Health Survey in 6 dimensions in the cost-effectiveness analyses [67].

 

Qualitative outcomes will be measured with open-ended questions. We have included open-ended questions in our previous trials and found that they yield valuable insights into participants’ feelings about the value of specific components of the interventions and the impact of the interventions on their lives. We therefore will include open-ended questions about these issues at the end of the 8-, 26- and 52-week follow-up interviews.

 

Measures Used in Mediator Analyses

 

In the MBSR arm, we will evaluate the mediating effects of increased mindfulness (measured with the Nonreactivity, Observing, Acting with Awareness, and Nonjudging subscales of the Five Facet Mindfulness Questionnaire short form [68-70]) and increased pain acceptance (measured with the Chronic Pain Acceptance Questionnaire [71,72]) on the primary outcomes. In the CBT arm, we will evaluate the mediating effects of improvements in pain beliefs and/or appraisals (measured with the Patient Self-Efficacy Questionnaire [73]; the Survey of Pain Attitudes 2-item Control, Disability, and Harm scales [74-76]; and the Pain Catastrophizing Scale [77-80]) and changes in the use of pain coping strategies (measured with the Chronic Pain Coping Inventory 2-item Relaxation scale and the complete Activity Pacing scale [81,82]) on the primary outcomes. Although we expect the effects of MBSR and CBT on outcomes to be mediated by different variables, we will explore the effects of all potential mediators on outcomes in both treatment groups.

 

Measures Used in the Cost-Effectiveness Analyses

 

Direct costs will be estimated using cost data extracted from the electronic medical records for back-related services provided or paid by GHC and from patient reports of care not covered by GHC. Indirect costs will be estimated using the Work Productivity and Activity Impairment questionnaire [83]. The effectiveness of the intervention will be derived from the SF-12 general health status measure [84].

 

Data Collection, Quality Control and Confidentiality

 

Data will be collected from participants by trained telephone interviewers using a computer-assisted telephone interview (CATI) version of the questionnaires to minimize errors and missing data. Questions about experiences with specific aspects of the interventions (for example, yoga, meditation, instruction in coping strategies) that would unmask interviewers to treatment groups will be asked at each time point after all other outcomes have been assessed. We will attempt to obtain outcome data from all participants in the trial, including those who never attend or drop out of the classes, those who discontinue enrollment in the health plan and those who move away. Participants who do not respond to repeated attempts to obtain follow-up data by telephone will be mailed a questionnaire including only the two primary outcome measures and offered $10 for responding.

 

We are will collect information at every stage of recruitment, randomization and treatment so that we can report patient flow according to the CONSORT (Consolidated Standards of Reporting Trials) guidelines [85]. To maintain the confidentiality of patient-related information in the database, unique participant study numbers will be used to identify patient outcomes and treatment data. Study procedures are in place to ensure that all masked personnel will remain masked to treatment group.

 

Protection of Human Participants and Assessment of Safety

 

Protection of Human Participants

 

The GHC Institutional Review Board (IRB) approved this study.

 

Safety Monitoring

 

This trial will be monitored for safety by an independent Data and Safety Monitoring Board (DSMB) composed of a primary care physician experienced in mindfulness, a biostatistician and a clinical psychologist with experience in treating patients with chronic pain.

 

Adverse Experiences

 

We will collect data on adverse experiences (AEs) from several sources: (1) reports from the CBT and MBSR instructors of any participants’ experiences of concern to them; (2) the 8-, 26- and 52-week CATI follow-up interviews in which the participants are asked about any harm they felt during the CBT or MBSR treatment and any serious health problems they had had during the respective time periods; and (3) spontaneous reports from participants. The project coinvestigators and a GHC primary care internist will review AE reports from all sources weekly. Any serious AEs will be reported promptly to the GHC IRB and the DSMB. AEs that are not serious will be recorded and included in regular DSMB reports. Any identified deaths of participants will be reported to the DSMB chair within 7 days of discovery, regardless of attribution.

 

Stopping Rules

 

The trial will be stopped only if the DSMB believes that there is an unacceptable risk of serious AEs in one or more of the treatment arms. In this case, the DSMB can decide to terminate one of the arms of the trial or the entire trial.

 

Statistical Issues

 

Sample Size and Detectable Differences

 

Our sample size was chosen to ensure adequate power to detect a statistically significant difference between each of the two mind–body treatment groups and the usual care group, as well as power to detect a statistically significant difference between the two mind–body treatment groups. Because we considered patient activity limitations to be the more consequential of our two co–primary outcome measures, we based our sample size calculations on the modified RDQ [30]. We specified our sample size on the basis of the expected percentage of patients with a clinically meaningful improvement measured with the RDQ at the 26-week assessment (that is, at least 30% relative to baseline) [57].

 

Because of multiple comparisons, we will use Fisher’s protected least significant difference test [86], first analyzing if there is any significant difference among all three groups (using the omnibus χ2 likelihood ratio test) for each outcome and each time point. If we find a difference, we will then test for pairwise differences between groups. We will need 264 participants (88 in each group) to achieve 90% power to find either mind–body treatment different from usual care on the RDQ. This assumes that 30% of the usual care group and 55% of each mind–body treatment group will have clinically meaningful improvement on the RDQ at 26 weeks, rates of improvement that are similar to those we observed in a similar back pain population in an evaluation of complementary and alternative treatments for back pain [87]. We will have at least 80% power to detect a significant difference between MBSR and CBT on the RDQ if MBSR is at least 20 percentage points more effective than CBT (that is, 75% of the MBSR group versus 55% of the CBT group).

 

Our other co–primary outcome is the pain bothersomeness rating. With a total sample size of 264 participants, we will have 80% power to detect a difference between a mind–body treatment group and usual care on the bothersomeness rating scale, assuming that 47.5% of usual care and 69.3% of each mind–body treatment group have 30% or more improvement from baseline on the pain bothersomeness rating scale. We will have at least 80% power to detect a significant difference between MBSR and CBT on the bothersomeness rating scale if MBSR is at least 16.7 percentage points more effective than CBT (that is, 87% of the MBSR group versus 69.3% of the CBT group).

 

When analyzing the primary outcomes as continuous measures, we will have 90% power to detect a 2.4-point difference between usual care and either mind–body treatment on the modified RDQ scale scores and a 1.1-point difference between usual care and either mind–body treatment on the pain bothersomeness rating scale (assumes normal approximation to compare two independent means with equal variances and a two-sided P = 0.05 significance level with standard deviations of 5.2 and 2.4 for RDQ and pain bothersomeness measures, respectively [88]. Assuming an 11% loss to follow-up (slightly higher than that found in our previous back pain trials), we plan to recruit a sample of 297 participants (99 per group).

 

Both of the co–primary outcomes will be tested at the P < 0.05 level at each time point because they address separate scientific questions. Analyses of both outcomes at all follow-up time points will be reported, imposing a more stringent requirement than simply reporting a sole significant outcome.

 

Statistical Analyses

 

Primary Analyses

 

In our comparisons of treatments based on the outcome measures, we will analyze outcomes assessed at all follow-up time points in a single model, adjusting for possible correlation within individuals and treatment group cohorts using generalized estimating equations [89]. Because we cannot reasonably make an assumption regarding constant or linear group differences over time, we will include an interaction term between treatment groups and time points. We plan to adjust for baseline outcome values, sex and age, as well as other baseline characteristics found to differ significantly by treatment group or follow-up outcomes, to improve precision and power of our statistical tests. We will conduct the following set of analyses for both the continuous outcome score and the binary outcome (clinically significant change from baseline), including all follow-up time points (4, 8, 26 and 52 weeks). The MBSR treatment will be deemed successful only if the 26-week time point comparisons are significant. The other time points will be considered secondary evaluations.

 

We will use an intent-to-treat approach in all analyses; that is, the assessment of individuals will be analyzed by randomized group, regardless of participation in any classes. This analysis minimizes biases that often occur when participants who do not receive the assigned treatments are excluded from analysis. The regression model will be in the following general form:

 

Regression Model General Form

 

where yt is the response at follow-up time t, baseline is the prerandomization value of the outcome measure, treatment includes dummy variables for the MBSR and CBT groups, time is a series of dummy variables indicating the follow-up times and z is a vector of covariates representing other variables adjusted for. (Note that α1, α2, α3 and α4 are vectors.) The referent group in this model is the usual care group. For binary and continuous outcomes, we will use appropriate link functions (for example, logit for binary). For each follow-up time point at which the omnibus χ2 test is statistically significant, we will go on to test whether there is a difference between MBSR and usual care to address aim 1 and a difference between MBSR and CBT to address aim 2. We will also report the comparison of CBT to usual care. When determining whether MBSR is an effective treatment for back pain, we will require that aim 1, the comparison of MBSR to usual care, must be observed.

 

On the basis of our previous back pain trials, we expect at least an 89% follow-up and, if that holds true, our primary analysis will be a complete case analysis, including all observed follow-up outcomes. However, we will adjust for all baseline covariates that are predictive of outcome, their probability of being missing and differences between treatment groups. By adjusting for these baseline covariates, we assume that the missing outcome data in our model are missing at random (given that baseline data are predictive of missing data patterns) instead of missing completely at random. We will also conduct sensitivity analysis using an imputation method for nonignorable nonresponses to evaluate whether our results are robust enough to compensate for different missing data assumptions [90].

 

Mediator Analyses If MBSR or CBT is found to be effective (relative to usual care and/or to each other) in improving either primary outcome at 26 or 52 weeks, we will move to aim 3 to identify the mediators of the effects of MBSR and group CBT on the RDQ and pain bothersomeness scale. We will perform the series of mediation analyses separately for the two primary outcomes (RDQ and pain bothersomeness scale scores) and for each separate treatment comparator of interest (usual care versus CBT, usual care versus MBSR and CBT versus MBSR). We will conduct separate mediator analyses for the 26- and 52-week outcomes (if MBSR or CBT is found to be effective at those time points).

 

Next, we describe in detail the mediator analysis for the 26-week time point. A similar analysis will be conducted for the 52-week time point. We will apply the framework of the widely used approach of Baron and Kenny [91]. Once we have demonstrated the association between the treatment and the outcome variable (the “total effect” of the treatment on the outcome), the second step will be to demonstrate the association between the treatment and each putative mediator. We will construct a regression model for each mediator with the 4- or 8-week score of the mediator as the dependent variable and the baseline score of the mediator and treatment indicator as independent variables. We will conduct this analysis for each potential mediator and will include as potential mediators in the following step only those that have a P-value ≤0.10 for the relationship with the treatment. The third step will be to demonstrate the reduction of the treatment effect on the outcome after removing the effect of the mediators. We will construct a multimediator inverse probability weighted (IPW) regression model [92]. This approach will allow us to estimate the direct effects of treatment after rebalancing the treatment groups with respect to the mediators. Specifically, we will first model the probability of the treatment effects, given the mediators (that is, all mediators that were found to be associated with treatment in step 2), using logistic regression and adjusting for potential baseline confounders. Using this model, we will obtain the estimated probability that each person received the observed treatment, given the observed mediator value. We will then use an IPW regression analysis to model the primary outcomes on treatment status while adjusting for the baseline levels of the outcome and mediator. Comparing the weighted model with the unweighted model will allow us to estimate how much of the direct effect of treatment on the associated outcome can be explained by each potential mediator. The inclusion in step 3 of all mediators found to be significant in step 2 will enable us to examine whether the specific variables that we hypothesized would differentially mediate the effects of MBSR versus CBT in fact mediate the effects of each treatment independently of the effects of the other “process variables”.

