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Cohort Studies

Back Clinic Cohort Studies. Cohort studies is a study design where one or more people (called cohorts) are followed and subsequent status evaluations with respect to a disease or outcome are conducted to determine which participants’ exposure characteristics (risk factors) are associated. As the study is conducted, the outcome from participants in each cohort is measured and relationships with specific characteristics determined. Cohort studies usually observe large groups of individuals and record their exposure to certain risk factors to find clues as to the possible causes of disease. They can be prospective studies that gather data going forward, or retrospective cohort studies, which look at data already collected. This type of research can also help identify social factors that influence health.

The fundamentals of a cohort study are:

a. Identify people who are free of disease at the beginning of study
b. Assemble cohorts of exposed and unexposed individuals
c. Follow cohorts for the development of incident outcomes
d. Compare the risks of incident outcomes in each cohort

Advantages

  1. Cheaper & easier than a randomized controlled trial (RCT)
  2. Standardization of criteria/outcome is possible
  3. Subjects can be matched, which limits the influence of confounding variables

Disadvantages

  1. Cohorts can be difficult to identify from confounding variables
  2. No randomization, which means that imbalances could exist
  3. Blinding/Masking is difficult
  4. The outcome of interest can take a long time to occur

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


Rapid Pain Relief for Herniated Discs in El Paso, TX

Rapid Pain Relief for Herniated Discs in El Paso, TX

Herniated discs are a debilitating condition characterized by pain, numbness and weakness in one or more limbs. While some people may experience no pain at all, those that do may often wish for fast pain relief to avoid long periods of sick leave from their jobs. Many healthcare professionals recommend surgery for patients with persistent and/or worsening herniated disc symptoms but other non-operative treatment options can help treat disc herniations. The purpose of the following article is to demonstrate how a�structured physiotherapy treatment model can provide rapid relief to patients who qualify for lumbar disc surgery.

 

A Structured Physiotherapy Treatment Model Can Provide Rapid Relief to Patients Who Qualify for Lumbar Disc Surgery: A Prospective Cohort Study

 

Abstract

 

  • Objective: To evaluate a structured physiotherapy treatment model in patients who qualify for lumbar disc surgery.
  • Design: A prospective cohort study.
  • Patients: Forty-one patients with lumbar disc herniation, diagnosed by clinical assessments and magnetic resonance imaging.
  • Methods: Patients followed a structured physiotherapy treatment model, including Mechanical Diagnosis and Therapy (MDT), together with graded trunk stabilization training. Study outcome measures were the Oswestry Disability Index, a visual analogue scale for leg and back pain, the Tampa Scale for Kinesiophobia, the European Quality of Life in 5 Dimensions Questionnaires, the Zung Self-Rating Depression Scale, the Self-Efficacy Scale, work status, and patient satisfaction with treatment. Questionnaires were distributed before treatment and at 3-, 12- and 24-month follow-ups.
  • Results: The patients had already improved significantly (p<0.001) 3 months after the structured physiotherapy treatment model in all assessments: disability, leg and back pain, kinesiophobia, health-related quality of life, depression and self-efficacy. The improvement could still be seen at the 2-year follow-up.
  • Conclusion: This study recommends adopting the structured physiotherapy treatment model before considering surgery for patients with symptoms such as pain and disability due to lumbar disc herniation.
  • Keywords: intervertebral disc displacement; rehabilitation; physical therapy modalities.

 

Introduction

 

Symptoms of lumbar disc herniation are relatively common in the general population, although the prevalence rates vary widely between different studies (1). Symptom severity also varies and, in many patients, pain and loss of function may lead to disability and long periods of sick leave (2). Spontaneous resolution of symptoms after a lumbar disc herniation is regarded as common, which makes it difficult to evaluate the effects of treatment. Furthermore, in studies evaluating spontaneous healing, different physiotherapy treatments are often included, together with pain medication (3�5), which makes it difficult to determine the extent of natural healing. On the other hand, in patients with sciatica, but without confirmed disc herniation on magnetic resonance imaging (MRI), approximately one-third of subjects recover 2 weeks after the onset of sciatica and approximately three-quarters recover after 3 months (6).

 

In contrast to evaluating spontaneous healing, surgery for lumbar disc herniation has been investigated in numerous studies. Surgery has been compared with a variety of treatments, such as education, chiropractic, unspecified physiotherapy, acupuncture, injections and medication (7�10). The non-surgical treatments have, however, been described only in vague terms, and variations in treatments have been used. Previous studies have reported favourable short-term (after 1 year) outcomes for surgery, but no major differences between surgical and other treatments have been demonstrated in the long term (over 2 years) (7, 10, 11). The conclusions that are drawn from the comparison between surgery and non-systematic non-surgical treatments may thus be misleading. This has been confirmed in a systematic review, which concluded that there is conflicting evidence as to whether surgery is more beneficial than nonsurgical care for both short- and long-term follow-up (12).

 

Kinesiophobia has been evaluated in patients after lumbar disc surgery, and almost 50% of patients were classified as having kinesiophobia (13). To our knowledge kinesiophobia has not been evaluated in patients with lumbar disc herniation treated with a structured physiotherapy treatment.

 

There are many different non-surgical treatment methods for patients with low-back pain and sciatica. One common management method is Mechanical Diagnosis and Therapy (MDT), also known as the McKenzie method, which aims to eliminate or minimize pain (14). A systematic review from 2004 of the efficacy of MDT showed that patients with low-back pain treated�with MDT reported a greater, more rapid reduction in pain and disability compared with non-steroidal anti-inflammatory drugs (NSAIDs), educational booklets, back massage and back care advice, strength training, spinal mobilization and general exercises (15). In a randomized controlled trial with a 1-year follow-up from 2008, Paatelma and co-workers (16) found that the McKenzie method was only marginally more effective compared with only giving advice to patients with low-back pain. For patients with low-back pain, sciatica and a verified lumbar disc herniation, it has, however, been shown that a selected group of patients who responded to MDT after 5 days of treatment also reported that they were satisfied after 55 weeks (17). The patients started treatment just 12 days after the onset of symptoms and the effects of spontaneous healing cannot therefore be excluded. Taken together, the treatment effects of MDT for patients with a verified lumbar disc herniation appear to require further evaluation.

 

Trunk stabilization exercises, which aim to restore deep trunk muscle control, have been used for the prevention and rehabilitation of low-back pain (18). A randomized controlled trial revealed a reduction in the recurrence of low-back pain episodes after specific trunk stabilization exercises compared with a control group receiving advice and the use of medication (19). Dynamic lumbar stabilization exercises have been found to relieve pain and improve function in patients who have undergone microdiscectomy (20). The effects of trunk stabilization exercises combined with MDT have, however, not been studied in patients with non-operated lumbar disc herniation. MDT is seldom recommended for patients with MRI verified lumbar disc herniation with a broken outer annulus. At our hospital, however, we have several years of good clinical experience of a combination of MDT and trunk stabilization exercises for this category of patients. To our knowledge, no previous study has investigated whether patients with a lumbar disc herniation verified by MRI, symptoms for at least 6 weeks (minimizing effects of spontaneous healing) and who qualified for disc surgery could improve with a structured physiotherapy treatment model including MDT and gradually progressive trunk stabilization exercises. The aim of this study was therefore to�evaluate a structured physiotherapy treatment model in patients who qualified for lumbar disc surgery.

 

Material and Methods

 

During the study inclusion period, 150 patients, who were referred to the orthopaedic clinic at Sahlgrenska University Hospital, Gothenburg, from November 2003 to January 2008, were identified as potential participants since disc herniation was confirmed with MRI. Inclusion criteria were: 18�65 years of age; MRI confirming disc herniation explaining the clinical findings; symptoms for at least 6 weeks (minimizing the effects of spontaneous healing) and pain distribution with concomitant neurological disturbances correlated to the affected nerve root. Exclusion criteria were: cauda equina syndrome, previous spinal surgery, other spinal diseases, such as spinal stenosis and spondylolisthesis, and inadequate command of Swedish. However, 70 patients were excluded because of spontaneous resolution of pain and symptoms. The remaining 80 patients met the inclusion criteria and qualified for surgery. Orthopaedic surgeons determined whether the patients qualified for lumbar disc surgery after MRI and physical examination according to the recommendations of the American Academy of Orthopaedic Surgeons for patients with lumbar disc herniation (21).

 

Figure 1 Study Flowchart

Initially, the study was planned as a randomized controlled trial (RCT) between a structured physiotherapy treatment model and surgery, but the number of patients was not sufficient to obtain acceptable power. Eighteen of the 80 patients were initially randomized to physiotherapy, 17 patients were randomized to surgery and 45 patients did not agree to undergo randomization. Twenty-seven of the 45 patients who did not agree to randomization agreed to take part in the structured physiotherapy treatment and 18 patients agreed to undergo surgery. A decision was therefore made solely to present a cohort of 45 patients treated according to the structured physiotherapytreatment protocol (Fig. 1). Patients were given verbal and written information and informed consent was obtained. The study was approved by the Regional Ethical Review Board.

 

Before structured physiotherapy treatment began, 4 patients recovered to the extent that they could no longer be accepted as surgical candidates and they were therefore excluded from the study. The remaining 41 patients treated according to the structured physiotherapy model are presented in this paper.

 

A Structured Physiotherapy Treatment Model

 

Six physiotherapists with credentialed examinations in MDT, which is an examination within the MDT concept after completing 4 courses of 4 days each for evaluating and treating patients with spinal problems. Following completion of these courses, an extensive literature study and practice in evaluating and treating patients is required before the examination can be completed. The physiotherapists involved in the study had 5�20 years of clinical experience of treating patients with back problems and herniated lumbar disc. The inter-examiner reliability of the MDT assessment has been shown to be good if the examiner is trained in the MDT method (22). The physiotherapists examined and treated the patients during a 9-week period (Table I). For the first 2 weeks of treatment, an MDT protocol was followed, based on clinical examinations of individual mechanical and symptomatic responses to positions and movements, with the aim of minimizing pain and with the emphasis on self-management (14). During the third week of treatment, graded trunk stabilization exercises were added to the MDT protocol. The purpose of graded trunk stabilization exercises was to improve muscle control (23). The low-load muscular endurance exercises were gradually increased in intensity on an individual�basis with respect to the patients� reported leg pain and the observed movement control and quality. During treatment, the patients were encouraged to continue exercising on their own at a gym, or to perform some other type of physical training of their own choice after the structured physiotherapy treatment was concluded. Four weeks after the completion of the 9-week physiotherapy treatment period, the patients attended a follow-up visit with the physiotherapist who had treated them. The aim of this visit was to encourage a high level of compliance with respect to continued trunk stabilization exercises and MDT practice (Table I).

 

Table 1 Treatment Procedures

 

Study Outcome Measures

 

The patients were given a battery of questionnaires to complete. Independent examiners, who were not involved in the treatment, distributed the questionnaires before treatment (baseline) and at the 3-, 12- and 24-month follow-ups.

 

The primary outcome measures were pain intensity in the leg, rated using a visual analogue scale (VAS) 0�100 mm (24) and the Oswestry Disability Index (ODI) 0�100 % (25). A score of 0�10 mm on the VAS was defined as no pain according to �berg et al. (26). An ODI score of 0�20% was defined as minimal or no disability, and a score of over 40% was defined as severe disability (25). These primary outcome measures are commonly used in evaluations after surgery for lowback pain and for assessing patients with lumbar disc herniation (27).

 

Secondary outcome measures included pain intensity in the back rated using a VAS and the degree of kinesiophobia using the Tampa Scale for Kinesiophobia (TSK). The TSK score varies between 17 and 68 and a cut-off more than 37 was defined as a high degree of kinesiophobia (28). Health-Related Quality of Life (HRQoL) in the European Quality of Life in 5 Dimensions Questionnaires (EQ-5D) was used. The EQ-5D includes 2 parts, EQ-5Dindex ranges from 0 to 1.0, where 1.0 is optimal health and EQ-5DVAS is a vertical visual analogue scale ranging from 0 (worst possible health state) to 100 (best possible health state) (29). The Zung Self-Rating Depression Scale (ZDS) ranges from 20�80 and the more depressed the patient is, the higher score (30). The Self-Efficacy Scale (SES) ranges from 8 to 64, with higher scores indicating more positive beliefs (31) was also used. Work status was measured using a 3-grade Likert scale: working full time, full-time sick leave and part-time sick leave. Likewise, patient�satisfaction with treatment was measured on a 3-grade Likert scale; satisfied, less satisfied and dissatisfied (32). These secondary outcome measures evaluate bio-psychosocial factors described as important in connection with lumbar disc surgery (33).

 

Table 2 Baseline Characteristics for the 41 Patients

 

Statistical Analyses

 

The results are presented as median values and interquartile range (IQR), except for age, which is presented as the mean and standard deviation (SD). Changes over time within the group were analysed with the Wilcoxon signed-rank test. Statistical significance was set at an alpha level of 0.05.

 

Results

 

The baseline characteristics are shown in Table II. No patient had undergone surgery at the 3-month follow-up. At the 12-month follow-up, 3 patients had undergone surgery and, at the 24-month follow-up, 1 additional patient had been operated on. After surgery, these 4 patients were excluded from further follow-ups (Fig. 1).

 

Change Over Time in Primary Outcome Measures

 

Disability. The patients showed significant improvements (p < 0.001) in ODI at the 3-month follow-up compared with baseline. The median (IQR) score decreased from 42 (27�53) to 14 (8�33). This improvement could still be seen at 12 and 24 months (Table III and Fig. 2). At baseline, 22 patients reported�severe disability (54%) and 3 patients reported no disability. The degree of disability decreased at the 3-month follow-up, as only 9 patients (22%) reported severe disability and 26 (64%) reported no disability. At 12- and 24-month follow-ups only 2 patients (5%) reported severe disability. At 12-month followup 26 patients still reported no disability, and at 24-month follow-up 27 patients reported no disability.

 

Figure 2 Visual Analogue Scale Leg Pain and Oswestry Disability Index

 

Leg pain. A significant reduction in patients� leg pain was found at the 3-month follow-up (p < 0.001) on the VAS compared with baseline. The median (IQR) on the VAS decreased from 60 (40�75) to 9 (2�27). This improvement could still be seen at the 12- and 24-month follow-ups (Table III and Fig. 2). Before treatment, all patients reported leg pain. Three months after treatment, the median on the VAS was 9 mm, i.e. classified as no leg pain (26). Twenty-three patients (56%) reported no leg pain at the 3-month follow-up. At the 12-month follow-up 22 patients reported no leg pain, and after 24 months 24 patients reported no leg pain.

 

Table 3 Changes Over Time in Primary and Secondary Outcome Measures

 

Change in Secondary Outcome Measures Over Time

 

Back pain. A significant improvement in back pain was found at the 3-month follow-up (p < 0.001) on the VAS compared with baseline. This improvement could still be seen at 12 and 24 months (Table III). At baseline, 6 patients (15%) reported no back pain. Three months after treatment began, 20 patients (49%) reported no back pain.

 

Figure 3 Number of Patients Classified with Kinesiophobia at Baseline

 

Kinesiophobia. The degree of kinesiophobia showed a significant improvement at the 3-month follow-up (p < 0.001) and the improvement could be seen throughout the follow-up period (Table III). Before treatment, 25 patients (61%) were classified as having kinesiophobia and 15 patients (37%) had no kinesiophobia, while data for 1 patient was missing. After 3 months, 15 patients (37%) had kinesiophobia and 26 (63%) had no kinesiophobia. At the 12-month follow-up, the number of patients with kinesiophobia had reduced to 4 (11%) (Fig. 3).

