Roni Evans

A Randomized Clinical Trial of Exercise and Spinal Manipulation for Patients With Chronic Neck Pain

Study Design. A randomized, parallel-group, single-blinded clinical trial was performed. After a 1-week baseline period, patients were randomized to 11 weeks of therapy, with posttreatment follow-up assessment 3, 6, and 12 months later. Objectives. To compare the relative efficacy of rehabilitative neck exercise and spinal manipulation for the management of patients with chronic neck pain. Summary of Background Data. Mechanical neck pain is a common condition associated with substantial morbidity and cost. Relatively little is known about the efficacy of spinal manipulation and exercise for chronic neck pain. Also, the combination of both therapies has yet to be explored. Methods. Altogether, 191 patients with chronic mechanical neck pain were randomized to receive 20 sessions of spinal manipulation combined with rehabilitative neck exercise (spinal manipulation with exercise), MedX rehabilitative neck exercise, or spinal manipulation alone. The main outcome measures were patient-rated neck pain, neck disability, functional health status (as measured by Short Form-36 [SF-36]), global improvement, satisfaction with care, and medication use. Range of motion, muscle strength, and muscle endurance were assessed by examiners blinded to patients’ treatment assignment. Results. Clinical and demographic characteristics were similar among groups at baseline. A total of 93% of the patients completed the intervention phase. The response rate for the 12-month follow-up period was 84%. Except for patient satisfaction, where spinal manipulative therapy and exercise were superior to spinal manipulation with (P = 0.03), the group differences in patient-rated outcomes after 11 weeks of treatment were not statistically significant (P = 0.13). However, the spinal manipulative therapy and exercise group showed greater gains in all measures of strength, endurance, and range of motion than the spinal manipulation group (P < 0.05). The spinal manipulation with exercise group also demonstrated more improvement in flexion endurance and in flexion and rotation strength than the MedX group (P < 0.03). The MedX exercise group had larger gains in extension strength and flexion–extension range of motion than the spinal manipulation group (P < 0.05). During the follow-up year, a greater improvement in patient-rated outcomes were observed for spinal manipulation with exercise and for MedX exercise than for spinal manipulation alone (P = 0.01). Both exercise groups showed very similar levels of improvement in patient-rated outcomes, although the spinal manipulation and exercise group reported greater satisfaction with care (P < 0.01). Conclusions. For chronic neck pain, the use of strengthening exercise, whether in combination with spinal manipulation or in the form of a high-technology MedX program, appears to be more beneficial to patients with chronic neck pain than the use of spinal manipulation alone. The effect of low-technology exercise or spinal manipulative therapy alone, as compared with no treatment or placebo, and the optimal dose and relative cost effectiveness of these therapies, need to be evaluated in future studies.

Effectiveness of manual therapies: the UK evidence report.

BackgroundThe purpose of this report is to provide a succinct but comprehensive summary of the scientific evidence regarding the effectiveness of manual treatment for the management of a variety of musculoskeletal and non-musculoskeletal conditions.MethodsThe conclusions are based on the results of systematic reviews of randomized clinical trials (RCTs), widely accepted and primarily UK and United States evidence-based clinical guidelines, plus the results of all RCTs not yet included in the first three categories. The strength/quality of the evidence regarding effectiveness was based on an adapted version of the grading system developed by the US Preventive Services Task Force and a study risk of bias assessment tool for the recent RCTs.ResultsBy September 2009, 26 categories of conditions were located containing RCT evidence for the use of manual therapy: 13 musculoskeletal conditions, four types of chronic headache and nine non-musculoskeletal conditions. We identified 49 recent relevant systematic reviews and 16 evidence-based clinical guidelines plus an additional 46 RCTs not yet included in systematic reviews and guidelines.Additionally, brief references are made to other effective non-pharmacological, non-invasive physical treatments.ConclusionsSpinal manipulation/mobilization is effective in adults for: acute, subacute, and chronic low back pain; migraine and cervicogenic headache; cervicogenic dizziness; manipulation/mobilization is effective for several extremity joint conditions; and thoracic manipulation/mobilization is effective for acute/subacute neck pain. The evidence is inconclusive for cervical manipulation/mobilization alone for neck pain of any duration, and for manipulation/mobilization for mid back pain, sciatica, tension-type headache, coccydynia, temporomandibular joint disorders, fibromyalgia, premenstrual syndrome, and pneumonia in older adults. Spinal manipulation is not effective for asthma and dysmenorrhea when compared to sham manipulation, or for Stage 1 hypertension when added to an antihypertensive diet. In children, the evidence is inconclusive regarding the effectiveness for otitis media and enuresis, and it is not effective for infantile colic and asthma when compared to sham manipulation.Massage is effective in adults for chronic low back pain and chronic neck pain. The evidence is inconclusive for knee osteoarthritis, fibromyalgia, myofascial pain syndrome, migraine headache, and premenstrual syndrome. In children, the evidence is inconclusive for asthma and infantile colic.

