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Both mindfulness-based stress reduction (MBSR) and cognitive-behavioral therapy (CBT) are effective for chronic low back pain (CLBP), but little is known regarding who might benefit more from one than the other. Using data from a randomized trial comparing MBSR, CBT, and usual care (UC) for adults aged 20 to 70 years with CLBP (N = 297), we examined baseline characteristics that moderated treatment effects or were associated with improvement regardless of treatment. Outcomes included 8-week function (modified Roland Disability Questionnaire), pain bothersomeness (0-10 numerical rating scale), and depression (Patient Health Questionnaire-8). There were differences in the effects of CBT versus MBSR on pain based on participant gender (P = .03) and baseline depressive symptoms (P = .01), but the only statistically significant moderator after Bonferroni correction was the nonjudging dimension of mindfulness. Scores on this measure moderated the effects of CBT versus MBSR on both function (P = .001) and pain (P = .04). Pain control beliefs (P.001) and lower anxiety (P.001) predicted improvement regardless of treatment. Replication of these findings is needed to guide treatment decision-making for CLBP. TRIAL REGISTRATION: The trial and analysis plan were preregistered in ClinicalTrials.gov (Identifier: NCT01467843). PERSPECTIVE: Although few potential moderators and nonspecific predictors of benefits from CBT or MBSR for CLBP were statistically significant after adjustment for multiple comparisons, these findings suggest potentially fruitful directions for confirmatory research while providing reassurance that patients could reasonably expect to benefit from either treatment.

Key Points Question What is the impact of including benchmark prevalence data of common findings in reports of spinal imaging ordered by primary care clinicians? Findings In this randomized clinical trial that included 250 401 adults, no overall decrease in subsequent spine-related health care utilization after the intervention was observed. However, there was a significant decrease in opioid prescriptions at 1 year in the intervention group compared with the control group. Meaning The findings of this study suggest that including epidemiological benchmarks on spinal imaging reports has little impact on subsequent spine-related utilization overall but may reduce subsequent opioid prescriptions., This randomized clinical trial evaluates the impact of including benchmark prevalence data in routine spinal imaging reports on subsequent spine-related health care utilization and opioid prescriptions., Importance Lumbar spine imaging frequently reveals findings that may seem alarming but are likely unrelated to pain. Prior work has suggested that inserting data on the prevalence of imaging findings among asymptomatic individuals into spine imaging reports may reduce unnecessary subsequent interventions. Objective To evaluate the impact of including benchmark prevalence data in routine spinal imaging reports on subsequent spine-related health care utilization and opioid prescriptions. Design, Setting, and Participants This stepped-wedge, pragmatic randomized clinical trial included 250 401 adult participants receiving care from 98 primary care clinics at 4 large health systems in the United States. Participants had imaging of their backs between October 2013 and September 2016 without having had spine imaging in the prior year. Data analysis was conducted from November 2018 to October 2019. Interventions Either standard lumbar spine imaging reports (control group) or reports containing age-appropriate prevalence data for common imaging findings in individuals without back pain (intervention group). Main Outcomes and Measures Health care utilization was measured in spine-related relative value units (RVUs) within 365 days of index imaging. The number of subsequent opioid prescriptions written by a primary care clinician was a secondary outcome, and prespecified subgroup analyses examined results by imaging modality. Results We enrolled 250 401 participants (of whom 238 886 [95.4%] met eligibility for this analysis, with 137 373 [57.5%] women and 105 497 [44.2%] aged >60 years) from 3278 primary care clinicians. A total of 117 455 patients (49.2%) were randomized to the control group, and 121 431 patients (50.8%) were randomized to the intervention group. There was no significant difference in cumulative spine-related RVUs comparing intervention and control conditions through 365 days. The adjusted median (interquartile range) RVU for the control group was 3.56 (2.71-5.12) compared with 3.53 (2.68-5.08) for the intervention group (difference, −0.7%; 95% CI, −2.9% to 1.5%; P = .54). Rates of subsequent RVUs did not differ between groups by specific clinical findings in the report but did differ by type of index imaging (eg, computed tomography: difference, −29.3%; 95% CI, −42.1% to −13.5%; magnetic resonance imaging: difference, −3.4%; 95% CI, −8.3% to 1.8%). We observed a small but significant decrease in the likelihood of opioid prescribing from a study clinician within 1 year of the intervention (odds ratio, 0.95; 95% CI, 0.91 to 1.00; P = .04). Conclusions and Relevance In this study, inserting benchmark prevalence information in lumbar spine imaging reports did not decrease subsequent spine-related RVUs but did reduce subsequent opioid prescriptions. The intervention text is simple, inexpensive, and easily implemented. Trial Registration ClinicalTrials.gov Identifier: NCT02015455

