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Clinical Case Series

Clinical Case Series Is the most basic type of study design, in which researchers describe the experience of a group of people. Case series describe individuals who develop a particular new disease or condition. This type of study can provide compelling reading because they present a detailed account of the clinical experience of individual study subjects. Dr. Alex Jimenez conducts his own case series studies.

A case study is a method of research that is commonly used in social sciences. It is a research strategy that investigates a phenomenon within a real context. They are based on in-depth investigation of a single person, group or event to explore the how of underlying problems/causes. It includes quantitative evidence and relies on multiple sources of evidence.

Case studies are an invaluable record of clinical practices of a profession. They do not provide specific guidance for the management of successive patients but they are a record of clinical interactions which help to frame questions for more rigorously designed clinical studies. They provide valuable teaching material, which demonstrate both classical and unusual information that can confront the practitioner. However, the majority of clinical interactions occur in the field and so it’s up to the practitioner to record and pass on the information.  Guidelines are intended to assist the relatively novice writer, practitioner or student to efficiently navigate the study to publication.

A Case series is a descriptive study design and its just a series of cases of any particular disease or disease discrepancy that one might observe in a clinical practice. These cases are described to suggest at best a hypothesis. However, there is no comparison group so there cannot be many conclusions about the disease or the disease process. Therefore, in terms of generating evidence regarding various aspects of a disease process this is more of a starting point. For Answers to any questions you may have please call Dr. Jimenez at 915-850-0900


Migraine Headache Treatment: Atlas Vertebrae Realignment

Migraine Headache Treatment: Atlas Vertebrae Realignment

Several types of headaches can affect the average individual and each may result due to a variety of injuries and/or conditions, however, migraine headaches can often have a much more complex reason behind them. Many healthcare professionals and numerous evidence-based research studies have concluded that a subluxation in the neck, or a misalignment of the vertebrae in the cervical spine, is the most common reason for migraine headaches. Migraine is characterized by severe head pain typically affecting one side of the head, accompanied by nausea and disturbed vision. Migraine headaches can be debilitating. The information below describes a case study regarding the effect of atlas vertebrae realignment on patients with migraine.

 

Effect of Atlas Vertebrae Realignment in Subjects with Migraine: An Observational Pilot Study

 

Abstract

 

Introduction. In a migraine case study, headache symptoms significantly decreased with an accompanying increase in intracranial compliance index following atlas vertebrae realignment. This observational pilot study followed eleven neurologist diagnosed migraine subjects to determine if the case findings were repeatable at baseline, week four, and week eight, following a National Upper Cervical Chiropractic Association intervention. Secondary outcomes consisted of migraine-specific quality of life measures. Methods. After examination by a neurologist, volunteers signed consent forms and completed baseline migraine-specific outcomes. Presence of atlas misalignment allowed study inclusion, permitting baseline MRI data collection. Chiropractic care continued for eight weeks. Postintervention reimaging occurred at week four and week eight concomitant with migraine-specific outcomes measurement. Results. Five of eleven subjects exhibited an increase in the primary outcome, intracranial compliance; however, mean overall change showed no statistical significance. End of study mean changes in migraine-specific outcome assessments, the secondary outcome, revealed clinically significant improvement in symptoms with a decrease in headache days. Discussion. The lack of robust increase in compliance may be understood by the logarithmic and dynamic nature of intracranial hemodynamic and hydrodynamic flow, allowing individual components comprising compliance to change while overall it did not. Study results suggest that the atlas realignment intervention may be associated with a reduction in migraine frequency and marked improvement in quality of life yielding significant reduction in headache-related disability as observed in this cohort. Future study with controls is necessary, however, to confirm these findings. Clinicaltrials.gov registration number is NCT01980927.

 

Introduction

 

It has been proposed that a misaligned atlas vertebra creates spinal cord distortion disrupting neural traffic of brain stem nuclei in the medulla oblongata encumbering normal physiology [1–4].

 

The objective of the National Upper Cervical Chiropractic Association (NUCCA) developed atlas correction procedure is restoration of misaligned spinal structures to the vertical axis or gravity line. Described as the “restoration principle,” realignment aims to reestablish a patient’s normal biomechanical relationship of the upper cervical spine to the vertical axis (gravity line). Restoration is characterized as being architecturally balanced, being capable of unrestricted range of motion, and allowing a significant decrease in gravitational stress [3]. The correction theoretically removes the cord distortion, created by an atlas misalignment or atlas subluxation complex (ASC), as specifically defined by NUCCA. Neurologic function is restored, specifically thought to be in the brain stem autonomic nuclei, which affect the cranial vascular system that includes Cerebrospinal Fluid (CSF) [3, 4].

 

The intracranial compliance index (ICCI) appears to be a more sensitive assessment of changes made in craniospinal biomechanical properties in symptomatic patients than the local hydrodynamic parameters of CSF flow velocities and cord displacement measurements [5]. Based on that information, previously observed relationships of increased intracranial compliance to marked reduction in migraine symptoms following atlas realignment provided incentive for using the ICCI as the study objective primary outcome.

 

ICCI affects the ability of the Central Nervous System (CNS) to accommodate physiologic volume fluctuations that occur, thereby avoiding ischemia of underlying neurologic structures [5, 6]. A state of high intracranial compliance enables any volume increase to occur in the intrathecal CNS space without causing an intracranial pressure increase that occurs primarily with arterial inflow during systole [5, 6]. Outflow occurs in the supine position via the internal jugular veins or when upright, via paraspinal or secondary venous drainage. This extensive venous plexus is valveless and anastomotic, allowing blood to flow in a retrograde direction, into the CNS through postural changes [7, 8]. Venous drainage plays an important role in regulating the intracranial fluid system [9]. Compliance appears to be functional and dependent on the free egress of blood via these extracranial venous drainage pathways [10].

 

Head and neck injury could create abnormal function of the spinal venous plexus that may impair spinal venous drainage, possibly because of autonomic dysfunction secondary to spinal cord ischemia [11]. This decreases accommodation of volume fluctuations within the cranium creating a state of decreased intracranial compliance.

 

Damadian and Chu describe return of a normal CSF outflow measured at mid-C-2, exhibiting a 28.6% reduction of the measured CSF pressure gradient in the patient where the atlas had been optimally realigned [12]. The patient reported freedom from symptoms (vertigo and vomiting when recumbent) consistent with the atlas remaining in alignment.

 

A hypertension study using the NUCCA intervention suggests a possible mechanism underlying the blood pressure decrease could be resultant from changes in cerebral circulation in relation to atlas vertebrae position [13]. Kumada et al. investigated a trigeminal-vascular mechanism in brain stem blood pressure control [14, 15]. Goadsby et al. have presented compelling evidence that migraine originates via a trigeminal-vascular system mediated through the brain stem and upper cervical spine [16–19]. Empirical observation reveals significant reduction of migraine patients’ headache disability after application of the atlas correction. Using migraine-diagnosed subjects seemed ideal for investigating proposed cerebral circulation changes following atlas realignment as originally theorized in the hypertension study conclusions and seemingly supported by a possible brain stem trigeminal-vascular connection. This would further advance a developing working pathophysiologic hypothesis of atlas misalignment.

 

Results from an initial case study demonstrated substantial increase in ICCI with decrease in migraine headache symptoms following the NUCCA atlas correction. A 62-year-old male with neurologist diagnosed chronic migraine volunteered for a before-after intervention case study. Using Phase Contrast-MRI (PC-MRI), changes in cerebral hemodynamic and hydrodynamic flow parameters were measured at baseline, 72 hours, and then four weeks after the atlas intervention. The same atlas correction procedure used in the hypertension study was followed [13]. 72 hours after study revealed a noteworthy change in the intracranial compliance index (ICCI), from 9.4 to 11.5, to 17.5 by week four, after intervention. Observed changes in venous outflow pulsatility and predominant secondary venous drainage in the supine position warranted additional investigation further inspiring a study of migraine subjects in this case series.

 

The possible effects of the atlas misalignment or ASC on venous drainage are unknown. Careful examination of intracranial compliance in relation to effects of an atlas misalignment intervention may provide insight into how the correction might influence migraine headache.

 

Using PC-MRI, this current study’s primary objective, and primary outcome, measured ICCI change from baseline to four and eight weeks following a NUCCA intervention in a cohort of neurologist selected migraine subjects. As observed in the case study, the hypothesis supposed that a subject’s ICCI would increase following the NUCCA intervention with a corresponding decrease in migraine symptoms. If present, any observed changes in venous pulsatility and drainage route were to be documented for further comparison. To monitor migraine symptoms response, the secondary outcomes included patient reported outcomes to measure any related change in Health Related Quality of Life (HRQoL), similarly used in migraine research. Throughout the study, subjects maintained headache diaries documenting the decrease (or increase) in the number of headache days, intensity, and medication used.

 

Conducting this observational case series, pilot study, allowed for additional investigation into aforementioned physiologic effects in further development of a working hypothesis into the pathophysiology of an atlas misalignment. Data required for estimation of statistically significant subject sample sizes and resolving procedural challenges will provide needed information for developing a refined protocol to conduct a blinded, placebo controlled migraine trial using the NUCCA correction intervention.

 

Methods

 

This research maintained compliance with the Helsinki Declaration for research on human subjects. The University of Calgary and Alberta Health Services Conjoint Health Research Ethics Board approved the study protocol and subject informed consent form, Ethics ID: E-24116. ClinicalTrials.gov assigned the number NCT01980927 after registration of this study (https://clinicaltrials.gov/ct2/show/NCT01980927).

 

Subject recruitment and screening occurred at the Calgary Headache Assessment and Management Program (CHAMP), a neurology-based specialist referral clinic (see Figure 1, Table 1). CHAMP evaluates patients resistant to standard pharmacotherapy and medical treatment for migraine headache that no longer provides migraine symptom relief. Family and primary care physicians referred potential study subjects to CHAMP making advertising unnecessary.

 

Figure 1 Subject Disposition and Study Flow

Figure 1: Subject disposition and study flow (n = 11). GSA: Gravity Stress Analyzer. HIT-6: Headache Impact Test-6. HRQoL: Health Related Quality of Life. MIDAS: Migraine Disability Assessment Scale. MSQL: Migraine-Specific Quality of Life Measure. NUCCA: National Upper Cervical Chiropractic Association. PC-MRI: Phase Contrast Magnetic Resonance Imaging. VAS: Visual Analog Scale.

 

Table 1 Subject Inclusion and Exclusion Criteria

Table 1: Subject inclusion/exclusion criteria. Potential subjects, naïve to upper cervical chiropractic care, demonstrated between ten and twenty-six headache days per month self-reported over the previous four months. Requisite was at least eight headache days per month, where intensity reached at least four, on a zero to ten Visual Analog Scale (VAS) pain scale.

 

Study inclusion required volunteers, between the ages of 21 and 65 years, that satisfy specific diagnostic criteria for migraine headache. A neurologist with several decades of migraine experience screened applicants utilizing the International Classification of Headache Disorders (ICHD-2) for study inclusion [20]. Potential subjects, naïve to upper cervical chiropractic care, must have demonstrated through self-report between ten and twenty-six headache days per month over the previous four months. At least eight headache days per month had to reach an intensity of at least four on a zero to ten VAS pain scale, unless treated successfully with a migraine-specific medication. At least four separate headache episodes per month separated by at least a 24-hour pain-free interval were required.

 

Significant head or neck trauma occurring within one year prior to study entry excluded candidates. Further exclusion criteria included acute medication overuse, a history of claustrophobia, cardiovascular or cerebrovascular disease, or any CNS disorder other than migraine. Table 1 describes the complete inclusion and exclusion criteria considered. Using an experienced board certified neurologist to screen potential subjects while adhering to the ICHD-2 and guided by the inclusion/exclusion criteria, the exclusion of subjects with other sources of headache such as muscular tension and medication overuse rebound headache would increase the likelihood of successful subject recruitment.

 

Those meeting initial criteria signed informed consent and then completed a baseline Migraine Disability Assessment Scale (MIDAS). The MIDAS requires twelve weeks to demonstrate clinically significant change [21]. This allowed adequate time to pass to discern any possible changes. Over the next 28 days, candidates recorded a headache diary providing baseline data while confirming the number of headache days and intensity required for inclusion. After the four weeks, the diary check diagnostic substantiation permitted administration of remaining baseline HRQoL measures:

 

  1. Migraine-Specific Quality of Life Measure (MSQL) [22],
  2. Headache Impact Test-6 (HIT-6) [23],
  3. Subject current global assessment of headache pain (VAS).

 

Referral to the NUCCA practitioner, to determine presence of atlas misalignment, confirmed need for intervention finalizing a subject’s study inclusion∖exclusion. Absence of atlas misalignment indicators excluded candidates. After scheduling appointments for NUCCA intervention and care, qualified subjects obtained baseline PC-MRI measures. Figure 1 summarizes subject disposition throughout the study.

 

The initial NUCCA intervention required three consecutive visits: (1) Day One, atlas misalignment assessment, before-correction radiographs; (2) Day Two, NUCCA correction with after-correction assessment with radiographs; and (3) Day Three, after-correction reassessment. Follow-up care occurred weekly for four weeks, then every two weeks for the remainder of the study period. At each NUCCA visit, subjects completed a current assessment of headache pain (please rate your headache pain on average over the past week) using a straight edge and pencil in marking a 100 mm line (VAS). One week after the initial intervention, subjects completed a “Possible Reaction to Care” questionnaire. This assessment has past been used for successfully monitoring adverse events related to various upper cervical correction procedures [24].

 

At week four, PC-MRI data were obtained and subjects completed an MSQL and HIT-6. End of study PC-MRI data were collected at week eight followed by a neurologist exit interview. Here, subjects completed final MSQOL, HIT-6, MIDAS, and VAS outcomes and headache diaries were collected.

 

At the week-8 neurologist visit, two willing subjects were offered a long-term follow-up opportunity for a total study period of 24 weeks. This involved further NUCCA reassessment monthly for 16 weeks after completion of the initial 8-week study. The purpose of this follow-up was to help determine if headache improvement continued contingent upon maintenance of atlas alignment while observing for any long-term effect of NUCCA care on ICCI. Subjects desiring to participate signed a second informed consent for this phase of study and continued monthly NUCCA care. At the end of 24 weeks from the original atlas intervention, the fourth PC-MRI imaging study occurred. At the neurologist exit interview, final MSQOL, HIT-6, MIDAS, and VAS outcomes and headache diaries were collected.

 

The same NUCCA procedure as previously reported was followed using the established protocol and standards of care developed through NUCCA Certification for assessment and atlas realignment or correction of the ASC (see Figures ​Figures22–5) [2, 13, 25]. Assessment for the ASC includes screening for functional leg-length inequality with the Supine Leg Check (SLC) and examination of postural symmetry using the Gravity Stress Analyzer (Upper Cervical Store, Inc., 1641 17 Avenue, Campbell River, BC, Canada V9W 4L5) (see Figures ​Figures22 and 3(a)–3(c)) [26–28]. If SLC and postural imbalances are detected, a three-view radiographic exam is indicated to determine the multidimensional orientation and degree of craniocervical misalignment [29, 30]. A thorough radiographic analysis provides information to determine a subject specific, optimal atlas correction strategy. The clinician locates anatomic landmarks from the three-view series, measuring structural and functional angles that have deviated from established orthogonal standards. The degree of misalignment and atlas orientation are then revealed in three dimensions (see Figures 4(a)–4(c)) [2, 29, 30]. Radiographic equipment alignment, reduction of collimator port size, high-speed film-screen combinations, special filters, specialized grids, and lead shielding minimize subject radiation exposure. For this study, average total measured Entrance Skin Exposure to subjects from the before-after-correction radiographic series was 352 millirads (3.52 millisieverts).

 

Figure 2 Supine Leg Check Screening Test SLC

Figure 2: Supine Leg Check Screening Test (SLC). Observation of an apparent “short leg” indicates possible atlas misalignment. These appear even.

 

Figure 3 Gravity Stress Analyzer GSA

Figure 3: Gravity Stress Analyzer (GSA). (a) Device determines postural asymmetry as a further indicator of atlas misalignment. Positive findings in the SLC and GSA indicate need for NUCCA radiographic series. (b) Balanced patient with no postural asymmetry. (c) Hip calipers used to measure pelvis asymmetry.

 

Figure 4 NUCCA Radiograph Series

Figure 4: NUCCA radiograph series. These films are used to determine atlas misalignment and developing a correction strategy. After-correction radiographs or postfilms ensure the best correction has been made for that subject.

 

Figure 5 Making a NUCCA Correction

Figure 5: Making a NUCCA correction. The NUCCA practitioner delivers a triceps pull adjustment. The practitioner’s body and hands are aligned to deliver an atlas correction along an optimal force vector using information obtained from radiographs.

 

The NUCCA intervention involves a manual correction of the radiographically measured misalignment in the anatomical structure between the skull, atlas vertebra, and cervical spine. Utilizing biomechanical principles based on a lever system, the doctor develops a strategy for proper

 

  1. subject positioning,
  2. practitioner stance,
  3. force vector to correct the atlas misalignment.

 

Subjects are placed on a side-posture table with the head specifically braced using a mastoid support system. Application of the predetermined controlled force vector for the correction realigns the skull to the atlas and neck to the vertical axis or center of gravity of the spine. These corrective forces are controlled in depth, direction, velocity, and amplitude, producing an accurate and precise reduction of the ASC.

 

Using the pisiform bone of the contact hand, the NUCCA practitioner contacts the atlas transverse process. The other hand encircles the wrist of the contact hand, to control the vector while maintaining the depth of force generated in application of the “triceps pull” procedure (see Figure 5) [3]. By understanding spinal biomechanics, the practitioner’s body and hands are aligned to produce an atlas correction along the optimal force vector. The controlled, nonthrusting force is applied along the predetermined reduction pathway. It is specific in its direction and depth to optimize the ASC reduction assuring no activation in the reactive forces of the neck muscles in response to the biomechanical change. It is understood that an optimal reduction of the misalignment promotes long-term maintenance and stability of spinal alignment.

 

Following a short rest period, an after-assessment procedure, identical to the initial evaluation, is performed. A postcorrection radiograph examination uses two views to verify return of the head and cervical spine into optimum orthogonal balance. Subjects are educated in ways to preserve their correction, thus preventing another misalignment.

 

Subsequent NUCCA visits were comprised of headache diary checks and a current assessment of headache pain (VAS). Leg length inequality and excessive postural asymmetry were used in determining the need for another atlas intervention. The objective for optimal improvement is for the subject to maintain the realignment for as long as possible, with the fewest number of atlas interventions.

 

In a PC-MRI sequence, contrast media are not used. PC-MRI methods collected two data sets with different amounts of flow sensitivity acquired by relating gradient pairs, which sequentially dephase and rephase spins during the sequence. The raw data from the two sets are subtracted to calculate a flow rate.

 

An on-site visit by the MRI Physicist provided training for the MRI Technologist and a data transfer procedure was established. Several practice scans and data transfers were performed to ensure data collection succeeded without challenges. A 1.5-tesla GE 360 Optima MR scanner (Milwaukee, WI) at the study imaging center (EFW Radiology, Calgary, Alberta, Canada) was used in imaging and data collection. A 12-element phased array head coil, 3D magnetization-prepared rapid-acquisition gradient echo (MP-RAGE) sequence was used in anatomy scans. Flow sensitive data were acquired using a parallel acquisition technique (iPAT), acceleration factor 2.

 

To measure blood flow to and from the skull base, two retrospectively gated, velocity-encoded cine-phase-contrast scans were performed as determined by individual heart rate, collecting thirty-two images over a cardiac cycle. A high-velocity encoding (70 cm/s) quantified high-velocity blood flow perpendicular to the vessels at the C-2 vertebra level includes the internal carotid arteries (ICA), vertebral arteries (VA), and internal jugular veins (IJV). Secondary venous flow data of vertebral veins (VV), epidural veins (EV), and deep cervical veins (DCV) were acquired at the same height using a low-velocity encoding (7–9 cm/s) sequence.

 

Subject data were identified by Subject Study ID and imaging study date. The study neuroradiologist reviewed MR-RAGE sequences to rule out exclusionary pathologic conditions. Subject identifiers were then removed and assigned a coded ID permitting transfer via a secured tunnel IP protocol to the physicist for analysis. Using proprietary software volumetric blood, Cerebrospinal Fluid (CSF) flow rate waveforms and derived parameters were determined (MRICP version 1.4.35 Alperin Noninvasive Diagnostics, Miami, FL).

 

Using the pulsatility-based segmentation of lumens, time-dependent volumetric flow rates were calculated by integrating the flow velocities inside the luminal cross-sectional areas over all thirty-two images. Mean flow rates were obtained for the cervical arteries, primary venous drainage, and secondary venous drainage pathways. Total cerebral blood flow was obtained by summation of these mean flow rates.

 

A simple definition of compliance is a ratio of volume and pressure changes. Intracranial compliance is calculated from the ratio of the maximal (systolic) intracranial volume change (ICVC) and pressure fluctuations during the cardiac cycle (PTP-PG). Change in ICVC is obtained from momentary differences between volumes of blood and CSF entering and exiting the cranium [5, 31]. Pressure change during the cardiac cycle is derived from the change in the CSF pressure gradient, which is calculated from the velocity-encoded MR images of the CSF flow, using the Navier-Stokes relationship between derivatives of velocities and the pressure gradient [5, 32]. An intracranial compliance index (ICCI) is calculated from the ratio of ICVC and pressure changes [5, 31–33].

 

Statistical analysis considered several elements. ICCI data analysis involved a one-sample Kolmogorov-Smirnov test revealing a lack of normal distribution in the ICCI data, which were therefore described using the median and interquartile range (IQR). Differences between baseline and follow-up were to be examined using a paired t-test.

 

NUCCA assessments data were described using mean, median, and interquartile range (IQR). Differences between baseline and follow-up were examined using a paired t-test.

 

Depending on the outcome measure, baseline, week four, week eight, and week twelve (MIDAS only) follow-up values were described using the mean and standard deviation. MIDAS data collected at initial neurologist screening had one follow-up score at the end of twelve weeks.

 

Differences from baseline to each follow-up visit were tested using a paired t-test. This resulted in numerous p values from two follow-up visits for each outcome except the MIDAS. Since one purpose of this pilot is to provide estimates for future research, it was important to describe where differences occurred, rather than to use a one-way ANOVA to arrive at a single p value for each measure. The concern with such multiple comparisons is the increase in Type I error rate.

 

To analyze the VAS data, each subject scores were examined individually and then with a linear regression line that adequately fits the data. Use of a multilevel regression model with both random intercepts and random slope provided an individual regression line fitted for each patient. This was tested against a random intercept-only model, which fits a linear regression line with a common slope for all subjects, while intercept terms are allowed to vary. The random coefficient model was adopted, as there was no evidence that random slopes significantly improved the fit to the data (using a likelihood ratio statistic). To illustrate the variation in the intercepts but not in the slope, the individual regression lines were graphed for each patient with an imposed average regression line on top.

 

Results

 

From initial neurologist screening, eighteen volunteers were eligible for inclusion. After completion of baseline headache diaries, five candidates did not meet inclusion criteria. Three lacked the required headache days on baseline diaries to be included, one had unusual neurological symptoms with persistent unilateral numbness, and another was taking a calcium channel blocker. The NUCCA practitioner found two candidates ineligible: one lacking an atlas misalignment and the second with a Wolff-Parkinson-White condition and severe postural distortion (39°) with recent involvement in a severe high impact motor vehicle accident with whiplash (see Figure 1).

 

Eleven subjects, eight females and three males, average age forty-one years (range 21–61 years), qualified for inclusion. Six subjects presented chronic migraine, reporting fifteen or more headache days a month, with a total eleven-subject mean of 14.5 headache days a month. Migraine symptom duration ranged from two to thirty-five years (mean twenty-three years). All medications were maintained unchanged for the study duration to include their migraine prophylaxis regimens as prescribed.

 

Per exclusion criteria, no subjects included received a diagnosis of headache attributed to traumatic injury to the head and neck, concussion, or persistent headache attributed to whiplash. Nine subjects reported a very remote past history, greater than five years or more (average of nine years) prior to neurologist screen. This included sports-related head injuries, concussion, and/or whiplash. Two subjects indicated no prior head or neck injury (see Table 2).

 

Table 2 Subject Intracranial Compliance Index ICCI Data

Table 2: Subject intracranial compliance index (ICCI) data (n = 11). PC-MRI6 acquired ICCI1 data reported at baseline, week four, and week eight following NUCCA5 intervention. Bolded rows signify subject with secondary venous drainage route. MVA or mTBI occurred at least 5 years prior to study inclusion, average 10 years.

 

Individually, five subjects demonstrated an increase in ICCI, three subject’s values remained essentially the same, and three showed a decrease from baseline to end of study measurements. Overall changes in intracranial compliance are seen in Table 2 and Figure 8. The median (IQR) values of ICCI were 5.6 (4.8, 5.9) at baseline, 5.6 (4.9, 8.2) at week four, and 5.6 (4.6, 10.0) at week eight. Differences were not statistically different. The mean difference between baseline and week four was −0.14 (95% CI −1.56, 1.28), p = 0.834, and between baseline and week eight was 0.93 (95% CI −0.99, 2.84), p = 0.307. These two subject’s 24-week ICCI study results are seen in Table 6. Subject 01 displayed an increasing trend in ICCI from 5.02 at baseline to 6.69 at week 24, whereas at week 8, results were interpreted as consistent or remaining the same. Subject 02 demonstrated a decreasing trend in ICCI from baseline of 15.17 to 9.47 at week 24.

 

Figure 8 Study ICCI Data Compared to Previously Reported Data in the Literature

Figure 8: Study ICCI data compared to previously reported data in the literature. The MRI time values are fixed at baseline, week 4, and week 8 after intervention. This study’s baseline values fall similar to the data reported by Pomschar on subjects presenting only with mTBI.

 

Table 6 24 Week Intracranial Compliance Index ICCI Data

Table 6: 24-week ICCI findings showing an increasing trend in subject 01 whereas at end of study (week 8), results were interpreted as consistent or remaining the same. Subject 02 continued to show a decreasing trend in ICCI.

 

Table 3 reports changes in NUCCA assessments. The mean difference from before to after the intervention is as follows: (1) SLC: 0.73 inches, 95% CI (0.61, 0.84) (p < 0.001); (2) GSA: 28.36 scale points, 95% CI (26.01, 30.72) (p < 0.001); (3) Atlas Laterality: 2.36 degrees, 95% CI (1.68, 3.05) (p < 0.001); and (4) Atlas Rotation: 2.00 degrees, 95% CI (1.12, 2.88) (p < 0.001). This would indicate that a probable change occurred following the atlas intervention as based on subject assessment.

 

Table 3 Descriptive Statistics of NUCCA Assessments

Table 3: Descriptive statistics [mean, standard deviation, median, and interquartile range (IQR2)] of NUCCA1 assessments before-after initial intervention (n = 11).

 

Headache diary results are reported in Table 4 and Figure 6. At baseline subjects had mean 14.5 (SD = 5.7) headache days per 28-day month. During the first month following NUCCA correction, mean headache days per month decreased by 3.1 days from baseline, 95% CI (0.19, 6.0), p = 0.039, to 11.4. During the second month headache days decreased by 5.7 days from baseline, 95% CI (2.0, 9.4), p = 0.006, to 8.7 days. At week eight, six of the eleven subjects had a reduction of >30% in headache days per month. Over 24 weeks, subject 01 reported essentially no change in headache days while subject 02 had a reduction of one headache day a month from study baseline of seven to end of study reports of six days.

 

Figure 6 Headache Days and Headache Pain Intensity from Diary

Figure 6: Headache days and headache pain intensity from diary (n = 11). (a) Number of headache days per month. (b) Average headache intensity (on headache days). Circle indicates the mean and the bar indicates the 95% CI. Circles are individual subject scores. A significant decrease in headache days per month was noticed at four weeks, almost doubling at eight weeks. Four subjects (#4, 5, 7, and 8) exhibited a greater than 20% decrease in headache intensity. Concurrent medication use may explain the small decrease in headache intensity.

 

At baseline, mean headache intensity on days with headache, on a scale of zero to ten, was 2.8 (SD = 0.96). Mean headache intensity showed no statistically significant change at four (p = 0.604) and eight (p = 0.158) weeks. Four subjects (#4, 5, 7, and 8) exhibited a greater than 20% decrease in headache intensity.

 

Quality of life and headache disability measures are seen in Table 4. The mean HIT-6 score at baseline was 64.2 (SD = 3.8). At week four after NUCCA correction, mean decrease in scores was 8.9, 95% CI (4.7, 13.1), p = 0.001. Week-eight scores, compared to baseline, revealed mean decrease by 10.4, 95% CI (6.8, 13.9), p = 0.001. In the 24-week group, subject 01 showed a decrease of 10 points from 58 at week 8 to 48 at week 24 while subject 02 decreased 7 points from 55 at week 8 to 48 at week 24 (see Figure 9).

 

Figure 9 24 Week HIT 6 Scores in Long Term Follow Up Subjects

Figure 9: 24-week HIT-6 scores in long-term follow-up subjects. Monthly scores continued to decrease after week 8, end of first study. Based on Smelt et al. criteria, it can be interpreted that a within-person minimally important change occurred between week 8 and week 24. HIT-6: Headache Impact Test-6.

 

MSQL mean baseline score was 38.4 (SD = 17.4). At week four after correction, mean scores for all eleven subjects increased (improved) by 30.7, 95% CI (22.1, 39.2), p < 0.001. By week eight, end of study, mean MSQL scores had increased from baseline by 35.1, 95% CI (23.1, 50.0), p < 0.001, to 73.5. The follow-up subjects continued to show some improvement with increasing scores; however, many scores plateaued remaining the same since week 8 (see Figures 10(a)–10(c)).

 

Figure 10 24 Week MSQL Scores in Long Term Follow p Subjects

Figure 10: ((a)–(c)) 24-week MSQL scores in long-term follow-up subjects. (a) Subject 01 has essentially plateaued after week 8 throughout to end of the second study. Subject 02 shows scores increasing over time demonstrating minimally important differences based on Cole et al. criteria by week 24. (b) Subject scores seem to peak by week 8 with both subjects showing similar scores reported at week 24. (c) Subject 2 scores remain consistent throughout the study while subject 01 shows steady improvement from baseline to the end of week 24. MSQL: Migraine-Specific Quality of Life Measure.

 

Mean MIDAS score at baseline was 46.7 (SD = 27.7). At two months after NUCCA correction (three months following baseline), the mean decrease in subject’s MIDAS scores was 32.1, 95% CI (13.2, 51.0), p = 0.004. The follow-up subjects continued to show improvement with decreasing scores with intensity showing minimal improvement (see Figures 11(a)–11(c)).

 

Figure 11 24 Week MIDAS Scores in Long Term Follow Up Subjects

Figure 11: 24-week MIDAS scores in long-term follow-up subjects. (a) Total MIDAS scores continued a decreasing trend over the 24-week study period. (b) Intensity scores continued improvement. (c) While 24-week frequency was higher than at week 8, improvement is observed when compared to baseline. MIDAS: Migraine Disability Assessment Scale.

 

Assessment of current headache pain from VAS scale data is seen in Figure 7. The multilevel linear regression model showed evidence of a random effect for the intercept (p < 0.001) but not for the slope (p = 0.916). Thus, the adopted random intercept model estimated a different intercept for each patient but a common slope. The estimated slope of this line was −0.044, 95% CI (−0.055, −0.0326), p < 0.001, indicating that there was a significant decrease in the VAS score of 0.44 per 10 days after baseline (p < 0.001). The mean baseline score was 5.34, 95% CI (4.47, 6.22). The random effects analysis showed substantial variation in the baseline score (SD = 1.09). As the random intercepts are normally distributed, this indicates that 95% of such intercepts lie between 3.16 and 7.52 providing evidence of substantial variation in the baseline values across patients. VAS scores continued showing improvement in the 24-week two-subject follow-up group (see Figure 12).

 

Figure 7 Subject Global Assessment of Headache VAS

Figure 7: Subject global assessment of headache (VAS) (n = 11). There was substantial variation in baseline scores across these patients. The lines show individual linear fit for each of eleven patients. The thick dotted black line represents the average linear fit across all eleven patients. VAS: Visual Analog Scale.

 

Figure 12 24 Week Follow Up Group Global Assessment of Headache VAS

Figure 12: 24-week follow-up group global assessment of headache (VAS). When subjects were queried, “please rate your headache pain on average over the past week” VAS scores continued showing improvement in the 24-week two-subject follow-up group.

 

The most obvious reaction to the NUCCA intervention and care reported by ten subjects was mild neck discomfort, rated an average of three out of ten on pain assessment. In six subjects, pain began more than twenty-four hours after the atlas correction, lasting more than twenty-four hours. No subject reported any significant effect on their daily activities. All subjects reported satisfaction with NUCCA care after one week, median score, ten, on a zero to ten rating scale.

 

Dr Jimenez White Coat

Dr. Alex Jimenez’s Insight

“I’ve been experiencing migraine headaches for several years now. Is there a reason for my head pain? What can I do to decrease or get rid of my symptoms?” Migraine headaches are believed to be a complex form of head pain, however, the reason for them is much the same as any other type of headache. A traumatic injury to the cervical spine, such as that of whiplash from an automobile accident or a sports injury, can cause a misalignment in the neck and upper back, which may lead to migraine. An improper posture can also cause neck issues which could lead to head and neck pain. A healthcare professional who specializes in spinal health issues can diagnose the source of your migraine headaches. Furthermore, a qualified and experienced specialist can perform spinal adjustments as well as manual manipulations to help correct any misalignments of the spine which could be causing the symptoms. The following article summarizes a case study based on the improvement of symptoms after atlas vertebrae realignment in participants with migraine.

 

Discussion

 

In this limited cohort of eleven migraine subjects, there was no statistically significant change in ICCI (primary outcome) after the NUCCA intervention. However, a significant change in HRQoL secondary outcomes did occur as summarized in Table 5. The consistency in the magnitude and direction of improvement across these HRQoL measures indicates confidence in enhancement of headache health over the two-month study following the 28-day baseline period.