Efficacy of Spinal Manipulation for Chronic Headache: A Systematic Review

BACKGROUND Chronic headache is a prevalent condition with substantial socioeconomic impact. Complementary or alternative therapies are increasingly being used by patients to treat headache pain, and spinal manipulative therapy (SMT) is among the most common of these. OBJECTIVE To assess the efficacy/effectiveness of SMT for chronic headache through a systematic review of randomized clinical trials. STUDY SELECTION Randomized clinical trials on chronic headache (tension, migraine and cervicogenic) were included in the review if they compared SMT with other interventions or placebo. The trials had to have at least 1 patient-rated outcome measure such as pain severity, frequency, duration, improvement, use of analgesics, disability, or quality of life. Studies were identified through a comprehensive search of MEDLINE (1966-1998) and EMBASE (1974-1998). Additionally, all available data from the Cumulative Index of Nursing and Allied Health Literature, the Chiropractic Research Archives Collection, and the Manual, Alternative, and Natural Therapies Information System were used, as well as material gathered through the citation tracking, and hand searching of non-indexed chiropractic, osteopathic, and manual medicine journals. DATA EXTRACTION Information about outcome measures, interventions and effect sizes was used to evaluate treatment efficacy. Levels of evidence were determined by a classification system incorporating study validity and statistical significance of study results. Two authors independently extracted data and performed methodological scoring of selected trials. DATA SYNTHESIS Nine trials involving 683 patients with chronic headache were included. The methodological quality (validity) scores ranged from 21 to 87 (100-point scale). The trials were too heterogeneous in terms of patient clinical characteristic, control groups, and outcome measures to warrant statistical pooling. Based on predefined criteria, there is moderate evidence that SMT has short-term efficacy similar to amitriptyline in the prophylactic treatment of chronic tension-type headache and migraine. SMT does not appear to improve outcomes when added to soft-tissue massage for episodic tension-type headache. There is moderate evidence that SMT is more efficacious than massage for cervicogenic headache. Sensitivity analyses showed that the results and the overall study conclusions remained the same even when substantial changes in the prespecified assumptions/rules regarding the evidence determination were applied. CONCLUSIONS SMT appears to have a better effect than massage for cervicogenic headache. It also appears that SMT has an effect comparable to commonly used first-line prophylactic prescription medications for tension-type headache and migraine headache. This conclusion rests upon a few trials of adequate methodological quality. Before any firm conclusions can be drawn, further testing should be done in rigorously designed, executed, and analyzed trials with follow-up periods of sufficient length.

Two-Year Follow-up of a Randomized Clinical Trial of Spinal Manipulation and Two Types of Exercise for Patients with Chronic Neck Pain

Study Design. Randomized clinical trial. Objectives. To compare the effects of spinal manipulation combined with low-tech rehabilitative exercise, MedX rehabilitative exercise, or spinal manipulation alone in patient self-reported outcomes over a two-year follow-up period. Summary of Background Data. There have been few randomized clinical trials of spinal manipulation and rehabilitative exercise for patients with neck pain, and most have only reported short-term outcomes. Methods. One hundred ninety-one patients with chronic neck pain were randomized to 11 weeks of one of the three treatments. Patient self-report questionnaires measuring pain, disability, general health status, improvement, satisfaction, and OTC medication use were collected after 5 and 11 weeks of treatment and 3, 6, 12, and 24 months after treatment. Data were analyzed taking into account all time points using repeated measures analyses. Results. Ninety-three percent (178) of randomized patients completed the 11-week intervention phase, and 76% (145) provided data at all evaluation time points over the two-year follow-up period. A difference in patient-rated pain with no group-time interaction was observed in favor of the two exercise groups [F(2141) = 3.2;P = 0.04]. There was also a group difference in satisfaction with care [F(2143) = 7.7;P = 0.001], with spinal manipulation combined with low-tech rehabilitative exercise superior to MedX rehabilitative exercise (P = 0.02) and spinal manipulation alone (P < 0.001). No significant group differences were found for neck disability, general health status, improvement, and OTC medication use, although the trend over time was in favor of the two exercise groups. Conclusion. The results of this study demonstrate an advantage of spinal manipulation combined with low-tech rehabilitative exercise and MedX rehabilitative exercise versus spinal manipulation alone over two years and are similar in magnitude to those observed after one-year follow-up. These results suggest that treatments including supervised rehabilitative exercise should be considered for chronic neck pain sufferers. Further studies are needed to examine the cost effectiveness of these therapies and how spinal manipulation compares to no treatment or minimal intervention.