 

Health-related quality of life, depression and self-efficacy. All 4 assessments (EQ-5Dindex, EQ-5DVAS, ZDS and SES) showed significant improvements at the 3-month follow-up (p < 0.001). This improvement could still be seen at 12 and 24 months (Table III).

 

Sick leave. At baseline, 22 patients (54%) were on full-time sick leave (Table IV), compared with 9 (22%) patients at�the 3-month follow-up. At baseline, 14 patients (34%) were working full time, compared with 22 (54%) at the 3-month follow-up.

 

Table 4 Number of Patients on Sick Leave at Each Follow Up

 

Satisfaction with Treatment

 

At the 3-month follow-up, 32 (78%) of 41 patients were satisfied with the structured physiotherapy treatment. Seven patients were less satisfied and 2 patients were dissatisfied. Both of the dissatisfied patients were later operated. At the 2-year follow-up, the number of satisfied patients was 29 (80%) of 36. Seven patients were less satisfied, but none dissatisfied after structured physiotherapy treatment.

 

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Dr. Alex Jimenez’s Insight

A disc herniation in the lumbar spine can cause pain, numbness and weakness in the lower back. Because of the severity of the symptoms, many patients seeking fast pain relief consider surgery. However, many non-operative treatment options can help improve as well as manage lumbar herniated disc symptoms.�A structured physiotherapy treatment model can provide rapid pain relief to patients who would otherwise qualify for lumbar disc surgery, according to the following article. Patients looking to avoid taking long periods of sick leave from work due to their symptoms may benefit from a structured physiotherapy treatment model. As with any type of injury and/or condition, the use of other treatment options should be properly considered before turning to surgical interventions for fast pain relief.

 

Discussion

 

The principal finding of this study was that patients who qualified for lumbar disc surgery improved to a statistically significant and clinically substantial degree just 3 months after the start of the structured physiotherapy treatment in all assessments: disability, leg and back pain, kinesiophobia, health-related quality of life, depression and self-efficacy. The improvements could still be seen at the 2-year follow-up.

 

The natural course of healing must be considered carefully, especially when evaluating treatment effects in patients with disc herniation. The symptoms often vary over time and many discs heal spontaneously and the symptoms cease. Approximately 75% of patients with sciatica, without an MRI-verified disc herniation, recover within 3 months, and approximately one-third of patients recover within 2 weeks after the onset of sciatica (6). The natural course of sciatica was evaluated in a randomized controlled trial (34), which compared NSAIDs with placebo. The patients were, however, examined within 14 days after the onset of radiating leg pain. After 3 months, 60% of the patients had recovered and, after 12 months, 70% had recovered. In order to minimize the influence of spontaneous healing in the present study, the patients were therefore included only if they had had persistent pain and disability for more than 6 weeks. In fact, the majority of the patients had had pain and disability for more than 3 months. It is therefore most likely that the effects of treatment seen in the present study are, in the majority of patients, an effect of the structured physiotherapy treatment model and not a result of spontaneous healing.

 

In the study by Weber et al. (34), the VAS leg pain mean score was reduced from 54 mm at baseline to 19 mm within 4 weeks for all 183 patients, regardless of treatment. After 1 year, the VAS leg pain mean score was 17 mm. The patients in the present study who were a little worse at baseline (60 mm) reported 9 mm on the VAS leg pain just 3 months after treatment. Consequently, in the present study, the median VAS level had already been reduced to under the no-pain score, defined as 0�10 on the VAS (26), at the 3-month follow-up and this was maintained to the 12- and 24-month follow-ups.

 

Physiotherapy treatment for patients with lumbar disc herniation can lead to improvements. Br�tz et al. (17) included a selected group of patients who responded with the centralization of pain after the first 5 daily sessions of treatment according to the MDT method. Centralization of pain is defined as a clinically induced change in the location of pain referred from the spine, that moves from the most distal position toward the lumbar midline (35). However, the patients� medium duration of symptoms before treatment was only 12 days and the possibility that patients recovered naturally cannot therefore be excluded (17).

 

In a retrospective study, 95 patients were treated with a functional restoration programme (36). The patients achieved significant improvements after a mean treatment period of 8.7 months. The evaluation was performed at discharge only. With a treatment period of this length, it is, however, difficult to differentiate between the effects of treatment and the natural healing process. In the present study, a shorter treatment period was adopted, and large and significant improvements were found after just 3 months and were still present at the 24-month follow-up. It is therefore not likely that the natural healing process was responsible for the positive results in the present study.

 

In a prospective study of 82 consecutive patients with acute severe sciatica, included for conservative management, only a minority of the patients had made a full recovery after 12 months (37). Twenty-five percent of the patients underwent surgery within 4 months and one-third had surgery within 1 year. In spite of the fact that the inclusion criteria in the present study followed the recommendations for surgery (21, 38), no patient required surgery at the 3-month follow-up and, after 12 months, only 3 patients (7%) had undergone surgery. The interpretation of the divergence could be that the structured physiotherapy treatment model used in the present study appeared to influence patients with lumbar disc herniation in a very positive direction. One recommendation is therefore to follow the structured physiotherapy treatment model before considering surgery.

 

In this study, MRI verification of disc herniation was an inclusion criterion. In clinical practice, MRI verification is not mandatory, as it is in surgical treatment, before introducing structured physiotherapy treatment to patients with symptoms from a disc herniation. Consequently, treatment according to the structured physiotherapy treatment model can start early after the commencement of symptoms, as it is not necessary to wait for an MRI. It is possible to speculate that, if treatment with a structured physiotherapy model starts earlier than in the present study, the improvements would be even better, further reducing the risk of persistent pain and accompanying problems. Moreover, the need for MRI is likely to diminish; this, however, should be further evaluated in future studies.

 

One explanation for the good results of this study could be that the patients followed a structured physiotherapy treatment model, comprising MDT and trunk stabilization exercises, allowing for an individual design and progression of the treatment. Similar results were described in a retrospective cohort study (39) using several treatment methods for pain control as well as for exercise training for patients with lumbar disc herniation. The evaluation was not carried out until approximately 31 months after treatment. The results of Saal et al. (39) and of the present study are in agreement, in that structured physiotherapy treatment can reduce symptoms, but symptoms were relieved much more rapidly in the present study.

 

In a multicentre study comprising 501 patients, randomized to surgery or non-operative care, 18% of the patients assigned to non-operative treatment underwent surgery within 6 weeks and 30% had surgery at approximately 3 months (7). The nonoperative treatment group received non-specified �usual care�, which could include a variety of different treatment methods. In contrast, the patients in the present study were offered a structured physiotherapy treatment model that included both bio-psychological and social components, as described in the International Classification of Functioning, Disability and Health (40).

 

There are many possible explanations for the positive effects seen in this present study, and 5 of these will now be discussed. Firstly, the patients were well informed about the design of the structured physiotherapy treatment model, including the timetable for different phases of the treatment and when the treatment was planned to end. This information enhanced the patients� opportunity for self-management and gave them an active role in treatment decision-making.

 

Secondly, the patients acquired strategies to deal with their pain by using the different activities and movements in order to reduce pain according to the MDT method (14). The MDT method aims to enhance the patients� ability to cope with the symptoms, motivate the patient to comply with the treatment and empower them to achieve independence. Leijon et al. (41) have shown that low levels of motivation plus pain are important factors that enhance non-adherence to physical activity. It therefore appears important to reduce pain and increase motivation as early as possible. It is reasonable to believe that, when the patients participated in the evaluation of different activities and exercises, this augmented their opportunity to discover the connection between activities and the following reduction or increase in symptoms. This could have led to the increased self-efficacy and empowerment of the patients. The use of empowerment in physiotherapy has been recommended in a review by Perrault (42), who argues that empowerment improves the intervention.

 

Thirdly, the intensity of exercises was gradually increased on an individual basis with respect to the patients� reported pain. The objective was to strengthen the patients� self-efficacy, which also improved significantly in the present study. Fourthly, the trunk stabilization exercises were conducted with the aim of increasing deep trunk muscle control (23). It can be speculated that the physiological effects of training may also have led to reduced pain through increased blood circulation, muscle relaxation and the release of pain-reducing substances, such as endorphins.

 

Finally, one reason for the improvements could be that the physiotherapists were experienced and well educated in the MDT method. Subsequently, the physiotherapists were able to guide the patients during the rehabilitation process. It is, however, not possible to determine whether and how much each of the reasons discussed above contributed to the improvements. It seems reasonable to assume that all 5 factors were operating.

 

In this study, the majority of patients experienced kinesiophobia before treatment started. As early as 3 months after the structured physiotherapy treatment started, the number of patients with kinesiophobia fell dramatically and the majority of patients no longer experienced kinesiophobia. These results are in agreement with those of a study of patients with chronic pain and high kinesiophobia who increased their physical activity level after a pain management programme designed to enable the patients to regain overall function (43).

 

There are some limitations to this study. It is not possible to exclude the possibility that some patients may have improved spontaneously without treatment. Measures were taken to limit this risk by using symptoms for at least 6 weeks as an inclusion criterion. Again, the majority of patients had symptoms for more than 3 months. Another limitation might relate to whether the patients were selected accurately for the study. Clinically experienced orthopaedic surgeons evaluated the clinical findings and the MRI scans and classified the patients as surgical candidates based on recommendations from the American Academy of Orthopaedic Surgeons for intervention for disc herniation published in 1993 (21). The patients included in the present study also fulfilled the recommendations as presented by Bono and co-workers in 2006 (38). The patients can therefore be regarded as serving as their own controls, and comparisons can be made with baseline symptoms and with patients from other studies. An RCT would have been the best way to explore different treatment options; however, we did not reach the number of patients required for an RCT. As the treatment model used in the present study has not been evaluated previously in a group of patients with long-standing pain, with the majority of the patients having pain for more than 3 months due to disc herniation, and, as the results are clinically interesting, it was decided to present the results as a cohort study.

 

In conclusion, this study shows that patients eligible for lumbar disc surgery improved significantly after treatment with the structured physiotherapy model, as early as 3 months after treatment, and the results could still be seen at the 24-month follow-up. Consequently, these patients did not qualify for lumbar disc surgery 3 months after the physiotherapy treatment started. Moreover, the majority of patients had symptoms for more than 3 months at the start of treatment and, for this reason, most of the spontaneous healing ought to have occurred before this study started. This study therefore recommends adoption of the structured physiotherapy treatment model before considering surgery when patients report symptoms such as pain and disability due to lumbar disc herniation.

 

Acknowledgements

 

The authors would like to thank physiotherapists Patrik Drevander, Christina Grund�n, Sofia Frid�n and Eva Fahlgren for treating the patients and Valter Sundh for statistical support. This study was supported by grants from the Health & Medical Care Committee of the V�stra G�taland Region, Ren�e Eander�s Foundation and Wilhelm & Martina Lundgren�s Foundation of Science.

 

Herniated discs can cause pain, numbness and weakness, a variety of symptoms which may often become so severe, that surgery might seem like the only option for fast relief. However, a�structured physiotherapy treatment model can provide rapid relief to patients who qualify for lumbar disc surgery, according to the results of the research study. 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: Neck Pain

 

Neck pain is a common complaint which can result due to a variety of injuries and/or conditions. According to statistics, automobile accident injuries and whiplash injuries are some of the most prevalent causes for neck pain among the general population. During an auto accident, the sudden impact from the incident can cause the head and neck to jolt abruptly back-and-forth in any direction, damaging the complex structures surrounding the cervical spine. Trauma to the tendons and ligaments, as well as that of other tissues in the neck, can cause neck pain and radiating symptoms throughout the human body.

 

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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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Close Accordion
Vertebrogenic Autonomic Dysfunction Subjective Symptoms: A Prospective Study

Vertebrogenic Autonomic Dysfunction Subjective Symptoms: A Prospective Study

The autonomic concomitants of cervical pathomechanics?(the posterior cervical sympathetic syndrome) have been?widely reported. The literature documenting the autonomic? manifestations of thoracic and lumbar articular dysfunctions? has not been as extensive. The present study? attempts to determine the incidence and nosography of ?vertebrogenic autonomic dysfunction (V.A.D.) in a sample?of 250 consecutive back pain subjects. Thirty-nine per cent?of all back pain subjects exhibited probable evidence of ?V.A.D. The incidence of V.A.D. was distributed as follows:?cervicogenic cephalalgia – 60%76 (i.e., disturbed?vision, dysequilibrium, gastrointestinal upset); thoracalgia?- 54% (ie., nausea, flatus); and lumbalgia – 31% (i e.,?constipation, urinary frequency, menstrual disturbances).

It is a well known clinical fact that diseases of the internal? organs may produce functional changes and symptoms ?or signs in the musculoskeletal system of the body. These ?somatic manifestations of visceral disease are fairly commonplace ?and are considered to be of importance in the?diagnosis and localization of internal disease. All clinicians ?have observed the conspicuous costovertebral angle muscle?spasm resulting from acute renal disorders (1). Abdominal?wall tension and tenderness are characteristic of certain?intra-abdominal and intrapelvic diseases (2-7). Coronary? disease is frequently accompanied by painful trigger areas?in the muscles of the chest and shoulder (8-9).?The premise that disorders of the musculoskeletal?system may reflexly cause autonomic dysfunction and?symptoms attributable to visceral malfunction is common?to both the chiropractic (10) and osteopathic schools (11),?but is not widely accepted by the medical profession. Physiologic ?research, based primarily on animal experimentation,?has demonstrated that somatovisceral reflex activity?is indeed a physiologic fact (12-19); however, much remains?to be done to understand the importance of these?reflexes in normal and abnormal human physiology. The ?literature of the osteopathic and chiropractic disciplines?has historically contained an abundance of anecdotal and?conceptual data in support of the somatovisceral reflex?hypothesis as a mechanism for symptom production in?man. Very little controlled clinical data has been presented?to support this hypothesis.

Palmer in 1895 (20) was probably one of the first to?report a simple cause and effect relationship regarding? somatovisceral symptom production in a patient. His subject?had apparently been working in a cramped position?and felt something “give in his back.” He claimed that he?simultaneously became deaf. Palmer examined the?patient’s spine and found a “displaced fourth dorsal vertebra”?(sympathetic vasomotor nerves to the cranium) and?corrected it with a manipulation. The patient’s hearing?was restored. Palmer thus deduced that the hearing loss?had been vertebrogenic in origin.

Three decades later, the allopathic observers, Barre in?1925 and Lieou in 1928, reported similar series of cases in?which disorders of the cervical spine were accompanied by?dysfunction of the organs of the head (21,22). In addition?to hearing loss, the following cervicogenic symptoms have?been observed: vertigo, dysequilibrium, tinnitus, scotomata,?decreased vision, dysphagia, dysphonia, cough, anxiety?and asthenia. (23)

The Barr6-Lieou syndrome (posterior cervical sympathetic ?syndrome) has been repeatedly recorded in the literature?since 1928. This syndrome represents a generally?accepted classic example of somatovisceral reflex?pathology and is to be found in much of the authoritative?orthopaedic literature of today (24).