 

Table 5 Summary Comparison of Measured Outcomes

Table 5: Summary Comparison of Measured Outcomes

 

Based on the case study results, this investigation hypothesized a significant increase in ICCI after the atlas intervention which was not observed. Use of PC-MRI allows quantification of the dynamic relationship between arterial inflow, venous outflow, and CSF flow between the cranium and the spinal canal [33]. Intracranial compliance index (ICCI) measures the brain’s ability to respond to incoming arterial blood during systole. Interpretation of this dynamic flow is represented by a monoexponential relationship existing between CSF volume and CSF pressure. With increased or higher intracranial compliance, also defined as good compensatory reserve, the incoming arterial blood can be accommodated by the intracranial contents with a smaller change in intracranial pressure. While a change in intracranial volume or pressure could occur, based on the exponential nature of the volume-pressure relationship, a change in after-intervention ICCI may not be realized. An advanced analysis of the MRI data and further study are required for pinpointing practical quantifiable parameters to use as an objective outcome sensitive for documenting a physiologic change following atlas correction.

 

Koerte et al. reports of chronic migraine patients demonstrate a significantly higher relative secondary venous drainage (paraspinal plexus) in the supine position when compared to age- and gender-matched controls [34]. Four study subjects exhibited a secondary venous drainage with three of those subjects demonstrating notable increase in compliance after intervention. The significance is unknown without further study. Similarly, Pomschar et al. reported that subjects with mild traumatic brain injury (mTBI) demonstrate an increased drainage through the secondary venous paraspinal route [35]. The mean intracranial compliance index appears significantly lower in the mTBI cohort when compared to controls.

 

Some perspective may be gained in comparison of this study’s ICCI data to previously reported normal subjects and those with mTBI seen in Figure 8 [5, 35]. Limited by the small number of subjects studied, the significance these study’s findings may have in relation to Pomschar et al. remains unknown, offering only speculation of possibilities for future exploration. This is further complicated by the inconsistent ICCI change observed in the two subjects followed for 24 weeks. Subject two with a secondary drainage pattern exhibited a decrease in ICCI following intervention. A larger placebo controlled trial with a statistically significant subject sample size could possibly demonstrate a definitive objectively measured physiologic change after application of the NUCCA correction procedure.

 

HRQoL measures are used clinically to assess the effectiveness of a treatment strategy to decrease pain and disability related to migraine headache. It is expected that an effective treatment improves patient perceived pain and disability measured by these instruments. All HRQoL measures in this study demonstrated significant and substantial improvement by week four following the NUCCA intervention. From week four to week eight only small improvements were noted. Again, only small improvements were noted in the two subjects followed for 24 weeks. While this study was not intended to demonstrate causation from the NUCCA intervention, the HRQoL results create compelling interest for further study.

 

From the headache diary, a significant decrease in headache days per month was noticed at four weeks, almost doubling at eight weeks. However, significant differences in headache intensity over time were not discernable from this diary data (see Figure 5). While the number of headaches decreased, subjects still used medication to maintain headache intensity at tolerable levels; hence, it is supposed that a statistically significant difference in headache intensity could not be determined. Consistency in the headache day numbers occurring in week 8 in the follow-up subjects could guide future study focus in determining when maximum improvement occurs to help in establishing a NUCCA standard of migraine care.

 

Clinically relevant change in the HIT-6 is important for completely understanding observed outcomes. A clinically meaningful change for an individual patient has been defined by the HIT-6 user guide as ≥5 [36]. Coeytaux et al., using four different analysis methods, suggest that a between-group difference in HIT-6 scores of 2.3 units over time may be considered clinically significant [37]. Smelt et al. studied primary care migraine patient populations in developing suggested recommendations using HIT-6 score changes for clinical care and research [38]. Dependent on consequences resulting from false positives or negatives, within-person minimally important change (MIC) using a “mean change approach” was estimated to be 2.5 points. When using the “receiver operating characteristic (ROC) curve analysis” a 6-point change is needed. Recommended between-group minimally important difference (MID) is 1.5 [38].

 

Using the “mean change approach,” all subjects but one reported a change (decrease) greater than −2.5. The “ROC analyses” also demonstrated improvement by all subjects but one. This “one subject” was a different person in each comparison analysis. Based on Smelt et al. criteria, the follow-up subjects continued to demonstrate within-person minimally important improvement as seen in Figure 10.

 

All subjects but two showed improvement on the MIDAS score between baseline and three-month results. The magnitude of the change was proportional to the baseline MIDAS score, with all subjects but three reporting an overall fifty percent or greater change. The follow-up subjects continued to show improvement as seen in continued decrease in scores by week 24; see Figures 11(a)–11(c).

 

Use of the HIT-6 and MIDAS together as a clinical outcome may provide a more complete assessment of headache-related disability factors [39]. The differences between the two scales can predict disability from headache pain intensity and headache frequency, by providing more information on factors related to the reported changes than either outcome used alone. While the MIDAS appears to change more by headache frequency, headache intensity seems to affect HIT-6 score more than the MIDAS [39].

 

How migraine headache affects and limits patient perceived daily functioning is reported by the MSQL v. 2.1, across three 3 domains: role restrictive (MSQL-R), role preventive (MSQL-P), and emotional functioning (MSQL-E). An increase in scores indicates improvement in these areas with values ranging from 0 (poor) to 100 (best).

 

MSQL scales reliability evaluation by Bagley et al. report results to be moderately to highly correlated with HIT-6 (r = −0.60 to −0.71) [40]. Study by Cole et al. reports minimally important differences (MID) clinical change for each domain: MSQL-R = 3.2, MSQL-P = 4.6, and MSQL-E = 7.5 [41]. Results from the topiramate study report individual minimally important clinical (MIC) change: MSQL-R = 10.9, MSQL-P = 8.3, and MSQL-E = 12.2 [42].

 

All subjects except one experienced an individual minimally important clinical change for MSQL-R of greater than 10.9 by the week-eight follow-up in MSQL-R. All but two subjects reported changes of more than 12.2 points in MSQL-E. Improvement in MSQL-P scores increased by ten points or more in all subjects.

 

Regression analysis of VAS ratings over time showed a significant linear improvement over the 3-month period. There was substantial variation in baseline scores across these patients. Little to no variation was observed in the rate of improvement. This trend appears to be the same in the subjects studied for 24 weeks as seen in Figure 12.

 

Dr Jimenez works on wrestler's neck

 

Many studies using pharmaceutical intervention have shown a substantial placebo effect in patients from migrainous populations [43]. Determining possible migraine improvement over six months, using another intervention as well as no intervention, is important for any comparison of results. The investigation into placebo effects generally accepts that placebo interventions do provide symptomatic relief but do not modify pathophysiologic processes underlying the condition [44]. Objective MRI measures may help in revealing such a placebo effect by demonstrating a change in physiologic measurements of flow parameters occurring after a placebo intervention.

 

Use of a three-tesla magnet for MRI data collection would increase the reliability of the measurements by increasing the amount of data used to make the flow and ICCI calculations. This is one of the first investigations using change in ICCI as an outcome in evaluating an intervention. This creates challenges in interpretation of MRI acquired data to base conclusions or further hypothesis development. Variability in relationships between blood flow to and from the brain, CSF flow, and heart rate of these subject-specific parameters has been reported [45]. Variations observed in a small three-subject repeated measures study have led to conclusions that information gathered from individual cases be interpreted with caution [46].

 

The literature further reports in larger studies significant reliability in collecting these MRI acquired volumetric flow data. Wentland et al. reported that measurements of CSF velocities in human volunteers and of sinusoidally fluctuating phantom velocities did not differ significantly between two MRI techniques used [47]. Koerte et al. studied two cohorts of subjects imaged in two separate facilities with different equipment. They reported that intraclass correlation coefficients (ICC) demonstrated a high intra- and interrater reliability of PC-MRI volumetric flow rate measurements remaining independent of equipment used and skill-level of the operator [48]. While anatomic variation exists between subjects, it has not prevented studies of larger patient populations in describing possible “normal” outflow parameters [49, 50].

 

Being based solely on patient subjective perceptions, there are limitations in using patient reported outcomes [51]. Any aspect affecting a subject’s perception in their quality of life is likely to influence the outcome of any assessment used. Lack of outcome specificity in reporting symptoms, emotions, and disability also limits interpretation of results [51].

 

Imaging and MRI data analysis costs precluded use of a control group, limiting any generalizability of these results. A larger sample size would allow for conclusions based on statistical power and reduced Type I error. Interpretation of any significance in these results, while revealing possible trends, remains speculation at best. The big unknown persists in the likelihood that these changes are related to the intervention or to some other effect unknown to the investigators. These results do add to the body of knowledge of previously unreported possible hemodynamic and hydrodynamic changes after a NUCCA intervention, as well as changes in migraine HRQoL patient reported outcomes as observed in this cohort.

 

The values of collected data and analyses are providing information required for estimation of statistically significant subject sample sizes in further study. Resolved procedural challenges from conducting the pilot allow for a highly refined protocol to successfully accomplish this task.

 

In this study, the lack of robust increase in compliance may be understood by the logarithmic and dynamic nature of intracranial hemodynamic and hydrodynamic flow, allowing individual components comprising compliance to change while overall it did not. An effective intervention should improve subject perceived pain and disability related to migraine headache as measured by these HRQoL instruments used. These study results suggest that the atlas realignment intervention may be associated with reduction in migraine frequency, marked improvement in quality of life yielding significant reduction in headache-related disability as observed in this cohort. The improvement in HRQoL outcomes creates compelling interest for further study, to confirm these findings, especially with a larger subject pool and a placebo group.

 

Acknowledgments

 

The authors acknowledge Dr. Noam Alperin, Alperin Diagnostics, Inc., Miami, FL; Kathy Waters, Study Coordinator, and Dr. Jordan Ausmus, Radiography Coordinator, Britannia Clinic, Calgary, AB; Sue Curtis, MRI Technologist, Elliot Fong Wallace Radiology, Calgary, AB; and Brenda Kelly-Besler, RN, Research Coordinator, Calgary Headache Assessment and Management Program (CHAMP), Calgary, AB. Financial support is provided by (1) Hecht Foundation, Vancouver, BC; (2) Tao Foundation, Calgary, AB; (3) Ralph R. Gregory Memorial Foundation (Canada), Calgary, AB; and (4) Upper Cervical Research Foundation (UCRF), Minneapolis, MN.

 

Abbreviations

 

  • ASC: Atlas subluxation complex
  • CHAMP: Calgary Headache Assessment and Management Program
  • CSF: Cerebrospinal Fluid
  • GSA: Gravity Stress Analyzer
  • HIT-6: Headache Impact Test-6
  • HRQoL: Health Related Quality of Life
  • ICCI: Intracranial compliance index
  • ICVC: Intracranial volume change
  • IQR: Interquartile range
  • MIDAS: Migraine Disability Assessment Scale
  • MSQL: Migraine-Specific Quality of Life Measure
  • MSQL-E: Migraine-Specific Quality of Life Measure-Emotional
  • MSQL-P: Migraine-Specific Quality of Life Measure-Physical
  • MSQL-R: Migraine-Specific Quality of Life Measure-Restrictive
  • NUCCA: National Upper Cervical Chiropractic Association
  • PC-MRI: Phase Contrast Magnetic Resonance Imaging
  • SLC: Supine Leg Check
  • VAS: Visual Analog Scale.

 

Conflict of Interests

 

The authors declare that there are no financial or any other competing interests regarding the publication of this paper.

 

Authors’ Contribution

 

H. Charles Woodfield III conceived the study, was instrumental in its design, helped in coordination, and helped to draft the paper: introduction, study methods, results, discussion, and conclusion. D. Gordon Hasick screened subjects for study inclusion/exclusion, provided NUCCA interventions, and monitored all subjects on follow-up. He participated in study design and subject coordination, helping to draft the Introduction, NUCCA Methods, and Discussion of the paper. Werner J. Becker screened subjects for study inclusion/exclusion, participated in study design and coordination, and helped to draft the paper: study methods, results and discussion, and conclusion. Marianne S. Rose performed statistical analysis on study data and helped to draft the paper: statistical methods, results, and discussion. James N. Scott participated in study design, served as the imaging consultant reviewing scans for pathology, and helped to draft the paper: PC-MRI methods, results, and discussion. All authors read and approved the final paper.

 

In conclusion, the case study regarding the improvement of migraine headache symptoms following atlas vertebrae realignment demonstrated an increase in the primary outcome, however, the average results of the research study also demonstrated no statistical significance. Altogether, the case study concluded that patients who received atlas vertebrae realignment treatment experienced considerable improvement in symptoms with decreased headache days. 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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Chiropractic Spinal Manipulative Therapy for Migraine

Chiropractic Spinal Manipulative Therapy for Migraine

Headaches can be a real aggravating issue, especially if these begin to occur more frequently. Even more so, headaches can become a bigger problem when the common type of head pain becomes a migraine. Head pain is often a symptom resulting from an underlying injury and/or condition along the cervical spine, or upper back and neck. Fortunately, a variety of treatment methods are available to help treat headaches. Chiropractic care is a well-known alternative treatment option which is commonly recommended for neck pain, headaches and migraines. The purpose of the following research study is to determine the effectiveness of chiropractic spinal manipulative therapy for migraine.

Chiropractic Spinal Manipulative Therapy for Migraine: a Study Protocol of a Single-Blinded Placebo-Controlled Randomised Clinical Trial

 

Abstract

 

Introduction

 

Migraine affects 15% of the population, and has substantial health and socioeconomic costs. Pharmacological management is first-line treatment. However, acute and/or prophylactic medicine might not be tolerated due to side effects or contraindications. Thus, we aim to assess the efficacy of chiropractic spinal manipulative therapy (CSMT) for migraineurs in a single-blinded placebo-controlled randomised clinical trial (RCT).

 

Method and Analysis

 

According to the power calculations, 90 participants are needed in the RCT. Participants will be randomised into one of three groups: CSMT, placebo (sham manipulation) and control (usual non-manual management). The RCT consists of three stages: 1 month run-in, 3 months intervention and follow-up analyses at the end of the intervention and 3, 6 and 12 months. The primary end point is migraine frequency, while migraine duration, migraine intensity, headache index (frequency x duration x intensity) and medicine consumption are secondary end points. Primary analysis will assess a change in migraine frequency from baseline to the end of the intervention and follow-up, where the groups CSMT and placebo and CSMT and control will be compared. Owing to two group comparisons, p values below 0.025 will be considered statistically significant. For all secondary end points and analyses, a p value below 0.05 will be used. The results will be presented with the corresponding p values and 95% CIs.

 

Ethics and Dissemination

 

The RCT will follow the clinical trial guidelines from the International Headache Society. The Norwegian Regional Committee for Medical Research Ethics and the Norwegian Social Science Data Services have approved the project. Procedure will be conducted according to the declaration of Helsinki. The results will be published at scientific meetings and in peer-reviewed journals.

 

Trial Registration Number

 

NCT01741714.

Keywords: Statistics & Research Methods

 

Strengths and Limitations of this Study

 

  • The study will be the first three-armed manual therapy randomised clinical trial (RCT) assessing the efficacy of chiropractic spinal manipulative therapy versus placebo (sham manipulation) and control (continue usual pharmacological management without receiving manual intervention) for migraineurs.
  • Strong internal validity, since a single chiropractor will conduct all interventions.
  • The RCT has the potential to provide a non-pharmacological treatment option for migraineurs.
  • Risk for dropouts is increased due to strict exclusion criteria and 17 months duration of the RCT.
  • A generally accepted placebo has not been established for manual therapy; thus, there is a risk for unsuccessful blinding, while the investigator who provides the interventions cannot be blinded for obvious reasons.

 

Background

 

Migraine is a common health problem with substantial health and socioeconomic costs. On the recent Global Burden of Disease study, migraine was ranked as the third most common condition.[1]

 

Image of a woman with a migraine demonstrated by lightning coming out of her head.

 

About 15% of the general population have migraine.[2, 3] Migraine is usually unilateral with pulsating and moderate/severe headache which is aggravated by routine physical activity, and is accompanied by photophobia and phonophobia, nausea and sometimes vomiting.[4] Migraine exists in two major forms, migraine without aura and migraine with aura (below). Aura is reversible neurological disturbances of the vision, sensory and/or speech function, occurring prior to the headache. However, intraindividual variations from attack to attack are common.[5, 6] The origin of migraine is debated. The painful impulses may originate from the trigeminal nerve, central and/or peripheral mechanisms.[7, 8] Extracranial pain sensitive structures include the skin, muscles, arteries, periosteum and joints. The skin is sensitive to all usual forms of pain stimuli, while temporal and neck muscles may especially be sources for pain and tenderness in migraine.[9–11] Similarly, the frontal supraorbital, superficial temporal, posterior and occipital arteries are sensitive to pain.[9, 12]

 

Notes

 

The International Classification of Headache Disorders-II Diagnostic Criteria for Migraine

 

Migraine without Aura

  • A. At least five attacks fulfilling criteria B–D
  • B. Headache attacks lasting 4–72 h (untreated or unsuccessfully treated)
  • C. Headache has at least two of the following characteristics:
  • 1. Unilateral location
  • 2. Pulsating quality
  • 3. Moderate or severe pain intensity
  • 4. Aggravated by or causing avoidance of routine physical activity
  • D. During headache at least one of the following:
  • 1. Nausea and/or vomiting
  • 2. Photophobia and phonophobia
  • E. Not attributed to another disorder
  • Migraine with aura
  • A. At least two attacks fulfilling criteria B–D
  • B. Aura consisting of at least one of the following, but no motor weakness:
  • 1. Fully reversible visual symptoms including positive features (ie, flickering lights, spots or lines) and/or negative features (ie, loss of vision). Moderate or severe pain intensity
  • 2. Fully reversible sensory symptoms including positive features (ie, pins and needles) and/or negative features (ie, numbness)
  • 3. Fully reversible dysphasic speech disturbance
  • C. At least two of the following:
  • 1. Homonymous visual symptoms and/or unilateral sensory symptoms
  • 2. At least one aura symptom develops gradually over ≥5 min and/or different aura symptoms occur in succession over ≥5 min
  • 3. Each symptom lasts ≥5 and ≤60 min
  • D. Headache fulfilling criteria B-D for 1.1 Migraine without aura begins during the aura or follows the aura within 60 min
  • E. Not attributed to another disorder

 

Pharmacological management is the first treatment option for migraineurs. However, some patients do not tolerate acute and/or prophylactic medicine due to side effects or contraindications due to comorbidity of other diseases or due to a wish to avoid medication for other reasons. The risk of medication overuse due to frequent migraine attacks represents a major health hazard with direct and indirect cost concerns. The prevalence of medication overuse headache (MOH) is 1–2% in the general population,[13–15] that is, about half the population suffering chronic headache (15 headache days or more per month) have MOH.[16] Migraine causes loss of 270 workdays per year per 1000 persons from the general population.[17] This corresponds to about 3700 work years lost per year in Norway due to migraine. The economic cost per migraineur was estimated to be $655 in USA and €579 in Europe per year.[18, 19] Owing to the high prevalence of migraine, the total cost per year was estimated to be $14.4 billion in the USA and €27 billion in the EU countries, Iceland, Norway and Switzerland at that time. Migraine costs more than neurological disorders such as dementia, multiple sclerosis, Parkinson’s disease and stroke.[20] Thus, non-pharmacological treatment options are warranted.

 

The Diversified technique and the Gonstead method are the two most commonly used chiropractic manipulative treatment modalities in the profession, used by 91% and 59%, respectively,[21, 22] along with other manual and non-manual interventions, that is, soft tissue techniques, spinal and peripheral mobilisation, rehabilitation, postural corrections and exercises as well as general nutrition and dietetic advice.

 

A few spinal manipulative therapy (SMT) randomised controlled trials (RCTs) using the Diversified technique have been conducted for migraine, suggesting an effect on migraine frequency, migraine duration, migraine intensity and medicine consumption.[23–26] However, common for previous RCTs are the methodological shortcomings such as inaccurate headache diagnosis, that is, questionnaire diagnoses used are imprecise,[27] inadequate or no randomisation procedure, lack of placebo group, and primary and secondary end points not prespecified.[28–31] In addition, previous RCTs did not consequently adhere to the recommended clinical guidelines from the International Headache Society (IHS).[32, 33] At present, no RCTs have applied the Gonstead chiropractic SMT (CSMT) method. Thus, considering the methodological shortcomings in previous RCTs, a clinical placebo-controlled RCT with improved methodological quality remains to be conducted for migraine.

 

The SMT mechanism of action on migraine is unknown. It is argued that migraine might originate from a complexity of nociceptive afferent responses involving the upper cervical spine (C1, C2 and C3), leading to a hypersensitivity state of the trigeminal pathway conveying sensory information for the face and much of the head.[34, 35] Research has thus suggested that SMT may stimulate neural inhibitory systems at different spinal cord levels, and might activate various central descending inhibitory pathways.[36–40] However, although the proposed physiological mechanisms are not fully understood, there are most likely additional unexplored mechanisms which could explain the effect SMT has on mechanical pain sensitisation.

 

Double image of a woman with a migraine and a diagram showcasing the human brain during a migraine.

 

The objective of this study is to assess the efficacy of CSMT versus placebo (sham manipulation) and controls (continue usual pharmacological management without receiving manual intervention) for migraineurs in an RCT.

 

Method and Design

 

This is a single-blinded placebo-controlled RCT with three parallel groups (CSMT, placebo and control). Our primary hypothesis is that CSMT gives at least 25% reduction in the average number of migraine days per month (30 days/month) as compared to placebo and control from baseline to the end of intervention, and we expect the same reduction to be maintained at 3, 6 and 12 months follow-up. If the CSMT treatment is effective, it will be offered to participants who received placebo or control after study completion, that is, after 12 months follow-up. The study will adhere to the recommended clinical trial guidelines from the IHS,32 33 and the methodological CONSORT and SPIRIT guidelines.[41, 42]

 

Patient Population

 

Participants will be recruited in the period January to September 2013 through the Akershus University Hospital, through general practitioners and media advertisement, that is, posters with general information will be put up at general practitioners’ offices along with oral information in the Akershus and Oslo counties, Norway. Participants will receive posted information about the project followed by a short telephone interview. Those recruited from the general practitioners’ offices will have to contact the clinical investigator whose contact details have been provided on the posters in order to obtain extensive information about the study.

 

Eligible participants are between 18 and 70 years of age and have at least one migraine attack per month. Participants are diagnosed according to the diagnostic criteria of the International Classification of Headache Disorders (ICHD-II) by a neurologist at the Akershus University Hospital.[43] They are only allowed to have co-occurrence of tension-type headache and not other primary headaches.

 

Exclusion criteria are contraindication to SMT, spinal radiculopathy, pregnancy, depression and CSMT within the previous 12 months. Participants whom during the RCT receive any manual interventions by physiotherapists, chiropractors, osteopaths or other health professionals to treat musculoskeletal pain and disability, including massage therapy, joint mobilisation and manipulation,[44] changed their prophylactic headache medicine or pregnancy will be withdrawn from the study at that time and be regarded as dropouts. They are allowed to continue and change their usual acute migraine medication throughout the trial.

 

In response to initial contact, participants fulfilling the inclusion criteria will be invited to further assessment by the chiropractic investigator. The assessment includes an interview and a physical examination with special emphasis on the whole spinal column. Oral and written information about the project will be provided in advance and oral and written consent will be obtained from all accepted participants during the interview and by the clinical investigator. In accordance with good clinical practice, all patients will be informed about the harms and benefits as well as possible adverse reactions of the intervention primarily including local tenderness and tiredness on the treatment day. No serious adverse events have been reported for the chiropractic Gonstead method.[45, 46] Participants randomised into active or placebo interventions will undergo a full spine radiographic examination and be scheduled for 12 intervention sessions. The control group will not be exposed to this assessment.

 

Clinical RCT

 

The clinical RCT consists of a 1 month run-in and 3 months intervention. Time profile will be assessed from baseline to the end of follow-up for all end points (Figure 1).

 

Figure 1 Study Flow Chart

Figure 1: Study flow chart. CSMT, chiropractic spinal manipulative therapy; Placebo, sham manipulation; Control, continue usual pharmacological management without receiving manual intervention.

 

Run-In

 

The participants will fill in a validated diagnostic paper headache diary 1 month prior to intervention which will be used as baseline data for all participants.[47, 48] The validated diary includes questions directly related to the primary and secondary end points. X-rays will be taken in standing position in the anterioposterior and lateral planes of the entire spine. The X-rays will be assessed by the chiropractic investigator.

 

Randomisation

 

Prepared sealed lots with the three interventions, that is, active treatment, placebo and the control group, will be subdivided into four subgroups by age and gender, that is, 18–39 and 40–70 years of age and men and women, respectively. Participants will be equally allocated to the three groups by allowing the participant to draw one lot only. The block randomisation will be administrated by an external trained party with no involvement from the clinical investigator.

 

Intervention

 

Active treatment consists of CSMT using the Gonstead method,[21] that is, a specific contact, high-velocity, low-amplitude, short-lever spinal with no postadjustment recoil directed to spinal biomechanical dysfunction (full spine approach) as diagnosed by standard chiropractic tests.

 

The placebo intervention consists of sham manipulation, that is, a broad non-specific contact, low-velocity, low-amplitude sham push manoeuvre in a non-intentional and non-therapeutic directional line. All the non-therapeutic contacts will be performed outside the spinal column with adequate joint slack and without soft tissue pretension so that no joint cavitations occur. In some sessions, the participant lay either prone on a Zenith 2010 HYLO bench with the investigator standing at the participant’s right side with his left palm placed on the participant’s right lateral scapular edge with the other hand reinforcing. In other sessions, the investigator will stand at the participant’s left side and place his right palm over the participant’s left scapular edge with the left hand reinforcing, delivering a non-intentional lateral push manoeuvre. Alternatively, the participant lay in the same side posture position as the active treatment group with the bottom leg straight and the top leg flexed with the top leg’s ankle resting on the bottom leg’s knee fold, in preparation for a side posture push move, which will be delivered as a non-intentional push in the gluteal region. The sham manipulation alternatives will be equally interchanged among the placebo participants according to protocol during the 12-week treatment period to strengthen the study validity. The active and the placebo groups will receive the same structural and motion assessment prior to and after each intervention. No additional cointerventions or advice will be given to participants during the trial period. The treatment period will include 12 consultations, that is, twice per week in the first 3 weeks followed by once a week in the next 2 weeks and once every second week until 12 weeks are reached. Fifteen minutes will be allocated per consultation for each participant. All interventions will be conducted at the Akershus University Hospital and administered by an experienced chiropractor (AC).

 

Image of an older man receiving chiropractic care for migraine relief.

 

Dr Jimenez works on wrestler's neck_preview

 

The control group will continue usual care, that is, pharmacological management without receiving manual intervention by the clinical investigator. The same exclusion criteria apply for the control group during the whole study period.

 

Blinding

 

After each treatment session, the participants who receive active or placebo intervention will complete a de-blinding questionnaire administrated by an external trained independent party with no involvement from the clinical investigator, that is, providing a dichotomous ‘yes’ or ‘no’ answer as to whether active treatment was received. This response was followed by a second question regarding how certain they were that active treatment was received on a 0–10 numeric rating scale (NRS), where 0 represents absolutely uncertain and 10 represents absolutely certainty. The control group and the clinical investigator can for obvious reasons not be blinded.[49, 50]

 

Follow-Up

 

Follow-up analysis will be conducted on the end points measured after the end of intervention and at 3, 6 and 12 months follow-up. During this period, all participants will continue to fill in a diagnostic paper headache diary and return it on a monthly basis. In the case of unreturned diary or missing values in the diary, the participants will be contacted immediately on detection to minimise recall bias. Participants will be contacted by phone to secure compliance.

 

Primary and Secondary End Points

 

The primary and secondary end points are listed below. The end points adhere to the recommended IHS clinical trial guidelines.[32, 33] We define number of migraine days as the primary end point and expect at least a 25% reduction in average number of days from baseline to the end of intervention, with the same level of reduction being maintained at follow-up. On the basis of previous reviews on migraine, a 25% reduction is considered to be a conservative estimate.[30] A 25% reduction is also expected in secondary end points from baseline to the end of intervention, retaining at follow-up for migraine duration, migraine intensity and headache index, where the index is calculated as number of migraine days (30 days)×average migraine duration (hours per day)×average intensity (0–10 NRS). A 50% reduction in medication consumption from baseline to the end of intervention and to follow-up is expected.

 

Notes

 

Primary and Secondary End Points

 

Primary End Points

  • 1. Number of migraine days in active treatment versus placebo group.
  • 2. Number of migraine days in active treatment versus control group.

Secondary End Points

  • 3. Migraine duration in hours in active treatment versus placebo group.
  • 4. Migraine duration in hours in active treatment versus control group.
  • 5. Self-reported VAS in active treatment versus placebo group.
  • 6. Self-reported VAS in active treatment versus control group.
  • 7. Headache index (frequency x duration x intensity) in active treatment versus placebo group.
  • 8. Headache index in active treatment versus control group.
  • 9. Headache medication dosage in active treatment versus placebo group.
  • 10. Headache medication dosage in active treatment versus control group.

 

*The data analysis is based on the run-in period versus end of intervention. Point 11–40 will be duplicate of point 1–10 above at 3, 6 and 12 months follow-up, respectively.

 

Data Processing

 

A flow chart of the participants is shown in Figure 2. Baseline demographic and clinical characteristics will be tabulated as means and SDs for continuous variables and proportions and percentages for categorical variables. Each of three groups will be described separately. Primary and secondary end points will be presented by suitable descriptive statistics in each group and for each time point. Normality of end points will be assessed graphically and transformation will be considered if necessary.

 

Figure 2 Expected Participant's Flow Diagram

Figure 2: Expected participant’s flow diagram. CSMT, chiropractic spinal manipulative therapy; Placebo, sham manipulation; Control, continue usual pharmacological management without receiving manual intervention.

 

Change in primary and secondary end points from baseline to the end of intervention and to follow-up will be compared between the active and placebo groups and the active and control groups. The null hypothesis states that there is no significant difference between the groups in average change, while the alternative hypothesis states that a difference of at least 25% exists.

 

Owing to the follow-up period, repeated recordings of primary and secondary end points will be available, and analyses of trend in primary and secondary end points will be of main interest. Intra-individual correlations (cluster effect) are likely to be present in data with repeated measurements. Cluster effect will thus be assessed by calculating intraclass correlation coefficient quantifying the proportion of total variation attributable to the intraindividual variations. The trend in end points will be assessed by a linear regression model for longitudinal data (linear mixed model) to correctly account for the possible cluster effect. The linear mixed model handles unbalanced data, enabling all available information from randomised patients to be included, as well as from dropouts. Regression models with fixed effects for time component and group allocation as well as the interaction between the two will be estimated. The interaction will quantify possible differences between groups regarding time trend in the end points and serve as an omnibus test. Random effects for patients will be included to adjust the estimates for intraindividual correlations. Random slopes will be considered. The linear mixed models will be estimated by the SAS PROC MIXED procedure. The two pairwise comparisons will be performed by deriving individual time point contrasts within each group with the corresponding p values and 95% CIs.

 

Both per-protocol and intention-to-treat analyses will be conducted if relevant. All analyses will be performed by a statistician, blinded for group allocation and participants. All adverse effects will also be registered and presented. Participants who experience any sort of adverse effects during the trial period will be entitled to call the clinical investigator on the project cell phone. The data will be analysed with SPSS V.22 and SAS V.9.3. Owing to two group comparisons in the primary end point, p values below 0.025 will be considered statistically significant. For all secondary end points and analyses, a significance level of 0.05 will be used. Missing values might appear in incomplete interview questionnaires, incomplete headache diaries, missed intervention sessions and/or due to dropouts. The pattern of missingness will be assessed and missing values handled adequately.

 

Power Calculation

 

Sample size calculations are based on the results in a recently published group comparison study on topiramate.[51] We hypothesise that the average difference in reduction of number of days with migraine per month between the active and the placebo groups is 2.5 days. The same difference is assumed between the active and control groups. SD for reduction in each group is assumed to be equal to 2.5. Under the assumption of, on average, 10 migraine days per month at baseline in each group and no change in the placebo or control group during the study, 2.5 days reduction corresponds to a reduction by 25%. Since primary analysis includes two group comparisons, we set a significance level at 0.025. A sample size of 20 patients is required in each group to detect a statistically significant average difference in reduction of 25% with 80% power. To allow for dropouts, the investigators plan to recruit 120 participants.

 

Dr Jimenez White Coat

Dr. Alex Jimenez’s Insight

“I’ve been recommended to seek chiropractic care for my migraine-type headaches. Is chiropractic spinal manipulative therapy effective for migraine?” Many different types of treatment options can be utilized to effectively treat migraine, however, chiropractic care is one of the most popular treatment approaches for naturally treating migraine. Chiropractic spinal manipulative therapy is the traditional high-velocity low-amplitude (HVLA) thrust. Also known as spinal manipulation, a chiropractor performs this chiropractic technique by applying a controlled sudden force to a joint while the body is positioned in a specific way. According to the following article, chiropractic spinal manipulative therapy can effectively help treat migraine.

 

Discussion

 

Methodological Considerations

 

Current SMT RCTs on migraine suggest treatment efficacy regarding migraine frequency, duration and intensity. However, a firm conclusion requires clinical single-blinded placebo-controlled RCTs with few methodological shortcomings.[30] Such studies should adhere to the recommended IHS clinical trial guidelines with migraine frequency as the primary end point and migraine duration, migraine intensity, headache index and medication consumption as secondary end points.[32, 33] The headache index, as well as a combination of frequency, duration and intensity, gives an indication of the total level of suffering. Despite the lack of consensus, the headache index has been recommended as an accepted standard secondary end point.[33, 52, 53] The primary and secondary end points will be collected prospectively in a validated diagnostic headache diary for all participants in order to minimise recall bias.[47, 48] To the best of our knowledge, this is the first prospective manual therapy in a three-armed single-blinded placebo-controlled RCT to be conducted for migraine. The study design adheres to the recommendations for pharmacological RCTs as far as possible. RCTs that include a placebo group and a control group are advantageous to pragmatic RCTs that compare two active treatment arms. RCTs also provide the best approach for producing safety as well as efficacy data.

 

Image of a woman with a migraine holding her head.

 

Unsuccessful blinding is a possible risk to the RCT. Blinding is often difficult as there is no single validated standardised chiropractic sham intervention which can be used as a control group for this date. It is, however, necessary to include a placebo group in order to produce a true net effect of the active intervention. Consensus about an appropriate placebo for a clinical trial of SMT among experts representing clinicians and academics has, however, not been reached.[54] No previous studies have, to the best of our knowledge, validated a successful blinding of a CSMT clinical trial with multiple treatment sessions. We intend to minimise this risk by following the proposed protocol for the placebo group.