Evidence-informed management of chronic low back pain with spinal manipulation and mobilization

The management of chronic low back pain (CLBP) has proven very challenging in North America, as evidenced by its mounting socioeconomic burden. Choosing among available nonsurgical therapies can be overwhelming for many stakeholders, including patients, health providers, policy makers, and third-party payers. Although all parties share a common goal and wish to use limited health-care resources to support interventions most likely to result in clinically meaningful improvements, there is often uncertainty about the most appropriate intervention for a particular patient. To help understand and evaluate the various commonly used nonsurgical approaches to CLBP, the North American Spine Society has sponsored this special focus issue of The Spine Journal, titled Evidence Informed Management of Chronic Low Back Pain Without Surgery. Articles in this special focus issue were contributed by leading spine practitioners and researchers, who were invited to summarize the best available evidence for a particular intervention and encouraged to make this information accessible to nonexperts. Each of the articles contains five sections (description, theory, evidence of efficacy, harms, and summary) with common subheadings to facilitate comparison across the 24 different interventions profiled in this special focus issue, blending narrative and systematic review methodology as deemed appropriate by the authors. It is hoped that articles in this special focus issue will be informative and aid in decision making for the many stakeholders evaluating nonsurgical interventions for CLBP.

Spinal Manipulation, Medication, or Home Exercise With Advice for Acute and Subacute Neck Pain: A Randomized Trial

BACKGROUND Mechanical neck pain is a common condition that affects an estimated 70% of persons at some point in their lives. Little research exists to guide the choice of therapy for acute and subacute neck pain. OBJECTIVE To determine the relative efficacy of spinal manipulation therapy (SMT), medication, and home exercise with advice (HEA) for acute and subacute neck pain in both the short and long term. DESIGN Randomized, controlled trial. (ClinicalTrials.gov registration number: NCT00029770) SETTING 1 university research center and 1 pain management clinic in Minnesota. PARTICIPANTS 272 persons aged 18 to 65 years who had nonspecific neck pain for 2 to 12 weeks. INTERVENTION 12 weeks of SMT, medication, or HEA. MEASUREMENTS The primary outcome was participant-rated pain, measured at 2, 4, 8, 12, 26, and 52 weeks after randomization. Secondary measures were self-reported disability, global improvement, medication use, satisfaction, general health status (Short Form-36 Health Survey physical and mental health scales), and adverse events. Blinded evaluation of neck motion was performed at 4 and 12 weeks. RESULTS For pain, SMT had a statistically significant advantage over medication after 8, 12, 26, and 52 weeks (P ≤ 0.010), and HEA was superior to medication at 26 weeks (P = 0.02). No important differences in pain were found between SMT and HEA at any time point. Results for most of the secondary outcomes were similar to those of the primary outcome. LIMITATIONS Participants and providers could not be blinded. No specific criteria for defining clinically important group differences were prespecified or available from the literature. CONCLUSION For participants with acute and subacute neck pain, SMT was more effective than medication in both the short and long term. However, a few instructional sessions of HEA resulted in similar outcomes at most time points. PRIMARY FUNDING SOURCE National Center for Complementary and Alternative Medicine, National Institutes of Health.