 

Cost-Effectiveness Analyses

 

A societal perspective cost–utility analysis (CUA) will be performed to compare the incremental societal costs revealed for each treatment arm (direct medical costs paid by GHC and the participant plus productivity costs) to incremental effectiveness in terms of change in participants’ QALYs [93]. This analysis will be possible only for study participants recruited from GHC. This CUA can be used by policymakers concerned with the broad allocation of health-related resources [94,95]. For the payer perspective, direct medical costs (including intervention costs) will be compared to changes in QALYs. This CUA will help us to determine whether it makes economic sense for MBSR to be a reimbursed service among this population. A bootstrap methodology will be used to estimate confidence intervals [96]. In secondary analyses conducted to assess the sensitivity of the results to different cost outcome definitions, such as varying assumptions of wage rates used to value productivity and the inclusion of non-back-related health-care resource utilization [97] in the total cost amounts, will also be considered. In cost-effectiveness analyses, we will use intention to treat and adjust for health-care utilization costs in the one calendar year prior to enrollment and for baseline variables that might be associated with treatment group or outcome, such as medication use, to control for potential confounders. We expect there will be minimal missing data, but sensitivity analyses (as described above for the primary outcomes) will also be performed to assess cost measures.

 

Dr Jimenez White Coat

Dr. Alex Jimenez’s Insight

Stress is the body’s response to physical or psychological pressure. Several factors can trigger stress, which in turn activates the “fight or flight” response, a defense mechanism which prepares the body for perceived danger. When stressed, the sympathetic nervous system becomes stimulated and secretes a complex combination of hormones and chemicals. Short-term stress can be helpful, however long-term stress has been connected to a variety of health issues, including back pain and sciatica symptoms. According to research studies, stress management has become an essential addition for many treatment options because stress reduction may help improve treatment outcome measures. Chiropractic care uses spinal adjustments and manual manipulations together with lifestyle modifications to treat the spine, the root of the nervous system, as well as to promote decreased stress levels through proper nutrition, fitness and sleep.

 

Discussion

 

In this trial, we will seek to determine whether an increasingly popular approach for dealing with stress—mindfulness-based stress reduction—is an effective and cost-effective treatment option for persons with chronic back pain. Because of its focus on the mind as well as the body, MBSR has the potential to address some of the psychosocial factors that are important predictors of poor outcomes. In this trial, we will compare the effectiveness and cost-effectiveness of MBSR with that of CBT, which has been found to be effective for back pain but is not widely available. The study will also explore psychosocial variables that may mediate the effects of MBSR and CBT on patient outcomes. If MBSR is found to be an effective and cost-effective treatment option for persons with chronic back pain, it will be a valuable addition to the treatment options available for patients with significant psychosocial contributors to this problem.

 

Trial Status

 

Recruitment started in August 2012 and was completed in April 2014.

 

Abbreviations

 

AE: Adverse event; CAM: Complementary and alternative medicine; CATI: Computer-assisted telephone interview; CBT: Cognitive-behavioral therapy; CLBP: Chronic low back pain; CUA: Cost–utility analysis; DSMB: Data and Safety Monitoring Board; GHC: Group Health Cooperative; ICD-9: International Classification of Diseases Ninth Revision; IPW: Inverse probability weighting; IRB: Institutional Review Board; MBSR: Mindfulness-based stress reduction; NCCAM: National Center for Complementary and Alternative Medicine; QALY: Quality-adjusted life-year.

 

Competing Interests

 

The authors declare that they have no competing interests.

 

Authors’ Contributions

 

DC and KS conceived of the trial. DC, KS, BB, JT, AC, BS, PH, RD and RH participated in refining the study design and implementation logistics and in the selection of outcome measures. AC developed plans for the statistical analyses. JT and AC developed plans for the mediator analyses. BS, BB and JT developed the materials for the CBT intervention. PH developed plans for the cost-effectiveness analyses. DC drafted the manuscript. All authors participated in the writing of the manuscript and read and approved the final manuscript.

 

Acknowledgements

 

The National Center for Complementary and Alternative Medicine (NCCAM) provided funding for this trial (grant R01 AT006226). The design of this trial was reviewed and approved by NCCAM’s Office of Clinical and Regulatory Affairs.

 

In conclusion, environmental, bodily and emotional stressors can trigger the “fight or flight response” in charge of preparing the the human body for danger. Although stress is essential to increase our performance, chronic stress can have a negative impact in the long-run, manifesting symptoms associated with back pain and sciatica. Chiropractic care utilizes a variety of treatment procedures, along with stress management methods and techniques, to help reduce stress as well as improve and manage symptoms associated with injuries and/or conditions of the musculoskeletal and nervous systems. Information referenced from the National Center for Biotechnology Information (NCBI). The scope of our information is limited to chiropractic as well as to spinal injuries and conditions. To discuss the subject matter, please feel free to ask Dr. Jimenez or contact us at 915-850-0900 .

 

 

Curated by Dr. Alex Jimenez

 

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Additional Topics: Back Pain

 

According to statistics, approximately 80% of people will experience symptoms of back pain at least once throughout their lifetimes. Back pain is a common complaint which can result due to a variety of injuries and/or conditions. Often times, the natural degeneration of the spine with age can cause back pain. Herniated discs occur when the soft, gel-like center of an intervertebral disc pushes through a tear in its surrounding, outer ring of cartilage, compressing and irritating the nerve roots. Disc herniations most commonly occur along the lower back, or lumbar spine, but they may also occur along the cervical spine, or neck. The impingement of the nerves found in the low back due to injury and/or an aggravated condition can lead to symptoms of sciatica.

 

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IMPORTANT TOPIC: EXTRA EXTRA: A Healthier You!

 

 

OTHER IMPORTANT TOPICS: EXTRA: Sports Injuries? | Vincent Garcia | Patient | El Paso, TX Chiropractor

 

 

 

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Stress Management & Low Back Pain in El Paso, TX

Stress Management & Low Back Pain in El Paso, TX

People experience stress on a regular basis. From worries about finances or employment to problems with your kids or significant other, even concerns about the condition of the world, can register as stressors for many individuals. Stress causes both acute (immediate) and chronic (long-term) health issues, including low back pain, a common symptom frequently reported by many patients who suffer from constant stress. Fortunately, several holistic treatment approaches, including chiropractic care, can help alleviate both the feelings and effect of stress, ultimately guiding people through proper stress management methods.

 

Symptoms of Stress

 

Stress triggers the body’s fight or flight response. The adrenaline surge you experience after hearing a loud sound is simply one of the remaining characteristics of our ancestors, afraid that that loud noise came from something which wanted to eat them.

 

Stress causes a number of physical changes in the body, starting with the brain. The heart rate increases and starts directing blood to the other extremities. Hearing and eyesight become more acute. And the adrenal glands begin secreting adrenaline as a means of preparing the body for physical exertion. This is exactly what the “flight or fight response” really means.

 

If you are walking alone at night and hear footsteps behind you, the fight of flight response can be incredibly effective towards your safety. However, if you experience prolonged stress, this sort of physical reaction contributes to a variety of health issues, such as high blood pressure, diabetes, a compromised immune system and muscle tissue damage. That’s because your body doesn’t recognize that there are different kinds of stress; it only knows that stress represents danger and it reacts accordingly.

 

Stress Management with Chiropractic Care

 

Chiropractic care can help improve as well as manage many symptoms of stress. This is because the spine is the root of the nervous system. Spinal adjustments and manual manipulations calm the fight or flight response by activating the parasympathetic system. Additionally, chiropractic can relieve pain and muscular tension, improve circulation, and correct spinal misalignments. These benefits all combine to ease the symptoms of stress, which reduces how stressed the patient feels.

 

A Well-Rounded Strategy

 

Chiropractors guide their patients through an assortment of stress management procedures, including dietary changes, exercise, meditation, and relaxation methods. A healthy diet can help the body handle an assortment of issues, including stress. Following a diet rich in fruits and vegetables, lean proteins, and complex carbohydrates, with minimal processed and prepackaged foods, can significantly improve overall health and wellness. Exercise is an effective stress reliever. The energy you expend through exercise relieves tension as well as the energy of stress. It also releases endorphins, which help elevate mood. Yoga is an especially effective kind of physical activity for relieving stress.

 

Meditation can be performed in a variety of ways and it can be practiced by various healthcare professionals. For some, writing in a journal is a kind of meditation, while others are more conventional in their strategy. Many relaxation techniques are closely linked to meditation, such as breathing exercises, releasing muscle tension, and listening to calming music or nature sounds.

 

  • Breathing exercises are simple and offer immediate stress relief. Begin with inhaling slowly and deeply through your nose, while counting to six and extending your stomach. Hold your breath for a count of four, then release the breath through your mouth, counting to six again. Repeat the cycle for three to five occasions.
  • Release muscle tension through a technique known as “progressive muscle relaxation”. Find a comfortable position, either sitting with your feet on the ground, or lying on your back. Work your way through each muscle group, beginning at your toes or your head, tensing the muscle for a count of five, and then releasing. Wait 30 minutes and then proceed to the next muscle group. Wondering how to tense the muscles of your face? For the face, raise your eyebrows as large as you can and feel the tension in your forehead and scalp. For the central portion of your own face, squint your eyes and wrinkle your nose and mouth. Finally, for the lower face, clench your teeth and pull back the corners of your mouth.
  • Soothing sounds like instrumental music or nature sounds help relax the body and the brain.

 

Maintaining a balanced lifestyle while also incorporating chiropractic care as a stress management strategy is an effective way to help improve and cope with the symptoms of stress. Reducing stress can ultimately help maintain your overall well-being.