Introduction The Subgrouping for Targeted Treatment (STarT Back) is a stratified care approach to LBP treatment. The predictive validity of STarT Back in Veterans Affairs (VA) primary care has not been demonstrated. Objective To examine the validity of the STarT Back tool for predicting future persistent disabling LBP in VA primary care. Design Cohort study. Setting VA primary care in Washington State. Participants Veterans seeking care for LBP in VA primary care clinics. Interventions Not applicable. Main outcome measures The STarT Back tool was used to classify Veterans according to their baseline risk group (low vs medium vs high). The primary study outcome, persistent disabling LBP, was defined as a Roland-Morris Disability Questionnaire (RMDQ) score ≥ 7 at 6-month follow-up. Analyses examined discrimination and calibration of the baseline STarT Back risk groups for prediction of persistent disabling LBP at 6-month follow-up. Results Of the study sample, 9% were females and 80% reported longstanding LBP (>5 year duration). Among 538 participants, the baseline STarT Back risk groups were associated with future persistent disabling LBP at 6-month follow-up. Within each baseline STarT Back risk group, the proportions with future persistent disabling LBP at 6-month follow-up were 54% (low risk), 88% (medium risk), and 97% (high risk). The baseline STarT Back risk groups had useful discrimination (area under the curve [AUC] 0.79) for predicting future persistent disabling LBP, but the proportion of Veterans persistent disabling LBP at 6-month follow-up was substantially higher than that observed in non-VA primary care settings. Conclusions The STarT Back risk groups had useful discrimination (AUC = 0.79) for future persistent disabling LBP, but calibration was poor, underestimating the risk of persistent disabling LBP. The STarT Back tool may require updating for use in VA primary care. This article is protected by copyright. All rights reserved.

BACKGROUND: Information on the prevalence of common imaging findings among patients without back pain in spine imaging reports might affect pain medication prescribing for patients with back pain. Prior research on inserting this text suggested a small reduction in opioid prescribing. OBJECTIVE: To evaluate the effect of epidemiologic information in spine imaging reports on non-opioid pain medication prescribing for primary care patients with back pain. DESIGN: Post hoc analysis of the Lumbar Imaging with Reporting of Epidemiology cluster-randomized trial. PARTICIPANTS: A total of 170,680 patients aged ≥ 18 years from four healthcare systems who received thoracolumbar, lumbar, or lumbosacral spine imaging from 2013 to 2016 and had not received a prescription for non-opioid pain medication in the preceding 120 days. INTERVENTION: Text of age- and modality-specific epidemiologic benchmarks indicating the prevalence of common findings in people without back pain inserted into thoracolumbar, lumbar, or lumbosacral spine imaging reports at intervention clinics. MAIN MEASURES: Primary outcomes: any non-opioid prescription within 90 days after index imaging, overall, and by sub-class (skeletal muscle relaxants, NSAIDs, gabapentinoids, tricyclic antidepressants, benzodiazepines, duloxetine). Secondary outcomes: count of non-opioid prescriptions within 90 days, overall, and by sub-class. KEY RESULTS: The intervention was not associated with the likelihood of patients receiving at least one prescription for new non-opioid pain-related medications, overall (adjusted OR, 1.02; 95% CI, 0.97–1.08) or by sub-class. The intervention was not associated with the number of prescriptions for any non-opioid medication (adjusted incidence rate ratio [IRR], 1.02; 95% CI, 0.99–1.04). However, the intervention was associated with more new prescriptions for NSAIDs (IRR, 1.12) and tricyclic antidepressants (IRR, 1.11). CONCLUSIONS: Inserting epidemiologic text in spine imaging reports had no effect on whether new non-opioid pain-related medications were prescribed but was associated with the number of new prescriptions for certain non-opioid sub-classes. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT02015455 SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s11606-021-06627-6.