Reports of somatically-induced visceral dysfunction have? not been confined to the cervical region, nor have they?been restricted to the literature of the chiropractic and?osteopathic schools. This is noteworthy, insofar as allopathic?training does not usually emphasize (or even include)?studies of somatovisceral reflex physiology. One?would therefore expect that allopathic observers would?approach their clinical observations with an absence of?bias and a low index of suspicion for somatovisceral?pathology. Nevertheless, such disorders have been obvious?enough to be noted and reported. Table 1 summarizes allopathic?observations in this regard as reported by Wills?(25), Ussher (26), Travell (27,28,29), Jackson (24), Cooper?(30), Lewit (31), Ushio et al (32), Love (33) and Ver Brugghen?(34).

The literature cited here would tend to indicate that ?somatically induced visceral dysfunction and symptom?production is indeed a clinical problem. The prevalence of?the problem is not known. The investigators reviewed in ?Table 1 have for the most part, not attempted to discover?the percentile incidence of autonomic symptoms in musculoskeletal?disease, nor have they made it clear whether?their data was based on consecutive groups of first-contact?patients or on treatment-resistant subjects who were referred?to their departments for special care.

vertebrogenic El Paso, TX

The purpose of this investigation was to determine the frequency of symptoms attributable to vertebrogenic autonomic dysfunction in a consecutive group of first-contact chiropractic patients.

Method

A pilot study, of the prospective-descriptive format, was designed. The focus of the study was on the anamnesis, with particular attention given to the sequence of clinical events. (For example, do patients with back pain simultaneously develop autonomic symptoms? If so, how often? 52 Do the autonomic symptoms disappear upon recovery from the spinal pain?) The emphasis then, was on seeking a parallelism between the development and disappearance of back pain with the development and disappearance of visceral symptoms.

Inclusion/Exclusion and Data Gathering:

The following guidelines for data gathering were adhered to throughout the study:

1. Two hundred and fifty consecutive first-contact patients who presented with back pain (cervical, thoracic or lumbar) comprised the sample for analysis.

2. After a thorough case-history was obtained from each subject, careful notation was made of associated symptoms. The phrasing of this latter aspect of the interview was as follows: “Have you, since the onset of your back pain, developed any other seemingly unrelated symptoms for example, have you felt generally ill? Have you been constipated? Have you had to empty your bladder more frequently – or less frequently?” Usually, four or five examples of known vertebrogenic symptoms were mentioned. See Table 1. A systems review followed. As additional symptoms were uncovered, it was determined whether or not their onset in any way paralleled the onset of back pain.

3. The patient was not given a r6sume prior to the beginning of treatment for his back pain. No further comment was made regarding the subject’s visceral symptoms, if present. No mention was made of any relationship between the spinal pain and the visceral symptoms. A chart of the autonomic nervous system was removed from the office. The patient was not told that analytical data was being gathered. The attempt here was to limit, as much as possible, the introduction of accentuated placebogenic and/or Hawthorne effects (35) into the study.

4. The subjects who were accepted as chiropractic patients were treated with spinal manipulative therapy (primarily chiropractic high velocity, controlled amplitude adjustment). In some cases, ancillary physical therapeutic methods were utilized as indicated. Patients who were referred to other health disciplines for care (i.e. surgery) remained in the study providing that follow-up data were available. (This study was not designed to test the effectiveness of manipulative therapy its sole purpose was to investigate spinovisceral symptom parallelism see illustrative case 4.)

5. The subjects were re-evaluated when they became asymptomatic with respect to their back pain or were much improved (at least 80%o by mutual patient-examiner agreement). The patients were at this time questioned regarding the status of any associated visceral symptoms that had been previously reported. The observation that recovery from visceral symptoms paralleled recovery from the spinal pain was taken to be confirmatory evidence of vertebrogenic autonomic dysfunction in that subject.

Subjects were excluded from the study for the following reasons: non-acceptance as a patient because of organic pathology or other contraindications, non-compliance, self-discharge from care, unsatisfactory recovery from the spinal complaint and incomplete admission or follow-up records. When a patient was dropped from the study, the next consecutive patient history was admitted to the data pool so that the target number of 250 subjects could be met.

A survey of drug usage by patients in this study revealed the following: 52% of patients did not use drugs at all; 32% has self-administered approximately 1 to 6 non-prescription analgesic tablets (i.e. aspirin, codeine) and had subsequently sought professional care; 16% were on regular therapeutic dosages of physician prescribed or self-administered pharmaceuticals either for spinal pain or for other unrelated conditions. Most of the subjects who had used pharmaceuticals remained in the study. They were included or excluded after careful analysis of the individual data (see data analysis guidelines).

Vertebrogenic Data Analysis:

The presence or absence of vertebrogenic autonomic dysfunction (V.A.D.) was determined from the admission and follow-up records on each subject. The likelihood of vertebrogenicity was determined on the strength of the gathered data. The information on each case was then categorized as yielding probable, possible or negative evidence of vertebrogenic autonomic dysfunction. The guidelines for categorization were as follows:

1. Probable: Patients who exhibited an unequivocal parallelism between the onset and abatement of back pain with the onset and abatement of visceral symptoms were considered to have evidence of probable vertebrogenic autonomic dysfunction.

2. Possible: If there was any doubt regarding the accuracy of the gathered data (e.g. inconsistency of the subject’s responses to questions) the findings were categorized as “possible V.A.D.” If any discrepancies were noted in spinovisceral symptom parallelism, the data was considered to yield evidence of possible vertebrogenic autonomic dysfunction. For example, patients who fully recovered from spinal pains, but were left with vestiges of autonomic symptoms or patients who recovered from autonomic symptoms but were left with some spinal pain, were placed in the V.A.D. possible category.

3. Negative: Subjects who developed back pain but did not experience any symptoms attributable to autonomic dysfunction were classified as “V.A.D. negative”.

As stated in the previous section, data from patients who had used pharmaceuticals were individually scrutinized for inclusion or exclusion, and categorization. This analytical process would best be illustrated by the following examples:

Case 1: This patient developed acute lumbalgia. He self-administered four 222 tablets� (total 32 mgs. codeine) on day 1 and presented here the next morning. He reported constipation as an associated symptom. The constipation resolved on day 3 although the lumbalgia continued. He remained in the study and was classified as “negative V.A.D.”

Case 2: This patient developed cervicalgia and self-administered 6 aspirin over day 1. She presented on day 2 and reported dizziness, gastric upset and flatus as associated symptoms. She discontinued her aspirin, but the autonomic symptoms persisted throughout the course of her treatment. All spinal and associated symptoms abated during the 3rd week. She remained in the study and was classified as “possible V.A.D.”

Case 3: This patient developed a severe cervical-brachial neuralgia. Her family physician prescribed Tylenol� and diazepam. She presented on day 10. She reported anorexia, nausea, flatus, blurred vision, dizziness and mental fogging as associated symptoms. On day 24 her cervicalgia and all associated symptoms had cleared, yet she remained on the prescribed medication. She was classified as “probable V.A.D.”

Results

Of the original 250 subjects who met the criteria for admission to the study, 22 were subsequently lost (20 with self-discharges and/or poor results, 2 with organic disease found on continuing examination) and replaced by next consecutive patients. Ninety-eight (39%) of all subjects exhibited “probable” and thirty-three (13%) exhibited “possible” autonomic dysfunction. Also noteworthy was the observation that four (2%) of the subjects experienced reactivation (relapse) of previously quiescent visceral disease during their back pain episodes (2 duodenal ulcers, 2 lower genitourinary infections).

The levels of spinal complaint fell into the following four categories:

1. cervicalgia with cephalalgia,

2. cervicalgia (with or without upper extremity pain),

3. thoracalgia, and

4. lumbalgia (with or without lower extremity pain).

The frequency of autonomic dysfunction for each category is given in Table 2. The frequency distributions of the various autonomic manifestations observed are given in Tables 3 – 6.

While Tables 3 – 6 give the frequency of symptoms observed in the present study, they do not give an accurate picture of vertebrogenic autonomic dysfunction as actually seen in clinical practice. Many of the subjects had multiple autonomic symptoms and these symptom complexes are not accurately portrayed by tables. The following case studies are instructive:

vertebrogenic El Paso, TXvertebrogenic El Paso, TX

Case 4: Mrs. F. presented with neck pain and headaches. She had sustained a whiplash injury 2 years previously and her symptoms had cleared with chiropractic therapy. Her present symptoms had recurred 2 months prior to her consultation here. She complained of a constant, moderate to severe upper cervical ache which radiated into the occipital-frontal regions. The cephalalgia occurred daily and intensified in the mid afternoon. She reported associated dizziness and difficulty in focusing her eyes. She could not clearly focus on close objects and stated that while driving, the windshield seemed to move back and forth in relation to her eyes. She was constantly squinting in an effort to see clearly. She had been seen by an optometrist 3 weeks previously with negative findings. On examination, cervical extension, right side-bending and left rotation were painful and limited. There was palpable paravertebral muscle spasm and restriction of motion in the upper cervical articulations. Trigger points were found here which reproduced the cephalalgia.

Cervicogenic autonomic dysfunction was objectivated with the following manoeuvres:

1. Triggers: Firm pressure over the right lamina of C2 precipitated an immediate bout of blurred vision and diplopia.

2. Resisted Motion: Resisted cervical extension (with the head fixed so as to exclude vestibular motion) resulted in an episode of “swooning” and vertigo.

3. Cervical Torsion: The patient’s head was fixed by an assistant (so as to exclude vestibular motion) and the torso was rotated, flexed, extended, side-bent and circumducted under the immobilized cranium. These maneuvers precipitated vertigo.

Cervicogenic autonomic dysfunction was further confirmed by the therapeutic test. The patient was treated with the manual adjustment of the upper cervical spine. The results were as follows:

1. The initial manipulation caused a transitory aggravation of the dizziness and the visual symptoms.

2.�This was quickly relieved by manual traction.

3.�The patient was fully recovered from all articular (pain) and non-articular (autonomic) symptoms by the tenth office visit. She remained asymptomatic over a 4 month follow-up period.

Case 5: Mrs. J. presented with low cervical, right scapular and right mid-thoracic pain of several months duration. There was associated dizziness, staggering and blurred vision. She had been referred to an ENT specialist who was non-commital in regards to a diagnosis. On examination, a trigger point was located on the antero-lateral aspect of C6-7 which reproduced her pain. The cervical torsion test was strongly positive the patient requiring support because of the precipitated vertigo. The lower cervical segments were adjusted and all symptoms abated after 5 visits. The patient has had several relapses over the ensuing months. Dysequilibrium has been a constant concomitant of each attack.

Case 6: Mr. R. Complained of a constant, dull mid-thoracic ache of 3 weeks duration. The symptoms had occurred after the patient spent several days working in the stooped forward position. The patient also complained of nausea and a feeling of a “lump” in the epigastric region. He stated that his food remained in his stomach for several hours after ingestion. He regurgitated frequently and was troubled with belching and flatus. He occasionally had crampy abdominal pains. On examination, the spinous processes and right costotransverse articulations of T4 to T7 were exquisitely tender. There was rhomboid. spasm on the right and mid-thoracic motion was�restricted. A single adjustment to this level was followed by immediate pain relief together with several minutes of massive gaseous eructation. All other symptoms cleared over the next few hours and did not recur over a 3 month follow-up period.

vertebrogenic El Paso, TXvertebrogenic El Paso, TXvertebrogenic El Paso, TXCase 7: Mr. V. presented with acute lumbo-sciatica of one week’s duration. The pain had occurred after a straight-legged lift. Mr. V. reported that since the occurrence of his injury he had been troubled with alternating bouts of constipation and diarrhea, urinary frequency, nocturia, partial urinary retention, impotence and “retraction” of the testes. He exhibited sciatic kyphoscoliosis. All trunk movements were limited and painful. Straight-leg raising, foot dorsiflexion and Valsalva maneuvers were positive. Deep springing of the L4 vertebra aggravated his pain. Sphincter tone was normal. A trial of manipulation afforded only temporary (hours-days) relief. The left Achilles reflex became sluggish and the patient was referred for neurosurgery. An L4 discotomy resulted in complete recovery from all spinal and visceral symptoms.

Case 8: Mrs. R. presented with an acute lumbalgia which referred to the left groin. The pain had occurred 4 days previously and since that time she had been troubled with constipation, flatus, urinary frequency and a burning dysuria. Her urinalysis was negative for abnormality. Lower lumbar and left sacroiliac dysfunctions were corrected with manipulation. All symptoms had cleared by the fourth office visit.

At the time of discharge from care, Mrs. R. asked if her bowel and bladder symptoms could have anything to do with the lower back. She stated that every time she had a lower back episode she developed the same pelvic symptoms. She, had had several unremarkable bowel, gall bladder and urinary investigations in regards to these symptoms.

Discussion:�Vertebrogenic Autonomic Dysfunction

The exact mechanism of spinovisceral symptom production is not conclusively known. Several pathophysiologic hypotheses could be advanced to explain these clinical phenomena. It is also possible that different pathological processes are operant in different individuals. Postulated mechanisms of spinovisceral symptom production are summarized below:

Pain: The autonomic concomitants of severe pain are well known. They are due to mass sympathetic stimulation and include such symptoms as agitation, hyperhidrosis, pupillary dilation and vomiting.

Stress-Endocrine: Selye (36) has pointed out that many disease states are accompanied by two groups of symptoms – the symptoms produced by the stressor and another group of symptoms resulting from the body’s endocrinal defense responses to the stressor. Using the eosinophil count as a stress indicator, I presented evidence which would suggest that 54% of severe lumbalgic episodes are accompanied by an alarm-endocrine reaction (37). It is possible that some of the symptoms observed in this study have an endocrine-chemical basis.

Somato-Psycho-Visceral Reflexes: It is well known that certain patients look at their pains through a psychological magnifying glass and develop all manner of unrelated symptoms. Psychogenic symptom production, no doubt, introduces an artifact into this study. It is, however, very interesting to note that most of the symptoms observed here, bear a segmental relationship to the level of spinal lesion (only one patient in this series had any knowledge of the anatomy of the autonomic nervous system). These segmental spino-psycho-visceral relationships may be explained by osteopathic research. In a brilliant experiment, Korr et al have shown that when the psyche is stimulated, maximum sympathetic outflow occurs at hyperirritable cord levels which have been previously sensitized (facilitated) by proprioceptive input from preexisting spinal joint lesions (38).

Somato-Visceral Reflexes: Somato-autonomic reflexes in the laboratory animal are a physiologic fact. They are observed under certain conditions in man. The postulated modus operandi in spinal lesions is as follows: the lesioned spinal joints trigger an increased afferent input (pain, proprioception) into the related cord segments. The lateral horn cells are facilitated via the internuncial neurons and impulses spill over into the sympathetic efferents causing activation (motor, vasomotor, secretory) of the target 56 viscera. Such sustained pathophysiologic activity could well be responsible for spinovisceral symptoms observed in back pain subjects.

Nerve Compression: It is well known that discal lesions, vertebral exostoses and stenosis may compress nervous tissue and cause autonomic dysfunction or paresis. It is also possible that root compression may interfere with axoplasmic flow. If, for the purpose of survey, one considers paresthesia/anesthesia to be indicative of nerve-tissue compromise, then 30% of first-contact patients presenting at this office have nerve compression syndromes. This could be responsible for autonomic dysfunction in selected patients.