 

Mindfulness-Based Stress Reduction and Cognitive-Behavioral Therapy for Chronic Low Back Pain: Similar Effects on Mindfulness, Catastrophizing, Self-Efficacy and Acceptance in a Randomized Controlled Trial

 

Abstract

 

Cognitive-behavioral therapy (CBT) is believed to improve chronic pain problems by decreasing patient catastrophizing and increasing patient self-efficacy for managing pain. Mindfulness-based stress reduction (MBSR) is believed to benefit chronic pain patients by increasing mindfulness and pain acceptance. However, little is known about how these therapeutic mechanism variables relate to each other or whether they are differentially impacted by MBSR versus CBT. In a randomized controlled trial comparing MBSR, CBT, and usual care (UC) for adults aged 20-70 years with chronic low back pain (CLBP) (N = 342), we examined (1) baseline relationships among measures of catastrophizing, self-efficacy, acceptance, and mindfulness; and (2) changes on these measures in the 3 treatment groups. At baseline, catastrophizing was associated negatively with self-efficacy, acceptance, and 3 aspects of mindfulness (non-reactivity, non-judging, and acting with awareness; all P-values <0.01). Acceptance was associated positively with self-efficacy (P < 0.01) and mindfulness (P-values < 0.05) measures. Catastrophizing decreased slightly more post-treatment with MBSR than with CBT or UC (omnibus P = 0.002). Both treatments were effective compared with UC in decreasing catastrophizing at 52 weeks (omnibus P = 0.001). In both the entire randomized sample and the sub-sample of participants who attended ≥6 of the 8 MBSR or CBT sessions, differences between MBSR and CBT at up to 52 weeks were few, small in size, and of questionable clinical meaningfulness. The results indicate overlap across measures of catastrophizing, self-efficacy, acceptance, and mindfulness, and similar effects of MBSR and CBT on these measures among individuals with CLBP.

 

Keywords: chronic back pain, self-efficacy, mindfulness, acceptance, catastrophizing, CBT, MBSR

 

Introduction

 

Cognitive-behavioral therapy (CBT) has been demonstrated effective, and is widely recommended, for chronic pain problems.[20] Mindfulness-based interventions (MBIs) also show promise for patients with chronic pain[12,14,25,44,65] and their use by this population is increasing. Understanding the mechanisms of action of psychosocial treatments for chronic pain and commonalities in these mechanisms across different therapies is critical to improving the effectiveness and efficiency of these treatments.[27,52] Key mechanisms of action of CBT for chronic pain include decreased catastrophizing and increased self-efficacy for managing pain.[6-8,56] Increased mindfulness is considered a central mechanism of change in MBIs,[14,26,30] which also increase pain acceptance.[16,21,27,38,59] However, little is known about the associations among pain catastrophizing, self-efficacy, acceptance, and mindfulness prior to psychosocial treatment or about differences in effects of CBT versus MBIs on these variables.

 

There is some evidence suggesting significant associations among these therapeutic mechanism variables. Evidence regarding relationships between catastrophizing and mindfulness is mixed. Some studies[10,18,46] have found negative associations between measures of pain catastrophizing and mindfulness. However, others found no significant relationship[19] or associations (inverse) between catastrophizing and some aspects of mindfulness (non-judging, non-reactivity, and acting with awareness) but not others (e.g., observing).[18] Catastrophizing has also been reported to be associated negatively with pain acceptance.[15,22,60] In a pain clinic sample, general acceptance of psychological experiences was associated negatively with catastrophizing and positively with mindfulness.[19] Pain self-efficacy has been observed to be correlated positively with acceptance and negatively with catastrophizing.[22]

 

Further suggesting overlap across mechanisms of different psychosocial treatments for chronic pain, increases in mindfulness[10] and acceptance[1,64] have been found after cognitive-behavioral pain treatments, and reductions in catastrophizing have been observed after mindfulness-based pain management programs.[17,24,37] Little research has examined effects of MBIs for chronic pain on self-efficacy, although a small pilot study of migraine patients found greater increases in self-efficacy with Mindfulness-Based Stress Reduction (MBSR) training than with usual care.[63] We were unable to identify any studies of the relationships among all these therapeutic mechanism variables or of changes in all these variables with CBT versus an MBI for chronic pain.

 

The aim of this study was to replicate and extend prior research by using data from a randomized controlled trial (RCT) comparing MBSR, CBT, and usual care (UC) for chronic low back pain (CLBP)[12] to examine: (1) baseline relationships among measures of mindfulness and pain catastrophizing, self-efficacy, and acceptance; and (2) short- and long-term changes on these measures in the 3 treatment groups. Based on theory and previous research, we hypothesized that: (1) at baseline, catastrophizing would be inversely related to acceptance, self-efficacy, and 3 dimensions of mindfulness (non-reactivity, non-judging, acting with awareness), but not associated with the observing dimension of mindfulness; (2) at baseline, acceptance would be associated positively with self-efficacy; and (3) from baseline to 26 and 52 weeks, acceptance and mindfulness would increase more with MBSR than with CBT and UC, and catastrophizing would decrease more and self-efficacy would increase more with CBT than with MBSR and UC.

 

Methods

 

Setting, Participants and Procedures

 

Study participants were enrolled in an RCT comparing group MBSR, group CBT, and UC for non-specific chronic back pain between September 2012 and April 2014. We previously reported details of the study methods,[13] Consolidated Standards of Reporting Trials (CONSORT) flow diagram,[12] and outcomes.[12] In brief, participants were recruited from Group Health, an integrated healthcare system in Washington State, and from mailings to residents of communities served by Group Health. Eligibility criteria included age 20 – 70 years, back pain for at least 3 months, patient-rated bothersomeness of pain during the previous week ≥4 (0 – 10 scale), and patient-rated pain interference with activities during the previous week ≥3 (0 – 10 scale). We used International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM)43 diagnostic codes from electronic medical records (EMR) of visits in the previous year and telephone screening to exclude patients with specific causes of low back pain. Exclusion criteria also included pregnancy, spine surgery in the previous 2 years, disability compensation or litigation, fibromyalgia or cancer diagnosis, other major medical condition, plans to see a medical specialist for back pain, inability to read or speak English, and participation in a “mind-body” treatment for back pain in the past year. Potential participants were told that they would be randomized to one of “two different widely-used pain self-management programs that have been found helpful for reducing pain and making it easier to carry out daily activities” or to continued usual care. Those assigned to MBSR or CBT were unaware of the specific treatment they would receive until the first intervention session. The study was approved by the Group Health institutional review board and all participants provided informed consent.

 

Participants were randomized to the MBSR, CBT, or UC conditions. Randomization was stratified based on the baseline value of the primary outcome, a modified version of the Roland Disability Questionnaire (RDQ),[42] into 2 back pain-related physical limitation stratification groups: moderate (RDQ score ≤12 on the 0 – 23 scale) and high (RDQ scores ≥13). To mitigate possible disappointment with not being randomized to CBT or MBSR, participants randomized to UC received $50 compensation. Data were collected from participants in computer-assisted telephone interviews by trained survey staff. All participants were paid $20 for each interview completed.

 

Measures

 

Participants provided descriptive information at the screening and baseline interviews, and completed the study measures at baseline (before randomization) and 8 (post-treatment), 26 (the primary study endpoint), and 52 weeks post-randomization. Participants also completed a subset of the measures at 4 weeks, but these data were not examined for the current report.

 

Descriptive Measures and Covariates

 

The screening and baseline interviews assessed, among other variables not analyzed for the present study, sociodemographic characteristics (age, gender, race, ethnicity, education, work status); pain duration (defined as length of time since a period of 1 or more weeks without low back pain); and number of days with back pain in the past 6 months. In this report, we describe the sample at baseline on these measures and on the primary outcome measures in the RCT: the modified Roland-Morris Disability Questionnaire (RDQ)[42] and a numerical rating of back pain bothersomeness. The RDQ, a widely-used measure of back pain-related functional limitations, asks whether 24 specific activities are limited today by back pain (yes or no).[45] We used a modified version that included 23 items[42] and asked about the previous week rather than today only. Back pain bothersomeness was measured by participants’ ratings of how bothersome their back pain was during the previous week on a 0 to 10 numerical rating scale (0 = “not at all bothersome” and 10 = “extremely bothersome”). The covariates for the current report were the same as those in our prior analyses of the interventions’ effects on the outcomes:[12] age, gender, education, and pain duration (less than one year versus at least one year since experiencing 1 week without low back pain). We decided a priori to control for these variables because of their potential to affect the therapeutic mechanism measures, participant response to treatment, and/or likelihood of obtaining follow-up information.

 

Measures of Potential Therapeutic Mechanisms

 

Mindfulness. Mindfulness has been defined as the awareness that emerges through purposeful, non-judgmental attention to the present moment.[29] We administered 4 subscales of the Five Facet Mindfulness Questionnaire-Short Form (FFMQ-SF):[5] Observing (noticing internal and external experiences; 4 items); Acting with Awareness (attending to present moment activities, as contrasted to behaving automatically while attention is focused elsewhere; 5 items); Non-reactivity (non-reactivity to inner experiences: allowing thoughts and feelings to arise and pass away without attachment or aversion; 5 items); and Non-judging (non-judging of inner experiences: engaging in a non-evaluative stance towards thoughts, emotions, and feelings; 5-item scale; however, one question [‘I make judgments about whether my thoughts are good or bad’] inadvertently was not asked.). The FFMQ-SF has been demonstrated to be reliable, valid, and sensitive to change.[5] Participants rated their opinion of what generally is true for them in terms of their tendency to be mindful in their daily lives (scale from 1 = ‘never or very rarely true’ to 5 = ‘very often or always true’). For each scale, the score was calculated as the mean of the answered items and thus the possible range was 1-5, with higher scores indicating higher levels of the mindfulness dimension. Prior studies have used sum scores rather than means, but we elected to use mean scores given the greater ease of interpretation.

 

Pain catastrophizing. The Pain Catastrophizing Scale (PCS) is a 13-item measure assessing pain-related catastrophizing, including rumination, magnification, and helplessness.[50] Participants rated the degree to which they had certain thoughts and feelings when experiencing pain (scale from 0 = ‘not at all’ to 4 = ‘all the time’). Item responses were summed to yield a total score (possible range = 0-52). Higher scores indicate greater endorsement of catastrophic thinking in response to pain.

 

Pain acceptance. The Chronic Pain Acceptance Questionnaire-8 (CPAQ-8), an 8-item version of the 20-item Chronic Pain Acceptance Questionnaire (CPAQ), has been shown to be reliable and valid.[22,23] It has 2 scales: Activity Engagement (AE; engagement in life activities in a normal manner even while pain is being experienced) and Pain Willingness (PW; disengagement from attempts to control or avoid pain). Participants rated items on a scale from 0 (‘never true’) to 6 (‘always true’). Item responses were summed to create scores for each subscale (possible range 0-24) and the overall questionnaire (possible range 0-48). Higher scores indicate greater activity engagement/pain willingness/pain acceptance. Prior research suggests that the 2 subscales are moderately correlated and that each makes an independent contribution to the prediction of adjustment in people with chronic pain.[22]

 

Pain self-efficacy. The Pain Self-efficacy Questionnaire (PSEQ) consists of 10 items assessing individuals’ confidence in their ability to cope with their pain and engage in activities despite their pain, each rated on a scale from 0 = ‘not at all confident’ to 6 = ‘completely confident.’[39] The questionnaire has been demonstrated to be valid, reliable, and sensitive to change.[39] Item scores are summed to yield a total score (possible range 0-60); higher scores indicate greater self-efficacy.