As a large national healthcare system, Veterans Health Administration (VHA) is ideally suited to build on its work to date and develop a safe, evidence-based, and comprehensive approach to the care of chronic musculoskeletal pain conditions that de-emphasizes opioid use and emphasizes non-pharmacological strategies. The VHA Office of Health Services Research and Development (HSR&D) held a state-of-the-art (SOTA) conference titled “Non-pharmacological Approaches to Chronic Musculoskeletal Pain Management” in November 2016. Goals of the conference were (1) to establish consensus on the current state of evidence regarding non-pharmacological approaches to chronic musculoskeletal pain to inform VHA policy in this area and (2) to begin to identify priorities for the future VHA research agenda. Workgroups were established and asked to reach consensus recommendations on clinical and research priorities for the following treatment strategies: psychological/behavioral therapies, exercise/movement therapies, manual therapies, and models for delivering multimodal pain care. Participants in the SOTA identified nine non-pharmacological therapies with sufficient evidence to be implemented across the VHA system as part of pain care. Participants further recommended that effective integration of these non-pharmacological approaches across the VHA and especially into VHA primary care, pain care, and mental health settings should be a priority, and that these treatments should be offered early in the course of pain treatment and delivered in a team-based, multimodal treatment setting concurrently with active self-care and self-management approaches. In addition, we recommend that VHA leadership and policy makers systematically address the barriers to implementation of these approaches by expanding opportunities for clinician and veteran education on the effectiveness of these strategies; supporting and funding further research to determine optimal dosage, duration, sequencing, combination, and frequency of treatment; emphasizing multimodal care with rigorous evaluation grounded in team-based approaches to test integrated models of delivery and stepped-care approaches; and working to address socioeconomic and cultural barriers to veterans’ access to non-pharmacological approaches.

IMPORTANCE: Migraine is the second leading cause of disability worldwide. Most patients with migraine discontinue medications due to inefficacy or adverse effects. Mindfulness-based stress reduction (MBSR) may provide benefit. OBJECTIVE: To determine if MBSR improves migraine outcomes and affective/cognitive processes compared with headache education. DESIGN, SETTING, AND PARTICIPANTS: This randomized clinical trial of MBSR vs headache education included 89 adults who experienced between 4 and 20 migraine days per month. There was blinding of participants (to active vs comparator group assignments) and principal investigators/data analysts (to group assignment). INTERVENTIONS: Participants underwent MBSR (standardized training in mindfulness/yoga) or headache education (migraine information) delivered in groups that met for 2 hours each week for 8 weeks. MAIN OUTCOMES AND MEASURES: The primary outcome was change in migraine day frequency (baseline to 12 weeks). Secondary outcomes were changes in disability, quality of life, self-efficacy, pain catastrophizing, depression scores, and experimentally induced pain intensity and unpleasantness (baseline to 12, 24, and 36 weeks). RESULTS: Most participants were female (n = 82, 92%), with a mean (SD) age of 43.9 (13.0) years, and had a mean (SD) of 7.3 (2.7) migraine days per month and high disability (Headache Impact Test-6: 63.5 [5.7]), attended class (median attendance, 7 of 8 classes), and followed up through 36 weeks (33 of 45 [73%] of the MBSR group and 32 of 44 [73%] of the headache education group). Participants in both groups had fewer migraine days at 12 weeks (MBSR: −1.6 migraine days per month; 95% CI, −0.7 to −2.5; headache education: −2.0 migraine days per month; 95% CI, −1.1 to −2.9), without group differences (P = .50). Compared with those who participated in headache education, those who participated in MBSR had improvements from baseline at all follow-up time points (reported in terms of point estimates of effect differences between groups) on measures of disability (5.92; 95% CI, 2.8-9.0; P

Cognitive behavioral therapy (CBT) is believed to improve chronic pain problems by decreasing patient catastrophizing and increasing patient self-efficacy for managing pain. Mindfulness-based stress reduction (MBSR) is believed to benefit patients with chronic pain by increasing mindfulness and pain acceptance. However, little is known about how these therapeutic mechanism variables relate to each other or whether they are differentially impacted by MBSR vs CBT. In a randomized controlled trial comparing MBSR, CBT, and usual care (UC) for adults aged 20 to 70 years with chronic low back pain (N = 342), we examined (1) baseline relationships among measures of catastrophizing, self-efficacy, acceptance, and mindfulness and (2) changes on these measures in the 3 treatment groups. At baseline, catastrophizing was associated negatively with self-efficacy, acceptance, and 3 aspects of mindfulness (nonreactivity, nonjudging, and acting with awareness; all P values

Despite improved knowledge about the benefits and harms of treatments for chronic back pain in the past several decades, there is a large and consequential mismatch between treatments found safe and effective and those routinely covered by health insurance. As a result, care for back pain has, if anything, deteriorated in recent decades-expenses are higher, harms are greater, and use of ineffective treatments is more common. Deficiencies in health care delivery processes and payment models are centrally involved in the failure to improve care for back pain. A key step for accelerating progress is changing insurance coverage policies to facilitate use of the safest and most helpful approaches while discouraging riskier and less effective treatments. Relatively simple changes in reimbursement policies may minimize harm and improve quality of life for many patients with chronic back and similar pain syndromes. Such changes might also reduce health care expenditures because the costs of treatments currently covered by insurance and their associated harms may well outweigh the costs of the relatively safe and effective treatments recommended by current guidelines but poorly covered by insurance. There is no justification for continuing the status quo-patients and clinicians deserve better.