Vascular Compromise: Cervical degenerative lesions may compromise the vertebral arteries and cause cranial symptoms. This mechanism could have been operative in aged patients; however, the slowly progressive cerebral dysfunction (39), which allegedly occurs with sustained neck torsion in this condition, was not observed in any of the subjects.

Proprioceptive Cross-Talk: It is possible that unequal cervical muscle tensions might feed the central nervous system with confusing proprioceptive information so as to disturb normal righting reflexes. This mechanism could explain the high incidence of dysequilibrium in subjects with neck injuries.

Other: The constipation observed in severe lumbalgic patients may be antalgic or due to lack of exercise.

The spinovisceral syndromes described here are typical of the symptom complexes observed in the everyday clinical practices of all manipulative practitioners. Further studies, to more precisely explore these common clinical problems, are warranted. The present study represents a first-attempt prospective investigation and the presented statistics may be considered to be “ball-park” figures only. A much larger subject population is required. Analysis of the gathered data in a preliminary study such as this, almost invariably exposes deficiencies in the original prospective design which could be corrected to improve future investigations (40). The following recommendations should be considered:

Investigator Artifact: Solo investigators who study their own patient populations may be subject to impaired objectivity. Future studies should utilize a multi-disciplinary team of investigators to design and carry out the project.

Data Artifacts: All data gathering methods (verbal interviews and questionnaires) are subject to error (40,41). The interview method was used in the present study. Future studies should include both verbal interviews and written questionnaires to facilitate cross-checking of the accuracy of the gathered data.

Psychologic Artifacts: Clinical studies are frequently criticized for failing to establish psychological base-lines for the studied subjects. Written questionnaires could incorporate standard psychological testing proforma.

Pharmacologic Artifacts: Investigator judgement (bias) was used in categorizing data on drug users. Future studies should exclude these subjects, or at least analyze their data in a separate category.

Statistical Artifacts: A much larger study population is required in order to establish accurate prevalence rates for vertebrogenic autonomic dysfunction. Formal statistical analysis is also required.

Follow-Up: The foregoing study was designed to be an acute investigation of a common clinical syndrome. It asked simple, straight-forward questions regarding the sequence of events during back pain episodes. While many of the subjects were followed for months, and even years, it is debatable if long term follow-up would bring forth any additional answers to the questions asked. It is important to note, however, that historical chiropractic and osteopathic theory, in common with the psychosomatic school, hypothesizes that long standing functional disorders may eventually lead to organic pathology. Follow-up of patients with recurrent spinal lesions, over many years, might constitute one way of testing this hypothesis.

Conclusions:�Vertebrogenic Autonomic Dysfunction

The autonomic manifestations of back pain have been explored. This preliminary study indicates that 39%o of all back pain subjects have symptoms attributable to irritation of the- autonomic nervous system by spinal lesions. Further studies, which incorporate more rigid protocol, are required to accurately describe the nosographic features of these common clinical syndromes.

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41. Koran L. The reliability of clinical- methods, data and judgments.
New Engl J Med 1975; 293: 642-646.

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Amazing Results from Herniated Disc Early Treatment | El Paso, TX

Amazing Results from Herniated Disc Early Treatment | El Paso, TX

A herniated disc is typically a very painful condition, especially if the inner gel-like substance of the intervertebral disc, known as the nucleus pulposus, pushes through the thick, outer ring of cartilage and puts pressure on the sensitive nerves of the spine. Discs are soft, rubbery pads found between each vertebrae of the spine that act as shock-absorbers, allowing the spine to bend and/or flex. An intervertebral disc may begin to rupture as a result of wear-and-tear or due to a sudden injury. Fortunately, most individuals who’ve suffered a herniated disc can find relief from a variety of non-operative treatments before considering surgery. The following article highlights the impact of early treatment for herniated discs in the lumbar spine, or low back.

 

The Impact of Early Recovery on Long-Term Outcomes in a Cohort of Patients Undergoing Prolonged Non-Operative Treatment for Lumbar Disc Herniation: Clinical Article

 

Abstract

 

Object

 

The authors comprehensively studied the recovery of individual patients undergoing treatment for lumbar disc herniation. The primary goal was to gain insight into the variability of individual patient utility scores within a treatment cohort. The secondary goal was to determine how the rates and variability of patient recovery over time, represented by improvement in utility scores, affected long-term patient outcomes.

 

Methods

 

EuroQol Group�5 Dimension (EQ-5D) scores were obtained at baseline and at 2, 4, 8, 12, 26, 38, and 52 weeks for 93 patients treated under a prolonged conservative care protocol for lumbar disc herniation. Gaussian kernel densities were used to estimate the distribution of utility scores at each time point. Logistic regression and multistate Markov models were used to characterize individual patient improvement over time. Fisher exact tests were used to compare the distribution of EQ-5D domain scores.

 

Results

 

The distribution of utility scores was bimodal at 1 year and effectively sorted patients into a �higher� utility group (EQ-5D = 1; 43% of cohort) and a �lower� utility group (EQ-5D ? 0.86; 57% of cohort). Fisher exact tests revealed that pain/discomfort, mobility, and usual activities significantly differed between the 2 utility groups (p ? 0.001). The utility groups emerged at 8 weeks and were stable for the remainder of the treatment period. Using utility scores from 8 weeks, regression models predicted 1-year outcomes with 62% accuracy.

 

Conclusions

 

This study is the first to comprehensively consider the utility recovery of individual patients within a treatment cohort for lumbar disc herniation. The results suggest that most utility is recovered during the early treatment period. Moreover, the findings suggest that initial improvement is critical to a patient’s long-term outcome: patients who do not experience significant initial recovery appear unlikely to do so at a later time under the same treatment protocol.

 

Abbreviations used in this paper: AUC = area under a receiver-operating curve; EQ-5D = EuroQol Group�5 Dimension. Address correspondence to: Matthew C. Cowperthwaite, Ph.D., The University of Texas at Austin, Texas Advanced Computing Center, J.J. Pickle Research Campus, ROC 1.101, 10100 Burnet Rd., Austin, TX 78758. email: mattccowp@mac.com.

 

Plublished online June 28, 2013; DOI: 10.3171/2013.5.SPINE12992.

 

Introduction

 

Lumbar disc herniation is one of the most common causes of low-back pain and radiculopathy.[4] Treatment for patients with a herniated lumbar disc usually begins with conservative care such as analgesics, epidural steroid injections, and physical therapy,[1,5] with surgery reserved for patients with severe nerve root or cauda equina dysfunction or if conservative therapy is unsuccessful in controlling the symptoms.

 

Several recent studies have compared the effectiveness of conservative care and surgical treatment protocols for treating herniated lumbar discs, and have arrived at varying conclusions.[2,3,9,10,15�18] However, these studies have generally considered outcomes over a period of years, which is a significant length of time for patients who are waiting for their quality of life to improve. In clinical practice, this often leads to the following dilemma: most patients, particularly those with moderate symptoms, would prefer to avoid surgery, but are unwilling to wait an indefinite period of time for their symptoms to resolve. Unsurprisingly, lumbar discectomy is the most frequently performed surgical procedure in the US.[17,18]

 

Moreover, the above-mentioned studies have typically compared the average difference between treatment groups, without regard for individual recovery within the cohort. Additionally, this approach assumes that recovery in the protocols being compared proceeded similarly between observation intervals. To better understand the treatment responses of individual patients and the time frames of their responses, we comprehensively analyzed a cohort of patients undergoing a prolonged conservative care treatment protocol to gain insight into the dynamics of individual patient recovery over time, and whether these recovery dynamics influence long-term outcomes.

 

Methods

 

Study Data Set

 

The data set contained 142 patients randomized to a protocol of prolonged conservative care as part of the Leiden�The Hague Spine Intervention Prognostic Study.[10,15] The Sciatica Trial was reviewed and approved by the Medical Ethics Committee of Leiden University Medical Center.[11] Patients were enrolled into the Sciatica Trial entirely in the Netherlands.

 

In the Sciatica Trial, all patients aged 18 to 65 years, with persistent radicular pain in the L-4, L-5, or S-1 dermatome (with or without mild neurological deficit), severe disabling leg pain (lumbosacral radicular syndrome) lasting 6�12 weeks, and radiologically (MRI) confirmed disc herniation were considered eligible to enroll in the trial. Cauda equina syndrome or severe paresis, prior complaints of lumbosacral radicular syndrome in the previous 12 months, history of same-level unilateral disc surgery, spinal canal stenosis, and degenerative or lytic spondylolisthesis were all exclusion criteria. Cohort demographics and baseline characteristics were previously described; all patients reported both back and leg pain, but leg pain was generally more severe (mean leg pain 67.2 � 27.7 vs back pain 33.8 � 29.6, measured on a 100-point, horizontal visual analog scale).[15]

 

The Sciatica Trial used a pragmatic study design: conservative-care management was influenced as little as possible and was supervised by each patient’s general practitioner. Use of analgesics and physical therapy was determined by the treating physician. In this cohort, 46 patients (32%) elected to have surgery before the end of the 1st year; the mean timing of surgery was 12.6 weeks after the start of treatment. The surgical patients and 3 additional subjects with more than 2 missing utility measures were removed from the sample, resulting in a cohort of 93 patients considered in the present study; the crossover patients will be discussed in a separate study (manuscript in preparation). Our results were qualitatively unchanged when the excluded patients were retained in the analyses (data not shown).

 

In the Leiden�The Hague Spine Intervention Prognostic Study the EQ-5D instrument was used to measure patient utility at baseline and at 2, 4, 8, 12, 26, 38, and 52 weeks after enrollment into the study. The average duration of sciatica prior to enrollment was 9.5 weeks.[10,15] Utility is a valuation of a patient’s quality of life on a scale between 0 (as bad as dead) and 1 (perfect health). To estimate utility, the EQ-5D assesses a patient’s functional impairment in 5 domains: mobility, self-care, usual activities, pain, and anxiety.[6] For each domain, patients self-report the scores of 1 (no problems), 2 (some problems), or 3 (extreme problems). Utility scores were computed using the US valuation model,[12] which clearly distinguishes patients reporting no health problems (EQ-5D = 1) from those reporting at least some health problems (EQ-5D ? 0.86). Our results are independent of the particular valuation model (not shown). Completeness of the EQ-5D measures during follow-up ranged from 98% at 2 weeks to 90% at 38 weeks.

 

Statistical Analysis

 

All statistical analyses were conducted using the R statistical environment (version 2.9.2; www.rproject.org/) with the additional �msm,�[8] �ROCR,�[14] and �rms�[7] packages (all freely available from cran.rproject.org). Continuous variables are presented as means (� SEM) and were compared using 2-tailed Student t-tests. Significance was assessed at an ? ? 0.05 significance level, unless otherwise indicated. Missing EQ-5D measures were imputed using the mean of the measures at adjacent time points; our results are qualitatively similar under forward or backward imputation schemes (not shown).

 

Gaussian kernel density estimates were computed to estimate the distribution of utility scores. The kernel density estimates were estimated using a Silverman’s �rule-of-thumb� bandwidth and a Gaussian smoothing kernel.[13] The left- and right-most points were set to the theoretical minimum and maximum EQ-5D values, respectively, so that the area under the density curve summed to 1.

 

To determine whether specific EQ-5D domains differed between utility groups, Fisher-exact tests were conducted on contingency tables of the number of patients in each utility group that reported scores of 1, 2, or 3. Significance was assessed using a Bonferroni-corrected p value of 0.01.

 

Two-state, continuous-time Markov models were used to study the patterns and probabilities of patients transitioning between a �lower� utility (EQ-5D ? 0.86) and a �higher� utility group (EQ-5D = 1). The threshold utility value defining the groups remained fixed over time and was used to assign each patient to a utility group at each observation time. The models were fitted using the �msm� package[14] with piecewise-constant transition intensity matrices (Qt) estimated for each time interval between the points t = 0, 4, 8, 12, 26, 38, 52 (t = 2 was omitted because there were insufficient transitions to yield a robust model). Transition intensities were permitted to change between subsequent observation intervals, but remained homogeneous within each observation interval. The starting transition intensities were based on the observed frequencies of transitions in the data set and were calculated using the formula

 

Article-Formula.jpg

 

in which nij is the observed number of transitions from Group i to Group j over the duration of the study period (T), and nj is the initial number of patients in Group j. The fitted models were robust to the choice of starting transition intensities and yielded qualitatively similar parameter estimates over a range of starting parameters (not shown). The likelihood function was maximized using a Nelder-Mead algorithm, and convergence was visually verified and typically occurred well short of the maximum number of iterations.

 

Logistic regression models were used to test whether utility measurements from earlier time points could predict long-term outcomes. These models only included utility values up to a particular time point as predictors, with the response variable being the patient’s 1-year outcome (higher or lower utility group) modeled as a dichotomous variable; no additional clinical or demographic covariates were included in the models. The models were fitted using the �rms� package[7] and the fit was assessed using chi-square tests (? ? 0.05). Separate regression models were created for all utility measurements up to and including those for 2, 4, 8, 12, and 26 weeks; for example, the 8-week model would include utility measurements at 0, 2, 4, and 8 weeks. The AUC statistic was used to assess the performance of the models and was calculated using the ROCR package.[14]

 

Results

 

Delineation of Higher and Lower Utility Groups

 

The distributions of patient utility scores markedly changed over the course of 1 year of conservative care (Fig. 1). At baseline, the majority of patients reported a relatively poor quality of life; the mean EQ-5D score was 0.55 (median 0.60). Two distinct utility groups were found to be present at baseline: a �lower� utility group (EQ-5D ? 0.86) and a �higher� utility group (EQ-5D = 1). At 6 months, the lower utility group (n = 62, 67%) was larger than the higher utility group (n = 31, 33%); at 1 year, the lower utility group (n = 53, 57%) had declined, but remained larger than the higher utility group (n = 40, 43%).

 

Figure 1 Distribution of EQ-5D Patient Utilities | El Paso, TX Chiropractor

Figure 1: Distribution of EQ-5D patient utilities at baseline, 6 months, and 1 year. The solid lines depict Gaussian kernel density estimates (right axis) of each distribution. The gray lines outline the histogram with the height of each bar representing the frequency of patients (left axis) in the equal-width bins (0.05) with utility greater than the lower bound and less than or equal to the upper bound. The bounds of both distributions are set to the theoretical minimum and maximum of the EQ-5D utility instrument.

 

EQ-5D Domain Scores Between Groups

 

The average scores in each domain of the EQ-5D (Table 1) suggested that the pain/discomfort (low score = 1.9, high score = 1.0), mobility (low score = 1.4, high score = 1.0), and usual activities (low score = 1.5, high score = 1.0) domains differed most significantly between the high and low utility groups (p ? 0.001). The anxiety (low score = 1.2, high score = 1.0) and self-care (low score = 1.1, high score = 1.0) domains differed much less between the 2 utility groups, although they were also significant (p < 0.01).

 

Table 1 Distribution of Scores in Each EQ-5D Domain | El Paso, TX Chiropractor

 

Trajectory of Patient Utility Over Time

 

The series of patient utility scores measured over the study period are referred to as utility �trajectories,� which were studied to understand how patients recovered over the study period. In the study cohort, all patients experienced improvement during at least 1 observation period; only 19.3% (n = 18) never experienced a decline during their recovery. Recovery was variable: 49.5% of the patients (n = 46) experienced at least 2 reversals, which were defined as improvements (declines) immediately followed by declines (improvements) at the next observation. Furthermore, only 29% of patients (n = 27) had stable trajectories with no reversals. Overall, increases in utility were 4 times more common than decreases in utility.