Supervised exercise, spinal manipulation, and home exercise for chronic low back pain: a randomized clinical trial

BACKGROUND CONTEXT Several conservative therapies have been shown to be beneficial in the treatment of chronic low back pain (CLBP), including different forms of exercise and spinal manipulative therapy (SMT). The efficacy of less time-consuming and less costly self-care interventions, for example, home exercise, remains inconclusive in CLBP populations. PURPOSE The purpose of this study was to assess the relative efficacy of supervised exercise, spinal manipulation, and home exercise for the treatment of CLBP. STUDY DESIGN/SETTING An observer-blinded and mixed-method randomized clinical trial conducted in a university research clinic in Bloomington, MN, USA. PATIENT SAMPLE Individuals, 18 to 65 years of age, who had a primary complaint of mechanical LBP of at least 6-week duration with or without radiating pain to the lower extremity were included in this trial. OUTCOME MEASURES Patient-rated outcomes were pain, disability, general health status, medication use, global improvement, and satisfaction. Trunk muscle endurance and strength were assessed by blinded examiners, and qualitative interviews were performed at the end of the 12-week treatment phase. METHODS This prospective randomized clinical trial examined the short- (12 weeks) and long-term (52 weeks) relative efficacy of high-dose, supervised low-tech trunk exercise, chiropractic SMT, and a short course of home exercise and self-care advice for the treatment of LBP of at least 6-week duration. The study was approved by local institutional review boards. RESULTS A total of 301 individuals were included in this trial. For all three treatment groups, outcomes improved during the 12 weeks of treatment. Those who received supervised trunk exercise were most satisfied with care and experienced the greatest gains in trunk muscle endurance and strength, but they did not significantly differ from those receiving chiropractic spinal manipulation or home exercise in terms of pain and other patient-rated individual outcomes, in both the short- and long-term. CONCLUSIONS For CLBP, supervised exercise was significantly better than chiropractic spinal manipulation and home exercise in terms of satisfaction with treatment and trunk muscle endurance and strength. Although the short- and long-term differences between groups in patient-rated pain, disability, improvement, general health status, and medication use consistently favored the supervised exercise group, the differences were relatively small and not statistically significant for these individual outcomes.

Spinal manipulative therapy and exercise for seniors with chronic neck pain

BACKGROUND CONTEXT Neck pain, common among the elderly population, has considerable implications on health and quality of life. Evidence supports the use of spinal manipulative therapy (SMT) and exercise to treat neck pain; however, no studies to date have evaluated the effectiveness of these therapies specifically in seniors. PURPOSE To assess the relative effectiveness of SMT and supervised rehabilitative exercise, both in combination with and compared to home exercise (HE) alone for neck pain in individuals ages 65 years or older. STUDY DESIGN/SETTING Randomized clinical trial. PATIENT SAMPLE Individuals 65 years of age or older with a primary complaint of mechanical neck pain, rated ≥3 (0-10) for 12 weeks or longer in duration. OUTCOME MEASURES Patient self-report outcomes were collected at baseline and 4, 12, 26, and 52 weeks after randomization. The primary outcome was pain, measured by an 11-box numerical rating scale. Secondary outcomes included disability (Neck Disability Index), general health status (Medical Outcomes Study Short Form-36), satisfaction (7-point scale), improvement (9-point scale), and medication use (days per week). METHODS This study was funded by the US Department of Health and Human Services, Health Resources and Services Administration. Linear mixed model analyses were used for comparisons at individual time points and for short- and long-term analyses. Blinded evaluations of objective outcomes were performed at baseline and 12 weeks. Adverse event data were collected at each treatment visit. RESULTS A total of 241 participants were randomized, with 95% reporting primary outcome data at all time points. After 12 weeks of treatment, the SMT with home exercise group demonstrated a 10% greater decrease in pain compared with the HE-alone group, and 5% change over supervised plus home exercise. A decrease in pain favoring supervised plus HE over HE alone did not reach statistical significance. Compared with the HE group, both combination groups reported greater improvement at week 12 and more satisfaction at all time points. Multivariate longitudinal analysis incorporating primary and secondary patient-rated outcomes showed that the SMT with HE group was superior to the HE-alone group in both the short- and long-term. No serious adverse events were observed as a result of the study treatments. CONCLUSIONS SMT with HE resulted in greater pain reduction after 12 weeks of treatment compared with both supervised plus HE and HE alone. Supervised exercise sessions added little benefit to the HE-alone program.

Spinal manipulation or mobilization for radiculopathy: a systematic review.