A recent Institute for Clinical and Economic Review provides evidence that some cognitive and mind-body therapies are effective for chronic low back pain and also cost-effective.

Diagnostic imaging is often the first step in evaluating patients with back pain and likely functions as a "gateway" to a subsequent cascade of interventions. However, lumbar spine imaging frequently reveals incidental findings among normal, pain-free individuals suggesting that treatment of these "abnormalities" may not be warranted. Our prior work suggested that inserting the prevalence of imaging findings in patients without back pain into spine imaging reports may reduce subsequent interventions. We are now conducting a pragmatic cluster randomized clinical trial to test the hypothesis that inserting this prevalence data into lumbar spine imaging reports for studies ordered by primary care providers will reduce subsequent spine-related interventions.We are using a stepped wedge design that sequentially randomizes 100 primary care clinics at four health systems to receive either standard lumbar spine imaging reports, or reports containing prevalence data for common imaging findings in patients without back pain. We capture all outcomes passively through the electronic medical record. Our primary outcome is spine-related intervention intensity based on Relative Value Units (RVUs) during the following year. Secondary outcomes include subsequent prescriptions for opioid analgesics and cross-sectional lumbar spine re-imaging.If our study shows that adding prevalence data to spine imaging reports decreases subsequent back-related RVUs, this intervention could be easily generalized and applied to other kinds of testing, as well as other conditions where incidental findings may be common. Our study also serves as a model for cluster randomized trials that are minimal risk and highly pragmatic.

Background context This is the first study to systematically evaluate the value of a longer treatment period for massage. We provide a framework of how to conceptualize an optimal dose in this challenging setting of nonpharmacologic treatments. Purpose The aim was to determine the optimal dose of massage for neck pain. Study design/setting Two-phase randomized trial for persons with chronic nonspecific neck pain. Primary randomization to one of five groups receiving 4 weeks of massage (30 minutes 2x/or 3x/wk or 60 minutes 1x, 2x, or 3x/wk). Booster randomization of participants to receive an additional six massages, 60 minutes 1x/wk, or no additional massage. Patient sample A total of 179 participants from Group Health and the general population of Seattle, WA, USA recruited between June 2010 and August 2011 were included. Outcome measures Primary outcomes self-reported neck-related dysfunction (Neck Disability Index) and pain (0–10 scale) were assessed at baseline, 12, and 26 weeks. Clinically meaningful improvement was defined as greater than or equal to 5-point decrease in dysfunction and greater than or equal to 30% decrease in pain from baseline. Methods Clinically meaningful improvement for each primary outcome with both follow-up times was analyzed using adjusted modified Poisson generalized estimating equations (GEEs). Secondary analyses for the continuous outcomes used linear GEEs. Results There were no observed differences by primary treatment group at 12 or 26 weeks. Those receiving booster dose had improvements in both dysfunction and pain at 12 weeks (dysfunction: relative risk [RR]=1.56 [1.08–2.25], p=.018; pain: RR=1.25 [0.98-1.61], p=.077), but those were nonsignificant at 26 weeks (dysfunction: RR=1.22 [0.85–1.74]; pain: RR=1.09 [0.82–1.43]). Subgroup analysis by primary and booster treatments found the booster dose only effective among those initially randomized to one of the 60-minute massage groups. Conclusions “Booster” doses for those initially receiving 60 minutes of massage should be incorporated into future trials of massage for chronic neck pain.

Economic evaluation alongside a randomized trial of cognitive-behavioral therapy (CBT) and mindfulness-based stress reduction (MBSR) versus usual care alone (UC) for chronic low back pain (CLBP).To determine 1-year cost-effectiveness of CBT and MBSR compared to 33 UC.CLBP is expensive in terms of healthcare costs and lost productivity. Mind-body interventions have been found effective for back pain, but their cost-effectiveness is unexplored.A total of 342 adults in an integrated healthcare system with CLBP were randomized to receive MBSR (n = 116), CBT (n = 113), or UC (n = 113). CBT and MBSR were offered in 8-weekly 2-hour group sessions. Cost-effectiveness from the societal perspective was calculated as the incremental sum of healthcare costs and productivity losses over change in quality-adjusted life-years (QALYs). The payer perspective only included healthcare costs. This economic evaluation was limited to the 301 health plan members enrolled ≥180 days in the years pre-and postrandomization.Compared with UC, the mean incremental cost per participant to society of CBT was $125 (95% confidence interval, CI: -4103, 4307) and of MBSR was -$724 (CI: -4386, 2778)-that is, a net saving of $724. Incremental costs per participant to the health plan were $495 for CBT over UC and -$982 for MBSR, and incremental back-related costs per participant were $984 for CBT over UC and -$127 for MBSR. These costs (and cost savings) were associated with statistically significant gains in QALYs over UC: 0.041 (0.015, 0.067) for CBT and 0.034 (0.008, 0.060) for MBSR.In this setting CBT and MBSR have high probabilities of being cost-effective, and MBSR may be cost saving, as compared with UC for adults with CLBP. These findings suggest that MBSR, and to a lesser extent CBT, may provide cost-effective treatment for CLBP for payers and society.2.