 

The utility of the entire cohort increased by 0.296 (51.8% above baseline; p ? 0.001, Wilcoxon Mann-Whitney test) over the year (Fig. 2), but was markedly faster during the first 2 months (0.022/week) than the final 3 months (0.005/week). Over the same time frames, utility scores improved by 0.178 (35.2% above the baseline average) over the first 2 months and by 0.063 (1.3% above the 9-month average) during the final 3 months. The mean utility scores significantly differed between the 2 final utility groups at 8 weeks and remained significant for the rest of the year (p < 0.01, Student t-test; Fig. 2).

 

Figure 2 Graph of Mean Patient Utilities | El Paso, TX Chiropractor

Figure 2: Graph of mean patient utilities at each measurement time point. Error bars represent 95% CIs about the mean. High and low utility group refers to the final group in which the patient belongs at the 1-year time point.

 

Modeling Patient Recovery

 

Given that 2 utility groups were present over the study period, Markov models were used to study the robustness of these groups by estimating the likelihood of patients switching between the groups. The models suggested that the average probability of a patient remaining within their utility group was 97.9% and 97.6% for patients currently in the low and high utility groups, respectively (Fig. 3). The probability of a patient transitioning from the low to the high utility group was 2.1%; the corresponding probability for transitions from the high to the low utility group was 2.3%.

 

Figure 3 Graphs of the Markov Transition Probabilities | El Paso, TX Chiropractor

Figure 3: Graphs of the Markov transition probabilities (per week) for transitions within (lower) and between (upper) utility groups. Each point is centered at the middle of each time interval and represents the maximum-likelihood estimate of the per-week transition probability during the entire interval. Error bars (mean width of the 95% CI was 1.8) were omitted for clarity because the differences were not significant.

 

The models also suggested that the likelihood of a patient transitioning to another utility group declined over the study period. During the first 8 weeks, 2.8% and 3.5% of patients experienced low-to-high and high-to-low transitions, respectively; over the last 3 months, 1.6% and 1.3% of patients experienced low-to-high and high-to-low group transitions, respectively.

 

Predicting Individual Patient Outcome

 

At 8 weeks, logistic regression models could predict a patient’s outcome (final utility group) with modest accuracy (AUC = 0.62, or 62%). The accuracy of the models steadily increased as data from later time points were included; the 26-week model performance was good with an AUC of 0.78 (Fig. 4). The amount of improvement in utility scores from baseline to 8 weeks was also investigated as a predictor of good outcome (higher utility group). Patients with EQ-5D scores that improved by at least 0.30 during the first 8 weeks of treatment were 60% more likely to have a good outcome.

 

Figure 4 Graph Showing the Accuracy of Classifiers Based on Patient Utilities | El Paso, TX Chiropractor

Figure 4: Graph showing the accuracy of classifiers based on patient utilities. The horizontal line is drawn at 0.50, above which models would perform better than randomly assigning patients to utility groups.

 

Dr Jimenez White Coat

Dr. Alex Jimenez’s Insight

Herniated disc commonly develop in the lumbar spine, or lower back. Also referred to as a slipped disc or a ruptured disc, a herniated disc occurs when the soft, gel-like center of an intervertebral disc pushes through a tear in its surrounding outer ring, known as the annulus fibrosus. The symptoms of a herniated disc are generally specific to the exact level of the spine where the disc herniation occurs and whether or not the nerve tissue has been irritated by the intervertebral disc material leaking out of the inside of the disc. The most common symptoms of a disc herniation include pain, numbness, weakness and tingling sensations as well as causing radiating symptoms along the upper or lower extremities. Depending on the severity of the symptoms, herniated disc treatment can include, drugs and/or medications, epidural injections, physical therapy, chiropractic, and surgery, among others. According to the following article, early treatment can help promote and manage a faster herniated disc recovery from prolonged non-operative treatment methods.

 

Discussion

 

Several studies have sought to compare the relative effectiveness of surgery and conservative care for treatment of a lumbar disc herniation.[4�9,11] Generally, these studies have compared �average� differences between the study cohorts, while the individual trajectories by which patient utility changes over time have received less attention. To our knowledge, this study provides the first comprehensive statistical analysis of individual patient-level utility data from a large cohort of patients randomized to a prolonged conservative-care treatment protocol for lumbar disc herniation.[9]

 

The decision to proceed with surgery is straightforward in patients with severe, disabling symptoms or neurological deficits. Likewise, the decision to continue conservative care is simple for patients with mild symptoms or those who are content to live with their symptoms indefinitely. However, patients with moderate symptoms often present a greater challenge because most patients would prefer to avoid surgery if possible, but are also not content to wait indefinitely for their pain to resolve. These patients often ask for more than just the overall probability they will improve eventually; they usually want to know when they will recover. Moreover, they are usually interested in whether their current symptoms and progress affect the probability and extent of their future improvement.

 

For patients with moderate symptoms, the following observations from our study may be useful. First, the utility scores for individual patients diverged sharply at 8 weeks and were thereafter easily classified as either those reporting no health problems (higher utility, EQ-5D = 1) or those reporting at least some health problems (lower utility, EQ-5D ? 0.86). Among the lower utility group, the �pain/discomfort,� �mobility,� and �usual activities� domains of the EQ-5D differed most significantly from the higher utility group, which could potentially represent incompletely treated radiculopathy. Second, most improvement occurred early: almost one-third of the overall improvement in utility came in the first 2 months, while only 1% occurred in the last 3 months. Third, recovery is variable, with most patients (80%) experiencing at least 1 interval of deterioration and only 19% continuously improving without any setbacks. This may provide some reassurance to patients with generally good recovery to �stay the course� without resorting to more invasive measures such as surgery simply because of what may be a brief transient decrease in quality of life. Lastly, the probability of moving into another group was quite low (2%), which may be considered when counseling a patient who is not improving with his or her current treatment regimen.

 

We note the following limitations inherent in this cohort study. First, this is an observational study, and therefore we cannot infer causality for the emergence of the 2 utility groups, and because the individual treatment plans were unknown to us, we cannot comment on any specific type of conservative therapy. However, even if one considers the patients in the low utility group as nonresponders to conservative therapy (which is likely at least partly incorrect), the study does not imply that surgery would necessarily be beneficial in these patients. Second, the EQ-5D scores a patient’s overall health, and therefore unknown comorbid conditions likely account for at least some of the patients residing in the lower utility group and for part of the utility fluctuations. However, in the clinical setting, it should be obvious as to whether a patient’s symptoms are resulting from unresolved radiculopathy or from preexisting comorbidities. Lastly, we excluded crossover patients from our analysis. Crossover patients are likely those with the most severe symptoms and thus our results may be limited to patients with mild to moderate symptoms. However, we believe this exclusion is appropriate because, as mentioned above, the decision to operate is fairly straightforward when a patient has severe symptoms. From a clinical standpoint, patients with moderate symptoms and without neurological deficits after 8 weeks need the most information about the potential time course and extent of their nonoperative recovery to make an informed treatment decision.

 

The focus of the present study is individual utility recovery within a patient cohort rather than comparing average response to different treatment protocols. The goal was to gain insight into the dynamics of utility recovery among individual patients treated conservatively, but our approach could be applied to almost any treatment protocol. Studies of the changes (improvements or declines) in individual utility over time are useful because they may provide insights into a patient’s perception of their current treatment protocol (for example, patients in the low utility group would likely report a poor response to treatment), and also to identify a point at which continuing the same treatment is unlikely to improve a patient’s quality of life. Patients entering a conservative-care treatment protocol are likely to experience an initial period of rapid recovery, followed by a longer phase of more modest recovery. Our results suggest that, once the long-term recovery phase begins, patients are unlikely to spontaneously change their recovery for better or worse under the same treatment protocol. Lastly, patient utility scores early in the treatment process were reasonable predictors of long-term outcomes. This study is a comprehensive characterization of individual patients’ recovery of health utility from a lumbar disc herniation, and provides a unique picture for clinicians taking care of these patients. Our findings suggest that most recovery occurs early during treatment, and this early recovery period is important to long-term outcomes.

 

Conclusions

 

In a cohort of patients undergoing prolonged conservative care for treatment of lumbar disc herniation, 57% of the patients had lingering health problems at 1 year. Utility was recovered most rapidly early in the treatment process, and the majority of utility was also recovered in the initial treatment period. After the initial recovery period, we could identify with reasonable accuracy those patients who would fully recover and those who would not. Over the course of the year, recovery was observed to be highly variable, although most fluctuations were relatively small and only transient. These findings suggest that patients not initially responding to their treatment protocol should consider other options because they are unlikely to respond at a later time. However, patients and clinicians should also be mindful of transient decreases in quality of life, and carefully consider any changes in their treatment plan.

 

Disclosure

 

This work was partially supported by a charitable grant from the St. David’s Foundation Impact Fund to Dr. Cowperthwaite, and does not necessarily represent the views of the Impact Fund or the St. David’s Foundation.

 

Author contributions to the study and manuscript preparation include the following. Conception and design: all authors. Acquisition of data: Cowperthwaite, van den Hout. Analysis and interpretation of data: all authors. Drafting the article: Cowperthwaite. Critically revising the article: all authors. Reviewed submitted version of manuscript: all authors. Approved the final version of the manuscript on behalf of all authors: Cowperthwaite. Statistical analysis: Cowperthwaite, van den Hout. Administrative/technical/material support: Cowperthwaite. Study supervision: Cowperthwaite.

 

In conclusion, early non-operative treatment of lumbar herniated disc can effectively improve as well as manage recovery outcomes in patients with the condition. It’s important for patients with disc herniations in the lumbar spine to comprehend the source of their issue before receiving appropriate treatment for their symptoms. Furthermore, non-operative treatment is effective in most patients, surgical interventions may be considered according to the individual’s recovery outcome. 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: Neck Pain

 

Neck pain is a common complaint which can result due to a variety of injuries and/or conditions. According to statistics, automobile accident injuries and whiplash injuries are some of the most prevalent causes for neck pain among the general population. During an auto accident, the sudden impact from the incident can cause the head and neck to jolt abruptly back-and-forth in any direction, damaging the complex structures surrounding the cervical spine. Trauma to the tendons and ligaments, as well as that of other tissues in the neck, can cause neck pain and radiating symptoms throughout the human body.

 

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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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References

1. Andersson GB, Brown MD, Dvorak J, Herzog RJ, Kambin P, Malter A, et al.: Consensus summary of the diagnosis and treatment of lumbar disc herniation. Spine (Phila Pa 1976) 21:24 Suppl75S�78S, 1996 Medline
2. Atlas SJ, Deyo RA, Keller RB, Chapin AM, Patrick DL, Long JM, et al.: The Maine Lumbar Spine Study, Part II. 1-year outcomes of surgical and nonsurgical management of sciatica. Spine (Phila Pa 1976) 21:1777�1786, 1996 Crossref, Medline
3. Atlas SJ, Deyo RA, Keller RB, Chapin AM, Patrick DL, Long JM, et al.: The Maine Lumbar Spine Study, Part III. 1-year outcomes of surgical and nonsurgical management of lumbar spinal stenosis. Spine (Phila Pa 1976) 21:1787�1795, 1996 Crossref, Medline
4. Baldwin NG: Lumbar disc disease: the natural history. Neurosurg Focus 13:2E2, 2002
5. Dawson E, Bernbeck J: The surgical treatment of low back pain. Phys Med Rehabil Clin N Am 9:489�495, x, 1998
6. EuroQol Group: EuroQol�a new facility for the measurement of health-related quality of life. The EuroQol Group Health Policy 16:199�208, 1990 Crossref, Medline
7. Harrell FE: Regression Modeling Strategies: With Applications to Linear Models, Logistic Regression and Survival Analysis New York, Springer, 2001
8. Jackson CH, Sharples LD, Thompson SG, Duffy SW, Couto E: Multistate Markov models for disease progression with classification error. The Statistician 52:193�209, 2003
9. Keller RB, Atlas SJ, Singer DE, Chapin AM, Mooney NA, Patrick DL, et al.: The Maine Lumbar Spine Study, Part I. Background and concepts. Spine (Phila Pa 1976) 21:1769�1776, 1996 Crossref, Medline
10. Peul WC, van den Hout WB, Brand R, Thomeer RTWM, Koes BW: Prolonged conservative care versus early surgery in patients with sciatica caused by lumbar disc herniation: two year results of a randomised controlled trial. BMJ 336:1355�1358, 2008 Crossref, Medline
11. Peul WC, van Houwelingen HC, van der Hout WB, Brand R, Eekhof JA, Tans JT, et al.: Prolonged conservative treatment or �early� surgery in sciatica caused by a lumbar disc herniation: rationale and design of a randomized trial [ISRCT 26872154]. BMC Musculoskelet Disord 6:8, 2005 Crossref, Medline
12. Shaw JW, Johnson JA, Coons SJ: US valuation of the EQ-5D health states: development and testing of the D1 valuation model. Med Care 43:203�220, 2005 Crossref, Medline
13. Silverman BW: Density Estimation for Statistics and Data Analysis London, Chapman & Hall, 1986
14. Sing T, Sander O, Beerenwinkel N, Lengauer T: ROCR: visualizing classifier performance in R. Bioinformatics 21:3940�3941, 2005
15. van den Hout WB, Peul WC, Koes BW, Brand R, Kievit J, Thomeer RTWM, et al.: Prolonged conservative care versus early surgery in patients with sciatica from lumbar disc herniation: cost utility analysis alongside a randomised controlled trial. BMJ 336:1351�1354, 2008 Crossref, Medline
16. Weber H: Lumbar disc herniation. A controlled, prospective study with ten years of observation. Spine (Phila Pa 1976) 8:131�140, 1983 Crossref, Medline
17. Weinstein JN, Lurie JD, Tosteson TD, Skinner JS, Hanscom B, Tosteson ANA, et al.: Surgical vs nonoperative treatment for lumbar disk herniation: the Spine Patient Outcomes Research Trial (SPORT) observational cohort. JAMA 296:2451�2459, 2006 Crossref, Medline
18. Weinstein JN, Tosteson TD, Lurie JD, Tosteson ANA, Hanscom B, Skinner JS, et al.: Surgical vs nonoperative treatment for lumbar disk herniation: the Spine Patient Outcomes Research Trial (SPORT): a randomized trial. JAMA 296:2441�2450, 2006 Crossref, Medline

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Cited By

1. Anurekha Ramakrishnan, MS, K. Michael Webb, MD, and Matthew C. Cowperthwaite, PhD. (2017) One-year outcomes of early-crossover patients in a cohort receiving nonoperative care for lumbar disc herniation. Journal of Neurosurgery: Spine 27:4, 391-396. . Online publication date: 1-Oct-2017. Abstract | Full Text | PDF (2037 KB)
2. Kimberly A Plomp, Una Strand Vi�arsd�ttir, Darlene A Weston, Keith Dobney, Mark Collard. (2015) The ancestral shape hypothesis: an evolutionary explanation for the occurrence of intervertebral disc herniation in humans. BMC Evolutionary Biology 15:1. . Online publication date: 1-Dec-2015. [Crossref]

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Migraine Pain & Lumbar Herniated Disc Treatment in El Paso, TX

Migraine Pain & Lumbar Herniated Disc Treatment in El Paso, TX

One of the most prevalent causes of lower back pain and sciatica may be due to the compression of the nerve roots in the low back from a lumbar herniated disc, or a ruptured disc in the lumbar spine. Common symptoms of lumbar herniated discs include varying intensities of pain, muscle spasms or cramping, sciatica and leg weakness as well as loss of proper leg function. While these may not appear to be closely associated with each other, a lumbar herniated disc may also affect the cervical spine, manifesting symptoms of migraine and headache. The purpose of the following articles is to educate patients and demonstrate the relation between migraine pain and lumbar herniated disc, further discussing the treatment of these two common conditions.