 

The placebo response is furthermore high in pharmacological and assumed similarly high for non-pharmacological clinical studies; however, it might even be higher in manual therapy RCTs were attention and physical contact is involved.[55] Similarly, a natural concern with regard to attention bias will be involved for the control group as it is not being seen by anyone or not seen as much by the clinical investigator as the other two groups.

 

There are always risks for dropouts due to various reasons. Since the trial duration is 17 months with a 12 month follow-up period, the risk for loss to follow-up is thus enhanced. Co-occurrence of other manual intervention during the trial period is another possible risk, as those who receive manipulation or other manual physical treatments elsewhere during the trial period will be withdrawn from the study and regarded as dropouts at the time of violation.

 

The external validity of the RCT might be a weakness as there is only one investigator. However, we found that advantageous to multiple investigators, in order to provide similar information to participants in all three groups and manual intervention in the CSMT and the placebo groups. Thus, we intend to eliminate inter-investigator variability which might be present if there are two or more investigators. Although the Gonstead method is the second most commonly used technique among chiropractors, we do not see an issue of concern when it comes to generalisability and external validity. Furthermore, the block randomisation procedure will provide a homogeneous sample across the three groups.

 

The internal validity is, however, strong by having one treating clinician. It reduces the risk of potential selection, information and experimental biases. Furthermore, the diagnosis of all participants is performed by experienced neurologists and not by questionnaires. A direct interview has higher sensitivity and specificity as compared to a questionnaire.[27] Individual motivational factors which can influence a participant’s perception and personal preferences when treating are both reduced by having one investigator. In addition, the internal validity is further strengthened by a concealed validated randomisation procedure. Since age and genders may play a role in migraine, block randomisation was found necessary to balance arms by age and gender in order to reduce possible age-related and/or gender-related bias.

 

Image of X-rays demonstrating loss of cervical lordosis as a possible cause for migraine.

X-rays demonstrating loss of cervical lordosis as a possible cause for migraine.

 

Conducting X-rays prior to the active and placebo interventions was found to be applicable in order to visualise posture, joint and disc integrity.[56, 57] Since the total X-ray radiation dose varies from 0.2–0.8 mSv, the radiation exposure was considered low.[58, 59] X-ray assessments were also found to be necessary in order to determine if full spine X-rays are useful in future studies or not.

 

Since we are unaware of the mechanisms of possible efficacy, and both spinal cord and central descending inhibitory pathways have been postulated, we see no reasons to exclude a full spine treatment approach for the intervention group. It has furthermore been postulated that pain in different spinal regions should not be regarded as separate disorders but rather as a single entity.[60] Similarly, including a full spine approach limits the differentiations between the CSMT and the placebo groups. Thus, it might strengthen the likelihood of successful blinding in the placebo group being achieved. In addition, all the placebo contacts will be performed outside the spinal column, thus minimising a possible spinal cord afferent input.

 

Innovative and Scientific Value

 

This RCT will highlight and validate the Gonstead CSMT for migraineurs, which has not previously been studied. If CSMT proves to be effective, it will provide a non-pharmacological treatment option. This is especially important as some migraineurs do not have efficacy of prescript acute and/or prophylactic medications, while others have non-tolerable side effects or comorbidity of other diseases that contradict medication while others wish to avoid medication for various reasons. Thus, if CSMT works, it can really have an impact on migraine treatment. The study also bridges cooperation between chiropractors and physicians, which is important in order to make healthcare more efficient. Finally, our method might be applied in future chiropractic and other manual therapy RCTs on headache.

 

Ethics and Dissemination

 

Ethics

 

The study has been approved by the Norwegian Regional Committee for Medical Research Ethics (REK) (2010/1639/REK) and the Norwegian Social Science Data Services (11–77). The declaration of Helsinki is otherwise followed. All data will be anonymised while participants must give oral and written informed consent. Insurance is provided through “The Norwegian System of Compensation to Patients” (NPE), which is an independent national body set up to process compensation claims from patients who have suffered an injury as a result of treatment under the Norwegian health service. A stopping rule was defined for withdrawing participants from this study in accordance with recommendations in the CONSORT extension for Better Reporting of Harms.[61] If a participant reports to their chiropractor or research staff a severe adverse event, he or she will be withdrawn from the study and referred to their general practitioner or hospital emergency department depending on the nature of the event. The final data set will be available to the clinical investigator (AC), the independent and blinded statistician (JSB) and Study Director (MBR). Data will be stored in a locked cabinet at the Research Centre, Akershus University Hospital, Norway, for 5 years.

 

Dissemination

 

This project is due for completion 3 years after the start. Results will be published in peer-reviewed international scientific journals in accordance with the CONSORT 2010 Statement. Positive, negative, as well as inconclusive results will be published. In addition, a written lay summary of the results will be available to study participants on request. All authors should qualify for authorship according to the International Committee of Medical Journal Editors, 1997. Each author should have participated sufficiently in the work to take public responsibility for the content. The final decision on the order of authorship will be decided when the project has been finalised. The results from the study may, moreover, be presented as posters or oral presentations at national and/or international conferences.

 

Acknowledgments

 

Akershus University Hospital kindly provided research facilities. Chiropractor Clinic1, Oslo, Norway, performed X-ray assessments.

 

Footnotes

 

Contributors: AC and PJT had the original idea for the study. AC and MBR obtained funding. MBR planned the overall design. AC prepared the initial draft and PJT commented on the final version of the research protocol. JSB performed all the statistical analyses. AC, JSB, PJT and MBR were involved in the interpretation and assisted in the revision and preparation of the manuscript. All authors have read and approved the final manuscript.

 

Funding: The study has received funding from Extrastiftelsen (grant number: 2829002), the Norwegian Chiropractic Association (grant number: 2829001), Akershus University Hospital (grant number: N/A) and University of Oslo in Norway (grant number: N/A).

 

Competing interests: None declared.

 

Patient consent: Obtained.

 

Ethics approval: The Norwegian Regional Committee for Medical Research Ethics approved the project (ID of the approval: 2010/1639/REK).

 

Provenance and peer review: Not commissioned; externally peer reviewed.

 

A Randomized Controlled Trial of Chiropractic Spinal Manipulative Therapy for Migraine

 

Abstract

 

Objective: To assess the efficacy of chiropractic spinal manipulative therapy (SMT) in the treatment of migraine.

 

Design: A randomized controlled trial of 6 months’ duration. The trial consisted of 3 stages: 2 months of data collection (before treatment), 2 months of treatment, and a further 2 months of data collection (after treatment). Comparison of outcomes to the initial baseline factors was made at the end of the 6 months for both an SMT group and a control group.

 

Setting: Chiropractic Research Center of Macquarie University.

 

Participants: One hundred twenty-seven volunteers between the ages of 10 and 70 years were recruited through media advertising. The diagnosis of migraine was made on the basis of the International Headache Society standard, with a minimum of at least one migraine per month.

 

Interventions: Two months of chiropractic SMT (diversified technique) at vertebral fixations determined by the practitioner (maximum of 16 treatments).

 

Main Outcome Measures: Participants completed standard headache diaries during the entire trial noting the frequency, intensity (visual analogue score), duration, disability, associated symptoms, and use of medication for each migraine episode.

 

Results: The average response of the treatment group (n = 83) showed statistically significant improvement in migraine frequency (P < .005), duration (P < .01), disability (P < .05), and medication use (P< .001) when compared with the control group (n = 40). Four persons failed to complete the trial because of a variety of causes, including change in residence, a motor vehicle accident, and increased migraine frequency. Expressed in other terms, 22% of participants reported more than a 90% reduction of migraines as a consequence of the 2 months of SMT. Approximately 50% more participants reported significant improvement in the morbidity of each episode.

 

Conclusion: The results of this study support previous results showing that some people report significant improvement in migraines after chiropractic SMT. A high percentage (>80%) of participants reported stress as a major factor for their migraines. It appears probable that chiropractic care has an effect on the physical conditions related to stress and that in these people the effects of the migraine are reduced.

 

In conclusion, chiropractic spinal manipulative therapy can be used effectively to help treat migraine, according to the research study. Furthermore, chiropractic care improved the individual’s overall health and wellness. The well-being of the human body as a whole is believed to be one of the biggest factors as to why chiropractic care is effective for migraine. Information referenced from the National Center for Biotechnology Information (NCBI). The scope of our information is limited to chiropractic as well as to spinal injuries and conditions. To discuss the subject matter, please feel free to ask Dr. Jimenez or contact us at 915-850-0900 .

 

Curated by Dr. Alex Jimenez

 

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Additional Topics: 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.

 

blog picture of cartoon paperboy big news

 

IMPORTANT TOPIC: EXTRA EXTRA: A Healthier You!

 

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References
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Evaluation of the McKenzie Method for Low Back Pain

Evaluation of the McKenzie Method for Low Back Pain

Acknowledging statistical data, low back pain can be the result of a variety of injuries and/or conditions affecting the lumbar spine and its surrounding structures. Most cases of low back pain, however, will resolve on their own in a matter of weeks. But when symptoms of low back pain become chronic, its essential for the affected individual to seek treatment from the most appropriate healthcare professional. The McKenzie method has been used by many healthcare specialists in the treatment of low back pain and its effects have been recorded widely throughout various research studies. The following two articles are being presented to evaluate the McKenzie method in the treatment of LBP in comparison to other types of treatment options.

 

Efficacy of the McKenzie Method in Patients With Chronic Nonspecific Low Back Pain: A Protocol of Randomized Placebo-Controlled Trial

 

Presented Abstract

 

  • Background: The McKenzie method is widely used as an active intervention in the treatment of patients with nonspecific low back pain. Although the McKenzie method has been compared with several other interventions, it is not yet known whether this method is superior to placebo in patients with chronic low back pain.
  • Objective: The purpose of this trial is to assess the efficacy of the McKenzie method in patients with chronic nonspecific low back pain.
  • Design: An assessor-blinded, 2-arm, randomized placebo-controlled trial will be conducted.
  • Setting: This study will be conducted in physical therapy clinics in São Paulo, Brazil.
  • Participants: The participants will be 148 patients seeking care for chronic nonspecific low back pain.
  • Intervention: Participants will be randomly allocated to 1 of 2 treatment groups: (1) McKenzie method or (2) placebo therapy (detuned ultrasound and shortwave therapy). Each group will receive 10 sessions of 30 minutes each (2 sessions per week over 5 weeks).
  • Measurements: The clinical outcomes will be obtained at the completion of treatment (5 weeks) and at 3, 6, and 12 months after randomization. The primary outcomes will be pain intensity (measured with the Pain Numerical Rating Scale) and disability (measured with the Roland-Morris Disability Questionnaire) at the completion of treatment. The secondary outcomes will be pain intensity; disability and function; kinesiophobia and global perceived effect at 3, 6, and 12 months after randomization; and kinesiophobia and global perceived effect at completion of treatment. The data will be collected by a blinded assessor.
  • Limitations: Therapists will not be blinded.
  • Conclusions: This will be the first trial to compare the McKenzie method with placebo therapy in patients with chronic nonspecific low back pain. The results of this study will contribute to better management of this population.
  • Subject: Therapeutic Exercise, Injuries and Conditions: Low Back, Protocols
  • Issue Section: Protocol

 

Low back pain is a major health condition associated with a high rate of absenteeism from work and a more frequent use of health services and work leave entitlements.[1] Low back pain recently was rated by the Global Burden of Disease Study as one of the 7 health conditions that most affect the world’s population,[2] and it is considered a debilitating health condition that affects the population for the greatest number of years over a lifetime.[2] The point prevalence of low back pain in the general population is reported to be up to 18%, increasing to 31% in the last 30 days, 38% in the last 12 months, and 39% at any point in life.[3] Low back pain also is associated with high treatment costs.[4] It is estimated that in European countries, the direct and indirect costs vary from €2 to €4 billion a year.[4] The prognosis of low back pain is directly related to the duration of the symptoms.[5,6] Patients with chronic low back pain have a less favorable prognosis compared with patients with acute low back pain[5,7] and are responsible for most of the costs for management of back pain, generating the need for research aimed at finding better treatments for these patients.

 

There is a great variety of interventions for the treatment of patients with chronic low back pain, including the McKenzie method developed by Robin McKenzie in New Zealand in 1981.[8] The McKenzie method (also known as Mechanical Diagnosis and Therapy [MDT]) is an active therapy that involves repeated movements or sustained positions and has an educational component with the purpose of minimizing pain and disability and improving spinal mobility.[8] The McKenzie method involves the assessment of symptomatic and mechanical responses to repeated movements and sustained positions. Patients’ responses to this assessment are used to classify them into subgroups or syndromes called derangement, dysfunction, and posture.[8–10] Classification according to one of these groups guides the treatment principles.

 

 

Derangement syndrome is the largest group and characterized by patients who demonstrate centralization (transition of pain from distal to proximal) or disappearance of pain[11] with repeated movement testing in one direction. These patients are treated with repeated movements or sustained positions that could reduce pain. Patients classified as having dysfunction syndrome are characterized by pain that occurs only at the end of the range of motion of only one movement.[8] The pain does not change or centralize with repeated movement testing. The treatment principle for patients with dysfunction is repeated movements in the direction that generated the pain. Finally, patients classified as having postural syndrome experience intermittent pain only during sustained positioning at the end of the range of motion (eg, sustained slumped sitting).[8] The treatment principle for this syndrome consists of posture correction.[11]

 

The McKenzie method also includes a strong educational component based on the books titled The Lumbar Spine: Mechanical Diagnosis & Therapy: Volume Two[11] and Treat Your Own Back.[12] This method, unlike other therapeutic methods, aims to make the patients as independent of the therapist as possible and thus capable of controlling their pain through postural care and the practice of specific exercises for their problem.[11] It encourages patients to move the spine in the direction that is not harmful to their problem, thus avoiding movement restriction due to kinesiophobia or pain.[11]

 

Two previous systematic reviews have analyzed the effects of the McKenzie method[9,10] in patients with acute, subacute, and chronic low back pain. The review by Clare et al[9] demonstrated that the McKenzie method showed better results in short-term pain relief and improvement of disability compared with active interventions such as physical exercise. The review by Machado et al[10] showed that the McKenzie method reduced pain and disability in the short term when compared with passive therapy for acute low back pain. For chronic low back pain, the 2 reviews were unable to draw conclusions about the effectiveness of the McKenzie method due to the lack of appropriate trials. The randomized controlled trials that have investigated the McKenzie method in patients with chronic low back pain[13–17] compared the method with other interventions such as resistance training,[17] the Williams method,[14] unsupervised exercises,[16] trunk strengthening,[15] and stabilization exercises.[13] Better results in reducing pain intensity were obtained with the McKenzie method compared with resistance training,[17] the Williams method,[14] and supervised exercise.[16] However, the methodological quality of these trials[13–17] is suboptimal.

 

It is known from the literature that the McKenzie method yields beneficial results when compared with some clinical interventions in patients with chronic low back pain; however, to date, no studies have compared the McKenzie method against a placebo treatment in order to identify its actual efficacy. Clare et al[9] highlighted the need to compare the McKenzie method with placebo therapy and to study the effects of the method in the long term. In other words, it is not known whether the positive effects of the McKenzie method are due to its real efficacy or simply to a placebo effect.

 

The objective of this study will be to assess the efficacy of the McKenzie method in patients with chronic nonspecific low back pain using a high-quality randomized placebo-controlled trial.

 

Method

 

Study Design

 

This will be an assessor-blinded, 2-arm, randomized placebo-controlled trial.

 

Study Setting

 

This study will be conducted in physical therapy clinics in São Paulo, Brazil.

 

Eligibility Criteria

 

The study will include patients seeking care for chronic nonspecific low back pain (defined as pain or discomfort between the costal margins and the inferior gluteal folds, with or without referred symptoms in the lower limbs, for at least 3 months[18]), with a pain intensity of at least 3 points as measured with the 0- to 10-point Pain Numerical Rating Scale, aged between 18 and 80 years, and able to read Portuguese. Patients will be excluded if they have any contraindication to physical exercise[19] or ultrasound or shortwave therapy, evidence of nerve root compromise (ie, one or more motor, reflex, or sensation deficits), serious spinal pathology (eg, fracture, tumor, inflammatory and infectious diseases), serious cardiovascular and metabolic diseases, previous back surgery, or pregnancy.

 

Procedure

 

First, the patients will be interviewed by the study’s blinded assessor, who will determine eligibility. Eligible patients will be informed about the objectives of the study and asked to sign a consent form. Next, the patient’s sociodemographic data and medical history will be recorded. The assessor will then collect the data related to the study outcomes at the baseline assessment, after completion of 5 weeks of treatment, and 3, 6, and 12 months after randomization. With the exception of baseline measurements, all other assessments will be collected over the telephone. All data entry will be coded, entered into an Excel (Microsoft Corporation, Redmond, Washington) spreadsheet, and double-checked prior to the analysis.

 

Evaluation of the McKenzie Method for Low Back Pain Body Image 3 | El Paso, TX Chiropractor

 

Outcome Measures

 

The clinical outcomes will be measured at the baseline assessment, after treatment, and 3, 6, and 12 months after random allocation. The primary outcomes will be pain intensity (measured with the Pain Numerical Rating Scale)[20] and disability (measured with the Roland-Morris Disability Questionnaire)[21,22] after completion of 5 weeks of treatment. The secondary outcomes will be pain intensity and disability 3, 6, and 12 months after randomization and disability and function (measured by the Patient-Specific Functional Scale),[20] kinesiophobia (measured with the Tampa Scale of Kinesiophobia),[23] and global perceived effect (measured with the Global Perceived Effect Scale)[20] after treatment and 3, 6, and 12 months after randomization. On the day of the baseline assessment, each patient’s expectancy for improvement also will be assessed using the Expectancy of Improvement Numerical Scale,[24] followed by assessment using the McKenzie method.[8] Patients may experience an exacerbation of symptoms after the baseline assessment due to the MDT physical examination. All measurements were previously cross-culturally adapted into Portuguese and clinimetrically tested and are described below.

 

Pain Numerical Rating Scale

 

The Pain Numerical Rating Scale is a scale that assesses the levels of pain intensity perceived by the patient using an 11-point scale (varying from 0 to 10), in which 0 represents “no pain” and 10 represents the “worst possible pain.”[20] The participants will be instructed to select the average of pain intensity based on the last 7 days.

 

Roland-Morris Disability Questionnaire

 

This questionnaire consists of 24 items that describe daily activities that patients have difficulty performing due to low back pain.[21,22] The higher the number of affirmative answers, the higher the level of disability associated with low back pain.[21,22] The participants will be instructed to complete the questionnaire based on the last 24 hours.

 

Patient-Specific Functional Scale

 

The Patient-Specific Functional Scale is a global scale; therefore, it can be used for any part of the body.[25,26] The patients will be asked to identify up to 3 activities that they feel unable to perform or that they have difficulty performing due to their low back pain.[25,26] Measurement will be taken using Likert-type, 11-point scales for each activity, with higher average scores (ranging from 0 to 10 points) representing better ability to perform the tasks.[25,26] We will calculate the average of these activities based on the last 24 hours, with a final score ranging from 0 to 10.

 

Global Perceived Effect Scale

 

The Global Perceived Effect Scale is a Likert-type, 11-point scale (ranging from −5 to +5) that compares the patient’s current condition with his or her condition at the onset of symptoms.[20] Positive scores apply to patients who are better and negative scores apply to patients who are worse in relation to the onset of symptoms.[20]

 

Tampa Scale of Kinesiophobia

 

This scale assesses the level of kinesiophobia (fear of moving) by means of 17 questions that deal with pain and intensity of symptoms.[23] The scores from each item vary from 1 to 4 points (eg, 1 point for “strongly disagree,” 2 points for “partially disagree,” 3 points for “agree,” and 4 points for “strongly agree”).[23] For the total score, it is necessary to invert the scores of questions 4, 8, 12, and 16.[23] The final score can vary from 17 to 68 points, with higher scores representing a higher degree of kinesiophobia.[23]

 

Expectancy of Improvement Numerical Scale

 

This scale assesses the patient’s expectancy for improvement after treatment in relationship to a specific treatment.[24] It consists of an 11-point scale varying from 0 to 10, in which 0 represents “no expectancy for improvement” and 10 represents “expectancy for the greatest possible improvement.”[24] This scale will be administered only on the first day of assessment (baseline) before the randomization. The reason for including this scale is to analyze whether the expectation of improvement will influence the outcomes.

 

Random Allocation

 

Before the treatment begins, the patients will be randomly allocated to their respective intervention groups. The random allocation sequence will be implemented by one of the researchers not involved with recruiting and assessing the patients and will be generated on Microsoft Excel 2010 software. This random allocation sequence will be inserted into sequentially numbered, opaque, sealed envelopes (to ensure that allocation is concealed from the assessor). The envelopes will be opened by the physical therapist who will treat the patients.

 

Blinding

 

Given the nature of the study, it is not possible to blind the therapists to the conditions of treatment; however, the assessor and the patients will be blinded to the treatment groups. At the end of the study, the assessor will be asked whether the patients were allocated to the real treatment group or to the placebo group in order to measure assessor blinding. A visual representation of the study design is presented in the Figure.

 

Figure 1 Flow Diagram of the Study

Figure 1: Flow Diagram of the Study.

 

Interventions

 

The participants will be allocated to groups receiving 1 of 2 interventions: (1) placebo therapy or (2) MDT. Participants in each group will receive 10 sessions of 30 minutes each (2 sessions per week over 5 weeks). The studies on the McKenzie method do not have a standard number of sessions given that some studies propose low doses of treatment,[16,17,27] and others recommend higher doses.[13,15]

 

For ethical reasons, on the first day of treatment, patients from both groups will receive an information booklet called The Back Book,[28] based on the same recommendations as the existing guidelines.[29,30] This booklet will be translated into Portuguese so that it can be completely understood by the study’s participants, who will receive additional explanations regarding the content of the booklet, if needed. Patients will be asked in each session if they have felt any different symptom. The chief investigator of the study will periodically audit the interventions.

 

Placebo Group

 

The patients allocated to the placebo group will be treated with detuned pulsed ultrasound for 5 minutes and detuned shortwave diathermy in pulsed mode for 25 minutes. The devices will be used with the internal cables disconnected to obtain the placebo effect; however, it will be possible to handle them and adjust doses and alarms as if they were connected to simulate the pragmatism of clinical practice as well as to increase credibility of use of these devices on the patients. This technique has been used successfully in previous trials with patients with low back pain.[31–35]

 

McKenzie Group

 

The patients of the McKenzie group will be treated according to the principles of the McKenzie method,[8] and the choice of therapeutic intervention will be guided by the physical examination findings and classification. Patients also will receive written instructions from the Treat Your Own Back[12] book and will be asked to perform home exercises based on the principles of McKenzie method.[11] The descriptions of the exercises that will be prescribed in this study are published elsewhere.[27] Adherence to home exercises will be monitored by means of a daily log that the patient will fill in at home and bring to the therapist at each subsequent session.

 

Evaluation of the McKenzie Method for Low Back Pain Body Image 2 | El Paso, TX Chiropractor

 

Statistical Methods

 

Sample Size Calculation

 

The study was designed to detect a difference of 1 point in pain intensity measured with the Pain Numerical Rating Scale[20 ](estimate for standard deviation=1.84 points)[31] and a difference of 4 points in disability associated with low back pain measured with the Roland-Morris Disability Questionnaire[21,22] (estimate for standard deviation=4.9 points).[31] The following specifications were considered: statistical power of 80%, alpha level of 5%, and follow-up loss of 15%. Therefore, the study will require a sample of 74 patients per group (148 in total).

 

Analysis of the Effects of Treatment

 

The statistical analysis of our study will follow intention-to-treat principles.[36] The normality of the data will be tested by visual inspection of histograms, and the characterization of the participants will be calculated using descriptive statistical tests. The between-group differences (effects of treatment) and their respective 95% confidence intervals will be calculated by constructing mixed linear models[37] using interaction terms of treatment groups versus time. We will conduct a secondary exploratory analysis to assess whether patients classified as having derangement syndrome have a better response to the McKenzie method (compared with placebo) than those with other classifications. For this assessment, we will use a 3-way interaction for group, time, and classification. For all of these analyses, we will use the IBM SPSS software package, version 19 (IBM Corp, Armonk, New York).

 

Ethics

 

This study was approved by the Research Ethics Committee of the Universidade Cidade de São Paulo (#480.754) and prospectively registered at ClinicalTrials.gov (NCT02123394). Any protocol modifications will be reported to the Research Ethics Committee as well as to the trial registry.

 

Dr Jimenez White Coat

Dr. Alex Jimenez’s Insight

Low back pain is one of the most common reasons people seek immediate medical attention for every year. Although many healthcare professionals are qualified and experienced in the diagnosis of the source of the patient’s low back pain, finding the right healthcare specialist who can provide the proper treatment for the individual’s LBP can be the real challenge. A variety of treatments can be used to treat low back pain, however, a wide array of healthcare professionals have started utilizing the McKenzie method in the treatment of patients with nonspecific low back pain. The purpose of the following article is to evaluate the effectiveness of the McKenzie method for low back pain, carefully analyzing the data of the research study.

 

Discussion

 

Potential Impact and Significance of the Study

 

The existing randomized controlled trials investigating the McKenzie method in patients with chronic low back pain have all used an alternative intervention as the comparison group.[14–17] To date, no study has compared the McKenzie method with a placebo treatment in patients with low back pain in order to identify its real efficacy, which is an important gap in the literature.[9] Interpretation of the previous comparative effectiveness studies is limited by the lack of knowledge of the efficacy of the McKenzie method for people with chronic low back pain. This study will be the first to compare McKenzie method with placebo therapy in patients with chronic nonspecific low back pain. A proper comparison against a placebo group will provide more unbiased estimates of the effects of this intervention. This type of comparison has already been done in trials aiming to assess the efficacy of motor control exercises for patients with chronic low back pain,[31] spinal manipulative therapy and diclofenac for patients with acute low back pain,[38] and exercise and advice for patients with subacute low back pain.[39]

 

Contribution to the Physical Therapy Profession and for Patients

 

The McKenzie method is one of the few methods used in physical therapy that advocates for the independence of patients.[8,12] This method also provides patients with tools to promote their autonomy in managing the current pain and even future recurrences.[12] We expect that patients treated with the McKenzie method will benefit more than the patients treated with the placebo treatment. If this hypothesis is confirmed in our study, the results will contribute to better clinical decision making of physical therapists. Moreover, the approach has the potential to reduce the burden associated with the recurrent nature of low back pain if patients can better self-manage future episodes.

 

Strengths and Weaknesses of the Study

 

This trial contemplates a substantial number of patients to minimize bias, and it was prospectively registered. We will use true randomization, concealed allocation, blinded assessment, and an intention-to-treat analysis. The treatments will be conducted by 2 therapists who were extensively trained to perform the interventions. We will monitor the home exercise program. Unfortunately, due to the interventions, we will not be able to blind the therapists to the treatment allocation. It is known from the literature that the McKenzie method yields beneficial results when compared with some clinical interventions in patients with chronic low back pain.[14–17] To date, however, no studies have compared the McKenzie method with a placebo treatment in order to identify its actual efficacy.

 

Future Research

 

The intention of this study group is to submit the results of this study to a top-level, international peer-reviewed journal. These published results may provide a basis for future trials that investigate the effectiveness of the McKenzie method when delivered at different doses (different numbers of sets, repetitions, and sessions), which is still unclear in the literature. Our secondary exploratory analysis aims to assess whether patients classified as having derangement syndrome have a better response to the McKenzie method (compared with placebo treatment) than those with other classifications. This assessment will contribute to a better understanding of possible subgroups of patients with chronic low back pain who respond best to specific interventions. This is an important issue, as exploring subgroups is currently considered the most important research priority in the field of low back pain.[40]

 

This study was fully funded by São Paulo Research Foundation (FAPESP) (grant number 2013/20075-5). Ms Garcia is funded by a scholarship from the Coordination for the Improvement of Higher Education Personnel/Brazilian Government (CAPES/Brazil).

 

The study was prospectively registered at ClinicalTrials.gov (trial registration: NCT02123394).

 

Predicting a Clinically Important Outcome in Patients with Low Back Pain Following McKenzie Therapy or Spinal Manipulation: A Stratified Analysis in a Randomized Controlled Trial

 

Presented Abstract

 

  • Background: Reports vary considerably concerning characteristics of patients who will respond to mobilizing exercises or manipulation. The objective of this prospective cohort study was to identify characteristics of patients with a changeable lumbar condition, i.e. presenting with centralization or peripheralization, that were likely to benefit the most from either the McKenzie method or spinal manipulation.
  • Methods: 350 patients with chronic low back pain were randomized to either the McKenzie method or manipulation. The possible effect modifiers were age, severity of leg pain, pain-distribution, nerve root involvement, duration of symptoms, and centralization of symptoms. The primary outcome was the number of patients reporting success at two months follow-up. The values of the dichotomized predictors were tested according to the prespecified analysis plan.
  • Results: No predictors were found to produce a statistically significant interaction effect. The McKenzie method was superior to manipulation across all subgroups, thus the probability of success was consistently in favor of this treatment independent of predictor observed. When the two strongest predictors, nerve root involvement and peripheralization, were combined, the chance of success was relative risk 10.5 (95% CI 0.71-155.43) for the McKenzie method and 1.23 (95% CI 1.03-1.46) for manipulation (P = 0.11 for interaction effect).
  • Conclusions: We did not find any baseline variables which were statistically significant effect modifiers in predicting different response to either McKenzie treatment or spinal manipulation when compared to each other. However, we did identify nerve root involvement and peripheralization to produce differences in response to McKenzie treatment compared to manipulation that appear to be clinically important. These findings need testing in larger studies.
  • Trial registration: Clinicaltrials.gov: NCT00939107
  • Electronic supplementary material: The online version of this article (doi:10.1186/s12891-015-0526-1) contains supplementary material, which is available to authorized users.
  • Keywords: Low back pain, McKenzie, Spinal manipulation, Predictive value, Effect modification

 

Background

 

The most recent published guidelines for the treatment of patients with persistent non-specific low back pain (NSLBP) recommend a program focusing on self-management after initial advice and information. These patients should also be offered structured exercises tailored to the individual patient and other modalities such as spinal manipulation [1,2].

 

Previous studies have compared the effect of the McKenzie-method, also known as Mechanical Diagnosis and Therapy (MDT), with that of spinal manipulation (SM) in heterogeneous populations of patients with acute and subacute NSLBP and found no difference in outcome [3,4].

 

Evaluation of the McKenzie Method for Low Back Pain Body Image 4 | El Paso, TX Chiropractor

 

Recently, the need for studies testing the effect of treatment strategies for subgroups of patients with NSLBP in primary care has been emphasized in consensus-papers [5,6] as well as the current European guidelines [7], based on the hypothesis that subgroup analyses, preferably complying with the recommendations of “Prognostic Factor Research”[8], will improve decision making towards the most effective management strategies. Although initial data show promising results, there is presently insufficient evidence to recommend specific methods of subgrouping in primary care [1,9].

 

Three randomized studies, comprising patients with predominantly acute or subacute low back pain (LBP), have tested the effects of MDT versus SM in a subgroup of patients that presented with centralization of symptoms or directional preference (favorable response to end range motions) during physical examination [10-12]. The conclusions drawn from these studies were not in concurrence and the usefulness was limited by a low methodological quality.

 

Our recent randomized study, comprising patients with predominantly chronic LBP (CLBP), found a marginally better overall effect of MDT versus SM in an equivalent group [13]. In order to pursue the idea of subgrouping further, it was part of the study plan to explore predictors based on patient characteristics that could assist the clinician in targeting the most favorable treatment to the individual patient.

 

The objective of this study was to identify subgroups of patients with predominantly CLBP, presenting with centralization or peripheralization, which were likely to benefit from either MDT or SM two months after the completion of treatment.

 

Methods

 

Data Collection

 

The present study is a secondary analysis of a previously published randomized controlled trial [13]. We recruited 350 patients from September 2003 through May 2007 at an outpatient back care centre in Copenhagen, Denmark.

 

Patients

 

Patients were referred from primary care physicians for treatment of persistent LBP. Eligible patients were between 18 and 60 years of age, suffering from LBP with or without leg pain for a period of more than 6 weeks, able to speak and understand the Danish language, and fulfilled the clinical criteria for centralization or peripheralization of symptoms during initial screening. Centralization was defined as the abolition of symptoms in the most distal body region (such as the foot, lower leg, upper leg, buttocks, or lateral low back) and peripheralization was defined as the production of symptoms in a more distal body region. These findings have previously been found to have acceptable degree of inter-tester reliability (Kappa value 0.64) [14]. The initial screening was performed prior to randomization by a physical therapist with a diploma in the MDT examination system. Patients were excluded if they were free of symptoms at the day of inclusion, demonstrated positive non-organic signs [15], or if serious pathology, i.e. severe nerve root involvement (disabling back or leg pain in combination with progressive disturbances in sensibility, muscle strength, or reflexes), osteoporosis, severe spondylolisthesis, fracture, inflammatory arthritis, cancer, or referred pain from the viscera, was suspected based on physical examination and/or magnetic resonance imaging. Other exclusion criteria were application for disability pension, pending litigation, pregnancy, co-morbidity, recent back surgery, language problems, or problems with communication including abuse of drugs or alcohol.

 

The trial population had predominantly CLBP lasting on average 95 weeks (SD 207), mean age was 37 years (SD10), mean level of back and leg pain was 30 (SD 11.9) on a Numeric Rating Scale ranging from 0 to 60, and mean level of disability was 13 (SD 4.8) on Roland Morris Disability Questionnaire (0-23). Our method of pain measurement reflects that back pain is often a fluctuating condition where pain location and severity might vary on a daily basis. Therefore, a validated comprehensive pain questionnaire [16] was used in order to guarantee that all aspects of back and leg pain intensity were recorded. The scales are outlined in the legend to Table 1.

 

Table 1 Comparison of Distribution of Baseline Variables Between Groups

 

After baseline measures were obtained, randomisation was carried out by a computer-generated list of random numbers in blocks of ten using sealed opaque envelopes.

 

Ethics

 

Ethical approval of the study was granted by Copenhagen Research Ethics Committee, file no 01-057/03. All patients received written information about the study and gave their written consent prior to participation.