Objective The aim of the present study was to determine the feasibility of a relaxation‐based yoga intervention for rheumatoid arthritis, designed and reported in accordance with Delphi recommendations for yoga interventions for musculoskeletal conditions. Methods Participants were recruited from a hospital database, and randomized to either eight weekly 75‐min yoga classes or a usual care control. Feasibility was determined by recruitment rates, retention, protocol adherence, participant satisfaction and adverse events. Secondary physical and psychosocial outcomes were assessed using self‐reported questionnaires at baseline (week 0), week 9 (primary time point) and week 12 (follow‐up). Results Over a 3‐month period, 26 participants with mild pain, mild to moderate functional disability and moderate disease activity were recruited into the study (25% recruitment rate). Retention rates were 100% for yoga participants and 92% for usual care participants at both weeks 9 and 12. Protocol adherence and participant satisfaction were high. Yoga participants attended a median of seven classes; additionally, seven of the yoga participants (54%) reported continuing yoga at home during the follow‐up period. No serious adverse events were related to the study. Secondary outcomes showed no group effects of yoga compared with usual care Conclusions A relaxation‐based yoga programme was found to be feasible and safe for participants with rheumatoid arthritis‐related pain and functional disability. Adverse events were minor, and not unexpected from an intervention including physical components. This pilot provides a framework for larger intervention studies, and supports further exploration of yoga as a complex intervention to assist with the management of rheumatoid arthritis.

Summary Objectives To identify the content and reporting details of randomised controlled trials of yoga for musculoskeletal conditions through a systematic review of the literature. Design Twenty electronic databases were searched to identify randomised controlled trials (RCTs) of yoga interventions for musculoskeletal conditions. Eligibility criteria were full-text, peer reviewed articles, of RCTs with yoga as a primary intervention, on a population aged 18 years and over, with a clinical diagnosis of a musculoskeletal condition. Data relating to study characteristics, yoga styles, yoga practices, home practice, and reporting were extracted and summarised. Results Seventeen articles met inclusion criteria, representing five musculoskeletal conditions: low back pain, osteoarthritis, rheumatoid arthritis, kyphosis, and fibromyalgia. 15 studies were non-residential, and two were residential. Study duration ranged from 1 to 24 weeks; weekly dosage of yoga ranged from 1 to 56h. Five styles of posture-based Hatha yoga were specified. Intervention content included seven yoga practises: postures, breathing, relaxation, meditation, philosophy, chanting, and cleansing practises. Ten studies either encouraged or requested home practice. Reporting details included class plans, posture lists, and diagrams. Due to insufficient detail regarding delivery of the yoga intervention only eight of the 17 interventions were considered replicable as reported. Conclusions Evaluation of study characteristics and yoga components indicated several areas of homogeneity across studies, suggesting an existing degree of standardisation. However, heterogeneity related to intervention content and reporting impeded determination of intervention content and delivery. Standardisation of content, nomenclature, and reporting details is recommended to enhance protocol transparency, replication, and comparison of intervention effectiveness.

Background:Yoga is a popular complementary and alternative medicine (CAM) therapy among people with rheumatoid arthritis (RA), perceived as offering self-management options for physical and psychosocial symptoms associated with RA.Objectives:The primary aims of the current pilot study are (1) to assess the feasibility and safety of a relaxation-focused yoga intervention tailored for people with RA and (2) to estimate the effect of yoga on RA-related pain, sleep quality, functional disability, disease activity, quality of life, anxiety, depression, and fatigue.Method:Twenty-eight participants with at least minimum levels of RA-related pain and sleep disturbance will be recruited from a local public hospital database. Participants meeting inclusion criteria will be randomized into either a yoga group (receiving an 8-week program of once-weekly 75-minute relaxation-based yoga classes and thrice-weekly home practice), or a usual care control group. Outcomes will be assessed at baseline, 9, and 12 week...