 

A Critical Review of Manual Therapy Use for Headache Disorders: Prevalence, Profiles, Motivations, Communication and Self-Reported Effectiveness

 

Abstract

 

Background

 

Despite the expansion of conventional medical treatments for headache, many sufferers of common recurrent headache disorders seek help outside of medical settings. The aim of this paper is to evaluate research studies on the prevalence of patient use of manual therapies for the treatment of headache and the key factors associated with this patient population.

 

Methods

 

This critical review of the peer-reviewed literature identified 35 papers reporting findings from new empirical research regarding the prevalence, profiles, motivations, communication and self-reported effectiveness of manual therapy use amongst those with headache disorders.

 

Results

 

While available data was limited and studies had considerable methodological limitations, the use of manual therapy appears to be the most common non-medical treatment utilized for the management of common recurrent headaches. The most common reason for choosing this type of treatment was seeking pain relief. While a high percentage of these patients likely continue with concurrent medical care, around half may not be disclosing the use of this treatment to their medical doctor.

 

Conclusions

 

There is a need for more rigorous public health and health services research in order to assess the role, safety, utilization and financial costs associated with manual therapy treatment for headache. Primary healthcare providers should be mindful of the use of this highly popular approach to headache management in order to help facilitate safe, effective and coordinated care.

 

Keywords: Headache, Migraine, Tension headache, Cervicogenic headache, Manual therapy, Physical therapy, Chiropractic, Osteopathy, Massage

 

Background

 

The co-occurrence of tension headache and migraine is very high [1]. Respectively, they are the second and third most common disorders worldwide with migraine ranking as the seventh highest specific cause of disability globally [2] and the sixteenth most commonly diagnosed condition in the US [3]. These common recurrent headache disorders place a considerable burden upon the personal health, finances and work productivity of sufferers [3�5] with migraine further complicated by an association with cardiovascular and psychiatric co-morbidities [6, 7].

 

Preventative migraine drug treatments include analgesics, anticonvulsants, antidepressants and beta-blockers. Preventative drug treatments for tension-type headaches can include analgesics, NSAIDs, muscle relaxants and botulinum toxin as well as anticonvulsants and antidepressants. While preventative drug treatments are successful for a significant proportion of sufferers, headache disorders are still reported as under-diagnosed and under-treated within medical settings [8�16] with other studies reporting sufferers can cease continuing with preventative headache medications long-term [9, 17].

 

There is a number of non-drug approaches also utilized for the prevention of headaches. These include psychological therapies such as cognitive behavioral therapy, relaxation training and EMG (electromyography) biofeedback. In addition, there is acupuncture, nutritional supplementation (including magnesium, B12, B6, and Coenzyme Q10) and physical therapies. The use of physical therapies is significant, with one recent global survey reporting physical therapy as the most frequently used �alternative or complementary treatment� for headache disorders across many countries [18]. One of the most common physical therapy interventions for headache management is manual therapy (MT), [19�21] which we define here as treatments including �spinal manipulation (as commonly performed by chiropractors, osteopaths, and physical therapists), joint and spinal mobilization, therapeutic massage, and other manipulative and body-based therapies� [22].

 

Positive results have been reported in many clinical trials comparing MT to controls [23�27], other physical therapies [28�30] and aspects of medical care [31�34]. More high quality research is needed however to assess the efficacy of MT as a treatment for common recurrent headaches. Recent systematic reviews of randomized clinical trials of MT for the prevention of migraine report a number of significant methodological short-comings and the need for more high quality research before any firm conclusions can be made [35, 36]. Recent reviews of MT trials for tension-type headache and cervicogenic headache are cautious in reporting positive outcomes and the strong need for further robust research [37�41]. Despite the limited clinical evidence there has been no critical review of the significant use of MT by headache populations.

 

Methods

 

The aim of this study is to report from the peer-reviewed literature; 1) the prevalence of MT use for the treatment of common recurrent headaches and 2) factors associated with this use across several key themes. The review further identifies key areas worthy of further research in order to better inform clinical practice, educators and healthcare policy within this area.

 

Design

 

A comprehensive search of peer-reviewed articles published in English between 2000 and 2015 reporting new empirical research findings of key aspects of MT use among patients with migraine and non-migraine headache disorders was undertaken. Databases searched were MEDLINE, AMED, CINAHL, EMBASE and EBSCO. The key words and phrases used were: �headache�, �migraine�, �primary headache�, �cephalgia�, �chronic headache� AND �manual therapy�, �spinal manipulation�, �manipulative therapy�, �spinal mobilization�, �chiropractic�, �osteopathy�, �massage�, �physical therapy� or �physiotherapy� AND then �prevalence�, �utilization� or �profile� was used for additional searches against the previous terms. The database search was accompanied by a hand search of prominent peer-reviewed journals. All authors accessed the reviewed literature (data) and provided input to analysis.

 

Due to the focus of the review, literature reporting randomized control trials and similar clinical research designs were excluded as were articles identified as letters, correspondence, editorials, case reports and commentaries. Further searches were undertaken of the bibliographies in the identified publications. All identified articles were screened and only those reporting new empirical findings on MT use for headache in adults were included in the review. Articles identified and selected for the review were research manuscripts mostly within epidemiological and health economics studies. The review includes papers reporting MT use pooled with the use of other therapies, but only where MT patients comprised a large proportion (as stated) of the included study population. Results were imported into Endnote X7 and duplicates removed.

 

Search Outcomes, Analyses and Quality Appraisal

 

Figure 1 outlines the literature search process. The initial search identified 3286 articles, 35 of which met the inclusion criteria. Information from each article was organized into a review table (Table 1) to summarise the findings of the included papers. Information is reported under two selected headache groups and within each individual MT profession – chiropractic, physiotherapy, osteopathy and massage therapy � where sufficient detail was available.

 

Figure 1 Flow Chart of Study Selection

Figure 1: Flow Chart of Study Selection.

 

Table 1 Research Based Studies of Manual Therapy Use

Table 1: Research-based studies of manual therapy use for headache disorders.

 

An appraisal of the quality of the articles identified for review was conducted using a quality scoring system (Table 2) developed for the critical appraisal of health literature used for prevalence and incidence of health problems [42] adapted from similar studies [43�45]. This scoring system was applicable to the majority of study designs involving surveys and survey-based structured interviews (29 of the 35 papers) but was not applicable to a small number of included studies based upon clinical records, secondary analysis or practitioner characteristics.

 

Table 2 Description of Quality Criteria and Scoring

 

Two separate authors (CM and JA) independently searched and scored the articles. Score results were compared and any differences were further discussed and resolved by all the authors. The quality score of each relevant article is reported in Table 3.

 

Table 3 Quality Score for Selected Studies

 

Results

 

The key findings of the 35 articles were grouped and evaluated using a critical review approach adapted from previous research [46, 47]. Based on the limited information available for other headache types, prevalence findings are reported within one of two categories – either as �migraine� for papers reporting studies where the population was predominately or entirely made up of migraine patients or as �headache� for papers where the study population was predominately other headache types (including tension-type headaches, cluster headaches, cervicogenic headache) and/or where the headache type was not clearly stated. Ten papers reported findings examining prevalence rates for the �migraine� category alone, 18 papers reported findings examining prevalence for the �headache� category alone and 3 papers reported findings for both categories. Based on the nature of the information available, prevalence use was categorised by manual therapy providers. The extracted data was then analysed and synthesized into four thematic categories: prevalence; profile and motivations for MT use; concurrent use and order of use of headache providers; and self-reported evaluation of MT treatment outcomes.

 

Prevalence of MT Use

 

Thirty-one of the reviewed articles with a minimum sample size (>100) reported findings regarding prevalence of MT use. The prevalence of chiropractic use for those with migraine ranged from 1.0 to 36.2% (mean: 14.4%) within the general population [19�21, 48�52] and from 8.9 to 27.1% (mean: 18.0%) within headache-clinic patient populations [53, 54]. The prevalence of chiropractic use for those reported as headache ranged from 4 to 28.0% (mean: 12.9%) within the general population [20, 48, 51, 55�57]; ranged from 12.0 to 22.0% (mean: 18.6%) within headache/pain clinic patient populations [58�60] and from 1.9 to 45.5% (mean: 9.8%) within chiropractic patient populations [61�69].

 

The prevalence use of physiotherapy for those with migraine ranged from 9.0 to 57.0% (mean: 24.7%) within the general population [19, 20, 48, 52] and from 4.9 to 18.7% (mean: 11.8%) within headache-clinic patient populations [54, 70]. The prevalence use of physiotherapy for those reported as headache ranged from 12.2 to 52.0% (mean: 32.1%) within the general population [20, 48] and from 27.8 to 35.0%% (mean: 31.4%) within headache/pain clinic populations [60, 70].

 

Massage therapy use for those with migraine ranged from 2.0 to 29.7% (mean: 15.6%) within the general population [49, 50, 71] and from 10.1 to 56.4% (mean: 33.9%) within headache-clinic populations [53, 54, 72, 73]. Massage/acupressure use for those reported as headache within headache/pain clinic patient populations ranged from 12.0 to 54.0% (mean: 32.5%) [58�60, 70].

 

Osteopathy use for those with migraine was reported as 1% within the general population [49]; as 2.7% within a headache-clinic patient population [53] and as 1.7% within an osteopathy patient population [74]. For headache the prevalence was 9% within a headache/pain clinic population [60] and ranged from 2.7 to 10.0% (mean: 6.4%) within osteopathy patient populations [74, 75].

 

The combined prevalence rate of MT use across all MT professions for those with migraine ranged from 1.0 to 57.0% (mean: 15.9%) within the general population; ranged from 2.7 to 56.4% (mean: 18.4%) within headache-clinic patient populations and was reported as 1.7% in one MT patient population. The combined prevalence rate of MT use across all MT professions for those reported as headache ranged from 4.0 to 52.0% (mean: 17.7%) within the general population; ranged from 9.0 to 54.0% (mean: 32.3%) within headache-clinic patient populations and from 1.9 to 45.5% (mean: 9.25%) within MT patient populations.

 

Profile and Motivations for MT Use

 

While patient socio-demographic profiles were not reported within headache populations that were exclusively using MT, several studies report these findings where MT users made up a significant percentage of the non-medical headache treatments utilized by the study population (range 40% � 86%: mean 63%). While findings varied for level of income [58, 70] and level of education, [70, 72, 73] this patient group were more likely to be older [70, 72], female [20], have a higher rate of comorbid conditions [58, 70, 76] and a higher rate of previous medical visits [20, 58, 70] when compared to the non-user group. Overall, this group were reported to have a higher level of headache chronicity or headache disability than non-users [20, 54, 58, 70, 72, 77].

 

Several studies within headache-clinic populations report patient motivations for the use of complementary and alternative headache treatments where MT users made up a significant proportion of the study population (range 40% � 86%: mean 63%) [58, 70, 72, 78]. From these studies the most common motivation reported by study patients was �seeking pain relief� for headache which accounted for 45.4% � 84.0% (mean: 60.5%) of responses. The second most common motivation was patient concerns regarding the �safety or side effects� of medical headache treatment, accounting for 27.2% � 53.0% (mean: 43.8%) of responses [58, 70, 72]. �Dissatisfaction with medical care� accounted for 9.2% � 35.0% (mean: 26.1%) of responses [58, 70, 72].

 

A limited number of reviewed papers (all from Italy) report on the source of either the referral or recommendation to MT for headache treatment [53, 58, 59]. From these studies, referral from a GP to a chiropractor ranged from 50.0 to 60.8% (mean: 55.7%), while referral from friends/relatives ranged from 33.0 to 43.8% (mean: 38.7%) and self-recommendation ranged from 0 to 16.7% (mean: 5.6%). For massage therapy, referral from a GP ranged from 23.2 to 50.0% (mean: 36.6%), while referral from friends/relatives ranged from 38.4 to 42.3% (mean: 40.4%) and self-recommendation ranged from 7.7 to 38.4% (mean: 23.1%). For acupressure, referral from a GP ranged from 33.0 to 50.0% (mean: 41.5%), while referral from friends/relatives was reported as 50% and self-recommendation ranged from 0 to 16.6% (mean: 8.3%). One study reported findings for osteopathy where referral from both GP�s and friends/relatives was reported as 42.8% and self-recommendation was reported as 14.4%. Overall, the highest proportion of referrals within these studies was from GPs to chiropractors for chronic tension-type headache (56.2%), cluster headache (50%) and migraine (60.8%).

 

Concurrent Use and Order of Use of Headache Providers and Related Communication of MT Users

 

Several studies report on the concurrent use of medical headache management with complementary and alternative therapies. In those studies where the largest percentage of the patient population were users of MT�s (range 57.0% � 86.4%: mean 62.8%), [58, 70, 78] concurrent use of medical care ranged between 29.5% and 79.0% (mean: 60.0%) of the headache patient population.

 

These studies further report on the level of patient non-disclosure to medical providers regarding the use of MT for headache. Non-disclosure ranged between 25.5 and 72.0% (mean: 52.6%) of the patient population, with the most common reason for non-disclosure reported as the doctor �never asking�, ranging from 37.0 to 80.0% (mean: 58.5%). This was followed by a patient belief that �it was not important for the doctor to know� or �none of the doctor�s business�, ranging from 10.0 to 49.8% (mean: 30.0%). This was followed by a belief that either �the doctor would not understand� or �would discourage� these treatments, ranging from 10.0 to 13.0% (mean: 11.5%) [53, 77].

 

One large international study reported the ordering of the typical provider of headache care by comparing findings between several countries for migraine patients [21]. Primary care providers followed by neurologists were reported as the first and second providers for migraine treatment for nearly all countries examined. The only exception was Australia, where those with chronic migraine selected chiropractors as typical providers at equal frequency to neurologists (14% for both) while those with episodic migraine selected chiropractors at a greater frequency to neurologists (13% versus 5%). Comparatively, chiropractors were selected as the typical provider for those with chronic migraine by 10% in USA and Canada, 1% in Germany and 0% for UK and France. Chiropractors were selected as the typical provider for those with episodic migraine by 7% in USA, 6% in Germany, 4% in Canada and by 1% in both the UK and France.

 

Self-Reported Effectiveness of MT Treatment Outcomes

 

Several headache and pain-clinic population studies provide findings for the self-reported effectiveness of MT headache treatment. For chiropractic, patient self-reporting of partially effective or fully effective headache relief ranged from 27.0 to 82.0% (mean: 45.0%) [53, 58�60, 78]. For massage therapy, patient self-reporting of partially effective or fully effective headache relief ranged from 33.0 to 64.5% (mean: 45.2%)[53, 58, 60, 73, 78], and for acupressure this ranged from 33.4 to 50.0% (mean: 44.5%) [53, 58, 59]. For osteopathy and physiotherapy, one study reported effectiveness as 17 and 36% respectively [60].