 

Treatments

 

The practitioners performing the treatments had no knowledge of the results of the initial screening. The treatment programs were designed to reflect daily practice as much as possible. Detailed information on these programs have been published earlier [13].

 

The MDT treatment was planned individually following the therapist’s pre-treatment physical assessment. Specific manual vertebral mobilization techniques including high velocity thrust were not allowed. An educational booklet describing self care [17] or a “lumbar roll” for correction of the seated position was sometimes provided to the patient at the discretion of the therapist. In the SM treatment, high velocity thrust was used in combination with other types of manual techniques. The choice of combination of techniques was at the discretion of the chiropractor. General mobilizing exercises, i.e. self-manipulation, alternating lumbar flexion/extension movements, and stretching, were allowed but not specific exercises in the directional preference. An inclined wedged pillow for correction of the seated position was available to the patients if the chiropractor believed this to be indicated.

 

In both treatment groups, patients were informed thoroughly of the results of the physical assessment, the benign course of back pain, and the importance of remaining physically active. Guidance on proper back care was also given. In addition, all patients were provided with a Danish version of “The Back Book” which previously has been shown to have beneficial effect on patients’ beliefs about back pain [18]. A maximum of 15 treatments for a period of 12 weeks were given. If considered necessary by the treating clinician, patients were educated in an individual program of self-administered mobilizing, stretching, stabilizing, and/or strengthening exercises at the end of the treatment period. Treatments were performed by clinicians with several years of experience. Patients were instructed to continue their individual exercises at home or at a gym for a minimum of two months after completion of the treatment at the back center. Because the patients suffered predominantly from CLBP we expected this period of self administered exercises to be necessary for the patients to experience the full effect of the intervention. Patients were encouraged not to seek any other kind of treatment during this two months period of self-administered exercises.

 

Evaluation of the McKenzie Method for Low Back Pain Body Image 5 | El Paso, TX Chiropractor

 

Outcome Measures

 

The primary outcome was the proportion of patients reporting success at follow-up two months after end of treatment. Treatment success was defined as a reduction of at least 5 points or a final score below 5 points on the 23-item modified Roland Morris Disability Questionnaire (RMDQ) [19]. A validated Danish version of RMDQ was used [20]. The definition of treatment success was based on the recommendations by others [21,22]. A sensitivity analysis using 30% relative improvement on RMDQ as definition of success was also performed. In accordance with the protocol [13], we considered a relative between-group difference of 15% in the number of patients with successful outcome to be minimal clinically important in our analysis of interaction.

 

Prespecified Predictor Variables

 

In order to reduce the likelihood of spurious findings [23], we restricted the number of candidate effect modifiers in the dataset to six. To increase the validity of our findings, a directional hypothesis was established for each variable according to the recommendations of Sun et al. [24] Four baseline variables have previously been suggested in randomized studies to be predictive of long term good outcome in patients with persistent LBP following MDT in comparison with strengthening training: centralization [25,26], or following SM in comparison to physiotherapy or treatment chosen by a general practitioner: age below 40 years [27,28], duration of symptoms more than 1 year [27], and pain below the knee [29]. As recommended by others [30], another two variables were added based on the participating experienced clinicians’ judgments of which characteristics they would expect to predict good outcome from their treatment compared to the other. The additional variables prioritized by the physiotherapists in the MDT group were signs of nerve root involvement and substantial leg pain. The additional variables prioritized by the chiropractors in the SM group were no signs of nerve root involvement and not substantial leg pain.

 

In a supplementary analysis, we took the opportunity to explore whether the inclusion of further six baseline variables, assumed to have prognostic value for good outcome in either of the treatment groups, would appear to have an effect modifying effect as well. To our knowledge, no further variables from previous one arm studies have been reported to have prognostic value of long term good outcome in patients with persistent LBP following MDT, whereas three variables have been reported to have prognostic value following SM: male gender [28], mild disability [28], and mild back pain [28]. Another three variables were agreed upon by the clinicians to be included in the supplementary analysis as they were assumed by experience from clinical practice to have prognostic value for good outcome regardless of treatment with MDT or SM: low number of days on sick leave past year, high patient expectations to recovery, and high patient expectations about coping with work tasks six weeks after initiation of treatment.

 

Dichotomization of possible predictor variables were made to allow for comparisons to be made with those of earlier studies. In cases where no cut off values could be found in the literature, dichotomization was performed above/below the median found in the sample. Definitions of variables are presented in the legend to Table 1.

 

Statistics

 

The entire intention-to-treat (ITT) population was used in all the analyses. The last score was carried forward for subjects with missing two months RMDQ scores (7 patients in the MDT group and 14 patients in the SM group). In addition, a post hoc per protocol analysis was carried out comprising only those 259 patients that completed the full treatment. The analysis plan was agreed in advance by the trial management group.

 

The possible predictors were dichotomized and the chance of success was investigated by estimating the relative risk (RR) of success in each of the two strata. The impact of the investigated predictors was estimated by comparing the chance of success between the treatment groups when divided into the two strata. To test for treatment effect modification of the predictors we performed chi-squared tests for interaction between intervention and the two different strata for each of the predictors. This is basically the same as an interaction from a regression model. Confidence intervals were also inspected for potential clinically important effects.

 

Following the univariate analysis, a multivariate analysis was planned including effect modifiers with a p-value below 0.1.

 

Dr. Alex Jimenez’s Insight

Low back pain can occur due to several types of injuries and/or conditions and its symptoms may be acute and/or chronic. Patients with low back pain can benefit from a variety of treatments, including chiropractic care. Chiropractic treatment is one of the most common alternative treatment options utilized to treat low back pain. According to the article, the results of the improvement of LBP with spinal adjustments and manual manipulations, along with the use of exercise, vary considerably among the participants. The focus of the following research study is to determine which patients are most likely to benefit from the McKenzie method as compared to spinal adjustments and manual manipulations.

 

Results

 

Participants were similar with respect to socio-demographic and clinical characteristics at baseline in the treatment groups. An overview of the distribution of the included dichotomized variables at baseline is provided in Table 1. No differences were found between the treatment groups.

 

Overall, the post hoc per protocol analysis did not produce outcome results that were different from the results of the ITT analysis and therefore only the results of the ITT analysis will be reported.

 

Figure 1 presents the distribution of predictors with regards to effect modification in the MDT group versus SM. In all subgroups, the probability of success with MDT was superior to that of SM. Because of low sample size, confidence intervals were wide and none of the predictors had a statistically significant treatment modifying effect. The predictors with a clinically important potential effect in favor of MDT compared to SM were nerve root involvement (28% higher proportion of patients with success when nerve root involvement was present than when absent) and peripheralization of symptoms (17% higher proportion of patients with success in case of peripheralization than in case of centralization). If present, nerve root involvement increased the chance of success following MDT 2.31 times compared to that of SM and 1.22 times if not present. This means that for the subgroup of patients with nerve root involvement receiving MDT, compared to those receiving SM, the relative effect appeared to be 1.89 times (2.31/1.22, P = 0.118) higher than for the subgroup with no nerve root involvement.

 

Figure 1 Treatment Effect Modified by Predictors

Figure 1: Treatment effect modified by predictors. The top point estimate and confidence intervals indicate overall effect without subgrouping. Subsequent pairs of point estimates and confidence intervals show the chances of treatment success.

 

Figure 2 presents the modifying effect of a composite of the two predictors with a clinically important potential effect. If signs of nerve root involvement and peripheralization were present at baseline, the chance of success with MDT compared to SM appeared 8.5 times higher than for the subgroup with no centralization and nerve root involvement. The number of patients was very small and the differences were not statistically significant (P = 0.11).

 

Figure 2 Impact of the Two Clinically Important Predictors Combined on Treatment Effect

Figure 2: Impact of the two clinically important predictors combined on treatment effect. RR = Relative Risk with Yates correction.

 

None of the prognostic candidate variables explored in the supplementary analysis appeared to have any clinically important modifying effect (Additional file 1: Table S1).

 

The results from the sensitivity analysis using 30% relative improvement on RMDQ as definition of success were not markedly different from those presented above (Additional file 2: Table S2).

 

Discussion

 

To our knowledge, this is the first study trying to identify effect modifiers when two mobilizing strategies, i.e. MDT and SM, are compared in a sample of patients with as changeable condition characterized by centralization or peripheralization.

 

Our study found that none of the potential effect modifiers were able to statistically significantly increase the overall effect of MDT compared to that of SM. However, the between-group difference for two of the variables exceeded our clinically important success-rate of 15% in number of patients with successful outcome, so our study is likely to have missed a true effect and, in that sense, did not have a large enough sample size.

 

The most apparent finding is that in our small subgroup of patients with signs of nerve root involvement, the relative chance of success appeared 1.89 times (2.31/1.22) higher than in patients with no nerve root involvement when treated with MDT, compared to those treated with SM. The difference was in the expected direction.

 

Evaluation of the McKenzie Method for Low Back Pain Body Image 7 | El Paso, TX Chiropractor

 

Although not statistically significant in our small sample, the variable peripheralization exceeded our clinically important success-rate of 15%, but was found not to be in the expected direction. No previous studies have assessed the effect modification of centralization or peripheralization in patients with CLBP. The RCT by Long et al. [25,26] concluded that patients with directional preference, including centralization, fared better 2 weeks after baseline than patients with no directional preference when treated with MDT in comparison with strengthening training. However, the outcome among peripheralizers was not reported, so the poor outcome reported in patients with no directional preference might be related to the subgroup of patients who responded with no change in symptoms during initial examination and not to those that responded with peripheralization. An alternative explanation might be that the effect modifying impact of centralization or peripheralization on MDT is dependent on the control treatment. Our findings suggest that future studies in this area need to involve predictive value of peripheralization as well as centralization.

 

When a composite of the two most promising predictors, peripheralization and signs of nerve root involvement, were present at baseline, the relative chance of success with MDT compared to SM appeared 8.5 times higher than for the subgroup with no centralization and nerve root involvement. The number of patients was very small and the confidence interval was wide. Therefore only a preliminary conclusion about interaction can be drawn and it calls for a validation in future studies.

 

In our study, there appeared to be no characteristic by which SM had better results compared to MDT. Thus, we could not support the results of two studies with a similar design as ours (two arms, sample of patients with persistent LBP, and outcome reported in terms of reduction of disability at long term follow up) [27,29]. In those studies, Nyiendo et al. [29] found a modifying effect of leg pain below knee on treatment by SM compared to that of the general practitioner six months after baseline, and Koes et al. [27] found a modifying effect of age below 40 years and symptom duration more than a year on treatment by SM compared to that of physiotherapy 12 months after baseline. However, results from those, as well as other previous RCTs comprising patients with persistent LBP, have supported our findings regarding the lack of effect modification of age [27,29,31], sex [29,31], baseline disability [27,29,31], and duration of symptoms [31], on SM when measured on reduction of disability 6-12 months after randomization. So, although evidence is emerging in patients with acute LBP regarding subgroup characteristics predictive of better results from SM compared to other types of treatment [32], we are still in the dark with respect to patients with persistent LBP.

 

The usefulness of choosing a criterion for success by combining an improvement of at least 5 points or an absolute score below 5 points on RMDQ is debatable. A total of 22 patients were considered successful based on score below 5 at follow up without having an improvement of at least 5 points. We therefore performed a sensitivity analysis using a relative improvement of at least 30% as criterion of success as recommended by others [22] (see Additional file 2: Table S2). As a result, the percentage of patients with successful outcome in the MDT group remained the same whereas 4 more patients were defined as successes in the SM group. Overall the sensitivity analysis did not produce outcome results that were markedly different from those of the primary analysis and therefore only those have been discussed above.

 

Strengths and Limitations

 

This study used data from a RCT, whereas many others have used single arm designs not suitable for the purpose of evaluating treatment effect modification [33]. In accordance with the recommendations by the PROGRESS group [8] we prespecified the possible predictors and also the direction of the effect. Furthermore, we limited the number of predictors included in order to minimize the chance of spurious findings.

 

The main limitation in secondary studies to previously conducted RCTs is that they are powered to detect overall treatment effect rather that effect modification. In recognition of the post hoc nature of our analysis, reflected in wide confidence intervals, we must emphasize that our findings are exploratory and require formal testing in a larger sample size.

 

Evaluation of the McKenzie Method for Low Back Pain Body Image 6 | El Paso, TX Chiropractor

 

Conclusions

 

In all subgroups, the probability of success with MDT was superior to that of SM. Although not statistically significant, the presence of nerve root involvement and peripheralization appear promising effect modifiers in favour of MDT. These findings need testing in larger studies.

 

Acknowledgements

 

The authors thank Jan Nordsteen and Steen Olsen for clinical expert advice, and Mark Laslett for comments and language correction.

 

This study was in part supported by grants from The Danish Rheumatism Association, The Danish Physiotherapy Organization, The Danish Foundation for Chiropractic Research and Continuous Education, and The Danish Institute for Mechanical Diagnosis and Therapy. RC/The Parker Institute acknowledge the funding support from the Oak Foundation. The funds were independent of the management, analyses, and interpretation of the study.

 

Footnotes

 

Competing interests: The authors declare that they have no competing interests.

 

Authors’ contributions: All authors were involved in the data analysis and the writing process, and the requirements for authorship have been met. All analyses were conducted by TP, RC, and CJ. TP conceived and led the study and was responsible for writing the first draft of the paper, but the other authors have participated throughout the writing process and have read and approved the final version.

 

In conclusion, the above two articles were presented in order to evaluate the McKenzie method in the treatment of LBP in comparison to other types of treatment options. The first research study compared the McKenzie method with placebo therapy in patients with low back pain, however, the results of the study still need additional evaluations. In the second research study, no significant results could predict a different response in the use of the McKenzie method. Information referenced from the National Center for Biotechnology Information (NCBI). The scope of our information is limited to chiropractic as well as to spinal injuries and conditions. To discuss the subject matter, please feel free to ask Dr. Jimenez or contact us at 915-850-0900 .

 

Curated by Dr. Alex Jimenez

 

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18. Burton AK, Waddell G, Tillotson KM, Summerton N. Information and advice to patients with back pain can have a positive effect. A randomized controlled trial of a novel educational booklet in primary care. Spine. 1999;24(23):2484–91. doi: 10.1097/00007632-199912010-00010. [PubMed] [Cross Ref] 19. Patrick DL, Deyo RA, Atlas SJ, Singer DE, Chapin A, Keller RB. Assessing health-related quality of life in patients with sciatica. Spine. 1995;20(17):1899–908. doi: 10.1097/00007632-199509000-00011. [PubMed] [Cross Ref] 20. Albert H, Jensen AM, Dahl D, Rasmussen MN. Criteria validation of the Roland Morris questionnaire. A Danish translation of the international scale for the assessment of functional level in patients with low back pain and sciatica [Kriterievalidering af Roland Morris Spørgeskemaet – Et oversat internationalt skema til vurdering af ændringer i funktionsniveau hos patienter med lændesmerter og ischias] Ugeskr Laeger. 2003;165(18):1875–80. [PubMed] 21. Bombardier C, Hayden J, Beaton DE. Minimal clinically important difference. Low back pain: outcome measures. J Rheumatol. 2001;28(2):431–8. [PubMed] 22. Ostelo RW, Deyo RA, Stratford P, Waddell G, Croft P, Von KM, et al. Interpreting change scores for pain and functional status in low back pain: towards international consensus regarding minimal important change. Spine. 2008;33(1):90–4. doi: 10.1097/BRS.0b013e31815e3a10. [PubMed] [Cross Ref] 23. Moons KG, Royston P, Vergouwe Y, Grobbee DE, Altman DG. Prognosis and prognostic research: what, why, and how? BMJ. 2009;338:1317–20. doi: 10.1136/bmj.b1317. [PubMed] [Cross Ref] 24. Sun X, Briel M, Walter SD, Guyatt GH. Is a subgroup effect believable? Updating criteria to evaluate the credibility of subgroup analyses. BMJ. 2010;340:c117. doi: 10.1136/bmj.c117. [PubMed] [Cross Ref] 25. Long A, Donelson R, Fung T. Does it matter which exercise? A randomized control trial of exercise for low back pain. Spine. 2004;29(23):2593–602. doi: 10.1097/01.brs.0000146464.23007.2a. [PubMed] [Cross Ref] 26. Long A, May S, Fung T. The comparative prognostic value of directional preference and centralization: a useful tool for front-line clinicians? J Man Manip Ther. 2008;16(4):248–54. doi: 10.1179/106698108790818332. [PMC free article] [PubMed] [Cross Ref] 27. Koes BW, Bouter LM, van Mameren H, Essers AH, Verstegen GJ, Hofhuizen DM, et al. A randomized clinical trial of manual therapy and physiotherapy for persistent back and neck complaints: subgroup analysis and relationship between outcome measures. J Manipulative Physiol Ther. 1993;16(4):211–9. [PubMed] 28. Leboeuf-Yde C, Gronstvedt A, Borge JA, Lothe J, Magnesen E, Nilsson O, et al. The nordic back pain subpopulation program: demographic and clinical predictors for outcome in patients receiving chiropractic treatment for persistent low”back pain. J Manipulative Physiol Ther. 2004;27(8):493–502. doi: 10.1016/j.jmpt.2004.08.001. [PubMed] [Cross Ref] 29. Nyiendo J, Haas M, Goldberg B, Sexton G. Pain, disability, and satisfaction outcomes and predictors of outcomes: a practice-based study of chronic low back pain patients attending primary care and chiropractic physicians. J Manipulative Physiol Ther. 2001;24(7):433–9. doi: 10.1016/S0161-4754(01)77689-0. [PubMed] [Cross Ref] 30. Foster NE, Hill JC, Hay EM. Subgrouping patients with low back pain in primary care: are we getting any better at it? Man Ther. 2011;16(1):3–8. doi: 10.1016/j.math.2010.05.013. [PubMed] [Cross Ref] 31. Underwood MR, Morton V, Farrin A. Do baseline characteristics predict response to treatment for low back pain? Secondary analysis of the UK BEAM dataset. Rheumatology (Oxford) 2007;46(8):1297–302. doi: 10.1093/rheumatology/kem113. [PubMed] [Cross Ref] 32. Slater SL, Ford JJ, Richards MC, Taylor NF, Surkitt LD, Hahne AJ. The effectiveness of sub-group specific manual therapy for low back pain: a systematic review. Man Ther. 2012;17(3):201–12. doi: 10.1016/j.math.2012.01.006. [PubMed] [Cross Ref] 33. Stanton TR, Hancock MJ, Maher CG, Koes BW. Critical appraisal of clinical prediction rules that aim to optimize treatment selection for musculoskeletal conditions. Phys Ther. 2010;90(6):843–54. doi: 10.2522/ptj.20090233. [PubMed] [Cross Ref][/accordion] [/accordions]

 

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Additional Topics: Sciatica

 

Sciatica is referred to as a collection of symptoms rather than a single type of injury or condition. The symptoms are characterized as radiating pain, numbness and tingling sensations from the sciatic nerve in the lower back, down the buttocks and thighs and through one or both legs and into the feet. Sciatica is commonly the result of irritation, inflammation or compression of the largest nerve in the human body, generally due to a herniated disc or bone spur.

 

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IMPORTANT TOPIC: EXTRA EXTRA: Treating Sciatica Pain

 

 

Pilates Chiropractor vs. McKenzie Chiropractor: Which is Better?

Pilates Chiropractor vs. McKenzie Chiropractor: Which is Better?

Low back pain, or LBP, is a very common condition which affects the lumbar spine, or the lower section of the spine. Approximately more than 3 million cases of LBP are diagnosed in the United States aline every year and about 80 percent of adults worldwide experience low back pain at some point during their lifetime. Low back pain is generally caused by injury to a muscle (strain) or ligament (sprain) or due to damage from a disease. Common causes of LBP include poor posture, lack of regular exercise, improper lifting, fracture, herniated discs and/or arthritis. Most cases of low back pain may often go away on their own, however, when LBP becomes chronic, it may be important to seek immediate medical attention. Two therapeutic methods have been utilized to improve LBP. The following article compares the effects of Pilates and McKenzie training on LBP.

 

A Comparison of the Effects of Pilates and McKenzie Training on Pain and General Health in Men with Chronic Low Back Pain: A Randomized Trial

 

Abstract

 

  • Background: Today, chronic low back pain is one of the special challenges in healthcare. There is no unique approach to treat chronic low back pain. A variety of methods are used for the treatment of low back pain, but the effects of these methods have not yet been investigated adequately.
  • Aim: The aim of this study was to compare the effects of Pilates and McKenzie training on pain and general health of men with chronic low back pain.
  • Materials and Methods: Thirty-six patients with chronic low back pain were chosen voluntarily and assigned to three groups of 12 each: McKenzie group, Pilates group, and control group. The Pilates group participated in 1-h exercise sessions, three sessions a week for 6 weeks. McKenzie group performed workouts 1 h a day for 20 days. The control group underwent no treatment. The general health of all participants was measured by the General Health Questionnaire 28 and pain by the McGill Pain Questionnaire.
  • Results: After therapeutic exercises, there was no significant difference between Pilates and McKenzie groups in pain relief (P = 0.327). Neither of the two methods was superior over the other for pain relief. However, there was a significant difference in general health indexes between Pilates and McKenzie groups.
  • Conclusion: Pilates and McKenzie training reduced pain in patients with chronic low back pain, but the Pilates training was more effective to improve general health.
  • Keywords: Chronic back pain, general health, Mckenzie training, pain, Pilates training

 

Introduction

 

Low back pain with a history of more than 3 months and without any pathological symptom is called chronic low back pain. For patient with chronic low back pain, the physician should take into consideration the likelihood of muscle pain development with spinal origin, in addition to low back pain with unknown origin. This type of pain may be mechanical (increase in pain with movement or physical pressure) or nonmechanical (increase in pain at the rest time).[1] Low back pain or spine pain is the most common musculoskeletal complication.[2] About 50%–80% of healthy people may experience low back pain during their lifetime, and about 80% of the problems are related to the spine and occur in the lumbar area.[3] Low back pain may be caused by trauma, infection, tumors, etc.[4] Mechanical injuries which are caused by overuse of a natural structure, deformity of an anatomical structure, or the injury in the soft tissue are the most common reasons for back pain. From occupational health perspective, back pain is among the most important reasons for the absence from work and occupational disability;[5] in fact, the longer the period of disease,[6] the less likely it is to improve and return to work.[1] Disability due to low back pain in addition to disturbance in doing daily and social activities has a very negative effect, from social and economic perspectives, on the patient and the community, which makes chronic low back pain highly important.[3] Today, chronic low back pain is one of the critical challenges in medicine. Patients with chronic low back pain are responsible for 80% of the costs paid for the treatment of low back pain that is also the reason for mobility restrictions in most people under 45 years.[7] In the developed countries, the overall cost paid for low back pain per year is 7.1 of total share of the gross national product. Clearly, most of the cost is related to counseling and treatment of patients with chronic low back pain rather than with intermittent and recursive low back pain.[8] The existence of various methods of treatment is because of no single cause of low back pain.[9] A variety of methods such as pharmacotherapy, acupuncture, infusions, and physical methods are the most common interventions for treatment of low back pain. However, the effects of these methods remain to be fully known.[6] An exercise program, developed based on the physical conditions of patients, can promote the quality of life in patients with chronic disease.[10,11,12,13,14]

 

 

Image of several women participating in Pilates exercises with the use of Pilates equipment. | El Paso, TX Chiropractor

 

Literature shows that the effect of exercise in controlling chronic low back pain is under study and there is strong evidence about the fact that movement therapy is effective to treat low back pain.[15] However, no specific recommendations exist about the type of exercise, and the effects of certain types of movement therapies have been determined in few studies.[9] Pilates training consists of the exercises that focus on improving flexibility and strength in all the body organs, without increasing the mass of muscles or destroying them. This training method consists of controlled movements that form a physical harmony between the body and brain, and can raise the ability of the body of people at any age.[16] In addition, people who do Pilates exercise would have better sleep and less fatigue, stress, and nervousness. This training method is based on standing, sitting, and lying positions, without intervals, jumping, and leaping; thus, it may reduce injuries resulting from the joint damage because the exercise movements in the ranges of motion in the above three positions are performed with deep breathing and muscle contraction.[17] McKenzie method, also called mechanical diagnosis and therapy and based on the patient’s active participation, is used and trusted by patients and the people who use this method worldwide. This method is based on physical therapy which has been frequently studied. The distinctive characteristic of this method is the principle of initial assessment.[18] This principle is a reliable and safe method to make a diagnosis that makes the correct treatment planning possible. In this way, the time and energy are not spent for costly tests, rather McKenzie therapists, using a valid indicator, quickly recognize that how much and how this method is fruitful for the patient. More appropriately, McKenzie method is a comprehensive approach based on the correct principles whose full understanding and following is very fruitful.[19] In the recent years, non-pharmacological approaches have attracted the attention of physicians and patients with low back pain.[20] Complementary therapies[21] and treatments with holistic nature (to increase physical and mental well-being) are appropriate to manage physical illness.[13] Complementary therapies can slow down disease progression and improve capacity and physical performance. The aim of the present study is to compare the effect of the Pilates and McKenzie training on pain and general health in men with chronic low back pain.

 

Image of several women engaging in McKenzie method exercises | El Paso, TX Chiropractor

 

Materials and Methods

 

This randomized clinical trial was conducted in Shahrekord, Iran. The total study population screened was 144. We decided to enroll at least 25% of the population, 36 individuals, using a systematic random sampling. First, the participants were numbered and a list was developed. The first case was selected using random number table and then one out of four patients was randomly enrolled. This process continued till a desired number of participants were enrolled. Then, the participants were randomly assigned to experimental (Pilates and McKenzie training) groups and control group. After explaining the research purposes to the participants, they were asked to complete the consent form for participation in the study. Furthermore, the patients were ensured that the research data are kept confidential and used only for research purposes.

 

Inclusion Criteria

 

The study population included men aged 40–55 years in Shahrekord, South-West Iran, with chronic back pain, that is, history of more than 3 months of low back pain and no specific disease or other surgery.

 

Exclusion Criteria

 

The exclusion criteria were low back arch or so-called army back, serious spinal pathology such as tumors, fractures, inflammatory diseases, previous spinal surgery, nerve root compromise in the lumbar region, spondylolysis or spondylolisthesis, spinal stenosis, neurological disorders, systemic diseases, cardiovascular diseases, and receiving other therapies simultaneously. The examiner who assessed the outcomes was blinded to group assignment. Twenty-four hours before the training, a pretest was administered to all three groups to determine pain and general health; and then, the training began after completion of the McGill Pain Questionnaire (MPQ) and the General Health Questionnaire-28 (GHQ-28). The MPQ can be used to evaluate a person experiencing significant pain. It can be used to monitor the pain over time and to determine the effectiveness of any intervention. Minimum pain score: 0 (would not be seen in a person with true pain), maximum pain score: 78, and the higher the pain score the more severe the pain. Investigators reported that the construct validity and the reliability of the MPQ were reported as a test-retest reliability of 0.70.[22] The GHQ is a self-administered screening questionnaire. Test-retest reliability has been reported to be high (0.78–0 0.9) and inter- and intra-rater reliability have both been shown to be excellent (Cronbach’s α 0.9–0.95). High internal consistency has also been reported. The lower the score is, the better the general health is.[23]

 

The participants in the experimental groups started training program under supervision of a sports medicine specialist. The training program consisted of 18 sessions of supervised individual training for both groups, with the sessions held three times per week for 6 weeks. Each training session lasted for an hour and was performed at the Physiotherapy Clinic in the School of Rehabilitation of the Shahrekord University of Medical Sciences in 2014–2015. The first experimental group performed Pilates training for 6 weeks, three times a week about an hour per session. In each session, first, a 5-min warm-up and preparation procedures were run; and at the end, stretching and walking were done to return to the baseline condition. In the McKenzie group, six exercises were used: Four extension-type exercises and two flexion-types. The extension-type exercises were performed in prone and standing positions, and the flexion-type exercises in the supine and sitting positions. Each exercise was run ten times. In addition, the participants conducted twenty daily individual training sessions for an hour.[18] After training of both groups, the participants filled out the questionnaires and then the collected data were presented in both descriptive and inferential statistics. Furthermore, the control group without any training, at the end of a period when other groups have completed, filled the questionnaire. Descriptive statistics were used for central tendency indicators such as mean (± standard deviation) and relevant diagrams were used to describe the data. Inferential statistics, one-way ANOVA and post hoc Tukey’s test, were used to analyze the data. Data analysis was done by SPSS Statistics for Windows, Version 21.0 (IBM Corp. Released 2012. IBM Armonk, NY: IBM Corp). P < 0.05 was considered statistically significant.

 

Dr. Alex Jimenez’s Insight

Alongside the use of spinal adjustments and manual manipulations for low back pain, chiropractic care commonly utilizes therapeutic exercise methods to improve LBP symptoms, restoring the affected individual’s strength, flexibility and mobility as well as promoting a faster recovery. The Pilates and McKenzie method of training, as mentioned in the article, are compared to determine which therapeutic exercise is best for treating low back pain. As a Level I Certified Pilates Instructor, Pilates training is implemented with chiropractic treatment to improve LBP more effectively. Patients participating in a therapeutic exercise method alongside a primary form of treatment for low back pain can experience additional benefits. McKenzie training can also be implemented with chiropractic treatment to further improve LBP symptoms. The purpose of this research study is to demonstrate evidence-based information on the benefits of Pilates and McKenzie methods for low back pain as well as to educate patients on which of the two therapeutic exercises should be considered to help treat their symptoms and achieve overall health and wellness.

 

Level I Certified Pilates Instructors at Our Location

 

Dr. Alex Jimenez D.C., C.C.S.T | Chief Clinical Director and Level I Certified Pilates Instructor

 

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Truide Torres | Director of Patient Relations Advocate Dept. and Level I Certified Pilates Instructor

Results

 

The results showed no significant difference between the case and control groups regarding the gender, marital status, job, educational level, and income. The results showed changes in pain index and general health in the participants before and after Pilates and McKenzie training in the two experimental and even control groups [Table 1].

 

Table 1 Mean Indexes of the Participants Before and After Intervention

 

A significant difference was seen in pain and general health between the control and the two experimental groups at the pre- and post-test, so that the exercise training (both Pilates and McKenzie) resulted in reduced pain and promoted general health; while in the control group, pain increased and general health declined.

 

Discussion

 

The results of this study indicate that back pain reduced and general health enhanced after exercise therapy with both Pilates and McKenzie training, but in the control group, pain was intensified. Petersen et al. study on 360 patients with chronic low back pain concluded that at the end of 8 weeks of McKenzie training and high-intensity endurance training and 2 months training at home, pain and disability decreased in McKenzie group at the end of 2 months, but at the end of 8 months, no differences were seen among the treatments.[24]

 

Image demonstrating a Pilates class with an Instructor | El Paso, TX Chiropractor

 

The results of another study show that McKenzie training is a beneficial method for reducing pain and increasing the movements of the spine in patients with chronic low back pain.[18] Pilates training can be an effective method for improving general health, athletic performance, proprioception, and reduction of pain in patients with chronic low back pain.[25] The improvements in strength seen in the participants in the present study were more likely to be due to decrease in pain inhibition than to neurological changes in muscle firing/recruitment patterns or to morphological (hypertrophic) changes in the muscle. In addition, neither of the treatments was superior over the other in view of reducing the intensity of pain. In the present study, 6 weeks of McKenzie training led to significant reduction in pain levels in men with chronic low back pain. The rehabilitation of patients with chronic low back pain is aimed to restore strength, endurance, and flexibility of soft tissues.

 

Udermann et al. showed that McKenzie training improved pain, disability, and psychosocial variables in patients with chronic low back pain, and back stretching training did not have any additional effect on pain, disability, and psychosocial variables.[26] The results of another study show that there is a reduction in pain and disability due to McKenzie method for at least 1 week in comparison with the passive treatment in patients with low back pain, but reduction in pain and disability due to McKenzie method in comparison with the active treatment methods is desirable within 12 weeks after treatment. Overall, McKenzie treatment is more effective than passive methods to treat low back pain.[27] One of the popular exercise therapies for patients with low back pain is McKenzie training program. McKenzie method leads to improvement of low back pain symptoms such as pain in the short-term. Moreover, McKenzie therapy is more effective in comparison with passive treatments. This training is designed to mobilize the spine and to strengthen the lumbar muscles. Previous studies have shown that weakness and atrophy in the body central muscles, particularly the transverse abdominal muscle in patients with low back pain.[28] The results of this research also showed that there was a significant difference in the general health indexes between Pilates and McKenzie groups. In the present study, 6 weeks of Pilates and McKenzie training led to a significant reduction in the level of general health (physical symptoms, anxiety, social dysfunction, and depression) in men with chronic low back pain and the general health in Pilates training group improved. The results of most studies show that exercise therapy reduces pain and improves general health in patients with chronic low back pain. Importantly, the agreement about the duration, type, and intensity of the training remains to be achieved and there is no definite training program that can have the best effect on patients with chronic low back pain. Therefore, more research is needed to determine the best duration and treatment method to reduce and improve general health in patients with low back pain. In the Al-Obaidi et al. study, pain, fear, and functional disability improved after 10 weeks of treatment in patients.[5]

 

Image of an Instructor demonstrating a patient the McKenzie method | El Paso, TX Chiropractor

 

Pilates Chiropractor vs. McKenzie Chiropractor: Which is Better? Body Image 6

 

Besides that McKenzie training increases the range of motion of lumbar flexion. Overall, neither of the two methods of treatment was superior over the other.[18]

 

Borges et al. concluded that after 6 weeks of treatment, the average index of pain in experimental group was lower than the control group. Furthermore, the general health of the experimental group exhibited greater improvement than the control group. The results of this research support recommending Pilates training to patients with chronic low back pain.[29] Caldwell et al. on the university students concluded that Pilates training and Tai chi guan improved mental parameters such as self-sufficiency, quality of sleep, and morality of students but had no effect on physical performance.[30] Garcia et al. study on 148 patients with nonspecific chronic low back pain concluded that treating patients with nonspecific chronic low back pain by McKenzie training and back school caused disability to improve after treatment, but quality of life, pain, and the range of motor flexibility did not change. McKenzie treatment is typically more effective on disability than back school program.[19]

 

The overall findings of this study are supported by the literature, demonstrating that a Pilates program may offer a low-cost, safe alternative to the treatment of low back pain in this specific group of patients. Similar effects have been found in patients with unspecific chronic low back pain.[31]

 

Our study had good levels of internal and external validity and thus can guide therapists and patients considering therapies of choice for back pain. The trial included a number of features to minimize bias such as prospectively registering and following a published protocol.