Complementary and alternative medicine (CAM) providers are becoming more integrated into the United States health care system. Because patients self-select CAM use, risk adjustment is needed to make the groups more comparable when analyzing utilization. This study examined how the choice of risk adjustment method affects assessment of CAM use on overall health care utilization.Insurance claims data for 2000-2003 from Washington State, which mandates coverage of CAM providers, were analyzed. Three (3) risk adjustment methods were compared in patients with musculoskeletal conditions: Adjusted Clinical Groups (ACG), Diagnostic Cost Groups (DCG), and the Charlson Index. Relative Value Units (RVUs) were used as a proxy for expenditures. Two (2) sets of median regression models were created: prospective, which used risk adjustments from the previous year to predict RVU in the subsequent year, and concurrent, which used risk adjustment measures to predict RVU in the same year.The sample included 92,474 claimants. Prospective models showed little difference in the effect of CAM use on RVU among the three risk adjustment methods, and all models had low predictive power (R(2) ≤0.05). In the concurrent models, coefficients were similar in direction and magnitude for all risk adjustment methods, but in some models the predicted effect of CAM use on RVU differed by as much as double between methods. Results of DCG and ACG models were similar and were stronger than Charlson models.Choice of risk adjustment method may have a modest effect on the outcome of interest.

Objectives Musculoskeletal conditions (MSCs) are the leading cause of disability and chronic pain in the developed world, impacting both functional ability and psychosocial health. The current review investigates the effectiveness of yoga on primary outcomes of functional ability, pain and psychosocial outcomes across a range of MSCs. Methods A comprehensive search of 20 databases was conducted for full-text, randomized controlled trials of yoga in clinically diagnosed MSCs. Result Seventeen studies met the inclusion criteria, involving 1,626 participants with low back pain (LBP), osteoarthritis (OA), rheumatoid arthritis (RA), kyphosis or fibromyalgia. Studies were quality rated, and analysed for the effect of yoga on primary outcomes, immediately post-intervention. Twelve studies were rated as good quality. Yoga interventions resulted in a clinically significant improvement in functional outcomes in mild-to-moderate LBP and fibromyalgia, and showed a trend to improvement in kyphosis. Yoga significantly improved pain in OA, RA and mild-to-severe LBP. Psychosocial outcomes were significantly improved in mild-to-moderate LBP and OA. Meta-analysis of good-quality studies showed a moderate treatment effect for yoga of −0.64 (95%CI −0.89 to −0.39) for functional outcomes and −0.61 (95%CI −0.97 to −0.26) for pain outcomes. Conclusions Evidence suggests that yoga is an acceptable and safe intervention, which may result in clinically relevant improvements in pain and functional outcomes associated with a range of MSCs. Future analysis of outcomes which take into account the amount of yoga received by participants may provide insight into any putative duration or dosage effects of yoga interventions for MSCs. Copyright © 2013 John Wiley & Sons, Ltd.

While previous studies focused on the effectiveness of individual complementary and alternative medical (CAM) therapies, the value of providing patients access to an integrated program involving multiple CAM and conventional therapies remains unknown. The objective of this study is to explore the feasibility and effects of a model of multidisciplinary integrative care for subacute low-back pain (LBP) in an academic teaching hospital.This was a pilot randomized trial comparing an individualized program of integrative care (IC) plus usual care to usual care (UC) alone for adults with LBP.Twenty (20) individuals with LPB of 3-12 weeks' duration were recruited from an occupational health clinic and community health center.Participants were randomized to 12 weeks of individualized IC plus usual care versus UC alone. IC was provided by a trained multidisciplinary team offering CAM therapies and conventional medical care.The outcome measures were symptoms (pain, bothersomeness), functional status (Roland-Morris score), SF-12, worry, and difficulty performing three self-selected activities.Over 12 weeks, participants in the IC group had a median of 12.0 visits (range 5-25). IC participants experienced significantly greater improvements at 12 weeks than those receiving UC alone in symptom bothersomeness (p=0.02) and pain (p=0.005), and showed greater improvement in functional status (p=0.08). Rates of improvement were greater for patients in IC than UC in functional status (p=0.02), bothersomeness (p=0.002), and pain scores (p=0.001). Secondary outcomes of self-selected most challenging activity, worry, and the SF-12 also showed improvement in the IC group at 12 weeks. These differences persisted at 26 weeks, but were no longer statistically significant.It was feasible for a multidisciplinary, outpatient IC team to deliver coordinated, individualized intervention to patients with subacute LBP. Results showed a promising trend for benefit of treating patients with persistent LBP with this IC model, and warrant evaluation in a full-scale study.