In this systematic review, we present a comprehensive and up-to-date systematic review of the literature as it relates to the efficacy and effectiveness of spinal manipulation or mobilization in the management of cervical, thoracic, and lumbar-related extremity pain. There is moderate quality evidence that spinal manipulation is effective for the treatment of acute lumbar radiculopathy. The quality of evidence for chronic lumbar spine-related extremity symptoms and cervical spine-related extremity symptoms of any duration is low or very low. At present, no evidence exists for the treatment of thoracic radiculopathy. Future high-quality studies should address these conditions.

Spinal manipulation and home exercise with advice for subacute and chronic back-related leg pain: A trial with adaptive allocation

Context Few studies evaluate the comparative effectiveness of conservative treatments for back-related leg pain. Contribution This randomized trial, involving 192 adults with subacute or chronic back-related leg pain, compared 12 weeks of home exercise and advice with spinal manipulative therapy plus home exercise and advice. Spinal manipulative therapy with home exercise and advice improved self-reported pain and function outcomes more than exercise and advice alone at 12 weeks, but differences between groups were not present at 52 weeks except for some secondary outcomes. Caution The intervention was not blinded. Implication Spinal manipulative therapy combined with home exercise and advice can improve short-term outcomes in patients with back-related leg pain. The Editors Back-related leg pain (BRLP) is an important symptom commonly associated with pervasive low back pain (LBP) conditions and, despite its socioeconomic effect, has been generally understudied. With poorer prognosis and quality of life, persons with BRLP have greater pain severity and incur more work loss, medication use, surgery, and health-related costs than those with uncomplicated LBP (16). Most patients with BRLP are treated with prescription medications and injections, although little to no evidence supports their use (7, 8). Surgical approaches are also commonly applied, although there is only some evidence for short-term effectiveness compared with less invasive treatments (9). Concerns are mounting about the overuse, costs, and safety of these conventional medical treatments (1018), warranting identification of more conservative treatment options. Spinal manipulative therapy (SMT), exercise, and education promoting self-management are increasingly recommended as low-risk strategies for BRLP (19). Although limited, evidence shows that these conservative approaches can be effective (2026). A recent systematic review by our group showed that SMT is superior to sham SMT for acute BRLP in the short and long term; however, the evidence for subacute and chronic BRLP is inconclusive, and high-quality research is needed to inform clinical and health policy decisions (20). The underlying mechanisms of SMT seem to be multifactorial, including improvement in spinal stiffness, muscle recruitment, and synaptic efficacy of central neurons (27, 28). The purpose of this study was to test the hypothesis that the addition of SMT to home exercise and advice (HEA) would be more effective than HEA alone for patients with subacute and chronic BRLP. Methods Design Overview This pragmatic trial used a parallel design with allocation by minimization and has been described previously (29). Patients were recruited between 2007 and 2010, and follow-up was completed in 2011. Institutional review boards approved the study protocol, and all patients provided written consent. The primary outcomes and most secondary outcomes were self-reported; objective measures were obtained by blinded examiners. There were no important changes to methods after trial commencement. Settings and Patients The trial was conducted at institution-affiliated research clinics at Northwestern Health Sciences University (Minneapolis, Minnesota) and Palmer College of Chiropractic (Davenport, Iowa). Patients were recruited through newspaper advertisements, direct mail, and community posters. Interested patients were initially screened by telephone interviews, followed by 2 in-person baseline evaluation visits. Inclusion criteria were age 21 years or older; BRLP based on Quebec Task Force on Spinal Disorders classifications 2, 3, 4, or 6 (radiating pain into the proximal or distal part of the lower extremity, with or without neurologic signs) (30); BRLP severity of 3 or greater (scale of 0 to 10); a current episode of 4 weeks or more; and a stable prescription medication plan in the previous month. Exclusion criteria were Quebec Task Force on Spinal Disorders classifications of 1, 5, 7, 8, 9, 10, and 11 (pain without radiation into the lower extremities, progressive neurologic deficits, the cauda equina syndrome, spinal fracture, spinal stenosis, surgical lumbar spine fusion, several incidents of lumbar spine surgery, chronic pain syndrome, visceral diseases, compression fractures or metastases, blood clotting disorders, severe osteoporosis, and inflammatory or destructive tissue changes of the spine). Patients could not be receiving ongoing treatment of leg pain or LBP; be pregnant or nursing; have current or pending litigation for workers compensation, disability, or personal injury; be