When results are combined across all MT professions the reporting of MT as either partially or fully effective ranged from 17.0 to 82.0% (mean 42.5%) [53, 58�60, 73, 78]. In addition, one general population study provides findings for the self-reported effectiveness for chiropractic and physiotherapy at 25.6 and 25.1% respectively for those with primary chronic headache and 38 and 38% respectively for those with secondary chronic headache [79].

 

Discussion

 

This paper provides the first critical integrative review on the prevalence and key factors associated with the use of MT treatment for headaches within the peer-reviewed literature. While study methodological limitations and lack of data prevent making strong conclusions, these findings raise awareness of issues of importance to policy-makers, educators, headache providers and future research.

 

Our review found that MT use was generally higher within medical headache-clinic populations when compared to general populations. However, the use of individual MT providers does vary between different regions and this is likely due to a number of factors including variation in public access, healthcare funding and availability of MT providers. For example, the use of physiotherapy for some headache types may be relatively higher in parts of Europe [20, 60] while the use of chiropractors for some headache types may be relatively higher in Australia and the USA [19, 21]. Overall, the prevalence use of MT for headache appears to be substantial and likely to be the most common type of physical therapy utilized for headache in many countries [19�21, 49]. More high quality epidemiological studies are needed to measure the prevalence of MT use across different headache types and sub-types, both within the general population and clinical populations.

 

Beyond prevalence, data is more limited regarding who, how and why headache patients seek MT. From the information available however, the healthcare needs of MT headache patients may be more complex and multi-disciplinary in nature compared to those under usual medical care alone. Socio-demographic findings suggest that users of MT and other complementary and alternative therapies have a higher level of headache disability and chronicity compared to non-users. This finding may correlate with the higher prevalence of MT users within headache-clinic populations and a history of more medical appointments. This may also have implications for future MT trial designs both in terms of the selection of trial subjects from inside versus outside MT clinical settings and the decision to test singular MT interventions versus MT in combination with other interventions.

 

Limited information suggests that a pluralistic approach toward the use of medical and non-medical headache treatments such as MT is common. While findings suggest MT is sought most often for reasons of seeking headache relief, the evidence to support the efficacy of MT for headache relief is still limited. MT providers must remain mindful of the quality of the evidence for a given intervention for a given headache disorder and to inform patients where more effective or safer treatment interventions are available. More research is needed to assess these therapies individually and through multimodal approaches and for studies to include long-term follow-up.

 

Information limited to Italy, suggests referral from GPs for MT headache treatment can be common in some regions, while this is less likely to widespread given the issue of patient non-disclosure to medical doctors regarding the use of this treatment in other studies. High quality healthcare requires open and transparent communication between patients and providers and between the providers themselves. Non-disclosure may adversely influence medical management should unresponsive patients require further diagnostic investigations [80] or the implementation of more effective approaches to headache management [81] or prevents discussion in circumstances where MT may be contraindicated [82]. Primary headache providers may benefit from paying particular attention to the possibility of non-disclosure of non-medical headache treatments. Open discussion between providers and patients about the use of MT for headache and the associated outcomes may improve overall patient care.

 

Future Research

 

Despite the strong need for more high quality research to assess the efficacy of MT as a treatment for headache, the substantial use of MT brings attention to the need for more public health and health services research within this area of headache management. The need for this type of research was identified in a recent global report on the use of headache-related healthcare resources [18]. Furthering this information can lead to improvements in healthcare policy and the delivery of healthcare services.

 

The substantial use of physical therapies such as MT has been under-reported within many of the national surveys reporting headache-related healthcare utilization [3, 5, 83�85]. Regardless, the role of physical therapies in headache management continues to be assessed, often within mainstream and integrated headache management settings [86�89]. Continuing this research may further our understanding of the efficacy and outcomes associated with a more multidisciplinary approach to headache management.

 

Further to this is the need for more research to understand the healthcare utilization pathways associated with those patients who use MT in their headache management. Little is known about the sociodemographic background, types of headaches, level of headache disability and comorbidities more common to this patient population. In turn, such information can provide insights that may be valuable to provider clinical decision-making and provider education.

 

Limitations

 

The design and findings of our review has a number of limitations. The design of the review was limited by a search within English language journals only. As a result, some research on this topic may have been missed. While the quality scoring system adopted for this review requires further validation, the data we collected was limited by the low to moderate quality of available papers which averaged 6.4 out of 10 points (Table 3). The low scoring was largely due to significant methodological issues and the small sample size associated with much of the collected papers. Much of the data on this topic was heterogeneous in nature (telephone, postal surveys and face-to-face interviews). There was a lack of validated practitioner and patient questionnaires to report findings, such as for questions on prevalence, where the time frames utilized varied between �currently�, �last 12 months� and �ever�.

 

Data on the prevalence of MT use for headache was limited particularly within individual MT provider populations when compared to data found within the general population and headache-clinic populations. Many studies assessed the use of MT for headache without identifying headache types. Only one study inside an MT population had reported the percentage of patients attending for reasons of migraine alone (osteopathy). The prevalence of MT use for headache was reported most within chiropractic patient population studies, however information was limited on the types of headache. We found no studies reporting the prevalence of headache patients within physiotherapy or massage therapy patient populations using our search terms.

 

A lack of data for some themes necessitated providing findings pooled with users of other non-medical headache providers. Data within many geographical regions was very limited with the most limited data was on the source of referral to MT headache providers (three papers from Italy only). These limitations support the call for more research to be focused exclusively within MT populations and different regional areas before stronger conclusions can be drawn.

 

Conclusion

 

The needs of those with headache disorders can be complex and multi-disciplinary in nature. Beyond clinical research, more high quality public health and health services research is needed to measure and examine a number of issues of significance to the delivery and use of MT�s within headache management. With unmet needs still remaining for many who suffer recurrent headaches, clinicians should remain cognizant of the use of MT�s and remain open to discussing this approach to headache management in order to ensure greater safety, effectiveness and coordination of headache care.

 

Acknowledgements

 

Not applicable.

 

Funding

 

This research received no specific grant from any funding agency in the public, commercial or not-for-profit sectors while the first author on this paper receives a PhD scholarship made available by the Australian Chiropractors� Association.

 

Availability of Data and Materials

 

Not applicable (all data is reported in article).

 

Authors’ Contributions

 

CM, JA and DS designed the paper. CM carried out the literature search, data collection and selection. CM and DS provided the analysis and interpretation. CM and JA wrote the drafts. All authors contributed to the critical review and intellectual content. All authors read and approved the final manuscript.

 

Competing Interests

 

The authors declare that they have no competing interests.

 

Consent for Publication

 

Not applicable.

 

Ethics Approval and Consent to Participate

 

Not applicable.

 

Publisher�s Note

 

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

 

Abbreviations

 

  • MT Manual therapy
  • EMG Electromyography

 

Contributor Information

 

Ncbi.nlm.nih.gov/pmc/articles/PMC5364599/

 

Dr Jimenez White Coat

Dr. Alex Jimenez’s Insight

A staggering 15% of the population suffers from migraines, a debilitating condition which affects an individual’s ability to engage in everyday activities. Although widely misunderstood by researches today, I believe that migraine pain can be a symptom of a much bigger underlying health issue. Lumbar herniated discs, or ruptured discs in the lumbar spine, are a common cause of lower back pain and sciatica. When the soft, gel-like center of a lumbar herniated disc compresses the nerve roots of the low back, it can result in symptoms of pain and discomfort, numbness and weakness in the lower extremities. What’s more, a lumbar herniated disc can unbalance the structure and function of the entire spine, eliciting symptoms along the cervical spine that could ultimately trigger migraines. People who constantly experience migraine pain often have to carefully go about their day in hopes of avoiding the blaze of another painful episode. Fortunately, many migraine pain and lumbar herniated disc treatment methods are available to help improve as well as manage the symptoms. Other treatment options can also be considered before surgical interventions.

 

Surgical versus Non-Operative Treatment for Lumbar Disc Herniation: Eight-Year Results for the Spine Patient Outcomes Research Trial (SPORT)

 

Abstract

 

Study Design

 

Concurrent prospective randomized and observational cohort studies.

 

Objective

 

To assess the 8-year outcomes of surgery vs. non-operative care.

 

Summary of Background Data

 

Although randomized trials have demonstrated small short-term differences in favor of surgery, long-term outcomes comparing surgical to non-operative treatment remain controversial.

 

Methods

 

Surgical candidates with imaging-confirmed lumbar intervertebral disc herniation meeting SPORT eligibility criteria enrolled into prospective randomized (501 participants) and observational cohorts (743 participants) at 13 spine clinics in 11 US states. Interventions were standard open discectomy versus usual non-operative care. Main outcome measures were changes from baseline in the SF-36 Bodily Pain (BP) and Physical Function (PF) scales and the modified Oswestry Disability Index (ODI – AAOS/Modems version) assessed at 6 weeks, 3 and 6 months, and annually thereafter.

 

Results

 

Advantages were seen for surgery in intent-to-treat analyses for the randomized cohort for all primary and secondary outcomes other than work status; however, with extensive non-adherence to treatment assignment (49% patients assigned to non-operative therapy receiving surgery versus 60% of patients assigned to surgery) these observed effects were relatively small and not statistically significant for primary outcomes (BP, PF, ODI). Importantly, the overall comparison of secondary outcomes was significantly greater with surgery in the intent-to-treat analysis (sciatica bothersomeness [p > 0.005], satisfaction with symptoms [p > 0.013], and self-rated improvement [p > 0.013]) in long-term follow-up. An as-treated analysis showed clinically meaningful surgical treatment effects for primary outcome measures (mean change Surgery vs. Non-operative; treatment effect; 95% CI): BP (45.3 vs. 34.4; 10.9; 7.7 to 14); PF (42.2 vs. 31.5; 10.6; 7.7 to 13.5) and ODI (?36.2 vs. ?24.8; ?11.2; ?13.6 to ?9.1).

 

Conclusion

 

Carefully selected patients who underwent surgery for a lumbar disc herniation achieved greater improvement than non-operatively treated patients; there was little to no degradation of outcomes in either group (operative and non-operative) from 4 to 8 years.

 

Keywords: SPORT, intervertebral disc herniation, surgery, non-operative care, outcomes

 

Introduction

 

Lumbar discectomy for relief of sciatica in patients with intervertebral disc herniation (IDH) is a well-researched and common indication for spine surgery, yet rates of this surgery exhibit considerable geographic variation.[1] Several randomized trials and large prospective cohorts have demonstrated that surgery provides faster pain relief and perceived recovery in patients with herniated disc.[2�6] The effect of surgery on longer term outcomes remains less clear.

 

In a classic RCT evaluating surgery versus non-operative treatment for lumbar IDH, Weber et al. showed a greater improvement in the surgery group at 1 year that was statistically significant; there was also greater improvement for surgery at 4 years, although not statistically significant, but no apparent difference in outcomes at 10 years.[2] However, a number of patients in the non-operative group eventually underwent surgery over that time, complicating the interpretation of the long-term results. The Maine Lumbar Spine Study, a prospective observational cohort, found greater improvement at one year in the surgery group that narrowed over time, but remained significantly greater in the surgical group for sciatica bothersomeness, physical function, and satisfaction, but no different for work or disability outcomes.[3] This paper reports 8-year results from the Spine Patient Outcomes Research Trial (SPORT) based on the continued follow-up of the herniated disc randomized and observational cohorts.

 

Methods

 

Study Design

 

SPORT is a randomized trial with a concurrent observation cohort conducted in 11 US states at 13 medical centers with multidisciplinary spine practices. The human subjects committees at each participating institution approved a standardized protocol for both the observational and the randomized cohorts. Patient inclusion and exclusion criteria, study interventions, outcome measures, and follow-up procedures have been reported previously.[5�8]

 

Patient Population

 

Men and women were eligible if they had symptoms and confirmatory signs of lumbar radiculopathy persisting for at least six weeks, disc herniation at a corresponding level and side on imaging, and were considered surgical candidates. The content of pre-enrollment non-operative care was not pre-specified in the protocol.[5�7] Specific enrollment and exclusion criteria are reported elsewhere.[6,7]

 

A research nurse at each site identified potential participants, verified eligibility and used a shared decision making video for uniformity of enrollment. Participants were offered enrollment in either the randomized trial or the observational cohort. Enrollment began in March of 2000 and ended in November of 2004.

 

Study Interventions

 

The surgery was a standard open discectomy with examination of the involved nerve root.[7,9] The non-operative protocol was �usual care� recommended to include at least: active physical therapy, education/counseling with home exercise instruction, and non-steroidal anti-inflammatory drugs if tolerated. Non-operative treatments were individualized for each patient and tracked prospectively.[5�8]

 

Study Measures

 

Primary endpoints were the Bodily Pain (BP) and Physical Function (PF) scales of the SF-36 Health Survey[10] and the AAOS/Modems version of the Oswestry Disability Index (ODI)[11] as measured at 6 weeks, 3 and 6 months, and annually thereafter. If surgery was delayed beyond six weeks, additional follow-up data was obtained 6 weeks and 3 months post-operatively. Secondary outcomes included patient self-reported improvement; work status; satisfaction with current symptoms and care;[12] and sciatica severity as measured by the sciatica bothersomeness index.[13,14] Treatment effect was defined as the difference in the mean changes from baseline between the surgical and non-operative groups.

 

Statistical Considerations

 

Initial analyses compared means and proportions for baseline patient characteristics between the randomized and observational cohorts and between the initial treatment arms of the individual and combined cohorts. The extent of missing data and the percentage of patients undergoing surgery were calculated by treatment arm for each scheduled follow-up. Baseline predictors of time until surgical treatment (including treatment crossovers) in both cohorts were determined via a stepwise proportional hazards regression model with an inclusion criterion of p < 0.1 to enter and p > 0.05 to exit. Predictors of missing follow-up visits at yearly intervals up to 8 years were separately determined via stepwise logistic regression. Baseline characteristics that predicted surgery or a missed visit at any time-point were then entered into longitudinal models of primary outcomes. Those that remained significant in the longitudinal models of outcome were included as adjusting covariates in all subsequent longitudinal regression models to adjust for potential confounding due to treatment selection bias and missing data patterns.[15] In addition, baseline outcome, center, age and gender were included in all longitudinal outcome models.

 

Primary analyses compared surgical and non-operative treatments using changes from baseline at each follow-up, with a mixed effects longitudinal regression model including a random individual effect to account for correlation between repeated measurements within individuals. The randomized cohort was initially analyzed on an intent-to-treat basis.[6] Because of cross-over, additional analyses were performed based on treatments actually received. In these as-treated analyses, the treatment indicator was a time-varying covariate, allowing for variable times of surgery. Follow-up times were measured from enrollment for the intent-to-treat analyses, whereas for the as-treated analysis the follow-up times were measured from the beginning of treatment (i.e. the time of surgery for the surgical group and the time of enrollment for the non-operative group), and baseline covariates were updated to the follow-up immediately preceding the time of surgery. This procedure has the effect of including all changes from baseline prior to surgery in the estimates of the non-operative treatment effect and all changes after surgery in the estimates of the surgical effect. The six-point sciatica scales and binary outcomes were analyzed via longitudinal models based on generalized estimating equations[16] with linear and logit link functions respectively, using the same intent-to-treat and adjusted as-treated analysis definitions as the primary outcomes. The randomized and observational cohorts were each analyzed to produce separate as-treated estimates of treatment effect. These results were compared using a Wald test to simultaneously test all follow-up visit times for differences in estimated treatment effects between the two cohorts.[15] Final analyses combined the cohorts.