PURPOSE We studied the openness of patients and clinicians to introducing a broader range of healing options into primary care. METHODS Focus groups were conducted with primary care patients (4 groups) and clinicians (3 groups) from an integrated medical care system in 2008. Transcripts of discussions were analyzed using an immersion/crystallization approach. RESULTS Both patients (n = 44) and clinicians (n = 32) were open to including a wider variety of healing options in primary care. Patients desired some evidence of effectiveness, although there was wide variation in the type of evidence required. Many patients believed that the clinician’s personal and practice experience was an important form of evidence. Patients wanted to share in the decision to refer and the choice of options. Clinicians were most concerned with safety of specific treatments, including some of the herbs and dietary supplements. They also believed they lacked adequate information about the nature, benefits, and risks of many alternatives, and they were not aware of local practitioners and resources to whom they could confidently refer their patients. Both patients and clinicians were concerned that services recommended be covered by insurance or be affordable to patients. CONCLUSIONS Integrating additional healing options into primary care may be feasible and desirable, as well as help meet the needs of patients with conditions that have not been responsive to standard medical treatments.

Study design Synthesis and analysis of presentation and discussion highlights, with a focus on emerging trends and promising new directions in primary care research on low back pain (LBP). Objective To present a summary of findings, themes, and insights from the Tenth International Forum on Primary Care Research on Low Back Pain, a meeting of researchers designed to share the latest concepts, methods, and results of research on LBP diagnosis, treatment, and disability prevention. Summary of background data Earlier Forum meetings have developed several common themes and general conclusions. These are contrasted with the presentations and discussions at the 10th International Forum. Results Major themes included concerns about the epidemic of chronic, disabling LBP, associated treatments, iatrogenesis, and the "LBP medical industrial complex"; the variability and complexity of outcomes and how their importance differed across patients in defining recovery and recurrence; the power of nonspecific effects, expectations, and therapeutic alliance; and the challenges of identifying important therapeutic subgroups. New research addressed early risk factor screening and linked intervention, nonmedical approaches to reframe the LBP problem and avoid unnecessary care, cognitive and behavioral aspects of LBP, and ways to train clinicians to implement these innovations. More appropriate use of longitudinal designs and a greater focus on implementation research was called for. Conclusion Although the field of primary care LBP research often seems to progress slowly, the Forum highlighted several important, promising developments that could substantially improve LBP research and primary care practice.

OBJECTIVE: To examine the predictive validity of the STarT Back tool for classifying people with back pain into categories of low, medium, and high risk of persistent disabling back pain, in US primary care. DESIGN: Secondary analysis of data from participants receiving usual care in a randomized clinical trial. SETTING: Primary care clinics. PARTICIPANTS: 1109 adults with back pain ≥18 years of age. Those with specific causes of back pain (pregnancy, disc herniation, vertebral fracture, spinal stenosis) and work-related injuries were not included. INTERVENTIONS: N/A MAIN OUTCOME MEASURES: The original 9-item version of the STarT Back tool, administered at baseline, stratified patients by their risk (low, medium, high) of persistent disabling back pain (‘STarT Back risk group’). Persistent disabling back pain was defined as Roland-Morris Disability Questionnaire scores of ≥7 at 6-month follow-up. RESULTS: STarT Back risk group was a significant predictor of persistent disabling back pain (p

Although massage is one of the most popular complementary and alternative medical (CAM) treatments for anxiety, its effectiveness has never been rigorously evaluated for a diagnosed anxiety disorder. This study evaluates the effectiveness of therapeutic massage for persons with generalized anxiety disorder (GAD).Sixty-eight persons with GAD were randomized to therapeutic massage (n=23), thermotherapy (n=22), or relaxing room therapy (n=23) for a total of 10 sessions over 12 weeks. Mean reduction in anxiety was measured by the Hamilton Anxiety Rating Scale (HARS). Secondary outcomes included 50% reduction in HARS and symptom resolution of GAD, changes in depressive symptoms (Patient Health Questionnaire (PHQ-8)), worry and GAD-related disability. We compared changes in these outcomes in the massage and control groups posttreatment and at 6 months using generalized estimating equation (GEE) regression.All groups had improved by the end of treatment (adjusted mean change scores for the HARS ranged from -10.0 to -13.0; P.001) and maintained their gains at the 26-week followup. No differences were seen between groups (P=.39). Symptom reduction and resolution of GAD, depressive symptoms, worry and disability showed similar patterns.Massage was not superior to the control treatments, and all showed some clinically important improvements, likely due to some beneficial but generalized relaxation response. Because the relaxing room treatment is substantially less expensive than the other treatments, a similar treatment packaged in a clinically credible manner might be the most cost effective option for persons with GAD who want to try relaxation-oriented CAM therapies.