 

Interventions

 

The 2 interventions were comparable in format (group), duration, frequency, and number of participants per group cohort. Both the MBSR and CBT interventions consisted of 8 weekly 2-hour sessions supplemented by home activities. For each intervention, we developed a therapist/instructor’s manual and participant’s workbook, both with structured and detailed content for each session. In each intervention, participants were assigned home activities and there was emphasis on incorporating intervention content in their daily lives. Participants were given materials to read at home and CDs with relevant content for home practice (e.g., meditation, body scan, and yoga in MBSR; relaxation and imagery exercises in CBT). We previously published detailed descriptions of both interventions,[12,13] but describe them briefly here.

 

MBSR

 

The MBSR intervention was modeled closely after the original program developed by Kabat-Zinn[28] and based on the 2009 MBSR instructor’s manual.[4] It consisted of 8 weekly sessions and an optional 6-hour retreat between the 6th and 7th sessions. The protocol included experiential training in mindfulness meditation and mindful yoga. All sessions included mindfulness exercises (e.g., body scan, sitting meditation) and mindful movement (most commonly, yoga).

 

CBT

 

The group CBT protocol included the techniques most commonly applied in CBT for CLBP[20,58] and used in prior studies.[11,33,41,51,53-55,57,61] The intervention included: (1) education about (a) chronic pain, (b) maladaptive thoughts (including catastrophizing) and beliefs (e.g., inability to control pain, hurt equals harm) common among individuals with chronic pain, (c) the relationships between thoughts and emotional and physical reactions, (d) sleep hygiene, and (e) relapse prevention and maintenance of gains; and (2) instruction and practice in identifying and challenging unhelpful thoughts, generating alternative appraisals that are more accurate and helpful, setting and working towards behavioral goals, abdominal breathing and progressive muscle relaxation techniques, activity pacing, thought-stopping and distraction techniques, positive coping self-statements, and coping with pain flare-ups. None of these techniques were included in the MBSR intervention, and mindfulness, meditation, and yoga techniques were not included in CBT. CBT participants were also given a book (The Pain Survival Guide[53]) and asked to read specific chapters between sessions. During each session, participants completed a personal action plan for activities to do between sessions.

 

Usual Care

 

Patients assigned to UC received no MBSR training or CBT as part of the study and received whatever health care they would customarily receive during the study period.

 

Instructors/Therapists and Treatment Fidelity Monitoring

 

As previously reported,[12] all 8 MBSR instructors received formal training in teaching MBSR from the Center for Mindfulness at the University of Massachusetts or equivalent training and had extensive previous experience teaching MBSR. The CBT intervention was conducted by 4 Ph.D.-level licensed psychologists with previous experience providing individual and group CBT to patients with chronic pain. Details of instructor training and supervision and treatment fidelity monitoring were provided previously.[12]

 

Statistical Analyses

 

We used descriptive statistics to summarize the observed baseline characteristics by randomization group, separately for the entire randomized sample and the subsample of participants who attended 6 or more of the 8 intervention classes (MBSR and CBT groups only). To examine the associations between the therapeutic mechanism measures at baseline, we calculated Spearman rho correlations for each pair of measures.

 

To estimate changes over time in the therapeutic mechanism variables, we constructed linear regression models with the change from baseline as the dependent variable, and included all post-treatment time points (8, 26, and 52 weeks) in the same model. A separate model was estimated for each therapeutic mechanism measure. Consistent with our approach for analyzing outcomes in the RCT,[12] we adjusted for age, gender, education, and baseline values of pain duration, pain bothersomeness, the modified RDQ, and the therapeutic mechanism measure of interest in that model. To estimate the treatment effect (difference between groups in change on the therapeutic mechanism measure) at each time point, the models included main effects for treatment group (CBT, MBSR, and UC) and time point (8, 26, and 52 weeks), and terms for the interactions between these variables. We used generalized estimating equations (GEE)[67] to fit the regression models, accounting for possible correlation between repeated measures from individual participants. To account for potential bias caused by differential attrition across treatment groups, our primary analysis used a 2-step GEE modeling approach to impute missing data on the therapeutic mechanism measures. This approach uses a pattern mixture model framework for non-ignorable non-response and adjusts the variance estimates in the final outcome model parameters to account for using imputed data.[62] We also, as a sensitivity analysis, conducted the regression analyses again with observed rather than imputed data to evaluate whether using imputed data had a substantial effect on the results and to allow direct comparison to other published studies.

 

The primary analysis included all randomized participants, using an intent-to-treat (ITT) approach. We repeated the regression analyses using the subsample of participants who were randomized to MBSR or CBT and who attended at least 6 of the 8 sessions of their assigned treatment (“as-treated” or “per protocol” analysis). For descriptive purposes, using regression models for the ITT sample with imputed data, we estimated mean scores (and their 95% confidence intervals [CI]) on the therapeutic mechanism variables at each time point adjusted for age, gender, education, and baseline values of pain duration, pain bothersomeness, and the modified RDQ.

 

To provide context for interpreting the results, we used t-tests and chi-square tests to compare the baseline characteristics of participants who did versus did not complete at least 6 of the 8 intervention sessions (MBSR and CBT groups combined). We compared intervention participation by group, using a chi-square test to compare the proportions of participants randomized to MBSR versus CBT who completed at least 6 of the 8 sessions.

 

Dr. Alex Jimenez’s Insight

Stress is primarily a part of the “fight or flight” response which helps the body effectively prepare for danger. When the body enters a state of mental or emotional strain or tension due to adverse or very demanding circumstances, a complex mix of hormones and chemicals, such as adrenaline, cortisol and norepinephrine, are secreted in order to prepare the body for physical and psychological action. While short-term stress provides us with the necessary amount of edge required to improve our overall performance, long-term stress has been associated to a variety of health issues, including low back pain and sciatica. Stress management methods and techniques, including meditation and chiropractic care, have been demonstrated to help improve treatment outcomes of low back pain and sciatica. The following article discusses several types of stress management treatments and describes their effect on overall health and wellness.

 

Results

 

Characteristics of the Study Sample

 

As previously reported,[12] among 1,767 individuals who expressed interest in the study and were screened for eligibility, 1,425 were excluded (most commonly due to pain not present for more than 3 months and inability to attend the intervention sessions). The remaining 342 individuals enrolled and were randomized. Among the 342 individuals randomized, 298 (87.1%), 294 (86.0%), and 290 (84.8%) completed the 8-, 26-, and 52-week assessments, respectively.

 

Table 1 shows the characteristics of the sample at baseline. Among all participants, the mean age was 49 years, 66% were female, and 79% reported having had back pain for at least one year without a pain-free week. On average, PHQ-8 scores were at the threshold for mild depressive symptom severity.[32] Mean scores on the Pain Catastrophizing Scale (16-18) were below the various cut-points suggested for clinically relevant catastrophizing (e.g., 24,47 3049). Pain Self-Efficacy Scale scores were somewhat higher on average (about 5 points on the 0-60 scale) in our sample as compared with the primary care patients with low back pain enrolled in an RCT evaluating group CBT in England,[33] and about 15 points higher than among individuals with chronic pain attending a mindfulness-based pain management program in England.[17]

 

Table 1 Baseline Characteristics

 

About half of participants randomized to MBSR (50.9%) or CBT (56.3%) attended at least 6 sessions of their assigned treatment; the difference between treatments was not statistically significant (chi-square test, P = 0.42). At baseline, those randomized to MBSR and CBT who completed at least 6 sessions, as compared to those who did not, were significantly older (mean [SD] = 52.2 [10.9] versus 46.5 [13.0] years) and reported significantly lower levels of pain bothersomeness (mean [SD] = 5.7 [1.3] versus 6.4 [1.7]), disability (mean [SD] RDQ = 10.8 [4.5] versus 12.7 [5.0]), depression (mean [SD] PHQ-8 = 5.2 [4.1] versus 6.3 [4.3]), and catastrophizing (mean [SD] PCS = 15.9 [10.3] versus 18.9 [9.8]), and significantly greater pain self-efficacy (mean [SD] PSEQ = 47.8 [8.3] versus 43.2 [10.3]) and pain acceptance (CPAQ-8 total score mean [SD] = 31.3 [6.2] versus 29.0 [6.7]; CPAQ-8 Pain Willingness mean [SD] = 12.3 [4.1] versus 10.9 [4.8]) (all P-values < 0.05). They did not differ significantly on any other variable shown in Table 1.

 

Baseline Associations Between Therapeutic Mechanism Measures

 

Table 2 shows the Spearman correlations between the therapeutic mechanism measures at baseline. Our hypotheses about the baseline relationships among these measures were confirmed. Catastrophizing was correlated negatively with 3 dimensions of mindfulness (non-reactivity rho = −0.23, non-judging rho = −0.30, and acting with awareness rho = −0.21; all P-values < 0.01), but not associated with the observing dimension of mindfulness (rho = −0.01). Catastrophizing was also correlated negatively with acceptance (total CPAQ-8 score rho = −0.55, Pain Willingness subscale rho = −0.47, Activity Engagement subscale rho = −0.40) and pain self-efficacy (rho = −0.57) (all P-values < 0.01). Finally, pain self-efficacy was correlated positively with pain acceptance (total CPAQ-8 score rho = 0.65, Pain Willingness subscale rho = 0.46, Activity Engagement subscale rho = 0.58; all P-values < 0.01).

 

Table 2 Spearman rho Correlations

 

Treatment Group Differences in Changes on Therapeutic Mechanism Measures Among all Randomized Participants

 

Table 3 shows the adjusted mean changes from baseline in each study group and the adjusted mean differences between treatment groups on the therapeutic mechanism measures at each follow-up in the entire randomized sample. Figure 1 shows the adjusted mean PCS scores for each group at each time point. Contrary to our hypothesis that catastrophizing would decrease more with CBT than with MBSR, catastrophizing (PCS score) decreased significantly more from pre- to post-treatment in the MBSR group than in the CBT group (MBSR versus CBT adjusted mean [95% CI] difference in change = −1.81 [−3.60, −0.01]). Catastrophizing also decreased significantly more in MBSR than in UC (MBSR versus UC adjusted mean [95% CI] difference in change = −3.30 [−5.11, −1.50]), whereas the difference between CBT and UC was not significant. At 26 weeks, the treatment groups did not differ significantly in change in catastrophizing from baseline. However, at 52 weeks, both the MBSR and the CBT groups showed significantly greater decreases than did the UC group, and there was no significant difference between MBSR and CBT.