 

Study Limitation

 

Small sample size enrolled in this study limits the generalization of the study findings.

 

Conclusion

 

The results of this study showed that 6-week Pilates and McKenzie training reduced pain in patients with chronic low back pain, but there was no significant difference between the effect of two therapeutic methods on pain and both exercise protocols had the same effect. In addition, Pilates and McKenzie training improved general health; however, according to the mean general health changes after the exercise therapy, it can be argued that the Pilates training has a greater effect in improving general health.

 

Financial Support and Sponsorship

 

Nil.

 

Conflicts of Interest

 

There are no conflicts of interest.

 

In conclusion, when comparing the effects of Pilates and McKenzie training on general health as well as on painful symptoms in men with chronic low back pain, the evidence-based research study determined that both the Pilates and the McKenzie method of training effectively reduced pain in patients with chronic LBP. There was no significant difference between the two therapeutic methods altogether, however, the mean results of the research study demonstrated that Pilates training was more effective towards improving general health in men with chronic low back pain than McKenzie training.  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: Sciatica

 

Sciatica is referred to as a collection of symptoms rather than a single type of injury or condition. The symptoms are characterized as radiating pain, numbness and tingling sensations from the sciatic nerve in the lower back, down the buttocks and thighs and through one or both legs and into the feet. Sciatica is commonly the result of irritation, inflammation or compression of the largest nerve in the human body, generally due to a herniated disc or bone spur.

 

blog picture of cartoon paperboy big news

 

IMPORTANT TOPIC: EXTRA EXTRA: Treating Sciatica Pain

 

 

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6. Dehkordi AH, Heydarnejad MS. Effect of booklet and combined method on parents’ awareness of children with beta-thalassemia major disorder. J Pak Med Assoc. 2008;58:485–7. [PubMed]
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8. Maas ET, Juch JN, Groeneweg JG, Ostelo RW, Koes BW, Verhagen AP, et al. Cost-effectiveness of minimal interventional procedures for chronic mechanical low back pain: Design of four randomised controlled trials with an economic evaluation. BMC Musculoskelet Disord. 2012;13:260. [PMC free article] [PubMed]
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12. Hassanpour Dehkordi A. Influence of yoga and aerobics exercise on fatigue, pain and psychosocial status in patients with multiple sclerosis: A Randomized Trial. J Sports Med Phys Fitness. 2015 [Epub ahead of print] [PubMed]
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15. van Middelkoop M, Rubinstein SM, Verhagen AP, Ostelo RW, Koes BW, van Tulder MW. Exercise therapy for chronic nonspecific low-back pain. Best Pract Res Clin Rheumatol. 2010;24:193–204. [PubMed]
16. Critchley DJ, Pierson Z, Battersby G. Effect of pilates mat exercises and conventional exercise programmes on transversus abdominis and obliquus internus abdominis activity: Pilot randomised trial. Man Ther. 2011;16:183–9. [PubMed]
17. Kloubec JA. Pilates for improvement of muscle endurance, flexibility, balance, and posture. J Strength Cond Res. 2010;24:661–7. [PubMed]
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19. Garcia AN, Costa Lda C, da Silva TM, Gondo FL, Cyrillo FN, Costa RA, et al. Effectiveness of back school versus McKenzie exercises in patients with chronic nonspecific low back pain: A randomized controlled trial. Phys Ther. 2013;93:729–47. [PubMed]
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25. Gladwell V, Head S, Haggar M, Beneke R. Does a program of pilates improve chronic non-specific low back pain? J Sport Rehabil. 2006;15:338–50.
26. Udermann BE, Mayer JM, Donelson RG, Graves JE, Murray SR. Combining lumbar extension training with McKenzie therapy: Effects on pain, disability, and psychosocial functioning in chronic low back pain patients. Gundersen Lutheran Med J. 2004;3:7–12.
27. Machado LA, Maher CG, Herbert RD, Clare H, McAuley JH. The effectiveness of the McKenzie method in addition to first-line care for acute low back pain: A randomized controlled trial. BMC Med. 2010;8:10. [PMC free article] [PubMed]
28. Kilpikoski S. The McKenzie Method in Assessing, Classifying and Treating Non-Specific Low Back Pain in Adults with Special Reference to the Centralization Phenomenon. Jyväskylä University of Jyväskylä 2010
29. Borges J, Baptista AF, Santana N, Souza I, Kruschewsky RA, Galvão-Castro B, et al. Pilates exercises improve low back pain and quality of life in patients with HTLV-1 virus: A randomized crossover clinical trial. J Bodyw Mov Ther. 2014;18:68–74. [PubMed]
30. Caldwell K, Harrison M, Adams M, Triplett NT. Effect of pilates and taiji quan training on self-efficacy, sleep quality, mood, and physical performance of college students. J Bodyw Mov Ther. 2009;13:155–63. [PubMed]
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Chiropractic for Low Back Pain and Sciatica

Chiropractic for Low Back Pain and Sciatica

Chiropractic Management of Low Back Pain and Low Back-Related Leg Complaints: A Literature Synthesis

 

Chiropractic care is a well-known complementary and alternative treatment option frequently used to diagnose, treat and prevent injuries and conditions of the musculoskeletal and nervous systems. Spinal health issues are among some of the most common reasons people seek chiropractic care, especially for low back pain and sciatica complaints. While there are many different types of treatments available to help improve low back pain and sciatica symptoms, many individuals will often prefer natural treatment options over the use of drugs/medications or surgical interventions. The following research study demonstrates a list of evidence-based chiropractic treatment methods and their effects towards improving a variety of spinal health issues.

 

Abstract

 

  • Objectives: The purpose of this project was to review the literature for the use of spinal manipulation for low back pain (LBP).
  • Methods: Asearch strategymodified fromthe Cochrane Collaboration reviewforLBP was conducted through the following databases: PubMed, Mantis, and the Cochrane Database. Invitations to submit relevant articles were extended to the profession via widely distributed professional news and association media. The Scientific Commission of the Council on Chiropractic Guidelines and Practice Parameters (CCGPP) was charged with developing literature syntheses, organized by anatomical region, to evaluate and report on the evidence base for chiropractic care. This article is the outcome of this charge. As part of the CCGPP process, preliminary drafts of these articles were posted on the CCGPP Web site www.ccgpp.org (2006-8) to allow for an open process and the broadest possible mechanism for stakeholder input.
  • Results: A total of 887 source documents were obtained. Search results were sorted into related topic groups as follows: randomized controlled trials (RCTs) of LBP and manipulation; randomized trials of other interventions for LBP; guidelines; systematic reviews and meta-analyses; basic science; diagnostic-related articles, methodology; cognitive therapy and psychosocial issues; cohort and outcome studies; and others. Each group was subdivided by topic so that team members received approximately equal numbers of articles from each group, chosen randomly for distribution. The team elected to limit consideration in this first iteration to guidelines, systematic reviews, meta-analyses, RCTs, and coh ort studies. This yielded a total of 12 guidelines, 64 RCTs, 13 systematic reviews/meta-analyses, and 11 cohort studies.
  • Conclusions: As much or more evidence exists for the use of spinal manipulation to reduce symptoms and improve function in patients with chronic LBP as for use in acute and subacute LBP. Use of exercise in conjunction with manipulation is likely to speed and improve outcomes as well as minimize episodic recurrence. There was less evidence for the use of manipulation for patients with LBP and radiating leg pain, sciatica, or radiculopathy. (J Manipulative Physiol Ther 2008;31:659-674)
  • Key Indexing Terms: Low Back Pain; Manipulation; Chiropractic; Spine; Sciatica; Radiculopathy; Review, Systematic

 

The Council on Chiropractic Guidelines and Practice Parameters (CCGPP) was formed in 1995 by the Congress of Chiropractic State Associations with assistance from the American Chiropractic Association, Association of Chiropractic Colleges, Council on Chiropractic Education, Federation of Chiropractic Licensing Boards, Foundation for the Advancement of Chiropractic Sciences, Foundation for Chiropractic Education and Research, International Chiropractors Association, National Association of Chiropractic Attorneys, and the National Institute for Chiropractic Research. The charge to the CCGPP was to create a chiropractic “best practices” document. The Council on Chiropractic Guidelines and Practice Parameters was delegated to examine all existing guidelines, parameters, protocols, and best practices in the United States and other nations in the construction of this document.

 

Toward that end, the Scientific Commission of CCGPP was charged with developing literature syntheses, organized by region (neck, low back, thoracic, upper and lower extremity, soft tissue) and the nonregional categories of nonmusculoskeletal, prevention/health promotion, special populations, subluxation, and diagnostic imaging.

 

The purpose of this work is to provide a balanced interpretation of the literature to identify safe and effective treatment options in the care of patients with low back pain (LBP) and related disorders. This evidence summary is intended to serve as a resource for practitioners to assist them in consideration of various care options for such patients. It is neither a replacement for clinical judgment nor a prescriptive standard of care for individual patients.

 

Image of a chiropractor performing spinal adjustments and manual manipulations for low back pain and sciatica.

 

Methods

 

Process development was guided by experience of commission members with the RAND consensus process, Cochrane collaboration, Agency for Health Care and Policy Research, and published recommendations modified to the needs of the council.

 

Identification and Retrieval

 

The domain for this report is that of LBP and low backrelated leg symptoms. Using surveys of the profession and publications on practice audits, the team selected the topics for review by this iteration.

 

Topics were selected based on the most common disorders seen and most common classifications of treatments used by chiropractors based on the literature. Material for review was obtained through formal hand searches of published literature and of electronic databases, with assistance from a professional chiropractic college librarian. A search strategy was developed, based upon the CochraneWorking Group for Low Back Pain. Randomized controlled trials (RCTs), systematic reviews/meta-analyses, and guidelines published through 2006 were included; all other types of studies were included through 2004. Invitations to submit relevant articles were extended to the profession via widely distributed professional news and association media. Searches focused on guidelines, meta-analyses, systematic reviews, randomized clinical trials, cohort studies, and case series.

 

Evaluation

 

Standardized and validated instruments used by the Scottish Intercollegiate Guidelines Network were used to evaluate RCTs and systematic reviews. For guidelines, the Appraisal of Guidelines for Research and Evaluation instrument was used. A standardized method for grading the strength of the evidence was used, as summarized in Figure 1. Each team’s multidisciplinary panel conducted the review and evaluation of the evidence.

 

Figure 1 Summary of Grading of Strength of Evidence

 

Search results were sorted into related topic groups as follows: RCTs of LBP and manipulation; randomized trials of other interventions for LBP; guidelines; systematic reviews and meta-analyses; basic science; diagnosticrelated articles; methodology; cognitive therapy and psychosocial issues; cohort and outcome studies; and others. Each group was subdivided by topic so that team members received approximately equal numbers of articles from each group, chosen randomly for distribution. On the basis of the CCGPP formation of an iterative process and the volume of work available, the team elected to limit consideration in this first iteration to guidelines, systematic reviews, meta-analyses, RCTs, and cohort studies.

 

Dr. Alex Jimenez’s Insight

How does chiropractic care benefit people with low back pain and sciatica? As a chiropractor experienced in the management of a variety of spine health issues, including low back pain and sciatica, spinal adjustments and manual manipulations, as well as other non-invasive treatment methods, can be safely and effectively implemented towards the improvement of back pain symptoms. The purpose of the following research study is to demonstrate the evidence-based effects of chiropractic in the treatment of injuries and conditions of the musculoskeletal and nervous systems. The information in this article can educate patients on how alternative treatment options can help improve their low back pain and sciatica. As a chiropractor, patients may also be referred to other healthcare professionals, such as physical therapists, functional medicine practitioners and medical doctors, to help them further manage their low back pain and sciatica symptoms. Chiropractic care can be used to avoid surgical interventions for spine health issues.

 

Results and Discussion

 

A total of 887 source documents were initially obtained. This included a total of 12 guidelines, 64 RCTs, 20 systematic reviews/meta-analyses, and 12 cohort studies. Table 1 provides an overall summary of the number of studies evaluated.

 

Table 1 Number of Sources Rated by the Interdisciplinary Team of Reviewers and Used in Formulating Conclusions

 

Assurance and Advice

 

The search strategy used by the team was that developed by van Tulder et al, and the team identified 11 trials. Good evidence indicates that patients with acute LBP on bed rest have more pain and less functional recovery than those who stay active. There is no difference in pain and functional status between bed rest and exercises. For sciatica patients, fair evidence shows no real difference in pain and functional status between bed rest and staying active. There is fair evidence of no difference in pain intensity between bed rest and physiotherapy but small improvements in functional status. Finally, there is little difference in pain intensity or functional status between shorter-term or longer-term bed rest.

 

A Cochrane review by Hagen et al demonstrated small advantages in short-term and long-term for staying active over bed rest, as did a high-quality review by the Danish Society of Chiropractic and Clinical Biomechanics, including 4 systematic reviews, 4 additional RCTS, and 6 guidelines, on acute LBP and sciatica. The Cochrane review by Hilde et al included 4 trials and concluded a small beneficial effect for staying active for acute, uncomplicated LBP, but no benefit for sciatica. Eight studies on staying active and 10 on bed rest were included in an analysis by the group of Waddell. Several therapies were coupled with advice to stay active and include analgesic medication, physical therapy, back school, and behavioral counseling. Bed rest for acute LBP was similar to no treatment and placebo and less effective than alternative treatment. Outcomes considered across the studies were rate of recovery, pain, activity levels, and work time loss. Staying active was found to have a favorable effect.

 

Review of 4 studies not covered elsewhere assessed the use of brochures/booklets. The trend was for no differences in outcome for pamphlets. One exception was noted—that those who received manipulation had less bothersome symptoms at 4 weeks and significantly less disability at 3 months for those who received a booklet encouraging staying active.

 

In summary, assuring patients that they are likely to do well and advising them to stay active and avoid bed rest is a best practice for management of acute LBP. Bed rest for short intervals may be beneficial for patients with radiating leg pain who are intolerant of weight bearing.

 

Adjustment/Manipulation/Mobilization Vs Multiple Modalities

 

This review considered literature on high-velocity, lowamplitude (HVLA) procedures, often termed adjustment or manipulation, and mobilization. The HVLA procedures use thrusting maneuvers applied quickly; mobilization is applied cyclically. The HVLA procedure and mobilization may be mechanically assisted; mechanical impulse devices are considered HVLA, and flexion-distraction methods and continuous passive motion methods are within mobilization.

 

Image of a chiropractor performing spinal adjustments and manual manipulations for low back pain and sciatica.

 

The team recommends adopting the findings of the systematic review by Bronfort et al, with a quality score (QS) of 88, covering literature up to 2002. In 2006, the Cochrane collaboration reissued an earlier (2004) review of spinal manipulative therapy (SMT) for back pain performed by Assendelft et al. This reported on 39 studies up to 1999, several overlapping with those reported by Bronfort et al using different criteria and a novel analysis. They report no difference in outcome from treatment with manipulation vs alternatives. As several additional RCTs had appeared in the interim, the rationale for reissuing the older review without acknowledging new studies was unclear.

 

Acute LBP. There was fair evidence that HVLA has better short-term efficacy than mobilization or diathermy and limited evidence of better short-term efficacy than diathermy, exercise, and ergonomic modifications.

 

Chronic LBP. The HVLA procedure combined with strengthening exercise was as effective for pain relief as nonsteroidal antiinflammatory dugs with exercise. Fair evidence indicated that manipulation is better than physical therapy and home exercise for reducing disability. Fair evidence shows that manipulation improves outcomes more than general medical care or placebo in the short-term and to physical therapy in the long-term. The HVLA procedure had better outcomes than home exercise, transcutaneous electrical nerve stimulation, traction, exercise, placebo and sham manipulation, or chemonucleolysis for disk herniation.

 

Mixed (Acute and Chronic) LBP. Hurwitz found that HVLA was the same as medical care for pain and disability; adding physical therapy to manipulation did not improve outcomes. Hsieh found no significant value for HVLA over back school or myofascial therapy. A short-term value of manipulation over a pamphlet and no difference between manipulation and McKenzie technique were reported by Cherkin et al. Meade contrasted manipulation and hospital care, finding greater benefit for manipulation over both short-term and long-term. Doran and Newell found that SMT resulted in greater improvement than physical therapy or corsets.

 

Acute LBP

 

Sick List Comparisons. Seferlis found that sick patients listed were significantly improved symptomatically after 1 month regardless of the intervention, including manipulation. Patients were more satisfied and felt that they were provided better explanations about their pain from practitioners who used manual therapy (QS, 62.5). Wand et al examined the effects of sick-listing oneself and noted that a group receiving assessment, advice, and treatment improved better than did a group getting assessment, advice, and who were put on a wait list for a 6-week period. Improvements were observed in disability, general health, quality of life, and mood, though pain and disability were not different at longterm follow-up (QS, 68.75).

 

Physiologic Therapeutic Modality and Exercise. Hurley and colleagues tested the effects of manipulation combined with interferential therapy compared to either modality alone. Their results showed all 3 groups improved function to the same degree, both at 6-month and at 12-month follow-up (QS, 81.25). Using a single-blinded experimental design to compare manipulation to massage and low-level electrostimulation, Godfrey et al found no differences between groups at the 2 to 3-week observation time frame (QS, 19). In the study by Rasmussen, results showed that 94% of the patients treated with manipulation were symptom-free within 14 days, compared to 25% in the group that received short-wave diathermy. Sample size was small, however, and as a result, the study was underpowered (QS, 18). The Danish systematic review examined 12 international sets of guidelines, 12 systematic reviews, and 10 randomized clinical trials on exercise. They found no specific exercises, regardless of type, that were useful for the treatment of acute LBP with the exception of McKenzie maneuvers.

 

Sham and Alternate Manual Method Comparisons. The study of Hadler balanced for effects of provider attention and physical contact with a first effort at a manipulation sham procedure. Patients in the group that entered the trial with greater prolonged illness at the outset were reported to have benefited from the manipulation. Similarly, they improved faster and to a greater degree (QS, 62.5). Hadler demonstrated that there was a benefit for a single session of manipulation compared to a session of mobilization (QS, 69). Erhard reported that the rate of positive response to manual treatment with a hand-heel rocking motion was greater than with extension exercises (QS, 25). Von Buerger examined the use of manipulation for acute LBP, comparing rotational manipulation to soft tissue massage. He found that the manipulation group responded better than the soft tissue group, although the effects occurred mainly in the short-term. The results were also hampered by the nature of the forced multiple choice selections on the data forms (QS, 31). Gemmell compared 2 forms of manipulation for LBP of less than 6 weeks of duration as follows: Meric adjusting (a form of HVLA) and Activator technique (a form of mechanically assisted HVLA). No difference was observed, and both helped to reduce pain intensity (QS, 37.5). MacDonald reported a short-term benefit in disability measures within the first 1 to 2 weeks of starting therapy for the manipulation group that disappeared by 4 weeks in a control group (QS, 38). The work of Hoehler, although containing mixed data for patients with acute and chronic LBP, is included here because a larger proportion of patients with acute LBP were involved in the study. Manipulation patients reported immediate relief more often, but there were no differences between groups at discharge (QS, 25).

 

Medication. Coyer showed that 50% of the manipulation group was symptom-free within 1 week and 87% were discharged symptom-free in 3 weeks, compared to 27% and 60%, respectively, of the control group (bed rest and analgesics) (QS, 37.5). Doran and Newell compared manipulation, physiotherapy, corset, or analgesic medication, using outcomes that examined pain and mobility. There were no differences between groups over time (QS, 25). Waterworth compared manipulation to conservative physiotherapy and 500 mg of diflunisal twice per day for 10 days. Manipulation showed no benefit for the rate of recovery (QS, 62.5). Blomberg compared manipulation to steroid injections and to a control group receiving conventional activating therapy. After 4 months, the manipulation group had less restricted motion in extension, less restriction in side-bending to both sides, less local pain on extension and right sidebending, less radiating pain, and less pain when performing a straight leg raise (QS, 56.25). Bronfort found no outcome differences between chiropractic care compared to medical care at 1 month of treatment, but there were noticeable improvements in the chiropractic group at both 3 and 6-month follow-up (QS, 31).

 

Subacute Back Pain

 

Staying Active. Grunnesjo compared combined effects of manual therapy with advice to stay active to advice alone in patients with acute and subacute LBP. The addition of manual therapy appeared to reduce pain and disability more effectively than the “stay active” concept alone (QS, 68.75).

 

Physiologic Therapeutic Modality and Exercise. Pope demonstrated that manipulation offered better pain improvement than transcutaneous electrical nerve stimulation (QS 38). Sims-Williams compared manipulation to “physiotherapy.” Results demonstrated a short-term benefit for manipulation on pain and ability to do light work. Differences between groups waned at 3 and 12-month follow-ups (QS, 43.75, 35). Skargren et al compared chiropractic to physiotherapy for patients with LBP who had no treatment for the prior month. No differences in health improvements, costs, or recurrence rates were noted between the 2 groups. However, based on Oswestry scores, chiropractic performed better for patients who had pain for less than 1 week, whereas the physiotherapy seemed to be better for those who had pain for more than 4 weeks (QS, 50).

 

The Danish systematic review examined 12 international sets of guidelines, 12 systematic reviews, and 10 randomized clinical trials on exercise. Results suggested that exercise, in general, benefits patients with subacute back pain. Use of a basic program that can be readily modified to meet individual patient needs is recommended. Issues of strength, endurance, stabilization, and coordination without excessive loading can all be addressed without the use of high-tech equipment. Intensive training consisting of greater than 30 and less than 100 hours of training are most effective.

 

Sham and Alternate Manual Method Comparisons. Hoiriis compared efficacy of chiropractic manipulation to placebo/ sham for subacute LBP. All groups improved on measures of pain, disability, depression, and Global Impression of Severity. Chiropractic manipulation scored better than placebo in reducing pain and Global Impression of Severity scores (QS, 75). Andersson and colleagues compared osteopathic manipulation to standard care to patients with subacute LBP, finding that both groups improved for a 12-week period at about the same rate (QS, 50).

 

Medication Comparisons. In a separate treatment arm of the study of Hoiriis, the relative efficacy of chiropractic manipulation to muscle relaxants for subacute LBP was studied. In all groups, pain, disability, depression, and Global Impression of Severity decreased. Chiropractic manipulation was more effective than muscle relaxants in reducing Global Impression of Severity scores (QS, 75).

 

Chronic LBP

 

Staying Active Comparisons. Aure compared manual therapy to exercise in patients with chronic LBP who were sick listed. Although both groups showed improvements in pain intensity, functional disability, general health, and return to work, the manual therapy group showed significantly greater improvements than did the exercise group for all outcomes. Results were consistent for both the short-term and the longterm (QS, 81.25).

 

Physician Consult/Medical Care/Education. Niemisto compared combined manipulation, stabilization exercise, and physician consultation to consultation alone. The combined intervention was more effective in reducing pain intensity and disability (QS, 81.25). Koes compared general practitioner treatment to manipulation, physiotherapy, and a placebo (detuned ultrasound). Assessments were made at 3, 6, and 12 weeks. The manipulation group had a quicker and larger improvement in physical function compared to the other therapies. Changes in spinal mobility in the groups were small and inconsistent (QS, 68). In a follow-up report, Koes found during subgroup analysis that improvement in pain was greater for manipulation than for other treatments at 12 months when considering patients with chronic conditions, as well as those who were younger than 40 years (QS, 43). Another study by Koes showed that many patients in the nonmanipulation treatment arms had received additional care during follow-up. Yet, improvement in the main complaints and in physical functioning remained better in the manipulation group (QS, 50). Meade observed that chiropractic treatment was more effective than hospital outpatient care, as assessed using the Oswestry Scale (QS, 31). An RCT conducted in Egypt by Rupert compared chiropractic manipulation, after medical and chiropractic evaluation. Pain, forward flexion, active, and passive leg raise all improved to a greater degree in the chiropractic group; however, the description of alternate treatments and outcomes was ambiguous (QS, 50).

 

Triano compared manual therapy to educational programs for chronic LBP. There was greater improvement in pain, function, and activity tolerance in the manipulation group, which continued beyond the 2-week treatment period (QS, 31).

 

Physiologic Therapeutic Modality. A negative trial for manipulation was reported by Gibson (QS, 38). Detuned diathermy was reported to achieve better results over manipulation, although there were baseline differences between groups. Koes studied the effectiveness of manipulation, physiotherapy, treatment by a general practitioner, and a placebo of detuned ultrasound. Assessments were made at 3, 6, and 12 weeks. The manipulation group showed a quicker and better improvement in physical function capacity compared to the other therapies. Flexibility differences between groups were not significant (QS, 68). In a follow-up report, Koes found that a subgroup analysis demonstrated that improvement in pain was greater for those treated with manipulation, both for younger (b40) patients and those with chronic conditions at 12-month follow-up (QS, 43). Despite many patients in the nonmanipulation groups received additional care during follow-up, improvements remained better in the manipulation group than in the physical therapy group (QS, 50). In a separate report by the same group, there were improvements in both the physiotherapy and manual therapy groups with regard to severity of complaints and global perceived effect compared to general practitioner care; however, the differences between the 2 groups was not significant (QS, 50). Mathews et al found that manipulation hastened recovery from LBP more than the control did.

 

Exercise Modality. Hemilla observed that SMT led to better long-term and short-term disability reduction compared to physical therapy or home exercise (QS, 63). A second article by the same group found that neither bone-setting nor exercise differed significantly from physical therapy for symptom control, though bone-setting was associated with improved lateral and forward-bending of the spine more than exercise (QS, 75). Coxhea reported that HVLA provided better outcomes when compared to exercise, corsets, traction, or no exercise when studied in the short-term (QS, 25). Conversely, Herzog found no differences between manipulation, exercise, and back education in reducing either pain or disability (QS, 6). Aure compared manual therapy to exercise in patients with chronic LBP who were also sick listed. Although both groups showed improvements in pain intensity, functional disability, and general health and returned to work, the manual therapy group showed significantly greater improvements than did the exercise group for all outcomes. This result persisted for both the short-term and the long-term (QS, 81.25). In the article by Niemisto and colleagues, the relative efficacy of combined manipulation, exercise (stabilizing forms), and physician consultation compared to consultation alone was investigated. The combined intervention was more effective in reducing pain intensity and disability (QS, 81.25). The United Kingdom Beam study found that manipulation followed by exercise achieved a moderate benefit at 3 months and a small benefit at 12 months. Likewise, manipulation achieved a small to moderate benefit at 3 months and a small benefit at 12 months. Exercise alone had a small benefit at 3 months but no benefit at 12 months. Lewis et al found improvement occurred when patients were treated by combined manipulation and spinal stabilization exercises vs use of a 10-station exercise class.

 

The Danish systematic review examined 12 international sets of guidelines, 12 systematic reviews, and 10 randomized clinical trials on exercise. Results suggested that exercise, in general, benefits patients with chronic LBP. No clear superior method is known. Use of a basic program that can be readily modified to meet individual patient needs is recommended. Issues of strength, endurance, stabilization, and coordination without excessive loading can all be addressed without the use of high-tech equipment. Intensive training consisting of greater than 30 and less than 100 hours of training are most effective. Patients with severe chronic LBP, including those off work, are treated more effectively with a multidisciplinary rehabilitation program. For post surgical rehabilitation, patients starting 4 to 6 weeks after disk surgery under intensive training receive greater benefit than with light exercise programs.

 

Sham and Alternate Manual Methods. Triano found that SMT produced significantly better results for pain and disability relief for the short-term, than did sham manipulation (QS, 31). Cote found no difference over time or for comparisons within or between the manipulation and mobilization groups (QS, 37.5). The authors posed that failure to observe differences may have been due to low responsiveness to change in the instruments used for algometry, coupled with a small sample size. Hsieh found no significant value for HVLA over back school or myofascial therapy (QS, 63). In the study by Licciardone, a comparison was made between osteopathic manipulation (which includes mobilization and soft tissue procedures as well as HVLA), sham manipulation, and a no-intervention control for patients with chronic LBP. All groups showed improvement. Sham and osteopathic manipulation were associated with greater improvements than seen in the no-manipulation group, but no difference was observed between the sham and manipulation groups (QS, 62.5). Both subjective and objective measures showed greater improvements in the manipulation group compared to a sham control, in a report by Waagen (QS, 44). In the work of Kinalski, manual therapy reduced the time of treatment of patients with LBP and concomitant intervertebral disk lesions. When disk lesions were not advanced, a decreased muscular hypertonia and increased mobility was noted. This article, however, was limited by a poor description of patients and methods (QS, 0).

 

Harrison et al reported a nonrandomized cohort controlled trial of treatment of chronic LBP consisting of 3-point bending traction designed to increase curvature of the lumbar spine. The experimental group received HVLA for pain control during the first 3 weeks (9 treatments). The control group received no treatment. Follow-up at a mean of 11 weeks showed no change in pain or curvature status for controls but a significant increase in curvature and reduction of pain in the experimental group. Average number of treatments to achieve this result was 36. Long-term followup at 17 months showed retention of benefits. No report of relationship between clinical changes and structural change was given.

 

Haas and colleagues examined the dose-response patterns of manipulation for chronic LBP. Patients were randomly allocated to groups receiving 1, 2, 3, or 4 visits per week for 3 weeks, with outcomes recorded for pain intensity and functional disability. A positive and clinically important effect of the number of chiropractic treatments on pain intensity and disability at 4 weeks was associated with the groups receiving the higher rates of care (QS, 62.5). Descarreaux et al extended this work, treating 2 small groups for 4 weeks (3 times per week) after 2 baseline evaluations separated by 4 weeks. One group was then treated every 3 weeks; the other did not. Although both groups had lower Oswestry scores at 12 weeks, at 10 months, the improvement only persisted for the extended SMT group.

 

Medication. Burton and colleagues demonstrated that HVLA led to greater short-term improvements in pain and disability than did chemonucleolysis for managing disk herniation (QS, 38). Bronfort studied SMT combined with exercise vs a combination of nonsteroidal antiinflammatory drugs and exercise. Similar results were obtained for both groups (QS, 81). Forceful manipulation coupled with sclerosant therapy (injection of a proliferant solution composed of dextrose-glycerine-phenol) was compared to lower force manipulation combined with saline injections, in a study by Ongley. The group receiving forceful manipulation with sclerosant fared better than the alternate group, but effects cannot be separated between the manual procedure and the sclerosant (QS, 87.5). Giles and Muller compared HVLA procedures to medication and acupuncture. Manipulation showed greater improvement in frequency of back pain, pain scores, Oswestry, and SF-36 compared to the other 2 interventions. Improvements lasted for 1 year. Weaknesses of the study were use of a compliers-only analysis as intention to treat for the Oswestry, and Visual Analogue Scale (VAS) was not significant.

 

Sciatica/Radicular/Radiating Leg Pain

 

Staying Active/Bed Rest. Postacchini studied a mixed group of patients with LBP, with and without radiating leg pain. Patients could be classified as acute or chronic and were evaluated at 3 weeks, 2 months, and 6 months postonset. Treatments included manipulation, drug therapy, physiotherapy, placebo, and bed rest. Acute back pain without radiation and chronic back pain responded well to manipulation; however, in none of the other groups did manipulation fare as well as other interventions (QS, 6).

 

Physician Consult/Medical Care/Education. Arkuszewski looked at patients with lumbosacral pain or sciatica. One group received drugs, physiotherapy, and manual examination, whereas the second added manipulation. The group receiving manipulation had a shorter treatment time and a more marked improvement. At 6-month follow-up, the manipulation group showed better neuromotor system function and a better ability to continue employment. Disability was lower in the manipulation group (QS, 18.75).

 

Physiologic Therapeutic Modality. Physiotherapy combined with manual manipulation and medication was examined by Arkuszewski, in contrast to the same scheme with manipulation added, as noted above. Outcomes from manipulation were better for neurologic and motor function as well as disability (QS, 18.75). Postacchini looked at patients with acute or chronic symptoms evaluated at 3 weeks, 2 months, and 6 months postonset. Manipulation was not as effective for managing the patients with radiating leg pain as the other treatment arms (QS, 6). Mathews and colleagues examined multiple treatments including manipulation, traction, sclerosant use, and epidural injections for back pain with sciatica. For patients with LBP and restricted straight leg raise test, manipulation conferred highly significant relief, more so than alternate interventions (QS, 19). Coxhead et al included among their subjects patients who had radiating pain at least to the buttocks. Interventions included traction, manipulation, exercise, and corset, using a factorial design. After 4 weeks of care, manipulation showed a significant degree of benefit on one of the scales used to assess progress. There were no real differences between groups at 4 months and 16 months posttherapy, however (QS, 25).

 

Exercise Modality. In the case of LBP after laminectomy, Timm reported that exercises conferred benefit both for pain relief and cost-effectiveness (QS, 25). Manipulation had only a small influence on improvement of either symptoms or function (QS, 25). In the study by Coxhead et al, radiating pain to at least the buttocks was better after 4 weeks of care for manipulation, in contrast to other treatments that disappeared 4 months and 16 months posttherapy (QS, 25).

 

Sham and Alternate Manual Method. Siehl looked at the use of manipulation under general anesthesia for patients with LBP and unilateral or bilateral radiating leg pain. Only temporary clinical improvement was noted when traditional electromyographic evidence of nerve root involvement was present. With negative electromyography, manipulation was reported to provide lasting improvement (QS, 31.25) Santilli and colleagues compared HVLA to soft tissue pressing without any sudden thrust in patients with moderate acute back and leg pain. The HVLA procedures were significantly more effective in reducing pain, reaching a pain-free status, and the total number of days with pain. Clinically significant differences were noted. The total number of treatment sessions was capped at 20 on a dosage of 5 times per week with care depending on pain relief. Follow-up showed relief persisting through 6 months.

 

Medication. Mixed acute and chronic back pain with radiation treated in a study using multiple treatment arms were evaluated at 3 weeks, 2 months, and 6 months postonset by the group of Postacchini. Medication management fared better than did manipulation when radiating leg pain was present (QS, 6). Conversely, for the work of Mathews and colleagues, the group of patients with LBP and limited straight leg raise test responded more to manipulation than to epidural steroid or sclerosants (QS, 19).