unable to read or comprehend English; or have evidence of substance abuse. Allocation A Web-based program assigned patients to treatment after the second baseline visit using a minimization algorithm based on the Taves method (31), balancing on 7 baseline characteristics previously shown to influence outcomes (3234). Baseline characteristics included age, BRLP duration, neurologic signs, distress, positive straight leg raise, time spent driving a vehicle, and pain aggravation with coughing or sneezing. Patients were assigned in a 1:1 ratio, stratified by site. The allocation algorithm was prepared by the study statistician before enrollment, and its administration was concealed from study personnel. Interventions The intervention protocols were developed and tested in previous pilot studies (32, 33). Both interventions were intended to be pragmatic in nature (for example, modified to patient presentation and needs) and were informed by commonly recommended clinical practices, patient preferences, and promising research evidence (19, 3538). Eleven chiropractors with a minimum of 5 years of practice experience delivered SMT in the SMT plus HEA group. Thirteen providers (7 chiropractors, 5 exercise therapists, and 1 personal trainer) delivered the HEA intervention. When possible, patients worked with the same providers during the 12-week course of care; however, to accommodate patient and provider schedules during the intervention period, providers were trained to comanage patients. Treatment fidelity was facilitated through standardized training, manuals of operation, and clinical documentation forms that were monitored weekly by research staff. SMT Plus HEA Group As many as 20 SMT visits were allowed, each lasting 10 to 20 minutes, including a brief history and examination. Patients assigned to SMT plus HEA also attended 4 HEA visits, as described in the HEA Group section. For SMT visits, the primary focus of treatment was on manual techniques (including high-velocity, low amplitude thrust procedures or low-velocity, variable amplitude mobilization maneuvers to the lumbar vertebral or sacroiliac joints). The specific spinal level treated and the number and frequency of SMT visits were determined by the clinician on the basis of patient-reported symptoms, palpation, and pain provocation tests (39). Adjunct therapies to facilitate SMT were used as needed and included light soft-tissue techniques (that is, active and passive muscle stretching and ischemic compression of tender points) and hot or cold packs. To facilitate adherence to HEA, chiropractors asked about patients adherence, reaffirmed main HEA messages, and answered questions as needed. HEA Group Home exercise and advice were delivered in four 1-hour, one-on-one visits during the 12-week intervention. The main program goals were to provide patients with the tools to manage existing pain, prevent pain recurrences, and facilitate engagement in daily activities. Instruction and practice were provided for positioning and stabilization exercises to enhance mobility and increase trunk endurance. These were individualized to patients lifestyles, clinical characteristics (including positional sensitivities), and fitness levels. Positioning exercises included extension and flexion motion cycles (patients were encouraged to perform 25 repetitions 3 times per day in the lying, standing, or seated position) (33, 40). Stabilization exercises included pelvic tilt, quadruped, bridging, abdominal curl-ups, and side bridging with positional variations appropriate to patients tolerance and abilities (41). Patients were instructed to do 8 to 12 repetitions of each stabilization exercise every other day. Patients were also instructed in methods for developing spine posture awareness related to their activities of daily living, such as lifting, pushing and pulling, sitting, and getting out of bed (42). Information about simple pain-management techniques, including cold, heat, and movement, was also provided. Printed materials were distributed to take home and review. They included instructions of exercises with photos and a modification of the Back in Action book (43), emphasizing movement and restoration of normal function and fitness (35, 44). To facilitate adherence to HEA, providers called or e-mailed patients 3 times (at 1, 4, and 9 weeks) to reaffirm main messages and answer exercise-related questions. Outcomes and Measurements Patients demographic and clinical characteristics were collected at their first baseline visit through self-report questionnaires, histories, and physical examinations. Self-reported outcomes were collected at the baseline visit and at 3, 12, 26, and 52 weeks via questionnaires independent of study personnel influence. Patients were queried in each questionnaire about attempts to influence their responses. The primary outcome measure was patient-rated typical level of leg pain during the past week using an 11-point numerical rating scale, a reliable, valid, and important patient-centered outcome (36, 4547). The primary end points were 12 weeks, which was the end of the intervention phase, and the 52-week follow-up. A complete description of all secondary outcome measures is provided elsewhere (29). The measures reported in this article include LBP, disability measured with the modified RolandMorris Disability Questionnaire (4850), physical and