 

Figure 1 Adjusted Mean PCS Scores

Figure 1: Adjusted mean Pain Catastrophizing Scale (PCS) scores (and 95% confidence intervals) at baseline (pre-randomization), 8 weeks (post-treatment), 26 weeks, and 52 weeks for participants randomized to CBT, MBSR, and UC. Estimated means are adjusted for participant age, gender, education, whether or not at least 1 year since week without pain, and baseline RDQ and pain bothersomeness.

 

Table 3 Adjusted Mean Change from Baseline and Adjusted Mean Differences

 

Figure 2 shows the adjusted mean PSEQ scores for each group at each time point. Our hypothesis that self-efficacy would increase more with CBT than with MBSR and with UC was only partially confirmed. Self-efficacy (PSEQ scores) did increase significantly more from pre- to post-treatment with CBT than with UC, but not with CBT relative to the MBSR group, which also increased significantly more than did the UC group (adjusted mean [95% CI] difference in change on PSEQ from baseline for CBT versus UC = 2.69 [0.96, 4.42]; CBT versus MBSR = 0.34 [−1.43, 2.10]; MBSR versus UC = 3.03 [1.23, 4.82]) (Table 3). The omnibus test for differences across groups in self-efficacy change was not significant at 26 or 52 weeks.

 

Figure 2 Adjusted Mean PSEQ Scores

Figure 2: Adjusted mean Pain Self-Efficacy Questionnaire (PSEQ) scores (and 95% confidence intervals) at baseline (pre-randomization), 8 weeks (post-treatment), 26 weeks, and 52 weeks for participants randomized to CBT, MBSR, and UC. Estimated means are adjusted for participant age, gender, education, whether or not at least 1 year since week without pain, and baseline RDQ and pain bothersomeness.

 

Our hypothesis that acceptance would increase more with MBSR than with CBT and with UC was generally not confirmed. The omnibus test for differences across groups was not significant for the total CPAQ-8 or the Activity Engagement subscale at any time point (Table 3). The test for the Pain Willingness subscale was significant at 52 weeks only, when both the MBSR and CBT groups showed greater increases as compared with UC, but not as compared with each other (adjusted mean [95% CI] difference in change for MBSR versus UC = 1.15 [0.05, 2.24]; CBT versus UC = 1.23 [0.16, 2.30]).

 

Our hypothesis that mindfulness would increase more with MBSR than with CBT was partially confirmed. Both the MBSR and CBT groups showed greater increases as compared with UC on the FFMQ-SF Non-reactivity scale at 8 weeks (MBSR versus UC = 0.18 [0.01, 0.36]; CBT versus UC = 0.28 [0.10, 0.46]), but differences at later follow-ups were not statistically significant (Table 3, Figure 3). There was a significantly greater increase on the Non-judging scale with MBSR versus CBT (adjusted mean [95% CI] difference in change = 0.29 [0.12, 0.46]) as well as between MBSR and UC (0.32 [0.13, 0.50]) at 8 weeks, but no significant difference between groups at later time points (Figure 4). The omnibus test for differences among groups was not significant for the Acting with Awareness or Observing scales at any time point.

 

Figure 3 Adjusted Mean FFMQ-SF Non Reactivity Scores

Figure 3: Adjusted mean Five Facet Mindfulness Questionnaire-Short Form (FFMQ-SF) Non-reactivity scores (and 95% confidence intervals) at baseline (pre-randomization), 8 weeks (post-treatment), 26 weeks, and 52 weeks for participants randomized to CBT, MBSR, and UC. Estimated means are adjusted for participant age, gender, education, whether or not at least 1 year since week without pain, and baseline RDQ and pain bothersomeness.

 

Figure 4 Adjusted Mean FFMQ-SF Non Judging Scores

Figure 4: Adjusted mean Five Facet Mindfulness Questionnaire-Short Form (FFMQ-SF) Non-judging scores (and 95% confidence intervals) at baseline (pre-randomization), 8 weeks (post-treatment), 26 weeks, and 52 weeks for participants randomized to CBT, MBSR, and UC. Estimated means are adjusted for participant age, gender, education, whether or not at least 1 year since week without pain, and baseline RDQ and pain bothersomeness.

 

The sensitivity analyses using observed rather than imputed data yielded almost identical results, with 2 minor exceptions. The difference between MBSR and CBT in change in catastrophizing at 8 weeks, although similar in magnitude, was no longer statistically significant due to slight confidence interval changes. Second, the omnibus test for the CPAQ-8 Pain Willingness scale at 52 weeks was no longer statistically significant (P = 0.07).

 

Treatment Group Differences in Changes on Therapeutic Mechanism Measures Among Participants Randomized to CBT or MBSR Who Completed at Least 6 Sessions

 

Table 4 shows the adjusted mean change from baseline and adjusted mean between-group differences on the therapeutic mechanism measures at 8, 26, and 52 weeks for participants who were randomized to MBSR or CBT and completed 6 or more sessions of their assigned treatment. The differences between MBSR and CBT were similar in size to those in the ITT sample. There were only a few differences in statistical significance of the comparisons. In contrast to the results using the ITT sample, the difference between MBSR and CBT in catastrophizing (PCS) at 8 weeks was no longer statistically significant and at 52 weeks, the CBT group increased significantly more than did the MBSR group on the FFMQ-SF Observing scale (adjusted mean difference in change from baseline for MBSR versus CBT = −0.30 [−0.53, −0.07]). The sensitivity analyses using observed rather than imputed data yielded no meaningful differences in results.

 

Table 4 Adjusted Mean Change from Baseline and Adjusted Mean Differences

 

Discussion

 

In this analysis of data from an RCT comparing MBSR, CBT, and UC for CLBP, our hypotheses that MBSR and CBT would differentially affect measures of constructs believed to be therapeutic mechanisms generally were not confirmed. For example, our hypothesis that mindfulness would increase more with MBSR than with CBT was confirmed for only 1 of 4 measured facets of mindfulness (non-judging). Another facet, acting with awareness, increased more with CBT than with MBSR at 26 weeks. Both differences were small. Increased mindfulness after a CBT-based multidisciplinary pain program[10] was reported previously; our findings further support a view that both MBSR and CBT increase mindfulness in the short-term. We found no long-term effects of either treatment relative to UC on mindfulness.

 

Also contrary to hypothesis, catastrophizing decreased more post-treatment with MBSR than with CBT. However, the difference between treatments was small and not statistically significant at later follow-ups. Both treatments were effective compared with UC in decreasing catastrophizing at 52 weeks. Although previous studies demonstrated reductions in catastrophizing after both CBT[35,48,56,57] and mindfulness-based pain management programs,[17,24,37] ours is the first to demonstrate similar decreases for both treatments, with effects up to 1 year.

 

Increased self-efficacy has been shown to be associated with improvements in pain intensity and functioning,[6] and an important mediator of CBT benefits.[56] However, contrary to our hypothesis, pain self-efficacy did not increase more with CBT than with MBSR at any time point. Compared with UC, there were significantly greater increases in self-efficacy with both MBSR and CBT post-treatment. These results mirror previous findings of positive effects of CBT, including group CBT for back pain,[33] on self-efficacy.[3,56,57] Little research has examined self-efficacy changes after MBIs for chronic pain, although self-efficacy increased more with MBSR than with usual care for patients with migraines in a pilot study[63] and more with MBSR than with health education for CLBP in an RCT.[37] Our findings add to knowledge in this area by indicating that MBSR has short-term benefits for pain self-efficacy similar to those of CBT.

 

Prior uncontrolled studies found equivalent increases in pain acceptance after group CBT and Acceptance and Commitment Therapy64 (which, unlike traditional CBT, specifically fosters pain acceptance), and increased acceptance after CBT-based multidisciplinary pain treatment.[1,2] In our RCT, acceptance increased in all groups over time, with only 1 statistically significant difference among the 3 groups across the 3 acceptance measures and 3 follow-up time points (a greater increase with both MBSR and CBT than with UC on the Pain Willingness subscale at 52 weeks). This suggests that acceptance may increase over time regardless of treatment, although this needs to be confirmed in additional research.

 

Two possibilities could explain our previously-reported findings of generally similar effectiveness of MBSR and CBT for CLBP:[12] (1) the treatment effects on outcomes were due to different, but equally effective, therapeutic mechanisms, or (2) the treatments had similar effects on the same therapeutic mechanisms. Our current findings support the latter view. Both treatments may improve pain, function, and other outcomes through different strategies that decrease individuals’ views of their pain as threatening and disruptive and encourage activity participation despite pain. MBSR and CBT differ in content, but both include relaxation techniques (e.g., progressive muscle relaxation in CBT, meditation in MBSR, breathing techniques in both) and strategies to decrease the threat value of pain (education and cognitive restructuring in CBT, accepting experiences without reactivity or judgment in MBSR). Thus, although CBT emphasizes learning skills for managing pain and decreasing negative emotional responses, and MBSR emphasizes mindfulness and meditation, both treatments may help patients relax, react less negatively to pain, and view thoughts as mental processes rather than as accurate representations of reality, thereby resulting in decreased emotional distress, activity avoidance, and pain bothersomeness.

 

Our analyses also revealed overlap among measures of different constructs believed to mediate the effects of MBSR and CBT on chronic pain outcomes. As hypothesized, prior to treatment, pain catastrophizing was associated negatively with pain self-efficacy, pain acceptance, and 3 dimensions of mindfulness (non-reactivity, non-judging, and acting with awareness), and pain acceptance was associated positively with pain self-efficacy. Pain acceptance and self-efficacy were also associated positively with measures of mindfulness. Our results are consistent with prior observations of negative associations between measures of catastrophizing and acceptance,[15,19,60] negative correlations between measures of catastrophizing and mindfulness,[10,46,18] and positive associations between measures of pain acceptance and mindfulness.[19]

 

As a group, to the extent that these measures reflect their intended constructs, these findings support a view of catastrophizing as inversely associated with two related constructs that reflect participation in customary activities despite pain but differ in emphasis on disengagement from attempts to control pain: pain acceptance (disengagement from attempts to control pain and participation in activities despite pain) and self-efficacy (confidence in ability to manage pain and participate in customary activities). The similarity of some questionnaire items further supports this view and likely contributes to the observed associations. For example, both the CPAQ-8 and the PSEQ contain items about doing normal activities despite pain. Furthermore, there is an empirical and conceptual basis for a view of catastrophizing (focus on pain with highly negative cognitive and affective responses) as also inversely associated with mindfulness (i.e., awareness of stimuli without judgment or reactivity), and for viewing mindfulness as consistent with, but distinct from, acceptance and self-efficacy. Further work is needed to clarify the relationships between these theoretical constructs and the extent to which their measures assess (a) constructs that are related but theoretically and clinically distinct versus (b) different aspects of an overarching theoretical construct.