 

Disk Herniation

 

Nwuga studied 51 subjects who were having a diagnosis of prolapsed intervertebral disk and who had been referred for physical therapy. Manipulation was reported to be superior to conventional therapy (QS, 12.5). Zylbergold found that there were no statistical differences between 3 treatments—lumbar flexion exercises, home care, and manipulation. Short-term follow-up and a small sample size were posed by the author as a basis for failing to reject the null hypothesis (QS, 38).

 

Exercise

 

Exercise is one of the most well-studied forms of treatment of low back disorders. There are many different approaches to exercise. For this report, it is important only to differentiate multidisciplinary rehabilitation. These programs are designed for patients with especially chronic condition with significant psychosocial problems. They involve trunk exercise, functional task training including work simulation/vocational training, and psychological counseling.

 

Image of a healthcare professional helping a patient perform exercises for low back pain and sciatica.

 

In a recent Cochrane review on exercise for the treatment of nonspecific LBP (QS, 82), effectiveness of exercise therapy in patients classified as acute, subacute, and chronic was compared to no treatment and alternate treatments. Outcomes included the assessment of pain, function, return to work, absenteeism, and/or global improvements. In the review, 61 trials met the inclusion criteria, most of which dealt with chronic (n = 43), whereas smaller numbers addressed acute (n = 11) and subacute (n = 6) pain. The general conclusions were as follows:

 

  • exercise is not effective as a treatment of acute LBP,
  • evidence that exercise was effective in chronic populations relative to comparisons made at follow-up periods,
  • mean improvements of 13.3 points for pain and 6.9 points for function were observed, and
  • there is some evidence that graded-activity exercise is effective for subacute LBP but only in the occupational setting

 

The review examined population and intervention characteristics, as well as outcomes to reach its conclusions. Extracting data on return to work, absenteeism, and global improvement proved so difficult that only pain and function could be quantitatively described.

 

Eight studies scored positively on key validity criteria. With regard to clinical relevance, many of the trials presented inadequate information, with 90% reporting the study population but only 54% adequately describing the exercise intervention. Relevant outcomes were reported in 70% of the trials.

 

Exercise for Acute LBP. Of the 11 trials (total n = 1192), 10 had nonexercise comparison groups. The trials presented conflicting evidence. Eight low-quality trials showed no differences between exercise and usual care or no treatment. Pooled data showed that there was no difference in shortterm pain relief between exercise and no treatment, no difference in early follow-up for pain when compared to other interventions, and no positive effect of exercise on functional outcomes.

 

Subacute LBP. In 6 studies (total n = 881), 7 exercise groups had a nonexercise comparison group. The trials offered mixed results with regard to evidence of effectiveness, with fair evidence of effectiveness for a graded-exercise activity program as the only notable finding. Pooled data did not show evidence to either support or refute the use of exercise for subacute LBP, either for decreasing pain or improving function.

 

Chronic LBP. There were 43 trials included in this group (total n = 3907). Thirty-three of the studies had nonexercise comparison groups. Exercise was at least as effective as other conservative interventions for LBP, and 2 high-quality studies and 9 lower-quality studies found exercise to be more effective. These studies used individualized exercise programs, focusing mainly on strengthening or trunk stabilization. There were 14 trials that found no difference between exercise and other conservative interventions; of these, 2 were rated highly and 12 rated lower. Pooling the data showed a mean improvement of 10.2 (95% confidence interval [CI], 1.31-19.09) points on a 100-mm pain scale for exercise compared to no treatment and 5.93 (95% CI, 2.21- 9.65) points compared to other conservative treatments. Functional outcomes also showed improvements as follows: 3.0 points at earliest follow-up compared to no treatment (95% CI, −0.53 to 6.48) and 2.37 points (95% CI, 1.04-3.94) compared to other conservative treatments.

 

Indirect subgroup analysis found that trials examining health care study populations had higher mean improvements in pain and physical functioning compared to their comparison groups or to trials set in occupational or general populations.

 

The review authors offered the following conclusions:

 

  1. In acute LBP, exercises are not more effective than other conservative interventions. Meta-analysis showed no advantage over no treatment of pain and functional outcomes over the short or long-term.
  2. There is fair evidence of effectiveness of a gradedactivity exercise program in subacute LBP in occupational settings. The effectiveness for other types of exercise therapy in other populations is unclear.
  3. In chronic LBP, there is good evidence that exercise is at least as effective as other conservative treatments. Individually designed strengthening or stabilizing programs appear to be effective in health care settings. Meta-analysis found functional outcomes significantly improved; however, the effects were very small, with a less than 3-point (of 100) difference between the exercise and comparison groups at earliest follow-up. Pain outcomes were also significantly improved in groups receiving exercises relative to other comparisons, with a mean of approximately 7 points. Effects were similar over longer follow-up, though confidence intervals increased. Mean improvements in pain and functioning may be clinically meaningful in studies from health care populations in which improvements were significantly greater than those observed in studies from general or mixed populations.

 

The Danish group review of exercise was able to identify 5 systematic reviews and 12 guidelines that discussed exercise for acute LBP, 1 systematic review and 12 guidelines for subacute, and 7 systematic reviews and 11 guidelines for chronic. Furthermore, they identified 1 systematic review that selectively evaluated for postsurgical cases. Conclusions were essentially the same as the Cochrane review, with the exceptions that there was limited support for McKenzie maneuvers for patients with acute condition and for intensive rehabilitation programs for 4 to 6 weeks after disk surgery over light exercise programs.

 

Natural and Treatment History for LBP

 

Most studies have demonstrated that nearly half of LBP will improve within 1 week, whereas nearly 90% of it will be gone by 12 weeks. Even more, Dixon demonstrated that perhaps as much as 90% of LBP will resolve on its own, without any intervention whatsoever. Von Korff demonstrated that a significant number of patients with acute LBP will have persistent pain if they are observed up to 2 years.

 

Phillips found that nearly 4 of 10 people will have LBP after an episode at 6 months from onset, even if the original pain has disappeared because more than 6 in 10 will have at least 1 relapse during the first year after an episode. These initial relapses occur within 8 weeks most commonly and may reoccur over time, though in decreasing percentages.

 

Workers’ compensation injury patients were observed for 1 year to examine symptom severity and work status. Half of those studied lost no work time in the first month after injury, but 30% did lose time from work due to their injury over the course of 1 year. Of those who missed work in the first month due to their injury and had already been able to return to work, nearly 20% had absence later in that same year. This implies that assessing return to work at 1 month after injury will fail to give an honest depiction of the chronic, episodic nature of LBP. Although many patients have returned to work, they will later experience continuing problems and work-related absences. Impairment present at more than 12 weeks postinjury may be far higher than what has been previously reported in the literature, where rates of 10% are common. In fact, the rates may go up to 3 to 4 times higher.

 

In a study by Schiotzz-Christensen and colleagues, the following was noted. In relation to sick leave, LBP has a favorable prognosis, with a 50% return to work within the first 8 days and only 2% on sick leave after 1 year. However, 15% had been on sick leave during the following year and about half continued to complain of discomfort. This suggested that an acute episode of LBP significant enough to cause the patient to seek a visit to a general practitioner is followed by a longer period of low-grade disability than previously reported. Also, even for those who returned to work, up to 16% indicated that they were not functionally improved. In another study looking at outcomes after 4 weeks after initial diagnosis and treatment, only 28% of patients did not experience any pain. More strikingly, the persistence of pain differed between groups that had radiating pain and those that did not, with 65% of the former feeling improvement at 4 weeks, vs 82% of the latter. The general findings from this study differ from others in that 72% of patients still experienced pain 4 weeks after initial diagnosis.

 

Hestbaek and colleagues reviewed a number of articles in a systematic review. The results showed that the reported proportion of patients who still experienced pain after 12 months after onset was 62% on average, with 16% sick-listed 6 months after onset, and with 60% experiencing relapse of work absence. Also, they found that the mean reported prevalence of LBP in patients who had past episodes of LBP was 56%, compared to just 22% for those who had no such history. Croft and colleagues performed a prospective study looking at the outcomes of LBP in general practice, finding that 90% of patients with LBP in primary care had stopped consulting with symptoms within 3 months; however, most were still experiencing LBP and disability 1 year after the initial visit. Only 25% had fully recovered within that same year.

 

There are even different results in the study by Wahlgren et al. Here, most patients continued to experience pain at both 6 and 12 months (78% and 72%, respectively). Only 20% of the sample had fully recovered by 6 months and only 22% by 12 months.

 

Von Korff has provided a lengthy list of data he considers relevant to assessing the clinical course of back pain as follows: age, sex, race/ethnicity, years of education, occupation, change in occupation, employment status, disability insurance status, litigation status, recency/age at first onset of back pain, recency/age when care was sought, recency of back pain episode, duration of current/most recent episode of back pain, number of back pain days, current pain intensity, average pain intensity, worst pain intensity, ratings of interference with activities, activity limitation days, clinical diagnosis for this episode, bed rest days, work loss days, recency of back pain flare-up, and duration of the most recent flare-up.

 

In a practice-based observational study by Haas et al of almost 3000 patients with acute and chronic condition treated by chiropractors and primary care medical doctors, pain was noted in patients with acute and chronic condition up to 48 months after enrollment. At 36 months, 45% to 75% of patients reported at least 30 days of pain in the prior year, and 19% to 27% of patients with chronic condition recalled daily pain over the previous year.

 

The variability noted in these and many other studies can be explained in part by the difficulty in making an adequate diagnosis, by the different classification schemes used in classifying LBP, by the different outcome tools used in each study and by many other factors. It also points up the extreme difficulty in getting a handle on the day-to-day reality for those who have LBP.

 

Common Markers and Rating Complexity for LBP

 

What Are the Relevant Benchmarks for Evaluating Process of Care?. One benchmark is described above, that being natural history. Complexity and risk stratification are important, as are cost issues; however, cost-effectiveness is beyond the scope of this report.

 

It is understood that patients with uncomplicated LBP improve faster than those with various complications, the most notable of which is radiating pain. Many factors may influence the course of back pain, including comorbidity, ergonomic factors, age, the level of fitness of the patient, environmental factors, and psychosocial factors. The latter is receiving a great deal of attention in the literature, though as noted elsewhere in this book, such consideration may not be justified. Any of these factors, alone or in combination, may hamper or retard the recovery period after injury.

 

It seems that biomechanical factors play an important role in the incidence of first-time episodes of LBP and its attendant problems such as work loss; psychosocial factors come into play more in subsequent episodes of LBP. The biomechanical factors can lead to tissue tearing, which then create pain and limited ability for years to follow. This tissue damage cannot be seen on standard imaging and may only be apparent upon dissection or surgery.

 

Risk factors for LBP include the following:

 

  • age, sex, severity of symptoms;
  • increased spinal flexibility, decreased muscle endurance;
  • prior recent injury or surgery;
  • abnormal joint motion or decreased body mechanics;
  • prolonged static posture or poor motor control;
  • work-related such as vehicle operation, sustained loads, materials handling;
  • employment history and satisfaction; and
  • wage status.

 

IJzelenberg and Burdorf investigated whether demographic, work-related physical, or psychosocial risk factors involved in the occurrence of musculoskeletal conditions determine subsequent health care use and sick leave. They found that within 6 months, nearly one third of industrial workers with LBP (or neck and upper extremity problems) had a recurrence of sick leave for that same problem and a 40% recurrence of health care use. Work-related factors associated with musculoskeletal symptoms were similar to those associated with health care use and sick leave; but, for LBP, older age and living alone strongly determined whether patients with these problems took any sick leave. The 12- month prevalence of LBP was 52%, and of those with symptoms at baseline, 68% had a recurrence of the LBP. Jarvik and colleagues add depression as an important predictor of new LBP. They found the use of MRI to be a less important predictor of LBP than depression.

 

What Are the Relevant Outcome Measures?. The Clinical Practice Guidelines formulated by the Canadian Chiropractic Association and the Canadian Federation of Chiropractic Regulatory Boards note that there are a number of outcomes that may be used to demonstrate change as a result of treatment. These should be both reliable and valid. According to the Canadian guidelines, appropriate standards are useful in chiropractic practice because they are able to perform the following:

 

  • consistently evaluate the effects of care over time;
  • help indicate the point of maximum therapeutic improvement;
  • uncover problems related to care such as noncompliance;
  • document improvement to the patient, doctor, and third parties;
  • suggest modifications of the goals of treatment if necessary;
  • quantify the clinical experience of the doctor;
  • justify the type, dose, and duration of care;
  • help provide a database for research; and
  • assist in establishing standards of treatment of specific conditions.

 

The broad general classes of outcomes include functional outcomes, patient perception outcomes, physiologic outcomes, general health assessments, and subluxation syndrome outcomes. This chapter addresses only functional and patient perception outcomes assessed by questionnaires and functional outcomes assessed by manual procedures.

 

Functional Outcomes. These are outcomes that measure the patient’s limitations in going about his or her normal daily activities. What is being looked at is the effect of a condition or disorder on the patient (ie, LBP, for which a specific diagnosis may not be present or possible) and its outcome of care. Many such outcome tools exist. Some of the better known include the following:

 

  • Roland Morris Disability Questionnaire,
  • Oswestry Disability Questionnaire,
  • Pain Disability Index,
  • Neck Disability Index,
  • Waddell Disability Index, and
  • Million Disability Questionnaire.

 

These are only some of the existing tools for assessing function.

 

In the existing RCT literature for LBP, functional outcomes have been shown to be the outcome that demonstrates the greatest change and improvement with SMT. Activities of daily living, along with patient selfreporting of pain, were the 2 most notable outcomes to show such improvement. Other outcomes fared less well, including trunk range of motion (ROM) and straight leg raise.

 

In the chiropractic literature, the outcome inventories used most frequently for LBP are the Roland Morris Disability Questionnaire and the Oswestry Questionnaire. In a study in 1992, Hsieh found that both tools provided consistent results over the course of his trial, although the results from the 2 questionnaires differed.

 

Patient Perception Outcomes. Another important set of outcomes involve patient perception of pain and their satisfaction with care. The first involves measuring changes in pain perception over time of its intensity, duration, and frequency. There are a number of valid tools available that can accomplish this, including the following:

 

Visual analog scale—this is a 10-cm line that has pain descriptions noted at both ends of that line representing no pain to intolerable pain; the patient is asked to mark a point on that line that reflects their perceived pain intensity. There are a number of variants for this outcome, including the Numerical Rating Scale (where the patient provides a number between 0 and 10 to represent the amount of pain they have) and the use of pain levels from 0 to 10 depicted pictorially in boxes, which the patient may check. All of these appear to be equally reliable, but for ease of use, either the standard VAS or Numerical Rating Scale is commonly used.

 

Pain diary—these may be used to help monitor a variety of different pain variables (for example, frequency, which the VAS cannot measure). Different forms may be used to collect this information, but it is typically completed on a daily basis.

 

McGill Pain Questionnaire—this scale helps quantify several psychologic components of pain as follows: cognitive-evaluative, motivational-affective, and sensory discriminative. In this instrument, there are 20 categories of words that describe the quality of pain. From the results, 6 different pain variables can be determined.

 

All of the above instruments have been used at various times to monitor the progress of treatment of back pain with SMT.

 

Patient satisfaction addresses both the effectiveness of care as well as the method of receiving that care. There are numerous methods of assessing patient satisfaction, and not all of them were designed to be specifically used for LBP or for manipulation. However, Deyo did develop one for use with LBP. His instrument examines the effectiveness of care, information, and caring. There is also the Patient Satisfaction Questionnaire, which assesses 8 separate indices (such as efficacy/outcomes or professional skill, for example). Cherkin noted that the Visit Specific Satisfaction Questionnaire can be used for chiropractic outcome assessment.

 

Recent work has shown that patient confidence and satisfaction with care are related to outcomes. Seferlis found that patients were more satisfied and felt that they were provided better explanations about their pain from practitioners who used manual therapy. Regardless of treatment, highly satisfied patients at 4 weeks were more likely than less satisfied patients to perceive greater pain improvement throughout 18-month follow-up in a study by Hurwitz et al. Goldstein and Morgenstern found a weak association between treatment confidence in the therapy they received and greater improvement in LBP. A frequent assertion is that benefits observed from application of manipulation methods are a result of physician attention and touching. Studies directly testing this hypothesis were conducted by Hadler et al in patients with acute condition and by Triano et al in patients with subacute and chronic condition. Both studies compared manipulation to a placebo control. In the study of Hadler, the control balanced for provider time attention and frequency, whereas Triano et al also added an education program with home exercise recommendations. In both cases, results demonstrated that although attention given to patients was associated with improvement over time, patients receiving manipulation procedures improved more quickly.

 

General Health Outcome Measures. This has traditionally been a difficult outcome to effectively measure but a number of more recent instruments are demonstrating that it can be done reliably. The 2 major instruments for doing so are the Sickness Impact Profile and the SF-36. The first assesses dimensions such as mobility, ambulation, rest, work, social interaction, and so on; the second looks primarily at well being, functional status, and overall health, as well as 8 other health concepts, to ultimately determine 8 indices that can be used to determine overall health status. Items here include physical functioning, social functioning, mental health, and others. This tool has been used in many settings and has also been adapted into shorter forms as well.

 

Physiologic Outcome Measures. The chiropractic profession has a number of physiologic outcomes that are used with regard to the patient care decision-making process. These include such procedures as ROM testing, muscle function testing, palpation, radiography, and other less common procedures (leg length analysis, thermography, and others). This chapter addresses only the physiologic outcomes assessed manually.

 

Range of Motion. This examination procedure is used by nearly every chiropractor and is used to assess impairment because it is related to spinal function. It is possible to use ROM as a means to monitor improvement in function over time and, therefore, improvement as it relates to the use of SMT. One can assess regional and global lumbar motion, for example, and use that as one marker for improvement.

 

Range of motion can be measured via a number of different means. One can use standard goniometers, inclinometers, and more sophisticated tools that require the use of specialized equipment and computers. When doing so, it is important to consider the reliability of each individual method. A number of studies have assessed various devices as follows:

 

  • Zachman found the use of the rangiometer moderately reliable,
  • Nansel found that using 5 repeated measures of cervical spine motion with an inclinometer to be reliable,
  • Liebenson found that the modified Schrober technique, along with inclinometers and flexible spinal rulers had the best support from the literature,
  • Triano and Schultz found that ROM for the trunk, along with trunk strength ratios and myoelectrical activity, was good indicator for LBP disability, and
  • a number of studies found that the kinematic measurement of ROM for spinal mobility is reliable.

 

Muscle Function. Evaluating muscle function may be done using an automated system or by manual means. Although manual muscle testing has been a common diagnostic practice within the chiropractic profession, there are few studies demonstrating clinical reliability for the procedure, and these are not considered to be of high quality.

 

Automated systems are more reliable and are capable of assessing muscle parameters such as strength, power, endurance, and work, as well as assess different modes of muscle contraction (isotonic, isometric, isokinetic). Hsieh found that a patient-initiated method worked well for specific muscles, and other studies have shown the dynamometer to have good reliability.

 

Leg Length Inequality. Very few studies of leg length have shown acceptable levels of reliability. The best methods for assessing reliability and validity of leg length involve radiographic means and are therefore subject to exposure to ionizing radiation. Finally, the procedure has not been studied as to validity, making the use of this as an outcome questionable.

 

Soft Tissue Compliance. Compliance is assessed by both manual and mechanical means, using the hand alone or using a device such as an algometer. By assessing compliance, the chiropractor is looking to assess muscle tone.

 

Early tests of compliance by Lawson demonstrated good reliability. Fisher found increases in tissue compliance with subjects involved in physical therapy. Waldorf found that prone segmental tissue compliance had good test/retest variation of less than 10%.

 

Pain tolerance assessed using these means has been found reliable, and Vernon found it was a useful measure in assessing the cervical paraspinal musculature after adjusting. The guidelines group from the Canadian Chiropractic Association and the Canadian Federation of Chiropractic Regulatory Boards concluded that “the assessments are safe and inexpensive and appear to be responsive to conditions and treatments commonly seen in chiropractic practice.”

 

Group Portrait Of Workers In Medical Professions

 

Conclusion

 

Existing research evidence regarding the usefulness of spinal adjusting/manipulation/mobilization indicates the following:

 

  1. As much or more evidence exists for the use of SMT to reduce symptoms and improve function in patients with chronic LBP as for use in acute and subacute LBP.
  2. Use of exercise in conjunction with manipulation is likely to speed and improve outcomes as well as minimize episodic recurrence.
  3. There was less evidence for the use of manipulation for patients with LBP and radiating leg pain, sciatica, or radiculopathy.
  4. Cases with high severity of symptoms may benefit by referral for comanagement of symptomswith medication.
  5. There was little evidence for the use of manipulation for other conditions affecting the low back and very few articles to support a higher rating.

 

Exercise and reassurance have been shown to be of value primarily in chronic LBP and low back problems associated with radicular symptoms. A number of standardized, validated tools are available to help capture meaningful clinical improvement over the course of low back care. Typically, functional improvement (as opposed to simple reported reduction in pain levels) may be clinically meaningful for monitoring responses to care. The literature reviewed remains relatively limited in predicting responses to care, tailoring specific combinations of intervention regimens (although the combination of manipulation and exercise may be better than exercise alone), or formulating condition-specific recommendations for frequency and duration of interventions. Table 2 summarizes the recommendations of the team, based on the review of the evidence.

 

Table 2 Summary of Conclusions

 

Practical Applications

 

  • Evidence exists for the use of spinal manipulation to reduce symptoms and improve function in patients with chronic, acute, and subacute LBP.
  • Exercise in conjunction with manipulation is likely to speed and improve outcomes and minimize recurrence

 

In conclusion, more evidence-based research studies have become available regarding the effectiveness of chiropractic care for low back pain and sciatica. The article also demonstrated that exercise should be used together with chiropractic to help speed up the rehabilitation process and further improve recovery. In most cases, chiropractic care can be used for the management of low back pain and sciatica, without the need for surgical interventions. However, if surgery is required to achieve recovery, a chiropractor may refer the patient to the next best healthcare professional. 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: Sciatica

 

Sciatica is referred to as a collection of symptoms rather than a single type of injury or condition. The symptoms are characterized as radiating pain, numbness and tingling sensations from the sciatic nerve in the lower back, down the buttocks and thighs and through one or both legs and into the feet. Sciatica is commonly the result of irritation, inflammation or compression of the largest nerve in the human body, generally due to a herniated disc or bone spur.

 

blog picture of cartoon paperboy big news

 

IMPORTANT TOPIC: EXTRA EXTRA: Treating Sciatica Pain

 

 

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  • Waldorf, T, Devlin, L, and Nansel, D. The comparative assessment of paraspinal tissue compliance on asymptomatic female and male subjects in both prone and standing positions. J Manipulative Physiol Ther. 1991; 4: 457–461
  • Ohrbach, R and Gale, E. Pressure pain threshold in normal muscles: reliability, measurement effects, and topographic differences. Pain. 1989; 37: 257–263
  • Vernon, H. Applying research-based assessments of pain and loss of function to the issue of developing standards of care in chiropractic. Chiropr Technique. 1990; 2: 121–126

 

Close Accordion
Effectiveness of Exercise: Neck, Hip & Knee Injuries from Auto Accidents

Effectiveness of Exercise: Neck, Hip & Knee Injuries from Auto Accidents

Based on statistical findings, approximately more than three million people in the United States are injured in an automobile accident every year. In fact, auto accidents are considered to be one of the most common causes for trauma or injury. Neck injuries, such as whiplash, frequently occur due to the sudden back-and-forth movement of the head and neck from the force of the impact. The same mechanism of injury can also cause soft tissue injuries in other parts of the body, including the lower back as well as the lower extremities. Neck, hip, thigh and knee injuries are common types of injuries resulting from auto accidents.

 

Abstract

 

  • Objective: The purpose of this systematic review was to determine the effectiveness of exercise for the management of soft tissue injuries of the hip, thigh, and knee.
  • Methods: We conducted a systematic review and searched MEDLINE, EMBASE, PsycINFO, the Cochrane Central Register of Controlled Trials, and CINAHL Plus with Full Text from January 1, 1990, to April 8, 2015, for randomized controlled trials (RCTs), cohort studies, and case-control studies evaluating the effect of exercise on pain intensity, self-rated recovery, functional recovery, health-related quality of life, psychological outcomes, and adverse events. Random pairs of independent reviewers screened titles and abstracts and assessed risk of bias using the Scottish Intercollegiate Guidelines Network criteria. Best evidence synthesis methodology was used.
  • Results: We screened 9494 citations. Eight RCTs were critically appraised, and 3 had low risk of bias and were included in our synthesis. One RCT found statistically significant improvements in pain and function favoring clinicbased progressive combined exercises over a “wait and see” approach for patellofemoral pain syndrome. A second RCT suggests that supervised closed kinetic chain exercises may lead to greater symptom improvement than open chain exercises for patellofemoral pain syndrome. One RCT suggests that clinic-based group exercises may be more effective than multimodal physiotherapy in male athletes with persistent groin pain.
  • Conclusion: We found limited high-quality evidence to support the use of exercise for the management of soft tissue injuries of the lower extremity. The evidence suggests that clinic-based exercise programs may benefit patients with patellofemoral pain syndrome and persistent groin pain. Further high-quality research is needed. (J Manipulative Physiol Ther 2016;39:110-120.e1)
  • Key Indexing Terms: Knee; Knee Injuries; Hip; Hip Injuries; Thigh; Thigh Pain; Exercise

 

Soft tissue injuries of the lower limb are common. In the United States, 36% of all injuries presenting to emergency departments are sprains and/or strains of the lower extremity. Among Ontario workers, approximately 19% of all approved lost time compensation claims are related to lower extremity injuries. Moreover, 27.5% of Saskatchewan adults injured in a traffic collision report pain in the lower extremity. Soft tissue injuries of the hip, thigh, and knee are costly and place a significant economic and disability burden on workplaces and compensation systems. According to the US Department of Labor Bureau of Statistics, the median time off work for lower extremity injuries was 12 days in 2013. Knee injuries were associated with the longest work absenteeism (median, 16 days).

 

Most soft tissue injuries of the lower limb are managed conservatively, and exercise is commonly used to treat these injuries. Exercise aims to promote good physical health and restore normal function of the joints and surrounding soft tissues through concepts which include range of motion, stretching, strengthening, endurance, agility, and proprioceptive exercises. However, the evidence about the effectiveness of exercise for managing soft tissue injuries of the lower limb is unclear.

 

Previous systematic reviews have investigated the effectiveness of exercise for the management of soft tissue injuries of the lower extremity. Reviews suggest that exercise is effective for the management of patellofemoral pain syndrome and groin injuries but not for patellar tendinopathy. To our knowledge, the only review reporting on the effectiveness of exercise for acute hamstring injuries found little evidence to support stretching, agility, and trunk stability exercises.

 

Image of trainer demonstrating rehabilitation exercises.

 

The purpose of our systematic review was to investigate the effectiveness of exercise compared to other interventions, placebo/sham interventions, or no intervention in improving self-rated recovery, functional recovery (eg, return to activities, work, or school), or clinical outcomes (eg, pain, health-related quality of life, depression) of patients with soft tissue injuries of the hip, thigh, and knee.

 

Methods

 

Registration

 

This systematic review protocol was registered with the International Prospective Register of Systematic Reviews on March 28, 2014 (CRD42014009140).

 

Eligibility Criteria

 

Population. Our review targeted studies of adults (≥18 years) and/or children with soft tissue injuries of the hip, thigh, or knee. Soft tissue injuries include but are not limited to grade I to II sprains/strains; tendonitis; tendinopathy; tendinosis; patellofemoral pain (syndrome); iliotibial band syndrome; nonspecific hip, thigh, or knee pain (excluding major pathology); and other soft tissue injuries as informed by available evidence. We defined the grades of sprains and strains according to the classification proposed by the American Academy of Orthopaedic Surgeons (Tables 1 and 2). Affected soft tissues in the hip include the supporting ligaments and muscles crossing the hip joint into the thigh (including the hamstrings, quadriceps, and adductor muscle groups). Soft tissues of the knee include the supporting intra-articular and extra-articular ligaments and muscles crossing the knee joint from the thigh including the patellar tendon. We excluded studies of grade III sprains or strains, acetabular labral tears, meniscal tears, osteoarthritis, fractures, dislocations, and systemic diseases (eg, infection, neoplasm, inflammatory disorders).

 

Table 1 Case Definition of Sprains

 

Table 2 Case Definition of Strains

 

Interventions. We restricted our review to studies that tested the isolated effect of exercise (ie, not part of a multimodal program of care). We defined exercise as any series of movements aimed at training or developing the body by routine practice or as physical training to promote good physical health.

 

Comparison Groups. We included studies that compared 1 or more exercise interventions to one another or one exercise intervention to other interventions, wait list, placebo/sham interventions, or no intervention.

 

Outcomes. To be eligible, studies had to include one of the following outcomes: (1) self-rated recovery; (2) functional recovery (eg, disability, return to activities, work, school, or sport); (3) pain intensity; (4) health-related quality of life; (5) psychological outcomes such as depression or fear; and (6) adverse events.

 

Study Characteristics. Eligible studies met the following criteria: (1) English language; (2) studies published between January 1, 1990, and April 8, 2015; (3) randomized controlled trials (RCTs), cohort studies, or case-control studies which are designed to assess the effectiveness and safety of interventions; and (4) included an inception cohort of a minimum of 30 participants per treatment arm with the specified condition for RCTs or 100 participants per group with the specified condition in cohort studies or case-control studies. Studies including other grades of sprains or strains in the hip, thigh, or knee had to provide separate results for participants with grades I or II sprains/strains to be included.

 

We excluded studies with the following characteristics: (1) letters, editorials, commentaries, unpublished manuscripts, dissertations, government reports, books and book chapters, conference proceedings, meeting abstracts, lectures and addresses, consensus development statements, or guideline statements; (2) study designs including pilot studies, cross-sectional studies, case reports, case series, qualitative studies, narrative reviews, systematic reviews (with or without meta-analyses), clinical practice guidelines, biomechanical studies, laboratory studies, and studies not reporting on methodology; (3) cadaveric or animal studies; and (4) studies on patients with severe injuries (eg, grade III sprains/strains, fractures, dislocations, full ruptures, infections, malignancy, osteoarthritis, and systemic disease).

 

Information Sources

 

We developed our search strategy with a health sciences librarian (Appendix 1). The Peer Review of Electronic Search Strategies (PRESS) Checklist was used by a second librarian to review the search strategy for completeness and accuracy. We searched MEDLINE and EMBASE, considered to be the major biomedical databases, and PsycINFO, for psychological literature through Ovid Technologies, Inc; CINAHL Plus with Full Text for nursing and allied health literature through EBSCOhost; and the Cochrane Central Register of Controlled Trials through Ovid Technologies, Inc, for any studies not captured by the other databases. The search strategy was first developed in MEDLINE and subsequently adapted to the other bibliographic databases. Our search strategies combined controlled vocabulary relevant to each database (eg, MeSH for MEDLINE) and text words relevant to exercise and soft tissue injuries of the hip, thigh, or knee including grade I to II sprain or strain injuries (Appendix 1). We also hand searched the reference lists of previous systematic reviews for any additional relevant studies.

 

Study Selection

 

A 2-phase screening process was used to select eligible studies. Random pairs of independent reviewers screened citation titles and abstracts to determine the eligibility of studies in phase 1. Screening resulted in studies being classified as relevant, possibly relevant, or irrelevant. In phase 2, the same pairs of reviewers independently screened the possibly relevant studies to determine eligibility. Reviewers met to reach consensus on the eligibility of studies and resolve disagreements. A third reviewer was used if consensus could not be reached.

 

Image of older patient engaging in upper rehabilitation exercises with a personal trainer.

 

Assessment of Risk of Bias

 

Independent reviewers were randomly paired to critically appraise the internal validity of eligible studies using the Scottish Intercollegiate Guidelines Network (SIGN) criteria. The impact of selection bias, information bias, and confounding on the results of a study was qualitatively evaluated using the SIGN criteria. These criteria were used to guide reviewers in making an informed overall judgment on the internal validity of studies. This methodology has been previously described. A quantitative score or a cutoff point to determine the internal validity of studies was not used for this review.

 

The SIGN criteria for RCTs were used to critically appraise the following methodological aspects: (1) clarity of the research question, (2) randomization method, (3) concealment of treatment allocation, (4) blinding of treatment and outcomes, (5) similarity of baseline characteristics between/among treatment arms, (6) cointervention contamination, (7) validity and reliability of outcome measures, (8) follow-up rates, (9) analysis according to intention-to-treat principles, and (10) comparability of results across study sites (where applicable). Consensus was reached through reviewer discussion. Disagreements were resolved by an independent third reviewer when consensus could not be reached. The risk of bias of each appraised study was also reviewed by a senior epidemiologist (PC). Authors were contacted when additional information was needed to complete the critical appraisal. Only studies with low risk of bias were included in our evidence synthesis.

 

Data Extraction and Synthesis of Results

 

Data were extracted from studies (DS) with low risk of bias to create evidence tables. A second reviewer independently checked the extracted data. We stratified results based on the duration of the condition (recent onset [0-3 months], persistent [N3 months], or variable duration [recent onset and persistent combined]).

 

We used standardized measures to determine the clinical importance of changes reported in each trial for common outcome measures. These include a between-group difference of 2/10 points on the Numeric Rating Scale (NRS), 2/10 cm difference on the Visual Analog Scale (VAS), and 10/100 point difference on the Kujala Patellofemoral scale, otherwise known as the Anterior Knee Pain Scale.

 

Statistical Analyses

 

Agreement between reviewers for the screening of articles was computed and reported using the κ statistic and 95% confidence interval (CI). Where available, we used data provided in the studies with a low risk of bias to measure the association between the tested interventions and the outcomes by computing the relative risk (RR) and its 95% CI. Similarly, we computed differences in mean changes between groups and 95% CI to quantify the effectiveness of interventions. The calculation of 95% CIs was based on the assumption that baseline and follow-up outcomes were highly correlated (r = 0.80).

 

Reporting

 

This systematic review was organized and reported based on the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement.