 

To evaluate the two treatment arms across all time-periods, the time-weighted average of the outcomes (area under the curve) for each treatment group was computed using the estimates at each time period from the longitudinal regression models and compared using a Wald test.[15]

 

Kaplan-Meier estimates of re-operation rates at 8 years were computed for the randomized and observational cohorts and compared via the log-rank test.[17,18]

 

Computations were done using SAS procedures PROC MIXED for continuous data and PROC GENMOD for binary and non-normal secondary outcomes (SAS version 9.1 Windows XP Pro, Cary, NC). Statistical significance was defined as p < 0.05 based on a two-sided hypothesis test with no adjustments made for multiple comparisons. Data for these analyses were collected through February 4, 2013.

 

Results

 

Overall, 1,244 SPORT participants with lumbar intervertebral disc herniation were enrolled (501 in the randomized cohort, and 743 in the observational cohort) (Figure 1). In the randomized cohort, 245 were assigned to surgical treatment and 256 to non-operative treatment. Of those randomized to surgery, 57% had surgery by 1 year and 60% by 8 years. In the group randomized to non-operative care, 41% of patients had surgery by 1 year and 48% by 8 years. In the observational cohort, 521 patients initially chose surgery and 222 patients initially chose non-operative care. Of those initially choosing surgery, 95% received surgery by 1 year; at 8 years 12 additional patients had undergone primary surgery. Of those choosing non-operative treatment, 20% had surgery by 1 year and 25% by 8 years. In both cohorts combined, 820 patients received surgery at some point during the first 8 years; 424 (34%) remained non-operative. Over the 8 years, 1,192 (96%) of the original enrollees completed at least 1 follow-up visit and were included in the analysis (randomized cohort: 94% and observational cohort 97%); 63% of initial enrollees supplied data at 8 years with losses due to dropouts, missed visits, or deaths (Figure 1).

 

Figure-1-Exclusion-Enrollment-Randomization-and-Follow-Up

Figure 1: Exclusion, enrollment, randomization and follow-up of trial participants.

 

Patient Characteristics

 

Baseline characteristics have been previously reported and are summarized in Table 1.[5,6,8] The combined cohorts had an overall mean age of 41.7 with slightly more men than women. Overall, the randomized and observational cohorts were similar. However, patients in the observational cohort had more baseline disability (higher ODI scores), were more likely to prefer surgery, more often rated their problem as worsening, and were slightly more likely to have a sensory deficit. Subjects receiving surgery over the course of the study were: younger; less likely to be working; more likely to report being on worker�s compensation; had more severe baseline pain and functional limitations; fewer joint and other co-morbidities; greater dissatisfaction with their symptoms; more often rated their condition as getting worse at enrollment; and were more likely to prefer surgery. Subjects receiving surgery were also more likely to have a positive straight leg test, as well as more frequent neurologic, sensory, and motor deficits. Radiographically, their herniations were more likely to be at the L4�5 and L5-S1 levels and to be posterolateral in location.

 

Table 1 Patient Baseline Demographic Characteristics, Comorbidities and Health Status Measures

Table 1: Patient baseline demographic characteristics, comorbidities and health status measures according to study cohort and treatment received.

 

Surgical Treatment and Complications

 

Overall surgical treatment and complications were similar between the two cohorts (Table 2). The average surgical time was slightly longer in the randomized cohort (80.5 minutes randomized vs. 74.9 minutes observational, p=0.049). The average blood loss was 75.3cc in the randomized cohort vs. 63.2cc in the observational, p=0.13. Only 6 patients total required intra-operative transfusions. There were no perioperative mortalities. The most common surgical complication was dural tear (combined 3% of cases). Re-operation occurred in a combined 11% of cases by 5 years, 12% by 6 years, 14% by 7 years, and 15% by 8 years post-surgery. The rates of reoperation were not significantly different between the randomized and observational cohorts. Eighty-seven of the 119 re-operations noted the type of re-operation; approximately 85% of these (74/87) were listed as recurrent herniations at the same level. One death occurred within 90 days post-surgery related to heart surgery at another institution; the death was judged to be unrelated and was reported to the Institutional Review Board and the Data and Safety Monitoring Board.

 

Table 2 Operative Treatments, Complications and Events

Cross-Over

 

Non-adherence to treatment assignment affected both treatment arms: patients chose to delay or decline surgery in the surgical arm and crossed over to surgery in the non-operative arm. (Figure 1) Statistically significant differences of patients crossing over to non-operative care within 8 years of enrollment were that they were older, had higher incomes, less dissatisfaction with their symptoms, more likely to have a disc herniation at an upper lumbar level, more likely to express a baseline preference for non-operative care, less likely to perceive their symptoms as getting worse at baseline, and had less baseline pain and disability (Table 3). Patients crossing over to surgery within 8 years were more dissatisfied with their symptoms at baseline; were more likely to perceive they were getting worse at baseline; more likely to express a baseline preference for surgery; and had worse baseline physical function and more self-rated disability.

 

Table 3 Statistically Significant Predictors of Adherence to Treatment

Table 3: Statistically significant predictors of adherence to treatment among RCT patients.

 

Main Treatment Effects

 

Intent-to-Treat Analysis In the intention-to-treat analysis of the randomized cohort, all measures over 8 years favored surgery but there were no statistically significant treatment effects in the primary outcome measures (Table 4 and Figure 2). In the overall intention-to-treat comparison between the two treatment groups over time (area-under the curve), secondary outcomes were significantly greater with surgery in the intention-to-treat analysis (sciatica bothersomeness (p=0.005), satisfaction with symptoms (p=0.013), and self-rated improvement (p=0.013)) (Figure 3) Improvement in sciatica bothersomeness index was also statistically significant in favor of surgery at most individual time point comparisons (although non-significant in years 6 and 7) (Table 4).

 

Figure-2-Primary-Outcomes-in-the-Randomized-and-Observational-Cohorts

Figure 2: Primary outcomes (SF-36 Bodily Pain and Physical Function, and Oswestry Disability Index) in the randomized and observational cohorts during 8 years of follow-up.

 

Figure-3-Secondary-Outcomes-in-the-Randomized-and-Observational-Cohorts.

Figure 3: secondary outcomes (Sciatica Bothersomeness, Satisfaction with Symptoms, and Self-rated Global Improvement) in the randomized and observational cohorts during 8 years of follow-up.

 

Table 4 Primary Analysis Results for Years 1 to 8

Table 4: Primary analysis results for years 1 to 8. Intent-to-treat for the randomized cohort and adjusted* analyses according to treatment received for the randomized and observational cohorts combined.

 

As-Treated Analysis The adjusted as-treated effects seen in the randomized and observational were similar. Accordingly, the cohorts were combined for the final analyses. Treatment effects for the primary outcomes in the combined as-treated analysis were clinically meaningful and statistically significant out to 8 years: SF-36 BP 10.9 p < 0.001 (95% CI 7.7 to 14); SF-36 PF 10.6 p<0.001 (95% CI 7.7 to 13.5); ODI ?11.3 p<0.001 (95% CI ?13.6 to ?9.1) (Table 4). The footnote for Table 4 describes the adjusting covariates selected for the final model.

 

Results from the intent-to-treat and as-treated analyses of the two cohorts are compared in Figure 2. In the combined analysis, treatment effects were statistically significant in favor of surgery for all primary and secondary outcome measures (with the exception of work status which did not differ between treatment groups) at each time point (Table 4 and Figure 3).

 

Loss-to-Follow-Up

 

At the 8-year follow-up, 63% of initial enrollees supplied data, with losses due to dropouts, missed visits, or deaths. Table 5 summarized the baseline characteristics of those lost to follow-up compared to those retained in the study at 8-years. Those who remained in the study at 8 years were – somewhat older; more likely to be female, white, college educated, and working at baseline; less likely to be disabled, receiving compensation, or a smoker; less symptomatic at baseline with somewhat less bodily pain, better physical function, less disability on the ODI, better mental health, and less sciatica bothersomeness. These differences were small but statistically significant. Table 6 summarizes the short-term outcomes during the first 2 years for those retained in the study at 8 years compared to those lost to follow-up. Those lost to follow-up had worse outcomes on average; however this was true in both the surgical and non-operative groups with non-significant differences in treatment effects. The long-term outcomes are therefore likely to be somewhat over-optimistic on average in both groups, but the comparison between surgical and non-operative outcomes appear likely to be un-biased despite the long-term loss to follow-up.

 

Table 5 Patient Baseline Demographic Characteristics, Comorbidities and Health Status Measures

Table 5: Patient baseline demographic characteristics, comorbidities, and health status measures according to patient follow-up status as of 02/01/2013 when the IDH8yr data were pulled.

 

Table 6 Time Weighted Average of Treatment Effects

Table 6: Time-weighted average of treatment effects at 2 years (AUC) from adjusted* as-treated randomized and observational cohorts combined primary outcome analysis, according to treatment received and patient follow-up status.

 

Discussion

 

In patients with a herniated disc confirmed by imaging and leg symptoms persisting for at least 6 weeks, surgery was superior to non-operative treatment in relieving symptoms and improving function. In the as-treated analysis, the treatment effect for surgery was seen as early as 6 weeks, appeared to reach a maximum by 6 months and persisted over 8 years; it is notable that the non-operative group also improved significantly and this improvement persisted with little to no degradation of outcomes in either group (operative and non-operative) between 4 and 8 years. In the longitudinal intention-to-treat analysis, all the outcomes showed small advantages for surgery, but only the secondary outcomes of sciatica bothersomeness, satisfaction with symptoms, and self-rated improvement were statistically significant. The persistent small benefit in the surgery group over time has made the overall intention-to-treat comparison more statistically significant over time despite high levels of cross-over. The large effects seen in the as-treated analysis after adjustments for characteristics of the crossover patients suggest that the intent-to-treat analysis may underestimate the true effect of surgery since the mixing of treatments due to crossover can be expected to create a bias toward the null in the intent-to-treat analyses.[4,19] Loss to follow-up among patients who were somewhat worse at baseline and with worse short-term outcomes probably leads to overly-optimistic estimated long-term outcomes in both surgery and non-operative groups but unbiased estimates of surgical treatment effects.

 

Comparisons to Other Studies

 

There are no other long-term randomized studies reporting the same primary outcome measures as SPORT. The results of SPORT primary outcomes at 2 years were quite similar to those of Peul et al but longer follow up for the Peul study is necessary for further comparison.[4,20] In contrast to the Weber study, the differences in the outcomes in SPORT between treatment groups remained relatively constant between 1 and 8 years of follow-up. One of the factors in this difference may be the sensitivity of the outcome measures � for example, sciatica bothersomeness, which was significantly different out to 8 years in the intention-to-treat, may be a more sensitive marker of treatment success than the general outcome measure used by Weber et al.[2]

 

The long-term results of SPORT are similar to the Maine Lumbar Spine Study (MLSS).[21] The MLSS reported statistically significantly greater improvements at 10 years in sciatica bothersomeness for the surgery group (?11.9) compared to the nonsurgical groups (?5.8) with a treatment effect of ?6.1 p=0.004; in SPORT the improvement in sciatica bothersomeness in the surgical group at 8 years was similar to the 10 year result in MLSS (?11) though the non-operative cohort in SPORT did better than their MLSS counterparts (?9.1) however the treatment effect in SPORT, while smaller, remained statistically significant (?1.5; p<0.001) due to the much larger sample size. Greater improvements in the non-operative cohorts between SPORT and MLSS may be related to differences in non-operative treatments over time, differences between the two cohorts since the MLSS and did not require imaging confirmation of IDH.

 

Over the 8 years there was little evidence of harm from either treatment. The 8-year rate of re-operation was 14.7%, which is lower than the 25% reported by MLSS at 10 years.[22]

 

Limitations

 

Although our results are adjusted for characteristics of cross over patients and control for important baseline covariates, the as-treated analyses presented do not share the strong protection from confounding that exists for an intent-to-treat analysis.[4�6] However, However, intent-to-treat analyses are known to be biased in the presence of noncompliance at the level observed in SPORT, and our adjusted as-treated analyses have been shown to produce accurate results under reasonable assumptions about the dependence of compliance on longitudinal outcomes.[23] Another potential limitation is the heterogeneity, of the non-operative treatment interventions, as discussed in our prior papers.[5,6,8] Finally, attrition in this long-term follow-up study meant that only 63% of initial enrollees supplied data at 8 years with losses due to dropouts, missed visits, or deaths; based on analyses at baseline and at short-term follow-up, this likely leads to somewhat overly-optimistic estimated long-term outcomes in both treatment groups but an unbiased estimation of surgical treatment effect.

 

Conclusions

 

In the intention-to-treat analysis, small, statistically insignificant surgical treatment effects were seen for the primary outcomes but statistically significant advantages for sciatica bothersomeness, satisfaction with symptoms, and self-rated improvement were seen out to 8 years despite high levels of treatment cross-over. The as-treated analysis combining the randomized and observational cohorts, which carefully controlled for potentially confounding baseline factors, showed significantly greater improvement in pain, function, satisfaction, and self-rated progress over 8 years compared to patients treated non-operatively. The non-operative group, however, also showed substantial improvements over time, with 54% reporting being satisfied with their symptoms and 73% satisfied with their care after 8 years.

 

Acknowledgments

 

The National Institute of Arthritis and Musculoskeletal and Skin Diseases (U01-AR45444; P60-AR062799) and the Office of Research on Women�s Health, the National Institutes of Health, and the National Institute of Occupational Safety and Health, the Centers for Disease Control and Prevention grant funds were received in support of this work. Relevant financial activities outside the submitted work: consultancy, grants, stocks.

 

This study is dedicated to the memories of Brieanna Weinstein and Harry Herkowitz, leaders in their own rights, who simply made the world a better place.

 

Footnotes

 

Other comorbidities include: stroke, diabetes, osteoporosis, cancer, fibromyalgia, cfs, PTSD, alcohol, drug dependency, heart, lung, liver, kidney, blood vessel, nervous system, hypertension, migraine, anxiety, stomach, bowel

 

In conclusion, individuals who suffer from migraine pain require the most effective type of treatment in order to help improve as well as manage their symptoms, particularly if their migraines were elicited from a lumbar herniated disc. The purpose of the following articles was to associate the two conditions with each other and demonstrate the results of the research above. Various treatment options can be considered before surgery for migraine pain and lumbar herniated disc 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: Neck Pain

 

Neck pain is a common complaint which can result due to a variety of injuries and/or conditions. According to statistics, automobile accident injuries and whiplash injuries are some of the most prevalent causes for neck pain among the general population. During an auto accident, the sudden impact from the incident can cause the head and neck to jolt abruptly back-and-forth in any direction, damaging the complex structures surrounding the cervical spine. Trauma to the tendons and ligaments, as well as that of other tissues in the neck, can cause neck pain and radiating symptoms throughout the human body.

 

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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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