 

It remains possible that MBSR and CBT differentially affect important mediators not assessed in this study. Our results highlight the need for further research to more definitively identify the mediators of the effects of MBSR and CBT on different pain outcomes, develop measures that assess these mediators most comprehensively and efficiently, better understand the relationships among therapeutic mechanism variables in affecting outcomes (e.g., decreased catastrophizing may mediate the effect of mindfulness on disability[10]), and refine psychosocial treatments to more effectively and efficiently impact these mediators. Research is also needed to identify patient characteristics associated with response to different psychosocial interventions for chronic pain.

 

Several study limitations warrant discussion. Participants had low baseline levels of psychosocial distress (e.g., catastrophizing, depression) and we studied group CBT, which has demonstrated efficacy,[33,40,55] resource-efficiency, and potential social benefits, but which may be less effective than individual CBT.[36,66] The results may not generalize to more distressed populations (e.g., pain clinic patients), which would have more room to improve on measures of maladaptive functioning and greater potential for treatments to differentially affect these measures, or to comparisons of MBSR with individual CBT.

 

Only somewhat over half of the participants randomized to MBSR or CBT attended at least 6 of the 8 sessions. Results could differ in studies with higher rates of treatment adherence; however, our results in “as-treated” analyses generally mirrored those of ITT analyses. Treatment adherence has been shown to be associated with benefits from both CBT for chronic back pain[31] and MBSR.[9] Research is needed to identify ways to increase MBSR and CBT session attendance, and to determine whether treatment effects on therapeutic mechanism and outcome variables are strengthened with greater adherence and practice.

 

Finally, our measures may not have adequately captured the intended constructs. For example, our mindfulness and pain acceptance measures were short forms of original measures; although these short forms have demonstrated reliability and validity, the original measures or other measures of these constructs might perform differently. Lauwerier et al.[34] note several problems with the CPAQ-8 Pain Willingness scale, including under-representation of pain willingness items. Furthermore, pain acceptance is measured differently across different pain acceptance measures, possibly reflecting differences in definitions.[34]

 

In sum, this is the first study to examine relationships among measures of key hypothesized mechanisms of MBSR and CBT for chronic pain – mindfulness and pain catastrophizing, self-efficacy, and acceptance – and to examine changes in these measures among participants in an RCT comparing MBSR and CBT for chronic pain. The catastrophizing measure was inversely associated with moderately inter-related measures of acceptance, self-efficacy, and mindfulness. In this sample of individuals with generally low levels of psychosocial distress at baseline, MBSR and CBT had similar short- and long-term effects on these measures. Measures of catastrophizing, acceptance, self-efficacy, and mindfulness may tap different aspects of a continuum of cognitive, affective, and behavioral responses to pain, with catastrophizing and activity avoidance at one end of the continuum and continued participation in usual activities and lack of negative cognitive and affective reactivity to pain at the other. Both MBSR and CBT may have therapeutic benefits by helping individuals with chronic pain shift from the former to the latter. Our results suggest the potential value of refining both measures and models of mechanisms of psychosocial pain treatments to more comprehensively and efficiently capture key constructs important in adaptation to chronic pain.

 

Summary

 

MBSR and CBT had similar short- and long-term effects on measures of mindfulness and pain catastrophizing, self-efficacy, and acceptance.

 

Acknowledgements

 

Research reported in this publication was supported by the National Center for Complementary & Integrative Health of the National Institutes of Health under Award Number R01AT006226. Preliminary results related to this study were presented in a poster at the 34th annual meeting of the American Pain Society, Palm Springs, May 2015 (Turner, J., Sherman, K., Anderson, M., Balderson, B., Cook, A., and Cherkin, D.: Catastrophizing, pain self-efficacy, mindfulness, and acceptance: Relationships and changes among individuals receiving CBT, MBSR, or usual care for chronic back pain).

 

Footnotes

 

Conflict of interest statement: Judith Turner receives royalties from PAR, Inc. on sales of the Chronic Pain Coping Inventory (CPCI) and CPCI/Survey of Pain Attitudes (SOPA) score report software. The other authors report no conflicts of interest.

 

In conclusion, stress is part of an essential response necessary to keep our body’s on edge in the case of danger, however, constant stress when there’s no real danger can become a real issue for many individuals, especially when symptoms of low back pain, among others begin to manifest. The purpose of the article above was to determine the effectiveness of stress management in the treatment of low back pain. Ultimately, stress management was concluded to help with treatment. Information referenced from the National Center for Biotechnology Information (NCBI). The scope of our information is limited to chiropractic as well as to spinal injuries and conditions. To discuss the subject matter, please feel free to ask Dr. Jimenez or contact us at 915-850-0900 .

 

Curated by Dr. Alex Jimenez

 

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Additional Topics: Back Pain

 

According to statistics, approximately 80% of people will experience symptoms of back pain at least once throughout their lifetimes. Back pain is a common complaint which can result due to a variety of injuries and/or conditions. Often times, the natural degeneration of the spine with age can cause back pain. Herniated discs occur when the soft, gel-like center of an intervertebral disc pushes through a tear in its surrounding, outer ring of cartilage, compressing and irritating the nerve roots. Disc herniations most commonly occur along the lower back, or lumbar spine, but they may also occur along the cervical spine, or neck. The impingement of the nerves found in the low back due to injury and/or an aggravated condition can lead to symptoms of sciatica.

 

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IMPORTANT TOPIC: EXTRA EXTRA: A Healthier You!

 

OTHER IMPORTANT TOPICS: EXTRA: Sports Injuries? | Vincent Garcia | Patient | El Paso, TX Chiropractor

 

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Herniated Disc & Sciatica Nonoperative Treatment in El Paso, TX

Herniated Disc & Sciatica Nonoperative Treatment in El Paso, TX

A herniated disc, also known as a slipped or ruptured disc, is a healthcare condition which occurs when a tear in the outer, fibrous ring of an intervertebral disc causes its soft, central portion to bulge out from the damaged, surrounding cartilage. Disc herniations are generally due to the degeneration of the outer ring of an intervertebral disc, known as the anulus fibrosus. Trauma, lifting injuries or straining may also cause a herniated disc. A tear in the intervertebral disc may result in the release of chemicals which may cause irritation and ultimately become the direct cause of severe back pain, even without nerve root compression.

 

Disc herniations also commonly develop following a previously existing disc protrusion, a healthcare condition in which the outermost layers of the anulus fibrosus remain intact, however, these can bulge if the disc is placed under pressure. Unlike a disc herniation, none of the gel-like section escapes the intervertebral disc. Herniated discs often heal on their own within several weeks. Severe disc herniations may require surgery, however, a variety of research studies have demonstrated that nonoperative treatment may help improve and manage the recovery process of a herniated disc without the need for surgical interventions.

 

Surgical vs Nonoperative Treatment for Lumbar Disk Herniation Using The Spine Patient Outcomes Research Trial (SPORT): A Randomized Trial

 

Abstract

 

  • Context: Lumbar diskectomy is the most common surgical procedure performed for back and leg symptoms in US patients, but the efficacy of the procedure relative to nonoperative care remains controversial.
  • Objective: To assess the efficacy of surgery for lumbar intervertebral disk herniation.
  • Design, Setting, and Patients: The Spine Patient Outcomes Research Trial, a randomized clinical trial enrolling patients between March 2000 and November 2004 from 13 multidisciplinary spine clinics in 11 US states. Patients were 501 surgical candidates (mean age, 42 years; 42% women) with imaging-confirmed lumbar intervertebral disk herniation and persistent signs and symptoms of radiculopathy for at least 6 weeks.
  • Interventions: Standard open diskectomy vs nonoperative treatment individualized to the patient.
  • Main Outcome Measures: Primary outcomes were changes from baseline for the Medical Outcomes Study 36-item Short-Form Health Survey bodily pain and physical function scales and the modified Oswestry Disability Index (American Academy of Orthopaedic Surgeons MODEMS version) at 6 weeks, 3 months, 6 months, and 1 and 2 years from enrollment. Secondary outcomes included sciatica severity as measured by the Sciatica Bothersomeness Index, satisfaction with symptoms, self-reported improvement, and employment status.
  • Results: Adherence to assigned treatment was limited: 50% of patients assigned to surgery received surgery within 3 months of enrollment, while 30% of those assigned to nonoperative treatment received surgery in the same period. Intent-to-treat analyses demonstrated substantial improvements for all primary and secondary outcomes in both treatment groups. Between-group differences in improvements were consistently in favor of surgery for all periods but were small and not statistically significant for the primary outcomes.
  • Conclusions: Patients in both the surgery and the nonoperative treatment groups improved substantially over a 2-year period. Because of the large numbers of patients who crossed over in both directions, conclusions about the superiority or equivalence of the treatments are not warranted based on the intent-to-treat analysis.
  • Trial Registration: clinicaltrials.gov Identifier: NCT00000410

 

Lumbar diskectomy is the most common surgical procedure performed in the United States for patients having back and leg symptoms; the vast majority of the procedures are elective. However, lumbar disk herniation is often seen on imaging studies in the absence of symptoms[1,2] and can regress over time without surgery.[3] Up to 15-fold variation in regional diskectomy rates in the United States[4] and lower rates internationally raise questions regarding the appropriateness of some of these surgeries.[5,6]

 

Several studies have compared surgical and nonoperative treatment of patients with herniated disk, but baseline differences between treatment groups, small sample sizes, or lack of validated outcome measures in these studies limit evidence-based conclusions regarding optimal treatment.[7-12] The Spine Patient Outcomes Research Trial (SPORT) was initiated in March 2000 to compare the outcomes of surgical and nonoperative treatment for lumbar intervertebral disk herniation, spinal stenosis, or degenerative spondylolisthesis.[13] The trial included both a randomized cohort and an observational cohort who declined to be randomized in favor of designating their own treatment but otherwise met all the other criteria for inclusion and who agreed to undergo follow-up according to the same protocol. This article reports intent-to-treat results through 2 years for the randomized cohort.

 

Methods

 

Study Design

 

SPORT was conducted at 13 multidisciplinary spine practices in 11 US states (California, Georgia, Illinois, Maine, Michigan, Missouri, Nebraska, New York, New Hampshire, Ohio, Pennsylvania). The human subjects committee of each participating institution approved a standardized protocol. All patients provided written informed consent. An independent data and safety monitoring board monitored the study at 6-month intervals.[13]

 

Patient Population

 

Patients were considered for inclusion if they were 18 years and older and diagnosed by participating physicians during the study enrollment period as having intervertebral disk herniation and persistent symptoms despite some nonoperative treatment for at least 6 weeks. The content of preenrollment nonoperative care was not prespecified in the protocol but included education/counseling (71%), physical therapy (67%), epidural injections (42%), chiropractic therapy (32%), anti-inflammatory medications (61%), and opioid analgesics (40%).