 

Dr. Alex Jimenez’s Insight

As a doctor of chiropractic, automobile accident injuries are one of the most common reasons people seek chiropractic care. From neck injuries, such as whiplash, to headaches and back pain, chiropractic can be utilized to safely and effectively restore the integrity of the spine after a car crash. A chiropractor like myself will often use a combination of spinal adjustments and manual manipulations, as well as a variety of other non-invasive treatment methods, to gently correct any spinal misalignments resulting from an auto accident injury. Whiplash and other types of neck injuries occur when the complex structures along the cervical spine are stretched beyond their natural range of movement due to the sudden back-and-forth movement of the head and neck from the force of the impact. Back injury, particularly in the lower spine, are also common as a result of an automobile accident. When the complex structures along the lumbar spine are damaged or injured, symptoms of sciatica may radiate down the lower back, into the buttocks, hips, thighs, legs and down into the feet. Knee injuries may also occur upon impact during an auto accident. Exercise is frequently used with chiropractic care to help promote recovery as well as improve strength, flexibility and mobility. Rehabilitation exercises are offered to patients to further restore the integrity of their body. The following research studies demonstrate that exercise, compared to non-invasive treatment options, is a safe and effective treatment method for individuals suffering with neck and lower extremity injury from a car crash.

 

Results

 

Study Selection

 

We screened 9494 citations based on the title and abstract (Figure 1). Of these, 60 full-text publications were screened, and 9 articles were critically appraised. The primary reasons for ineligibility during full text screening were (1) ineligible study design, (2) small sample size (n b 30 per treatment arm), (3) multimodal interventions not allowing isolation of the effectiveness of exercise, (4) ineligible study population, and (5) interventions not meeting our definition of exercise (Figure 1). Of those critically appraised, 3 studies (reported in 4 articles) had low risk of bias and were included in our synthesis. The interrater agreement for the screening of the articles was κ = 0.82 (95% CI, 0.69-0.95). The percentage agreement for the critical appraisal of studies was 75% (6/8 studies). Disagreement was resolved through discussion for 2 studies. We contacted authors from 5 studies during critical appraisal to request additional information and 3 responded.

 

Figure 1 Flowchart Used for the Study

 

Study Characteristics

 

The studies with low risk of bias were RCTs. One study, conducted in the Netherlands, examined the effectiveness of a standardized exercise program compared to a “wait and see” approach in participants with patellofemoral pain syndrome of variable duration. A second study, with outcomes reported in 2 articles, compared the benefit of closed vs open kinetic chain exercises in individuals with variable duration patellofemoral pain syndrome in Belgium. The final study, conducted in Denmark, investigated active training compared to a multimodal physiotherapy intervention for the management of persistent adductor-related groin pain.

 

Two RCTs used exercise programs that combined strengthening exercises with balance or agility training for the lower extremity. Specifically, the strengthening exercises consisted of both isometric and concentric contractions of the quadriceps, hip adductor, and gluteal muscles for the management of patellofemoral pain46 and hip adductors and muscles of the trunk and pelvis for adductor-related groin pain. The exercise programs ranged from 646 to 1243 weeks in duration and were supervised and clinic based with additional daily home exercises. The exercise programs were compared to a “wait and see” approach or to multimodal physiotherapy. The third RCT compared 2 different 5-week protocols which combined either closed or open kinetic chain strengthening and stretching exercises for the lower extremity musculature.

 

Meta-analysis was not performed due to heterogeneity of accepted studies with respect to patient populations, interventions, comparators, and outcomes. Principles of best evidence synthesis were used to develop evidence statements and perform a qualitative synthesis of findings from studies with low risk of bias.

 

Risk of Bias Within Studies

 

The studies with low risk of bias had a clearly defined research question, used appropriate blinding methods where possible, reported adequate similarity of baseline characteristics between treatment arms, and performed an intention-to-treat analyses where applicable (Table 3). The RCTs had follow-up rates greater than 85%. However, these studies also had methodological limitations: insufficient detail describing methods for allocation concealment (1/3), insufficient detail describing methods of randomization (1/3), the use of outcome measures that have not been demonstrated to be valid or reliable (ie, muscle length and successful treatment) (2/3), and clinically important differences in baseline characteristics (1/3).

 

Table 3 Risk of Bias for Accepted Randomized Control Trials Based on SIGN Criteria

 

Of 9 relevant articles, 5 were deemed to have high risk of bias. These studies had the following limitations: (1) poor or unknown randomization methods (3/5); (2) poor or unknown allocation concealment methods (5/ 5); (3) outcome assessor not blinded (4/ 5); (4) clinically important differences in baseline characteristics (3/5); (5) dropouts not reported, insufficient information regarding dropouts per group or large differences in dropout rates between treatment arms (N15%) (3/5); and (6) a lack of information about or no intention-to-treat analysis (5/5).

 

Summary of Evidence

 

Patellofemoral Pain Syndrome of Variable Duration. Evidence from 1 RCT suggests that a clinic-based progressive exercise program may provide short- and long-term benefit over usual care for the management of patellofemoral pain syndrome of variable duration. van Linschoten et al randomized participants with a clinical diagnosis of patellofemoral pain syndrome of 2 months to 2 years duration to (1) a clinic-based exercise program (9 visits over 6 weeks) consisting of progressive, static, and dynamic strengthening exercises for the quadriceps, adductor, and gluteal muscles and balance and flexibility exercises, or (2) a usual care “wait and see” approach. Both groups received standardized information, advice, and home-based isometric exercises for the quadriceps based on recommendations from Dutch General Practitioner guidelines (Table 4). There were statistically significant differences favoring the exercise group for (1) pain (NRS) at rest at 3 months (mean change difference 1.1/10 [95% CI, 0.2-1.9]) and 6 months (mean change difference 1.3/10 [95% CI, 0.4-2.2]); (2) pain (NRS) with activity at 3 months (mean change difference 1.0/10 [95% CI, 0.1-1.9]) and 6 months (mean change difference 1.2/10 [95% CI, 0.2-2.2]); and (3) function (Kujala Patellofemoral Scale [KPS]) at 3 months (mean change difference 4.9/100 [95% CI, 0.1-9.7]). However, none of these differences were clinically important. Furthermore, there were no significant differences in the proportion of participants reporting recovery (fully recovered, strongly recovered), but the exercise group was more likely to report improvement at 3-month follow-up (odds ratio [OR], 4.1 [95% CI, 1.9-8.9]).

 

Image of patient engaging in rehabilitation exercises.

 

Evidence from a second RCT suggests that physiotherapist- supervised closed kinetic chain leg exercises (where the foot remains in constant contact with a surface) may provide short-term benefit compared to supervised open kinetic chain exercises (where the limb moves freely) for some patellofemoral pain syndrome symptoms (Table 4). All participants trained for 30 to 45 minutes, 3 times per week for 5 weeks. Both groups were instructed to perform static lower limb stretching after each training session. Those randomized to closed chain exercises performed supervised (1) leg presses, (2) knee bends, (3) stationary biking, (4) rowing, (5) step-up and step-down exercises, and (6) progressive jumping exercises. Open chain exercise participants performed (1) maximal quad muscle contraction, (2) straight-leg raises, (3) short arc movements from 10° to full knee extension, and (4) leg adduction. Effect sizes were not reported, but the authors reported statistically significant differences favoring closed kinetic chain exercise at 3 months for (1) frequency of locking (P = .03), (2) clicking sensation (P = .04), (3) pain with isokinetic testing (P = .03), and (4) pain during night (P = .02). The clinical significance of these results is unknown. There were no statistically significant differences between groups for any other pain or functional measures at any follow-up period.

 

Table 4 Evidence Table for Accepted Randomized Control Trials on the Effectiveness of Exercise for Soft Tissue Injuries of the Hip, Thigh, or Knee

 

Table 4 Evidence Table for Accepted Randomized Control Trials on the Effectiveness of Exercise for Soft Tissue Injuries of the Hip, Thigh, or Knee

 

Persistent Adductor-Related Groin Pain

 

Evidence from 1 RCT suggests that a clinic-based group exercise program is more effective than a multimodal program of care for persistent adductor-related groin pain. Hölmich et al studied a group of male athletes with a clinical diagnosis of adductor-related groin pain of greater than 2 months duration (median duration, 38-41 weeks; range, 14-572 weeks) with or without osteitis pubis. Participants were randomized to (1) a clinic-based group exercise program (3 sessions per week for 8-12 weeks) consisting of isometric and concentric resistance strengthening exercises for the adductors, trunk, and pelvis; balance and agility exercises for the lower extremity; and stretching for the abdominals, back, and lower extremity (with the exception of the adductor muscles) or (2) a multimodal physiotherapy program (2 visits per week for 8-12 weeks) consisting of laser; transverse friction massage; transcutaneous electrical nerve stimulation (TENS); and stretching for the adductors, hamstrings, and hip flexors (Table 4). Four months after the intervention, the exercise group was more likely to report that their condition was “much better” (RR, 1.7 [95% CI, 1.0-2.8]).

 

Adverse Events

 

None of the included studies commented on the frequency or nature of adverse events.

 

Discussion

 

Summary of Evidence

 

Our systematic review examined the effectiveness of exercise for the management of soft tissue injuries of the hip, thigh, or knee. Evidence from 1 RCT suggests that a clinic-based progressive combined exercise program may offer additional short- or long-term benefit compared to providing information and advice for the management of patellofemoral pain syndrome of variable duration. There is also evidence that supervised closed kinetic chain exercises may be beneficial for some patellofemoral pain syndrome symptoms compared to open kinetic chain exercises. For persistent adductor-related groin pain, evidence from 1 RCT suggests that a clinic-based group exercise program is more effective than a multimodal program of care. Despite the common and frequent use of exercise prescription, there is limited high-quality evidence to inform the use of exercise for the management of soft tissue injuries of the lower extremity. Specifically, we did not find high-quality studies on exercise for the management of some of the more commonly diagnosed conditions including patellar tendinopathy, hamstring sprain and strain injuries, hamstring tendinopathy, trochanteric bursitis, or capsular injuries of the hip.

 

Image of Dr. Jimenez demonstrating rehabilitation exercises to patient.

 

Previous Systematic Reviews

 

Our results are consistent with findings from previous systematic reviews, concluding that exercise is effective for the management of patellofemoral pain syndrome and groin pain. However, the results from previous systematic reviews examining the use of exercise for the management of patellar tendinopathy and acute hamstring injuries are inconclusive. One review noted strong evidence for use of eccentric training, whereas others reported uncertainty of whether isolated eccentric exercises were beneficial for tendinopathy compared to other forms of exercise. Furthermore, there is limited evidence of a positive effect from stretching, agility and trunk stability exercises, or slump stretching for the management of acute hamstring injuries. Differing conclusions between systematic reviews and the limited number of studies deemed admissible in our work may be attributed to differences in methodology. We screened reference lists of previous systematic reviews, and most studies included in the reviews did not meet our inclusion criteria. Many studies accepted in other reviews had small sample sizes (b30 per treatment arm). This increases the risk of residual confounding while also reducing the effect size precision. Furthermore, a number of systematic reviews included case series and case studies. These types of studies are not designed to assess the effectiveness of interventions. Finally, previous reviews included studies where exercise was part of a multimodal intervention, and as a consequence, the isolated effect of exercise could not be ascertained. Of the studies that satisfied our selection criteria, all were critically appraised in our review, and only 3 had low risk of bias and were included in our synthesis.

 

Strengths

 

Our review has many strengths. First, we developed a rigorous search strategy that was independently reviewed by a second librarian. Second, we defined clear inclusion and exclusion criteria for the selection of possibly relevant studies and only considered studies with adequate sample sizes. Third, pairs of trained reviewers screened and critically appraised eligible studies. Fourth, we used a valid set of criteria (SIGN) to critically appraise studies. Finally, we restricted our synthesis to studies with low risk of bias.

 

Limitations and Recommendations for Future Research

 

Our review also has limitations. First, our search was limited to studies published in the English language. However, previous reviews have found that the restriction of systematic reviews to English language studies has not led to a bias in reported results. Second, despite our broad definition of soft tissue injuries of the hip, thigh, or knee, our search strategy may not have captured all potentially relevant studies. Third, our review may have missed potentially relevant studies published before 1990. We aimed to minimize this by hand searching the reference lists of previous systematic reviews. Finally, critical appraisal requires scientific judgment that may differ between reviewers. We minimized this potential bias by training reviewers in the use of the SIGN tool and using a consensus process to determine study admissibility. Overall, our systematic review highlights a deficit of strong research in this area.

 

High-quality studies on the effectiveness of exercise for the management of soft tissue injuries of the lower extremity are needed. Most studies included in our review (63%) had a high risk of bias and could not be included in our synthesis. Our review identified important gaps in the literature. Specifically, studies are needed to inform the specific effects of exercises, their long-term effects, and the optimal doses of intervention. Furthermore, studies are needed to determine the relative effectiveness of different types of exercise programs and if the effectiveness varies for soft tissue injuries of the hip, thigh, and knee.

 

Conclusion

 

There is limited high-quality evidence to inform the use of exercise for the management of soft tissue injuries of the hip, thigh, and knee. The current evidence suggests that a clinic-based progressive combined exercise program may lead to improved recovery when added to information and advice on resting and avoiding pain provoking activities for the management of patellofemoral pain syndrome. For persistent adductor-related groin pain, a supervised clinic- based group exercise program is more effective than multimodal care in promoting recovery.

 

Funding Sources and Potential Conflicts of Interest

 

This study was funded by the Ontario Ministry of Finance and the Financial Services Commission of Ontario (RFP no. OSS_00267175). The funding agency was not involved in the collection of data, data analysis, interpretation of data, or drafting of the manuscript. The research was undertaken, in part, thanks to funding from the Canada Research Chairs program. Pierre Côté has previously received funding from a Grant from the Ontario Ministry of Finance; consulting for the Canadian Chiropractic Protective Association; speaking and/or teaching arrangements for the National Judicial Institute and Société des Médecins Experts du Quebec; trips/travel, European Spine Society; board of directors, European Spine Society; grants: Aviva Canada; fellowship support, Canada Research Chair Program–Canadian Institutes of Health Research. No other conflicts of interest were reported for this study.

 

Contributorship Information

 

  • Concept development (provided idea for the research): D.S., C.B., P.C., J.W., H.Y., S.V.
  • Design (planned the methods to generate the results): D.S., C.B., P.C., H.S., J.W., H.Y., S.V.
  • Supervision (provided oversight, responsible for organization and implementation, writing of the manuscript): D.S., P.C.
  • Data collection/processing (responsible for experiments, patient management, organization, or reporting data): D.S., C.B., H.S., J.W., D.e.S., R.G., H.Y., K.R., J.C., K.D., P.C., P.S., R.M., S.D., S.V.
  • Analysis/interpretation (responsible for statistical analysis, evaluation, and presentation of the results): D.S., C.B., P.C., H.S., M.S., K.R., L.C.
  • Literature search (performed the literature search): A.T.V.
  • Writing (responsible for writing a substantive part of the manuscript): D.S., C.B., P.C., H.S.
  • Critical review (revised manuscript for intellectual content, this does not relate to spelling and grammar checking): D.S., P.C., H.S., J.W., D.e.S., R.G., M.S., A.T.V., H.Y., K.R., J.C., K.D., L.C., P.S., S.D., R.M., S.V.

 

Practical Applications

 

  • There is evidence to suggest that clinic-based exercises may benefit patients with patellofemoral pain syndrome or adductor-related groin pain.
  • Supervised progressive exercises may be beneficial for patellofemoral pain syndrome of variable duration compared to information/advice.
  • Supervised closed kinetic chain exercises may provide more benefit compared to open kinetic chain exercises for some patellofemoral pain syndrome symptoms.
  • Self-rated improvement in persistent groin pain is higher after a clinic-based group exercise program compared to multimodal physiotherapy.

 

Are Non-Invasive Interventions Effective for the Management of Headaches Associated with Neck Pain?

 

Furthermore, other non-invasive interventions, as well as non-pharmacological interventions, are also commonly utilized to help treat symptoms of neck pain and headaches associated with neck injuries, such as whiplash, caused by automobile accidents. As mentioned before, whiplash is one of the most common types of neck injuries resulting from auto accidents. Chiropractic care, physical therapy and exercise, can be used to improve the symptoms of neck pain, according to the following research studies.

 

Abstract

 

Purpose

 

To update findings of the 2000–2010 Bone and Joint Decade Task Force on Neck Pain and its Associated Disorders and evaluate the effectiveness of non-invasive and non-pharmacological interventions for the management of patients with headaches associated with neck pain (i.e., tension-type, cervicogenic, or whiplash-related headaches).

 

Methods

 

We searched five databases from 1990 to 2015 for randomized controlled trials (RCTs), cohort studies, and case–control studies comparing non-invasive interventions with other interventions, placebo/sham, or no interventions. Random pairs of independent reviewers critically appraised eligible studies using the Scottish Intercollegiate Guidelines Network criteria to determine scientific admissibility. Studies with a low risk of bias were synthesized following best evidence synthesis principles.

 

Results

 

We screened 17,236 citations, 15 studies were relevant, and 10 had a low risk of bias. The evidence suggests that episodic tension-type headaches should be managed with low load endurance craniocervical and cervicoscapular exercises. Patients with chronic tension-type headaches may also benefit from low load endurance craniocervical and cervicoscapular exercises; relaxation training with stress coping therapy; or multimodal care that includes spinal mobilization, craniocervical exercises, and postural correction. For cervicogenic headaches, low load endurance craniocervical and cervicoscapular exercises; or manual therapy (manipulation with or without mobilization) to the cervical and thoracic spine may also be helpful.

 

Image of elderly couple participating in low-impact rehabilitation exercises.

 

Conclusions

 

The management of headaches associated with neck pain should include exercise. Patients who suffer from chronic tension-type headaches may also benefit from relaxation training with stress coping therapy or multimodal care. Patients with cervicogenic headache may also benefit from a course of manual therapy.

 

Keywords

 

Non-invasive interventions, Tension-type headache, Cervicogenic headache, Headache attributed to whiplash injury, Systematic review

 

Notes

 

Acknowledgments

 

We would like to acknowledge and thank all of the individuals who have made important contributions to this review: Robert Brison, Poonam Cardoso, J. David Cassidy, Laura Chang, Douglas Gross, Murray Krahn, Michel Lacerte, Gail Lindsay, Patrick Loisel, Mike Paulden, Roger Salhany, John Stapleton, Angela Verven, and Leslie Verville. We would also like to thank Trish Johns-Wilson at the University of Ontario Institute of Technology for her review of the search strategy.

 

Compliance with Ethical Standards

 

Conflict of Interest

 

Dr. Pierre Côté has received a grant from the Ontario government, Ministry of Finance, funding from the Canada Research Chairs program, personal fees from National Judicial Institute for lecturing, and personal fees from European Spine Society for teaching. Drs. Silvano Mior and Margareta Nordin have received reimbursement for travel expenses to attend meetings for the study. The remaining authors report no declarations of interest.

 

Funding

 

This work was supported by the Ontario Ministry of Finance and the Financial Services Commission of Ontario [RFP# OSS_00267175]. The funding agency had no involvement in the study design, collection, analysis, interpretation of data, writing of the manuscript or decision to submit the manuscript for publication. The research was undertaken, in part, thanks to funding from the Canada Research Chairs program to Dr. Pierre Côté, Canada Research Chair in Disability Prevention and Rehabilitation at the University of Ontario Institute of Technology.

 

In conclusion, exercise included in chiropractic care and other non-invasive interventions should be utilized as an essential part of treatment to further help improve the symptoms of neck injury as well as that of hip, thigh and knee injury. According to the above research studies, exercise, or physical activity, is beneficial towards speeding up recovery time for patients with automobile accident injuries and for restoring strength, flexibility and mobility to the affected structures of the spine. 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

 

Green-Call-Now-Button-24H-150x150-2-3.png

 

Additional Topics: Sciatica

 

Sciatica is referred to as a collection of symptoms rather than a single type of injury or condition. The symptoms are characterized as radiating pain, numbness and tingling sensations from the sciatic nerve in the lower back, down the buttocks and thighs and through one or both legs and into the feet. Sciatica is commonly the result of irritation, inflammation or compression of the largest nerve in the human body, generally due to a herniated disc or bone spur.

 

blog picture of cartoon paperboy big news

 

IMPORTANT TOPIC: EXTRA EXTRA: Treating Sciatica Pain

 

 

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Close Accordion
Comparison of Chiropractic & Hospital Outpatient Care for Back Pain

Comparison of Chiropractic & Hospital Outpatient Care for Back Pain

Back pain is one of the most common causes people visit their healthcare professional every year. A primary care physician is often the first doctor who can provide treatment for a variety of injuries and/or conditions, however, among those individuals seeking complementary and alternative treatment options for back pain, most people choose chiropractic care. Chiropractic care focuses on the diagnosis, treatment and prevention of trauma and disease of the musculoskeletal and nervous systems, by correcting misalignments of the spine through the use of spinal adjustments and manual manipulations.

 

Approximately 35% of individuals seek chiropractic treatment for back pain caused by automobile accidents, sports injuries, and a variety of muscle strains. When people suffer an trauma or injury as a result of an accident, however, they may first receive treatment for their symptoms of back pain in a hospital. Hospital outpatient care describes treatment which does not require an overnight stay at a medical facility. A research study conducted an analysis comparing the effects of chiropractic care and hospital outpatient management for back pain. The results are described in detail below.

 

Abstract

 

Objective: To compare the effectiveness over three years of chiropractic and hospital outpatient management for low back pain.

 

Design: Randomised allocation of patients to chiropractic or hospital outpatient management.

 

Setting: Chiropractic clinics and hospital outpatient departments within reasonable travelling distance of each other in I I centres.

 

Subjects: 741 men and women aged 18-64 years with low back pain in whom manipulation was not contraindicated.

 

Outcome measures: Change in total 0swestry questionnaire score and in score for pain and patient satisfaction with allocated treatment.

 

Results: According to total 0swestry scores improvement in all patients at three years was about 291/6 more in those treated by chiropractors than in those treated by the hospitals. The beneficial effect of chiropractic on pain was particularly clear. Those treated by chiropractors had more further treatments for back pain after the completion of trial treatment. Among both those initially referred from chiropractors and from hospitals more rated chiropractic helpful at three years than hospital management.

 

Conclusions: At three years the results confirm the findings of an earlier report that when chiropractic or hospital therapists treat patients with low back pain as they would in day to day practice those treated by chiropractic derive more benefit and long term satisfaction than those treated by hospitals.

 

Introduction

 

In 1990 we reported greater improvement in patients with low back pain treated by chiropractic compared with those receiving hospital outpatient management. The trial was “pragmatic” in allowing the therapists to treat patients as they would in day to day practice. At the time of our first report not all patients had been in the trial for more than six months. This paper presents the full results up to three years for all patients for whom follow up information from Oswestry questionnaires and for other outcomes was available for analysis. We also present data on pain from the questionnaire, which is by definition the main complaint prompting referral or self referral.

 

Image 1 Comparison of Chiropractic & Hospital Outpatient Care for Back Pain

 

Methods

 

Methods were fully described in our first report. Patients initially referred or presenting either to a chiropractic clinic or in hospital were randomly allocated to be treated either by chiropractic or in hospital. A total of 741 patients started treatment. Progress was measured with the Oswestry questionnaire on back pain, which gives scores for I 0 sections for example, intensity of pain and difficulty with lifting, walking, and travelling. The result is expressed on a scale ranging from 0 (no pain or difficulties) to 100 (highest score for pain and greatest difficulty on all items). For an individual item, such as pain, scores range from 0 to 10. The main outcome measures are the changes in Oswestry score from before treatment to each follow up. At one, two, and three years patients were also asked about further treatment since the completion of their trial treatment or since the previous annual questionnaire. At the three year follow up patients were asked whether they thought their allocated trial treatment had helped their back pain.

 

In the random allocation of treatment minimisation was used within each centre to establish groups for the analysis of results according to initial referral clinic, length of current episode (more or less than ‘a month), presence or absence of a history of back pain, and an Oswestry score at entry of > 40 or <=40%.

 

Results were analysed on an intention to treat basis (subject to the availability of data at follow up as well as at entry for individual patients). Differences between mean changes were tested by unpaired t tests, and X2 tests were used to test for differences in proportions between the two treatment groups.

 

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Dr. Alex Jimenez’s Insight

Chiropractic is a natural form of health care which purpose is to restore and maintain the function of the musculoskeletal and nervous systems, promoting spinal health and allowing the body to heal itself naturally. Our philosophy emphasizes on the treatment of the human body as a whole, rather than on the treatment of a single injury and/or condition. As an experienced chiropractor, my goal is to properly assess patients in order to determine which type of treatment will most effectively heal their individual type of health issue. From spinal adjustments and manual manipulations to physical activity, chiropractic care can help correct spinal misalignments that cause back pain.

 

Results

 

Follow up Oswestry questionnaires were returned by a consistently higher proportion of patients allocated to chiropractic than to hospital treatment. At six weeks, for example, they were returned by 95% and 89% of chiropractic and hospital patients, respectively and at three years by 77% and 70%.

 

Mean (SD) scores before treatment were 29-8 (14-2) and 28-5 (14-1) in the chiropractic and hospital treatment groups, respectively. Table I shows the differences between the mean changes in total Oswestry scores according to randomly allocated treatment group. The difference at each follow up is the mean change for the chiropractic group minus the mean change for the hospital group.

 

Table 1 Differences Between Mean Changes in Oswestry Scores

 

Positive differences therefore reflect more improvement (due to a greater change in score) in those treated by chiropractic than in hospital (negative differences the reverse). The 3-18 percentage point difference at three years in table I represents a 29% greater improvement in patients treated with chiropractic compared with hospital treatment, the absolute improvement in the two groups at this time being 14-1 and 10-9 percentage points, respectively. As in the first report those with short current episodes, a history of back pain, and initially high Oswestry scores tended to derive most benefit from chiropractic. Those referred by chiropractors consistently derived more benefit from chiropractic than those referred by hospitals.

 

Table II shows changes between the scores on pain intensity before treatment and the corresponding scores at the various follow up intervals. All these changes were positive that is, indicated improvement but were all significantly greater in those treated by chiropractic, including the changes early on that is, at six weeks and six months, when the proportions returning questionnaires were high. As with the results based on the full Oswestry score the improvement due to chiropractic was greatest in those initially referred by chiropractors, although there was also a non-significant improvement (ranging from 9% at six months to 34% at three years) due to chiropractic at each follow up interval in those referred by hospitals.

 

Table 2 Changes in Scores from Section on Pain Intensity in Oswestry Questionnaire

 

Other scores for individual items on the Oswestry index to show significant improvement attributable to chiropractic were ability to sit for more than a short time and sleeping (P=0’004 and 0 03, respectively, at three years), though the differences were not as consistent as for pain. Other scores (personal care, lifting, walking, standing, sex life, social life, and travelling) also nearly all improved more in the patients treated with chiropractic, though most of the differences were small compared with the differences for pain.

 

Higher proportions of patients allocated to chiropractic sought further treatment (of any kind) for back pain after completion of trial treatment than those managed in hospital. For example, between one and two years after trial entry 122/292 (42%) patients treated with chiropractic compared with 80/258 (3 1%) of hospital treated patients did so (Xl=6 8, P=0 0 1).

 

Table III shows the proportions of patients at three years who thought their allocated trial treatment had helped their back pain. Among those initially referred by hospitals as well as among those initially referred by chiropractors higher proportions treated by chiropractic considered that treatment had helped compared with those treated in hospital.

 

Table 3 Number of Patients at Three Year Follow Up

 

Key Messages

 

  • Back pain often remits spontaneously
  • Effective treatments for non-remitting episodes need to be more clearly identified
  • Chiropractic seems to be more effective than hospital management, possibly because more treatments are spread over longer time periods
  • A growing number of NHS purchasers are making complementary treatments, including chiropractic, available
  • Further trials to identify the effective components of chiropractic are needed

 

Discussion

 

The results at six weeks and six months shown in table I are identical with those in our first report, as all patients had then been followed up for six months. The findings at one year are similar as many patients had also been followed up then. The considerably larger numbers of patients with data now available at two and three years show smaller benefits at these intervals than previously, though these still significantly favour chiropractic. The substantial benefit of chiropractic on intensity of pain is evident early on and then persists. The consistently larger proportions lost to follow up throughout the trial in those treated in hospital than in those treated by chiropractic suggests greater satisfaction with chiropractic. This conclusion is supported (table III) by the higher proportions in each referral group considering chiropractic helpful by comparison with hospital treatment.

 

Image of medical researchers recording clinical findings on the results of low back pain treatment.

 

The main criticism of the trial after our first report centred on its “pragmatic” nature, particularly the larger number of chiropractic than hospital treatments and the longer period over which the chiropractic treatments were spread and which were deliberately allowed. These considerations and any consequences of the higher proportions of patients allocated to chiropractic who received further treatment in the later stages of follow up, however, do not apply to the results at six weeks and only apply to a limited extent at six months, when the proportions followed up were high and extra treatment had either not occurred at all or was not yet extensive. Benefits atributable to chiropractic were already evident (especially on pain, table II) at these shorter intervals.

 

We believe there is now more support for the need for “fastidious” trials focusing on specific components of management and on their feasibility. Meanwhile, the results of our trial show that chiropractic has a valuable part to play in the management of low back pain.

 

We thank Dr Iain Chalmers for commenting on an earlier draft of the paper. We thank the nurse coordinators, medical staff, physiotherapists, and chiropractors in the 11 centres for their work, and Dr Alan Breen of the British Chiropractic Association for his help. The centres were in Harrow Taunton, Plymouth, Bournemouth and Poole, Oswestry, Chertsey, Liverpool, Chelmsford, Birmingham, Exeter, and Leeds. Without the assistance of many staff members in each the trial could not have been completed.

 

Funding: Medical Research Council, the National Back Pain Association, the European Chiropractors Union, and the King Edward’s Hospital Fund for London.

 

Conflict of interest: None.

 

In conclusion, after three years, the results of the research study comparing chiropractic care and hospital outpatient management for low back pain determined that people treated by chiropractic experienced more benefits as well as long-term satisfaction than those treated by hospitals. Because back pain is one of the most common causes people visit their healthcare professional every year, its essential to seek the most effective type of health care. Information referenced from the National Center for Biotechnology Information (NCBI). The scope of our information is limited to chiropractic as well as to spinal injuries and conditions. To discuss the subject matter, please feel free to ask Dr. Jimenez or contact us at 915-850-0900 .

 

Curated by Dr. Alex Jimenez

 

References

 

  1. Meade TW, Dyer S, Browne W, Townsend J, Frank AO. Low back pain of mechanical origin: randomised comparison of chiropractic and hospital outpatient treatment. BMJ. 1990 Jun 2;300(6737):1431–1437. [PMC free article] [PubMed]
  2. Fairbank JC, Couper J, Davies JB, O’Brien JP. The Oswestry low back pain disability questionnaire. Physiotherapy. 1980 Aug;66(8):271–273. [PubMed]
  3. Pocock SJ, Simon R. Sequential treatment assignment with balancing for prognostic factors in the controlled clinical trial. Biometrics. 1975 Mar;31(1):103–115. [PubMed]

 

Green-Call-Now-Button-24H-150x150-2-3.png

 

Additional Topics: Sciatica

 

Sciatica is referred to as a collection of symptoms rather than a single type of injury or condition. The symptoms are characterized as radiating pain, numbness and tingling sensations from the sciatic nerve in the lower back, down the buttocks and thighs and through one or both legs and into the feet. Sciatica is commonly the result of irritation, inflammation or compression of the largest nerve in the human body, generally due to a herniated disc or bone spur.

 

blog picture of cartoon paperboy big news

 

IMPORTANT TOPIC: EXTRA EXTRA: Treating Sciatica Pain

 

 

Vertebral Artery Dissection Found During Chiropractic Examination

Vertebral Artery Dissection Found During Chiropractic Examination

Acknowledging the subsequent information below, approximately more than 2 million people are injured in automobile accidents each year and among those incidents, the majority of the people involved are diagnosed with whiplash and/or neck injury by a healthcare professional. When the complex structure of the neck is subjected to trauma, tissue damage and other medical complications may occur. Vertebral artery dissection, or VAD, is characterized by a flap-like tear on the inner lining of the vertebral artery in charge of supplying blood to the brain. After the tear, blood can then enter the arterial wall and form a blood clot, thickening the artery wall and often impeding blood flow.

 

Through years of experience practicing chiropractic care, VAD may often follow after trauma to the neck, such as that which occurs in an automobile accident, or whiplash injury. The symptoms of vertebral artery dissection include head and neck pain as well as intermittent or permanent stroke symptoms, such as difficulty speaking, impaired coordination and loss of vision. VAD, or vertebral artery dissection, is generally diagnosed with a contrast-enhanced CT or MRI scan.

 

Abstract

 

A 30-year-old woman presented to an emergency department with sudden onset of transient loss of left peripheral vision. Owing to a history of migraine headaches, she was released with a diagnosis of ocular migraine. Two days later, she sought chiropractic care for the chief symptom of severe neck pain. The chiropractor suspected the possibility of vertebral artery dissection (VAD). No manipulation was performed; instead, MR angiography (MRA) of the neck was obtained, which revealed an acute left VAD with early thrombus formation. The patient was placed on aspirin therapy. Repeat MRA of the neck 3 months later revealed resolution of the thrombus, without progression to stroke. This case illustrates the importance for all healthcare providers who see patients with neck pain and headache to be attentive to the symptomatic presentation of possible VAD in progress.

 

Background

 

Vertebral artery dissection (VAD) leading to stroke is an uncommon but potentially serious disorder. The incidence of stroke related to the vertebrobasilar system varies from 0.75 to 1.12/100 000 person-years. The pathological process in VAD typically involves dissection of the wall of the artery followed sometime later by thrombus formation, which may cause arterial occlusion or may lead to embolisation, causing occlusion of one or more of the distal branches off the vertebral artery, including the basilar artery, which can be catastrophic. VAD typically occurs in patients who have an inherent, transitory weakness in the arterial wall. In at least 80% of cases, the initial symptoms include neck pain with or without headache.

 

Many patients with VAD may in the early stages present to chiropractors seeking relief from neck pain and headache, without realising they are experiencing VAD. In many of these cases, the patient later develops a stroke. Until recently, it was assumed that the dissection (and subsequent stroke) was caused by cervical manipulative therapy (CMT). However, while early studies found an association between visits to a chiropractor and subsequent stroke related to VAD, recent data suggest that this relationship is not causal.

 

This case report is illustrative of the scenario in which a patient with an undiagnosed VAD in evolution consulted a chiropractor for neck pain and headache. After thorough history and examination, the chiropractor suspected VAD and did not perform CMT. Instead, the patient was referred for further evaluation, which detected a VAD in progress. Prompt diagnosis and anticoagulant treatment were thought to have averted progression to a stroke.

 

Case Presentation

 

A 30-year-old otherwise healthy woman consulted a chiropractor (DBF), reporting of right-sided neck pain in the suboccipital region. The patient reported that, 3 days previously, she had gone to the local hospital emergency department (ED) because of the sudden onset of loss of left peripheral vision. The visual symptoms interfered with her ability to see through her left eye; this was accompanied by ‘numbness’ in her left eyelid. About 2 weeks prior to this ED visit, she had experienced an episode of acute left-sided neck pain with severe left-sided headache. She also related a history of migraine headache without prodrome. She was released from the ED with a tentative diagnosis of ocular migraine. She had never been previously diagnosed with ocular migraine, nor had she ever experienced any visual disturbances with her previous migraines.

 

Shortly after the left-sided ocular symptoms resolved, she suddenly developed right-sided neck pain without provocation, for which she sought chiropractic treatment. She also reported a transient episode of right-sided visual disturbance occurring that same day as well. This was described as sudden blurriness that was of short duration and resolved spontaneously earlier in the day of her presentation for chiropractic examination. When she presented for the initial chiropractic examination, she denied current visual disturbance. She said that she was not experiencing any numbness, paraesthesia or motor loss in the upper or lower extremities. She denied ataxia or difficulty with balance. Medical history was remarkable for childbirth 2½ months prior to initial presentation. She stated that her migraine headaches were associated with her menstrual cycle. Family history was remarkable for a spontaneous ascending thoracic aortic aneurysm in her older sister, who was about 30 years of age when her aneurysm had occurred.

 

Investigations

 

Based on the history of sudden onset of severe upper cervical pain and headache with visual disturbance and ocular numbness, the DC was concerned about the possibility of early VAD. Urgent MR angiography (MRA) of the neck and head, along with MRI of the head, was ordered. No cervical spine examination or manipulation was performed because of the suspicion that the neck pain was related to VAD rather than to a ‘mechanical’ cervical disorder.

 

MRA of the neck demonstrated that the left vertebral artery was small and irregular in calibre, extending from the C7 level cephalad to C2, consistent with dissection. There was a patent true lumen with a surrounding cuff of T1 hyper-intensity, consistent with dissection with subintimal thrombus within the false lumen (Figures 1 and ​2). MRI of the head with and without contrast, and MRA of the head without contrast, were both unremarkable. Specifically, there was no intracranial extension of dissection or evidence of infarction. MR perfusion of the brain revealed no focal perfusion abnormalities.

 

Figure 1 Axial Proton Density Image - Image 1

Figure 1: Axial proton density image demonstrates circumferential hyper-intensity surrounding the left cervical vertebral artery (representing the false lumen). Note decreased calibre of true lumen (black flow void) with respect to the right vertebral artery.

 

Figure 2 Axial Image from Three Dimensional Time of Flight MRA - Image 2

Figure 2: Axial image from three-dimensional time-of-flight MRA demonstrates T1 hypointense dissection flap separating the true lumen (lateral) from the false lumen (medial). MRA, MR angiography.

 

Differential Diagnosis

 

The ED released the patient with a tentative diagnosis of ocular migraine, due to her history of migraine headaches. However, the patient stated that the left-sided headache was atypical—“like nothing I’ve ever experienced before.” Her previous migraines were associated with her menstrual cycle, but not with any vision changes. She had never been previously diagnosed with ocular migraine. MRA of the cervical region revealed that the patient actually had an acute dissection with thrombus formation in the left vertebral artery.

 

Treatment

 

Owing to the potential of impending stroke associated with an acute VAD with thrombus formation, the patient was admitted to the neurology stroke service for close neurological monitoring. During her admission, the patient did not experience any recurrence of neurological deficits and her headaches improved. She was discharged the following day with a diagnosis of left VAD and transient ischaemic attack. She was instructed to avoid vigorous exercise and trauma to the neck. Daily aspirin (325 mg) was prescribed, to be continued for 3–6 months after discharge.

 

Outcome and Follow-Up

 

After discharge from the stroke service, the patient had no recurrence of headache or visual disturbances, and her posterior neck pain symptoms resolved. Repeat imaging was performed 3 months after presentation, which demonstrated improved calibre of the cervical left vertebral artery with resolution of the thrombus within the false lumen (Figure 3). Imaging of the intracranial compartment remained normal, without evidence of interval infarction or perfusion asymmetry.

 

Figure 3 Maximum Intensity Projection MIP Images - Image 3

Figure 3: Maximum intensity projection (MIP) images from three-dimensional time-of-flight MRA (left image is at time of presentation and right image is at 3-month follow-up). The initial imaging demonstrates markedly diminutive calibre of the left vertebral artery

 

Discussion

 

The pathophysiological process of VAD is thought to start with degeneration of the tissues at the medial-adventitial border of the vertebral artery, leading to the development of microhaematomata within the wall of the artery and, eventually, arterial tear. This can lead to leakage of blood into the arterial wall, causing occlusion of the lumen with subsequent thrombus formation and embolisation, resulting in stroke related to one of the branches of the vertebral artery. This pathological process is similar to that of spontaneous carotid artery dissection, spontaneous thoracic aortic dissection and spontaneous coronary artery dissection. All these conditions tend to occur in younger adults and some have speculated that they may be part of a common inherited pathophysiological process. Notable in this case is the fact that the patient’s older sister had experienced a spontaneous thoracic aortic aneurysm (probably a dissection) at around the same age (30 years) as this patient was when she experienced her VAD.

 

While the dissection is often sudden, the luminal compromise and complications of VAD can develop gradually leading to variable symptoms and presentation, depending on the stage of the disease. The dissection itself, which develops some time before the onset of neural ischaemia, can cause stimulation of nociceptive receptors within the artery, producing pain that is most commonly felt in the upper cervical spine or head. Only after the pathophysiological process progresses to the point of complete arterial occlusion or thrombus formation with distal embolisation does the full manifestation of infarction occur. However, as illustrated in this case, neurological symptoms can develop early in the process, particularly in cases in which the true lumen demonstrates significant calibre decrease secondary to compression.

 

There are several interesting aspects to this case. First, it highlights the importance of spine clinicians being alert to the possibility that what may appear to be typical ‘mechanical’ neck pain could be something potentially more sinister, such as VAD. The sudden onset of severe suboccipital pain, with or without headache, and accompanying brainstem related neurological symptoms, should alert the clinician to the possibility of VAD. As in the case reported here, patients with a history of migraine will typically describe the headache as different from their usual migraine. A careful neurological examination should be performed, looking for possible subtle neurological deficits, although the neurological examination will often be negative in the early stages of VAD.

 

Second, a triad of symptoms raised concern that the patient might be experiencing a VAD in progress. The symptom triad included: (1) spontaneous onset of severe upper cervical pain; (2) severe headache that was distinctly different from the patient’s usual migraine headaches; and (3) brainstem-related neurological symptoms (in the form of transient visual disturbance). Notably, careful neurological examination was negative. Nonetheless, the history was of sufficient concern to prompt immediate investigation.

 

When VAD is suspected but no frank signs of stroke are present, immediate vascular imaging is indicated. While the optimal imaging evaluation of VAD remains controversial, MRA or CTA are the diagnostic studies of choice given their excellent anatomic delineation and ability to evaluate for complications (including infarction and changes in brain perfusion). Some advocate the use of Doppler ultrasound; however, it has limited utility given the course of the vertebral artery in the neck and limited evaluation of the vertebral arteries cephalad to the origin. Additionally, ultrasound imaging is unlikely to allow visualisation of the dissection itself and thus can be negative in the absence of significant arterial occlusion.

 

Third, this case is interesting in light of the controversy about cervical manipulation as a potential ‘cause’ of VAD. While case reports have presented patients who have experienced stroke related to VAD after cervical manipulation, and case–control studies have found a statistical association between visits to chiropractors and stroke related to VAD, further investigation has indicated that the association is not causal. Cassidy et al found that a patient who experiences stroke related to VAD is just as likely to have visited a primary care practitioner as to have visited a chiropractor prior to having the stroke. The authors suggested that the most likely explanation for the statistical association between visits to chiropractors and subsequent VAD is that a patient who experiences the initial symptoms of VAD (neck pain with or without headache) seeks medical attention for these symptoms (from a chiropractor, primary care practitioner, or another type of practitioner), then subsequently experiences the stroke, independent of any action taken by the practitioner.

 

It is important to note that, while there have been reported cases of carotid artery dissection after cervical manipulation, case–control studies have not found this association. The initial symptoms of carotid dissection (neurological symptoms, with neck and head pain less common than VAD), aortic dissection (sudden onset of severe, ‘tearing’ pain) and coronary artery dissection (acute severe chest pain, ventricular fibrillation) are likely to cause the individual to immediately seek ED care, rather than seek chiropractic care. However, VAD has seemingly benign initial symptoms—neck pain and headache—which are symptoms that commonly cause patients to seek out chiropractic care. This may explain why only VAD is associated with visits to chiropractors, while these other types of dissections are not; patients with these other conditions, which have much more alarming symptoms, simply do not present to chiropractors.

 

This case is a good example of a patient with VAD in progress presenting to a chiropractor for the purpose of seeking relief from neck pain. Fortunately, the chiropractor was astute enough to ascertain that the patient’s symptoms were not suggestive of a ‘mechanical’ cervical spine disorder, and appropriate diagnostic investigation was performed. However, if manipulation had been performed, the VAD that was already in progress from natural history may have been blamed on manipulation, after being detected on MRA imaging. Fortunately, in this case, the chiropractor was able to assist with early detection and treatment, and subsequently a stroke was likely averted.

 

Learning Points

 

  • A case is presented in which a patient saw a chiropractor, while seeking treatment for neck pain, and the history raised concern for possible vertebral artery dissection (VAD).
  • Rather than providing manipulative treatment, the chiropractor referred the patient for advanced imaging, which confirmed the diagnosis of VAD.
  • The case illustrates the importance of paying attention to subtle historical factors in patients with VAD.
  • It also serves as an example of a patient with a VAD in progress seeking the services of a chiropractor for the initial symptoms of the disorder.
  • In this case, early detection of the dissection occurred and the patient had a full recovery without any subsequent stroke.

 

Acknowledgments

 

The authors would like to acknowledge the assistance of Pierre Cote, DC, PhD, for his assistance with reviewing this manuscript.

 

Footnotes

 

Contributors: All the authors acknowledge that they have contributed the following to the submission of this manuscript: conception and design, drafting of the manuscript, critical revisions of the manuscript, literature review and references, and proof reading of the final manuscript.

 

Competing interests: None declared.

 

Patient consent: Obtained.

 

Provenance and peer review: Not commissioned; externally peer reviewed.

 

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 .

 

Cited by Dr. Alex Jimenez

 

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Additional Topics: Wellness

 

Overall health and wellness are essential towards maintaining the proper mental and physical balance in the body. From eating a balanced nutrition as well as exercising and participating in physical activities, to sleeping a healthy amount of time on a regular basis, following the best health and wellness tips can ultimately help maintain overall well-being. Eating plenty of fruits and vegetables can go a long way towards helping people become healthy.

 

blog picture of cartoon paperboy big news

 

IMPORTANT TOPIC: EXTRA EXTRA: Treating Sciatica Pain

 

 

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References
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2. Boyle E, Cote P, Grier AR et al. Examining vertebrobasilar artery stroke in two Canadian provincesSpine 2008;33(4 Suppl):S170–5. doi:10.1097/BRS.0b013e31816454e0 [PubMed]
3. Lee VH, Brown RD Jr, Mandrekar JN et al. Incidence and outcome of cervical artery dissection: a population-based studyNeurology 2006;67:1809–12. doi:10.1212/01.wnl.0000244486.30455.71[PubMed]
4. Schievink WI. Spontaneous dissection of the cartoid and vertebral arteriesN Engl J Med 2001;344:898–906. doi:10.1056/NEJM200103223441206 [PubMed]
5. Volker W, Dittrich R, Grewe S et al. The outer arterial wall layers are primarily affected in spontaneous cervical artery dissectionNeurology 2011;76:1463–71. doi:10.1212/WNL.0b013e318217e71c [PubMed]
6. Gottesman RF, Sharma P, Robinson KA et al. Clinical characteristics of symptomatic vertebral artery dissection: a systematic reviewNeurologist 2012;18:245–54. doi:10.1097/NRL.0b013e31826754e1[PMC free article] [PubMed]
7. Cassidy JD, Boyle E, Cote P et al. Risk of vertebrobasilar stroke and chiropractic care: results of a population-based case-control and case-crossover studySpine 2008;33(4 Suppl):S176–83. doi:10.1097/BRS.0b013e3181644600 [PubMed]
8. Rothwell DM, Bondy SJ, Williams JI. Chiropractic manipulation and stroke: a population-based case-control studyStroke 2001;32:1054–60. doi:10.1161/01.STR.32.5.1054 [PubMed]
9. Smith WS, Johnston SC, Skalabrin EJ et al. Spinal manipulative therapy is an independent risk factor for vertebral artery dissectionNeurology 2003;60:1424–8. doi:10.1212/01.WNL.0000063305.61050.E6[PubMed]
10. Volker W, Besselmann M, Dittrich R et al. Generalized arteriopathy in patients with cervical artery dissectionNeurology 2005;64:1508–13. doi:10.1212/01.WNL.0000159739.24607.98 [PubMed]
11. Evangelista A, Mukherjee D, Mehta RH et al. Acute intramural hematoma of the aorta: a mystery in evolutionCirculation 2005;111:1063–70. doi:10.1161/01.CIR.0000156444.26393.80 [PubMed]
12. Tweet MS, Hayes SN, Pitta SR et al. Clinical features, management, and prognosis of spontaneous coronary artery dissectionCirculation 2012;126:579–88. doi:10.1161/CIRCULATIONAHA.112.105718[PubMed]
13. Choi S, Boyle E, Cote P et al. A population-based case-series of Ontario patients who develop a vertebrobasilar artery stroke after seeing a chiropractorJ Manipulative Physiol Ther 2011;34:15–22. doi:10.1016/j.jmpt.2010.11.001 [PubMed]
14. Naggara O, Louillet F, Touze E et al. Added value of high-resolution MR imaging in the diagnosis of vertebral artery dissectionAJNR Am J Neuroradiol 2010;31:1707–12. doi:10.3174/ajnr.A2165 [PubMed]
15. Haynes MJ, Vincent K, Fischhoff C et al. Assessing the risk of stroke from neck manipulation: a systematic reviewInt J Clin Pract 2012;66:940–7. doi:10.1111/j.1742-1241.2012.03004.x[PMC free article] [PubMed]
16. Nebelsieck J, Sengelhoff C, Nassenstein I et al. Sensitivity of neurovascular ultrasound for the detection of spontaneous cervical artery dissectionJ Clin Neurosci 2009;16:79–82. doi:10.1016/j.jocn.2008.04.005 [PubMed]
17. Bendick PJ, Jackson VP. Evaluation of the vertebral arteries with duplex sonographyJ Vasc Surg1986;3:523–30. doi:10.1016/0741-5214(86)90120-5 [PubMed]
18. Murphy DR. Current understanding of the relationship between cervical manipulation and stroke: what does it mean for the chiropractic profession? Chiropr Osteopat 2010;18:22 doi:10.1186/1746-1340-18-22[PMC free article] [PubMed]
19. Engelter ST, Grond-Ginsbach C, Metso TM et al. Cervical artery dissection: trauma and other potential mechanical trigger eventsNeurology 2013;80:1950–7. doi:10.1212/WNL.0b013e318293e2eb [PubMed]
20. Peters M, Bohl J, Thömke F et al. Dissection of the internal carotid artery after chiropractic manipulation of the neckNeurology 1995;45:2284–6. doi:10.1212/WNL.45.12.2284 [PubMed]
21. Nadgir RN, Loevner LA, Ahmed T et al. Simultaneous bilateral internal carotid and vertebral artery dissection following chiropractic manipulation: case report and review of the literatureNeuroradiology2003;45:311–14. doi:10.1007/s00234-003-0944-x [PubMed]
22. Dittrich R, Rohsbach D, Heidbreder A et al. Mild mechanical traumas are possible risk factors for cervical artery dissectionCerebrovasc Dis 2007;23:275–81. doi:10.1159/000098327 [PubMed]
23. Chung CL, Cote P, Stern P et al. The association between cervical spine manipulation and carotid artery dissection: a systematic review of the literatureJ Manipulative Physiol Ther 2014; doi:10.1016/j.jmpt.2013.09.005 doi:10.1016/j.jmpt.2013.09.005 [PubMed]
24. Thomas LC, Rivett DA, Attia JR et al. Risk factors and clinical features of craniocervical arterial dissectionMan Ther 2011;16:351–6. doi:10.1016/j.math.2010.12.008 [PubMed]
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What are Case Reports & Case Series?

What are Case Reports & Case Series?

The diagnosis of a variety of diseases has been effectively determined through clinical and experimental data. Research studies provide valuable information on the pathogenesis of many conditions and are often the primary source of information regarding new diseases or conditions. Case reports and case series are first level research studies, offering the most initial insights on a particular health issue through the personal experience of one or more people with a disease or condition. The following article describes the purpose of case reports and case series, and how they provide clinical and experimental data.

 

Learning Objectives

 

1. Case reports and case series describe the experience of one or more people with a disease.
2. Case reports and case series are often the first data alerting to a new disease or condition.
3. Case reports and case series have specific limitations:

  • a. Lack of a denominator to calculate rates of disease
  • b. Lack of a comparison group
  • c. Selecting study populations
  • d. Sampling variation

 

Case Reports and Case Series

 

Case reports and case series represent the most basic type of study design, in which researchers describe the experience of a single person (case report) or a group of people (case series). Typically, case reports and case series describe individuals who develop a particular new disease or condition. Case reports and case series can provide compelling reading because they present a detailed account of the clinical experience of individual study subjects. In contrast, studies that evaluate large numbers of individuals typically summarize the data using statistical measures, such as means and proportions.

 

Example 3.1. A case series describes 15 young women who develop breast cancer; 9 of these women report at least once weekly ingestion of foods packaged with the estrogenic chemical bisphenol A (BPA). Urine testing confirms the presence of BPA among all nine case women.

 

It is tempting to surmise from these data that BPA might be causally related to breast cancer. However, case reports/case series have important limitations that preclude inference of a causal relationship.

First, case reports/case series lack denominator data that are necessary to calculate the rate of disease. The denominator refers to the population from which the diseased subjects arose. For example, to calculate the incidence proportion or incidence rate of breast cancer among women exposed to BPA, the total number of women who were exposed to BPA or the total number of person-years at risk is needed.

 

Table 1 - Incidence Proportion & Incidence Rate

 

Disease rates are needed for comparison with historically reported disease rates, or with rates from a selected comparison group. Unfortunately, obtaining the necessary denominator data may not be easy. In this example, additional data sources are needed to determine the total number of BPA-exposed women from whom the breast cancer cases arose. The case series data alone cannot be used to calculate the rate of breast cancer because they do not include the total number of women who were exposed to BPA.

 

A second problem with case report/case series report data is the lack of a comparison group. The 60% prevalence of BPA exposure among women with breast cancer seems unusually high, but what is prevalence of BPA exposure among women without breast cancer? This comparison is critical for addressing the hypothesis that BPA might be a cause of breast cancer.

 

A third limitation of case reports/case series is that these studies often describe highly select individuals who may not represent the general population. For example, it is possible that the 15 breast cancer cases originated from a single hospital in a community with high levels of air pollution or other potential carcinogens. Under these conditions, a fair estimate of breast cancer incidence among non-BPA exposed women from the same community would be required to make an inference that BPA causes breast cancer.

 

A fourth limitation of case reports/case series is sampling variation. This concept will be explored in detail later in this book. The basic idea is that there is tremendous natural variation in disease development in humans. The fact that 9 of 15 women with breast cancer reported BPA exposure is interesting; however, this number may be very different in the next case series of 15 women with breast cancer simply due to chance. A precise estimate of the rate of a disease, independent from chance, can be obtained only by increasing the number of diseased subjects.

 

Recall the list of factors that are used to judge whether a factor may be a cause of disease:

 

1. Randomized evidence
2. Strength of association
3. Temporal relationship between exposure and outcome
4. Dose-response association
5. Biological plausibility

 

In general, case reports/case series rely almost exclusively on biological plausibility to make their case for causation. For the BPA and breast cancer case series, there is no randomized evidence, no measure of the strength of association between BPA and breast cancer, no reported dose–response association, and no evidence that BPA exposure preceded the development of breast cancer. The inference for causation derives completely from previous biological knowledge regarding the estrogenic effects of BPA.

 

Despite limitations of case series data, they may be highly suggestive of an important new association, disease process, or unintended side effect of a medication or treatment.

 

Example 3.2. In 2007, a case series described three cases of male prepubertal gynecomastia. The report included detailed information on each subjects’ age, body size, serum levels of endogenous steroids, and known exposures to exogenous hormones. It was discovered that all three otherwise healthy boys had been exposed to some product containing lavender oil (lotion, shampoo, soap), and that in each case, the gynecomastia resolved upon discontinuation of the product. Subsequent in vitro studies demonstrated endocrine-disrupting activity of lavender oil. This novel case series data may lead to further investigations to determine whether lavender oil, a common ingredient in commercially available products, may be a cause of gynecomastia.

 

Example 3.3. A vaccine designed to prevent rotavirus infection was found to cause weakening of the intestinal muscle layers in animals. Following release of the vaccine, a number of cases of intussusception (when one portion of the bowel slides into the next) were reported in children who received the vaccine, with some fatal cases. The strong biological plausibility underlying this initial association, and knowledge that intussusception is otherwise rare in infants, was highly suggestive of a causal relationship and the vaccine was removed from the market.

 

Information referenced from B. Kestenbaum, Epidemiology and Biostatistics: An Introduction to Clinical Research, DOI 10.1007/978-0-387-88433-2_3, © Springer Science+Business Media, LLC 2009. 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 .

 

Referenced by Dr. Alex Jimenez

 

Green-Call-Now-Button-24H-150x150-2-3.png

 

Additional Topics: Wellness

 

Overall health and wellness are essential towards maintaining the proper mental and physical balance in the body. From eating a balanced nutrition as well as exercising and participating in physical activities, to sleeping a healthy amount of time on a regular basis, following the best health and wellness tips can ultimately help maintain overall well-being. Eating plenty of fruits and vegetables can go a long way towards helping people become healthy.

 

blog picture of cartoon paperboy big news

 

IMPORTANT TOPIC: EXTRA EXTRA: Treating Sciatica Pain

 

 

Management of Sciatica: Nonsurgical & Surgical Therapies

Management of Sciatica: Nonsurgical & Surgical Therapies

Consider the following, sciatica is a medical term used to describe a collective group of symptoms resulting from the irritation or compression of the sciatic nerve, generally due to an injury or aggravated condition. Sciatica is commonly characterized by radiating pain along the sciatic nerve, which runs down one or both legs from the lower back. The following case vignette discusses Mr. Winston’s medical condition, a 50-year-old bus driver who reported experiencing chronic, lower back and leg pain associated with sciatica during a 4-week time period. Ramya Ramaswami, M.B., B.S., M.P.H., Zoher Ghogawala, M.D., and James N. Weinstein, D.O., provide a comprehensive analysis of the various treatment options available to treat sciatica, including undergoing lumbar disk surgery and receiving nonsurgical therapy.

 

On a personal note, as a practicing doctor of chiropractic, choosing the correct treatment care for any type of injury or condition can be a personal and difficult decision. If the circumstances are favorable, the patient may determine what is the best form of treatment for their type of medical issue. While nonsurgical therapies, such as chiropractic care, can often be utilized to improve symptoms of sciatica, more severe cases of sciatica may require surgical interventions to treat the source of the issue. In most cases, nonsurgical therapies should be considered first, before turning to surgical therapies for sciatica.

 

Case Vignette

 

A Man with Sciatica Who is Considering Lumbar Disk Surgery

 

Ramya Ramaswami, M.B., B.S., M.P.H.

 

Mr. Winston, a 50-year-old bus driver, presented to your office with a 4-week history of pain in his left leg and lower back. He described a combination of severe sharp and dull pain that originated in his left buttock and radiated to the dorsolateral aspect of his left thigh, as well as vague aching over the lower lumbar spine. On examination, passive raising of his left leg off the table to 45 degrees caused severe pain that simulated his main symptom, and the pain was so severe that you could not lift his leg further. There was no leg or foot weakness. His body-mass index (the weight in kilograms divided by the square of the height in meters) was 35, and he had mild chronic obstructive pulmonary disease as a result of smoking one pack of cigarettes every day for 22 years. Mr. Winston had taken a leave of absence from his work because of his symptoms. You prescribed 150 mg of pregabalin per day, which was gradually increased to 600 mg daily because the symptoms had not abated.

 

Now, 10 weeks after the initial onset of his symptoms, he returns for an evaluation. The medication has provided minimal alleviation of his sciatic pain. He has to return to work and is concerned about his ability to complete his duties at his job. He undergoes magnetic resonance imaging, which shows a herniated disk on the left side at the L4–L5 root. You discuss options for the next steps in managing his sciatica. He is uncertain about invasive procedures such as lumbar disk surgery but feels limited by his symptoms of pain.

 

Treatment Options

 

Which of the following would you recommend for Mr. Winston?

 

  1. Undergo lumbar disk surgery.
  2. Receive nonsurgical therapy.

 

To aid in your decision making, each of these approaches is defended in a short essay by an expert in the field. Given your knowledge of the patient and the points made by the experts, which option would you choose?

 

Option 1: Undergo Lumbar Disk Surgery
Option 2: Receive Nonsurgical Therapy

 

1. Undergo Lumbar Disk Surgery

 

Zoher Ghogawala, M.D.

 

Mr. Winston’s case represents a common scenario in the management of symptomatic lumbar disk herniation. In this particular case, the patient’s symptoms and the physical examination are consistent with nerve-root compression and inflammation directly from an L4–L5 herniated disk on his left side. The patient does not have weakness but has ongoing pain and has been unable to work for the past 10 weeks despite receiving pregabalin. Two questions emerge: first, does lumbar disk surgery (microdiskectomy) provide outcomes that are superior to those with continued nonoperative therapy in patients with more than 6 weeks of symptoms; and second, does lumbar microdiskectomy improve the likelihood of return to work in patients with these symptoms?

 

The highest quality data on the topic come from the Spine Patient Outcomes Research Trial (SPORT). The results of the randomized, controlled trial are difficult to interpret because adherence to the assigned treatment strategy was suboptimal. Only half the patients who were randomly assigned to the surgery group actually underwent surgery within 3 months after enrollment, and 30% of the patients assigned to nonoperative treatment chose to cross over to the surgical group. In this study, the patients who underwent surgery had greater improvements in validated patient-reported outcomes. The treatment effect of microdiskectomy was superior to that of nonoperative treatment at 3 months, 1 year, and 2 years. Moreover, in an as-treated analysis, the outcomes among patients who underwent surgery were superior to those among patients who received nonoperative therapy. Overall, the results of SPORT support the use of microdiskectomy in this case.

 

Results of clinical trials are based on a comparison of treatment options in study populations and may or may not apply to individual patients. SPORT did not specify what type of nonoperative therapy was to be used. Physical therapy was used in 73% of the patients, epidural injections in 50%, and medical therapies (e.g., nonsteroidal antiinflammatory drugs) in more than 50%. In the case of Mr. Winston, pregabalin has been tried, but physical therapy and epidural glucocorticoid injections have not been attempted. Despite widespread use of physical therapy for the treatment of lumbar disk herniation, the evidence supporting its effectiveness is inconclusive, according to published guidelines of the North American Spine Society. On the other hand, there is evidence that transforaminal epidural glucocorticoid injection provides short-term relief (30 days) in patients with nerve-root symptoms directly related to a herniated disk. Overall, there is evidence, from SPORT and from a randomized trial from the Netherlands published in the Journal, that early surgery between 6 and 12 weeks after the onset of symptoms provides greater alleviation of leg pain and better overall pain relief than prolonged conservative therapy.

 

The ability to return to work has not been formally studied in comparisons of operative with nonoperative treatments for lumbar disk herniation. Registry data from the NeuroPoint-SD study showed that more than 80% of the patients who were working before disk herniation returned to work after surgery. The ability to return to work may be dependent on the type of vocation, since patients who are manual laborers may need more time to recover to reduce the risk of reherniation.

 

It is well recognized that many patients who have a symptomatic lumbar disk herniation will have improvement spontaneously over several months. Surgery can alleviate symptoms more quickly by immediately removing the offending disk herniation from the affected nerve root. The risk–benefit equation will vary among individual patients. In the case of Mr. Winston, obesity and mild pulmonary disease might increase the risk of complications from surgery, although in SPORT, 95% of surgical patients did not have any operative or postoperative complication. For Mr. Winston, a patient with pain that has persisted for more than 6 weeks, microdiskectomy is a rational option that is supported by high-quality evidence.

 

2. Receive Nonsurgical Therapy

 

James N. Weinstein, D.O.

 

This case involves a common presentation of low back pain radiating to the buttock and posterolateral thigh that might represent either referred mechanical pain or radiculopathy. Classic radiculopathy resulting from compression of a lower lumbar nerve root (L4, L5, or S1) results in pain that radiates distal to the knee and is often accompanied by weakness or numbness in the respective myotome or dermatome. In this case, the pain is proximal to the knee and is not associated with weakness or numbness. In SPORT, surgery resulted in faster recovery and a greater degree of improvement than nonoperative treatment in patients with pain that radiated distal to the knee and was accompanied by neurologic signs or symptoms. However, since Mr. Winston would not have met the inclusion criteria for SPORT, the results of diskectomy in this case would be somewhat unpredictable. He does not have radiculopathy that radiates below the knee, and he does not have weakness or numbness; nonoperative treatment should be exhausted before any consideration of a surgical procedure that in most cases has not been shown to be effective in patients with this type of presentation. In this issue of the Journal, Mathieson and colleagues report the results of a randomized, controlled trial that showed that pregabalin did not significantly alleviate pain related to sciatica. Mr. Winston has been treated only with pregabalin; therefore, other conservative options should be explored.

 

Saal and Saal reported that more than 80% of patients with radiculopathy associated with a lumbar disk herniation had improvement in a matter of months with exercise-based physical therapy. In the nonoperative SPORT cohort, patients had significant improvement from baseline, and approximately 60% of those with classic radiculopathy who initially received nonoperative treatment avoided surgery. Mr. Winston has had minimal treatment and has had symptoms for only 10 weeks. He should undergo a course of exercise-based physical therapy and a trial of a nonsteroidal antiinflammatory medication and may consider a lumbar epidural glucocorticoid injection. Although there is little evidence of the effectiveness of these nonoperative options alone, the combination of these treatments and the benign natural history of the patient’s condition could result in alleviation or resolution of symptoms. If these interventions — and time — do not resolve his symptoms, surgery could be considered as a final option, but it may not have long-term effectiveness and could in and of itself cause the possibility of more harm than good. Mr. Winston has risk factors, such as obesity and a history of smoking, that have been shown to contribute to poor surgical outcomes of certain spinal procedures.

 

Mr. Winston has symptoms of back pain that interfere with his quality of life. He would need to understand, through shared decision making, that a nonsurgical approach is likely to be more effective than surgery over time.

 

Information referenced from the National Center for Biotechnology Information (NCBI) and the New England Journal of Medicine (NEJM). 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 .

 

Cited by Dr. Alex Jimenez

 

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Additional Topics: Wellness

 

Overall health and wellness are essential towards maintaining the proper mental and physical balance in the body. From eating a balanced nutrition as well as exercising and participating in physical activities, to sleeping a healthy amount of time on a regular basis, following the best health and wellness tips can ultimately help maintain overall well-being. Eating plenty of fruits and vegetables can go a long way towards helping people become healthy.

 

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IMPORTANT TOPIC: EXTRA EXTRA: Treating Sciatica Pain

 

 

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References

 

  • 1. Weinstein JN, Tosteson TD, Lurie JD, et al. Surgical vs nonoperative treatment for lumbar disk herniation: the Spine Patient Outcomes Research Trial (SPORT): a randomized trial. JAMA 2006;296:24412450

  • 2. Weinstein JN, Lurie JD, Tosteson TD, et al. Surgical vs nonoperative treatment for lumbar disk herniation: the Spine Patient Outcomes Research Trial (SPORT) observational cohort. JAMA 2006;296:24512459

  • 3. Kreiner DS, Hwang SW, Easa JE, et al. An evidence-based clinical guideline for the diagnosis and treatment of lumbar disc herniation with radiculopathy. Spine J 2014;14:180191

  • 4. Ghahreman A, Ferch R, Bogduk N. The efficacy of transforaminal injection of steroids for the treatment of lumbar radicular pain. Pain Med 2010;11:11491168

  • 5. Peul WC, van Houwelingen HC, van den Hout WB, et al. Surgery versus prolonged conservative treatment for sciatica. N Engl J Med 2007;356:22452256

  • 6. Ghogawala Z, Shaffrey CI, Asher AL, et al. The efficacy of lumbar discectomy and single-level fusion for spondylolisthesis: results from the NeuroPoint-SD registry: clinical article. J Neurosurg Spine 2013;19:555563

  • 7. Deyo RA, Weinstein JN. Low back pain. N Engl J Med 2001;344:363370

  • 8. Lurie JD, Tosteson TD, Tosteson AN, et al. Surgical versus nonoperative treatment for lumbar disc herniation: eight-year results for the spine patient outcomes research trial. Spine (Phila Pa 1976) 2014;39:316

  • 9. Mathieson S, Maher CG, McLachlan AJ, et al. Trial of pregabalin for acute and chronic sciatica. N Engl J Med 2017;376:11111120

  • 10. Saal JA, Saal JS. Nonoperative treatment of herniated lumbar intervertebral disc with radiculopathy: an outcome study. Spine (Phila Pa 1976) 1989;14:431437

  • 11. Pinto RZ, Maher CG, Ferreira ML, et al. Drugs for relief of pain in patients with sciatica: systematic review and meta-analysis. BMJ 2012;344:e497e497

  • 12. Pearson A, Lurie J, Tosteson T, et al. Who should have surgery for an intervertebral disc herniation? Comparative effectiveness evidence from the Spine Patient Outcomes Research Trial. Spine 2012;37:140149

  • 13. Weeks WB, Weinstein JN. Patient-reported data can help people make better health care choices. Harvard Business Review. September 21, 2015

 

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