 

Specific inclusion criteria at enrollment were radicular pain (below the knee for lower lumbar herniations, into the anterior thigh for upper lumbar herniations) and evidence of nerve-root irritation with a positive nerve-root tension sign (straight leg raise–positive between 30° and 70° or positive femoral tension sign) or a corresponding neurologic deficit (asymmetrical depressed reflex, decreased sensation in a dermatomal distribution, or weakness in a myotomal distribution). Additionally, all participants were surgical candidates who had undergone advanced vertebral imaging (97% magnetic resonance imaging, 3% computed tomography) showing disk herniation (protrusion, extrusion, or sequestered fragment)[14] at a level and side corresponding to the clinical symptoms. Patients with multiple herniations were included if only one of the herniations was considered symptomatic (ie, if only one was planned to be operated on).

 

Exclusion criteria included prior lumbar surgery, cauda equina syndrome, scoliosis greater than 15°, segmental instability (>10° angular motion or >4-mm translation), vertebral fractures, spine infection or tumor, inflammatory spondyloarthropathy, pregnancy, comorbid conditions contraindicating surgery, or inability/unwillingness to have surgery within 6 months.

 

Study Interventions

 

The surgery was a standard open diskectomy with examination of the involved nerve root.[15,16] The procedure agreed on by all participating centers was performed under general or local anesthesia, with patients in the prone or knee-chest position. Surgeons were encouraged to use loupe magnification or a microscope. Using a midline incision reflecting the paraspinous muscles, the interlaminar space was entered as described by Delamarter and McCullough.[15] In some cases the medial border of the superior facet was removed to provide a clear view of the involved nerve root. Using a small annular incision, the fragment of disk was removed as described by Spengler.[16] The canal was inspected and the foramen probed for residual disk or bony pathology. The nerve root was decompressed, leaving it freely mobile.

 

The nonoperative treatment group received “usual care,” with the study protocol recommending that the minimum nonsurgical treatment include at least active physical therapy, education/counseling with home exercise instruction, and nonsteroidal anti-inflammatory drugs, if tolerated. Other nonoperative treatments were listed, and physicians were encouraged to individualize treatment to the patient; all nonoperative treatments were tracked prospectively.[13,17]

 

Study Measures

 

The primary measures were the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) bodily pain and physical function scales[18-21] and the American Academy of Orthopaedic Surgeons MODEMS version of the Oswestry Disability Index (ODI).[22] As specified in the trial protocol, the primary outcomes were changes from baseline in these scales at 6 weeks, 3 months, 6 months, and 1 and 2 years from enrollment.

 

Secondary measures included patient self-reported improvement, work status, and satisfaction with current symptoms and with care.[23] Symptom severity was measured by the Sciatica Bothersomeness Index (range, 0-24; higher scores represent worse symptoms).[24,25]

 

Recruitment, Enrollment, and Randomization

 

A research nurse at each site identified potential participants and verified eligibility. For recruitment and informed consent, evidence-based videotapes described the surgical and non-operative treatments and the expected benefits, risks, and uncertainties.[26,27] Participants were offered enrollment in either the randomized trial or a concurrent observational cohort, the results of which are reported in a companion article.

 

Enrollment began in March 2000 and ended in November 2004. Baseline variables were collected prior to randomization. Patients self-reported race and ethnicity using National Institutes of Health categories.

 

Computer-generated random treatment assignment based on permuted blocks (randomly generated blocks of 6, 8, 10, and 12)[28] within sites occurred immediately after enrollment via an automated system at each site, ensuring proper allocation concealment. Study measures were collected at baseline and at regularly scheduled follow-up visits. Short-term follow-up visits occurred at 6 weeks and 3 months. If surgery was delayed beyond 6 weeks, additional follow-up data were obtained 6 weeks and 3 months postoperatively. Longer-term follow-up visits occurred at 6 months, 1 year from enrollment, and annually thereafter.

 

Statistical Analyses

 

We originally determined a sample size of 250 patients in each treatment group to be sufficient (with a 2-sided significance level of .05 and 85% power) to detect a 10-point difference in the SF-36 bodily pain and physical functioning scales or a similar effect size in the ODI. This difference corresponded to patients’ reports of being “a little better” in the Maine Lumbar Spine Study (MLSS).[29] The sample size calculation allowed for up to 20% missing data but did not account for any specific levels of nonadherence.

 

The analyses for the primary and secondary outcomes used all available data for each period on an intent-to-treat basis. Predetermined end points for the study included results at each of 6 weeks, 3 months, 6 months, 1 year, and 2 years. To adjust for the possible effect of missing data on the study results, the analysis of mean changes for continuous outcomes was performed using maximum likelihood estimation for longitudinal mixed-effects models under “missing at random” assumptions and including a term for treatment center. Comparative analyses were performed using the single imputation methods of baseline value carried forward and last value carried forward, as well as a longitudinal mixed model controlling for covariates associated with missed visits.[30]

 

For binary secondary outcomes, longitudinal logistic regression models were fitted using generalized estimating equations[31] as implemented in the PROC GENMOD program of SAS version 9.1 (SAS Institute Inc, Cary, NC). Treatment effects were estimated as differences in the estimated proportions in the 2 treatment groups.

 

P<.05 (2-sided) was used to establish statistical significance. For the primary outcomes, 95% confidence intervals (CIs) for mean treatment effects were calculated at each designated time point. Global tests of the joint hypothesis of no treatment effect at any of the designated periods were performed using Wald tests[32] as implemented in SAS. These tests account for the intraindividual correlation due to repeated measurements over time.[32]

 

Nonadherence to randomly assigned treatment may mean that the intention-to-treat analysis underestimates the real benefit of the treatment.[33,34] As a preplanned sensitivity analysis, we also estimated an “as-treated” longitudinal analysis based on comparisons of those actually treated surgically and nonoperatively. Repeated measures of outcomes were used as the dependent variables, and treatment received was included as a time-varying covariate. Adjustments were made for the time of surgery with respect to the original enrollment date to approximate the designated follow-up times. Baseline variables that were individually found to predict missing data or treatment received at 1 year were included to adjust for possible confounding.

 

Results

 

SPORT achieved full enrollment, with 501 (25%) of 1991 eligible patients enrolled in the randomized trial. A total of 472 participants (94%) completed at least 1 follow-up visit and were included in the analysis. Data were available for between 86% and 73% of patients at each of the designated follow-up times (Figure 1).

 

Figure 1 Flow Diagram of the SPORT RCT of Disc Herniation

Figure 1: Flow Diagram of the SPORT Randomized Controlled Trial of Disk Herniation: Exclusion, Enrollment, Randomization, and Follow-up.

 

Patient Characteristics

 

Baseline patient characteristics are shown in Table 1. Overall, the study population had a mean age of 42 years, with majorities being male, white, employed, and having attended at least some college; 16% were receiving disability compensation. All patients had radicular leg pain, 97% in a classic dermatomal distribution. Most of the herniations were at L5-S1, posterolateral, and were extrusions by imaging criteria.[14] The 2 randomized groups were similar at baseline.

 

Table 1 Patient Baseline Demographics

 

Nonoperative Treatments

 

A variety of nonoperative treatments were used during the study (Table 2). Most patients received education/counseling (93%) and anti-inflammatory medications (61%) (nonsteroidal anti-inflammatory drugs, cyclooxygenase 2 inhibitors, or oral steroids); 46% received opiates; more than 50% received injections (eg, epidural steroids); and 29% were prescribed activity restriction. Forty-four percent received active physical therapy during the trial; however, 67% had received it prior to enrollment.

 

Table 2 Nonoperative Treatments

 

Surgical Treatment and Complications

 

Table 3 gives the characteristics of surgical treatment and complications. The median surgical time was 75 minutes (interquartile range, 58-90), with a median blood loss of 49.5 mL (interquar-tile range, 25-75). Only 2% required transfusions. There were no perioperative deaths; 1 patient died from complications of childbirth 11 months after enrollment. The most common intraoperative complication was dural tear (4%). There were no postoperative complications in 95% of patients. Reoperation occurred in 4% of patients within 1 year of the initial surgery; more than 50% of the reoperations were for recurrent herniations at the same level.

 

Table 3 Operative Treatments, Complications and Events

 

Nonadherence

 

Nonadherence to treatment assignment affected both groups, ie, some patients in the surgery group chose to delay or decline surgery, and some in the nonoperative treatment group crossed over to receive surgery (Figure 1). The characteristics of crossover patients that were statistically different from patients who did not cross over are shown in Table 4. Those more likely to cross over to receive surgery tended to have lower incomes, worse baseline symptoms, more baseline disability on the ODI, and were more likely to rate their symptoms as getting worse at enrollment than the other patients receiving nonoperative treatment. Those more likely to cross over to receive nonoperative care were older, had higher incomes, were more likely to have an upper lumbar disk herniation, less likely to have a positive straight leg–raising test result, had less pain, better physical function, less disability on the ODI, and were more likely to rate their symptoms as getting better at enrollment than the other surgery patients.

 

Table 4 Statistically Significant Baseline Demographics

 

Missing Data

 

The rates of missing data were equivalent between the groups at each time point, with no evidence of differential dropout according to assigned treatment. Characteristics of patients with missed visits were very similar to those of the rest of the cohort except that patients with missing data were less likely to be married, more likely to be receiving disability compensation, more likely to smoke, more likely to display baseline motor weakness, and had lower baseline mental component summary scores on the SF-36.

 

Intent-to-Treat Analyses

 

Table 5 shows estimated mean changes from baseline and the treatment effects (differences in changes from baseline between treatment groups) for 3 months, 1 year, and 2 years. For each measure and at each point, the treatment effect favors surgery. The treatment effects for the primary outcomes were small and not statistically significant at any of the points. As shown in Figure 2, both treatment groups showed strong improvements at each of the designated follow-up times, with small advantages for surgery. However, for each primary outcome the combined global test for any difference at any period was not statistically significant. This test accounts for intraindividual correlations as described in the “Methods” section.

 

Figure 2 Mean Scores Over Time

Figure 2: Mean Scores Over Time for SF-36 Bodily Pain and Physical Function Scales and Oswestry Disability Index.

 

Table 5 Treatment Effects for Primary and Secondary Outcomes

Table 5: Treatment Effects for Primary and Secondary Outcomes Based on Intent-to-Treat Analyses*

 

For the secondary outcome of sciatica bothersomeness, Table 5 and Figure 3 show that there were greater improvements in the Sciatica Bothersomeness Index in the surgery group at all designated follow-up times: 3 months (treatment effect, −2.1; 95% CI, −3.4 to −0.9), 1 year (treatment effect, −1.6; 95% CI, −2.9 to −0.4), and 2 years (treatment effect, −1.6; 95% CI, −2.9 to −0.3), with results of the global hypothesis test being statistically significant (P=.003). Patient satisfaction with symptoms and treatment showed small effects in favor of surgery while employment status showed small effects in favor of nonoperative care, but none of these changes was statistically significant. Self-rated progress showed a small statistically significant advantage for surgery (P=.04).

 

Figure 3 Measures Over Time

Figure 3: Measures Over Time for Sciatica Bothersomeness Index, Employment Status, Satisfaction With Symptoms, Satisfaction With Care, and Self-rated Improvement.

 

As-treated analyses based on treatment received were performed with adjustments for the time of surgery and factors affecting treatment crossover and missing data. These yielded far different results than the intent-to-treat analysis, with strong, statistically significant advantages seen for surgery at all follow-up times through 2 years. For example, at 1 year the estimated treatment effects for the SF-36 bodily pain and physical function scales, the ODI, and the sciatica measures were 15.0 (95% CI, 10.9 to 19.2), 17.5 (95% CI, 13.6 to 21.5), −15.0 (95% CI, −18.3 to −11.7), and −3.2 (95% CI, −4.3 to −2.1), respectively.

 

Sensitivity analysis was performed for 4 different analytic methods of dealing with the missing data. One method was based on simple mean changes for all patients with data at a given time point with no special adjustment for missing data. Two methods used single imputation methods—baseline value carried forward and last value carried forward.[32] The latter method used the same mixed-models approach for estimating mean changes as given in Table 5 but also adjusted for factors affecting the likelihood of missing data. Treatment effect estimates at 1 year ranged from 1.6 to 2.9 for the SF-36 bodily pain scale, 0.74 to 1.4 for the physical function scale, −2.2 to −3.3 for the ODI, and −1.1 to −1.6 for the sciatica measures. Given these ranges, there appear to be no substantial differences between any of these methods.

 

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Dr. Alex Jimenez’s Insight

Herniated disc symptoms vary on the location of the condition and on the surrounding soft tissues affected along the spine. Lumbar disc herniations, one of the most common area for herniated discs to occur, are characterized by the compression of the nerve roots along the lower back and can generally cause symptoms of sciatica. Surgery is commonly recommended to treat disc herniations, however, numerous treatment methods can help manage the condition without the need of surgical interventions. A research study conducted on sciatica caused by herniated discs determined that about 73 percent of participants experienced an improvement in symptoms with nonoperative treatment. The results of this article concluded that nonoperative treatment can be as effective as surgery in the treatment of herniated discs.

 

Comment

 

Both operated and nonoperated patients with intervertebral disk herniation improved substantially over a 2-year period. The intent-to-treat analysis in this trial showed no statistically significant treatment effects for the primary outcomes; the secondary measures of sciatica severity and self-reported progress did show statistically significant advantages for surgery. These results must be viewed in the context of the substantial rates of nonadherence to assigned treatment. The pattern of nonadherence is striking because, unlike many surgical studies, both the surgical and nonoperative treatment groups were affected.[35] The most comparable previous trial[8] had 26% crossover into surgery at 1 year, but only 2% crossover out of surgery. The mixing of treatments due to crossover can be expected to create a bias toward the null.[34] The large effects seen in the as-treated analysis and the characteristics of the crossover patients suggest that the intent-to-treat analysis underestimates the true effect of surgery.

 

SPORT findings are consistent with clinical experience in that relief of leg pain was the most striking and consistent improvement with surgery. Importantly, all patients in this trial had leg pain with physical examination and imaging findings that confirmed a disk herniation. There was little evidence of harm from either treatment. No patients in either group developed cauda equina syndrome; 95% of surgical patients had no intraoperative complications. The most common complication, dural tear, occurred in 4% of patients, similar to the 2% to 7% noted in the meta-analysis by Hoffman et al,7 2.2% seen in the MLSS,[29] and 4% in the recent series from Stanford.[36]

 

One limitation is the potential lack of representativeness of patients agreeing to be randomized to surgery or nonoperative care; however, the characteristics of patients agreeing to participate in SPORT were very similar to those in other studies.[29,36] The mean age of 42 years was similar to the mean ages in the MLSS,[29] the series of Spangfort,[37] and the randomized trial by Weber,[8] and only slightly older than those in the recent series from Stanford (37.5 years).[36] The proportion of patients receiving workers’ compensation in SPORT (16%) was similar to the proportion in the Stanford population (19%) but lower than that in the MLSS population (35%), which specifically oversampled patients receiving compensation. Baseline functional status was also similar, with a mean baseline ODI of 46.9 in SPORT vs 47.2 in the Stanford series, and a mean baseline SF-36 physical function score of 39 in SPORT vs 37 in the MLSS.

 

The strict eligibility criteria, however, may limit the generalizability of these results. Patients unable to tolerate symptoms for 6 weeks and demanding earlier surgical intervention were not included, nor were patients without clear signs and symptoms of radiculopathy with confirmatory imaging. We can draw no conclusions regarding the efficacy of surgery in these other groups. However, our entry criteria followed published guidelines for patient selection for elective diskectomy, and our results should apply to the majority of patients facing a surgical decision.[38,39]

 

To fully understand the treatment effect of surgery compared with nonoperative treatment, it is worth noting how each group fared. The improvements with surgery in SPORT were similar to those of prior series at 1 year: for the ODI, 31 points vs 34 points in the Stanford series; for the bodily pain scale, 40 points vs 44 in the MLSS; and for sciatica bothersomeness, 10 points vs 11 in the MLSS. Similarly, Weber[8] reported 66% “good” results in the surgery group, compared with the 76% reporting “major improvement” and 65% satisfied with their symptoms in SPORT.

 

The observed improvements with nonoperative treatment in SPORT were greater than those in the MLSS, resulting in the small estimated treatment effect. The nonoperative improvement of 37, 35, and 9 points in bodily pain, physical function, and sciatica bothersomeness, respectively, were much greater than the improvements of 20, 18, and 3 points reported in the MLSS. The greater improvement with nonoperative treatment in SPORT may be related to the large proportion of patients (43%) who underwent surgery in this group.

 

The major limitation of SPORT is the degree of nonadherence with randomized treatment. Given this degree of crossover, it is unlikely that the intent-to-treat analysis can form the basis of a valid estimate of the true treatment effect of surgery. The “as-treated” analysis with adjustments for possible confounders showed much larger effects in favor of surgical treatment. However, this approach does not have the strong protection against confounding that is afforded by randomization. We cannot exclude the possibility that baseline differences between the as-treated groups, or the selective choice of some but not other patients to cross over into surgery, may have affected these results, even after controlling for important covariates. Due to practical and ethical constraints, this study was not masked through the use of sham procedures. Therefore, any improvements seen with surgery may include some degree of “placebo effect.”

 

Another potential limitation is that the choice of nonoperative treatments was at the discretion of the treating physician and patient. However, given the limited evidence regarding efficacy for most nonoperative treatments for lumbar disk herniation and individual variability in response, creating a limited, fixed protocol for nonoperative treatment was neither clinically feasible nor generalizable. The nonoperative treatments used were consistent with published guidelines.[17,38,39] Compared with the MLSS, SPORT had lower use of activity restriction, spinal manipulation, transcutaneous electrical nerve stimulation, and braces and corsets, and higher rates of epidural steroid injections and use of narcotic analgesics. This flexible nonoperative protocol had the advantages of individualization that considered patient preferences in the choice of nonoperative treatment and of reflecting current practice among multidisciplinary spine practices. However, we cannot make any conclusion regarding the effect of surgery vs any specific nonoperative treatment. Similarly, we cannot adequately assess the relative efficacy of any differences in surgical technique.

 

Conclusion

 

Patients in both the surgery and nonoperative treatment groups improved substantially over the first 2 years. Between-group differences in improvements were consistently in favor of surgery for all outcomes and at all time periods but were small and not statistically significant except for the secondary measures of sciatica severity and self-rated improvement. Because of the high numbers of patients who crossed over in both directions, conclusions about the superiority or equivalence of the treatments are not warranted based on the intent-to-treat analysis alone.

 

Acknowledgments & Footnotes

 

Ncbi.nlm.nih.gov/pmc/articles/PMC2553805/

 

Manipulation or Microdiskectomy for Sciatica? A Prospective Randomized Clinical Study

 

Abstract

 

Objective: The purpose of this study was to compare the clinical efficacy of spinal manipulation against microdiskectomy in patients with sciatica secondary to lumbar disk herniation (LDH).

Methods: One hundred twenty patients presenting through elective referral by primary care physicians to neurosurgical spine surgeons were consecutively screened for symptoms of unilateral lumbar radiculopathy secondary to LDH at L3-4, L4-5, or L5-S1. Forty consecutive consenting patients who met inclusion criteria (patients must have failed at least 3 months of nonoperative management including treatment with analgesics, lifestyle modification, physiotherapy, massage therapy, and/or acupuncture) were randomized to either surgical microdiskectomy or standardized chiropractic spinal manipulation. Crossover to the alternate treatment was allowed after 3 months.

Results: Significant improvement in both treatment groups compared to baseline scores over time was observed in all outcome measures. After 1 year, follow-up intent-to-treat analysis did not reveal a difference in outcome based on the original treatment received. However, 3 patients crossed over from surgery to spinal manipulation and failed to gain further improvement. Eight patients crossed from spinal manipulation to surgery and improved to the same degree as their primary surgical counterparts.

Conclusions: Sixty percent of patients with sciatica who had failed other medical management benefited from spinal manipulation to the same degree as if they underwent surgical intervention. Of 40% left unsatisfied, subsequent surgical intervention confers excellent outcome. Patients with symptomatic LDH failing medical management should consider spinal manipulation followed by surgery if warranted.

 

In conclusion, a herniated disc causes the soft, central portion of an intervertebral disc to bulge out a tear in its outer, fibrous ring as a result of degeneration, trauma, lifting injuries or straining. Most disc herniations can heal on their own but those considered to be severe may require surgical interventions to treat them. Research studies, such as the one above, have demonstrated that nonoperative treatment may help the recovery of a herniated disc without the need for surgery. Information referenced from the National Center for Biotechnology Information (NCBI). The scope of our information is limited to chiropractic as well as to spinal injuries and conditions. To discuss the subject matter, please feel free to ask Dr. Jimenez or contact us at 915-850-0900 .

 

Curated by Dr. Alex Jimenez

 

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Additional Topics: Back Pain

 

According to statistics, approximately 80% of people will experience symptoms of back pain at least once throughout their lifetimes. Back pain is a common complaint which can result due to a variety of injuries and/or conditions. Often times, the natural degeneration of the spine with age can cause back pain. Herniated discs occur when the soft, gel-like center of an intervertebral disc pushes through a tear in its surrounding, outer ring of cartilage, compressing and irritating the nerve roots. Disc herniations most commonly occur along the lower back, or lumbar spine, but they may also occur along the cervical spine, or neck. The impingement of the nerves found in the low back due to injury and/or an aggravated condition can lead to symptoms of sciatica.

 

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OTHER IMPORTANT TOPICS: EXTRA: Sports Injuries? | Vincent Garcia | Patient | El Paso, TX Chiropractor

 

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