Background The relationship between patient expectations about a treatment and the treatment outcomes, particularly for Complementary and Alternative Medicine (CAM) therapies, is not well understood. Using qualitative data from a larger study to develop a valid expectancy questionnaire for use with participants starting new CAM therapies, we examined how participants’ expectations of treatment changed over the course of a therapy. Methods We conducted semi-structured qualitative interviews with 64 participants initiating one of four CAM therapies (yoga, chiropractic, acupuncture, massage) for chronic low back pain. Participants just starting treatment were interviewed up to three times over a period of 3 months. Interviews were transcribed verbatim and analyzed using a qualitative mixed methods approach incorporating immersion/crystallization and matrix analysis for a decontexualization and recontextualization approach to understand changes in thematic emphasis over time. Results Pre-treatment expectations consisted of conjecture about whether or not the CAM therapy could relieve pain and improve participation in meaningful activities. Expectations tended to shift over the course of treatment to be more inclusive of broader lifestyle factors, the need for long-term pain management strategies and attention to long-term quality of life and wellness. Although a shift toward greater acceptance of chronic pain and the need for strategies to keep pain from flaring was observed across participants regardless of therapy, participants varied in their assessments of whether increased awareness of the need for ongoing self-care and maintenance strategies was considered a “positive outcome”. Regardless of how participants evaluated the outcome of treatment, participants from all four therapies reported increased awareness, acceptance of the chronic nature of pain, and attention to the need to take responsibility for their own health. Conclusions The shift in treatment expectations to greater acceptance of pain and the need for continued self-care suggests that future research should explore how CAM practitioners can capitalize on these shifts to encourage feelings of empowerment rather than disappointment surrounding realizations of the need for continued engagement with self-care.

Objective To describe chiropractic care using data collected at the time of each patient visit. Methods Random samples of chiropractors licensed in Arizona and Massachusetts were recruited to participate in interviews about their training, demographics, and practice characteristics. Interviewees were then recruited to record information about patient condition, evaluation, care, and visit disposition on 20 consecutive patient visits. Results Data for 2550 chiropractic patient visits were recorded. Care for low back, head and neck pain accounted for almost three quarters of visits. Extremity conditions and wellness care accounted for approximately half of the remaining visits. Spinal and soft tissue examinations were the most frequently reported diagnostic procedures (80% and 56% of visits, respectively), and high-velocity spinal manipulation techniques were the most frequently reported therapeutic procedures (almost 85% of visits). Rehabilitation exercises, thermal modalities, electric stimulation, and counseling/education/self-care were each performed during approximately 25% of visits. Approximately 85% of patients seen were self-referred, whereas only approximately 5% came from medical physicians. Approximately 35% of visits had an expected source of payment directly from the patient. Approximately 80% of visits ended with a plan for the patient to return at a specified time. Conclusion These findings are consistent with the findings of previous studies and confirm that chiropractors use conventional patient assessment approaches with specific attention to spinal and musculoskeletal procedures, infrequently incorporating interventions commonly associated with other complimentary and alternative care providers. These findings illustrate that diagnostic assessment and follow-up are integral to chiropractic clinical encounters and offer a baseline for best practices development. The data also offer insight into chiropractic use and may be of interest to chiropractic leaders and education planners for professional development purposes.

The objective of this study was to examine the characteristics of mental health visits to Complementary and Alternative Medicine (CAM) providers. A representative sample of acupuncturists, chiropractors, massage therapists, and naturopathic physicians in four states reported on 8933 consecutive visits, including demographic characteristics; presenting complaints; referral source; treatments provided; disposition; and other sources of care for the presenting problem. The proportion of visits for a mental health complaint ranged from 7% to 11% for acupuncture, massage, and naturopathic physicians to less than 1% for chiropractors. For acupuncturists, massage therapists, and naturopaths, 69-87% of patients making mental health visits were self-referred. The CAM provider discussed care with a conventional medical provider in 6-20% of cases and was aware of concomitant conventional medical care in an additional 10-30%. Only 1-5% were subsequently referred to conventional providers. For acupuncturists, massage therapists, and naturopaths, the proportion of visits for mental health concerns is similar to that in conventional primary care. Mental health visits to chiropractors are much less common, but this may reflect differences in true prevalence or differences in presentation. Among those seeking CAM care for mental disorders, concomitant treatment by conventional medical providers is common, but communication or coordination of care is rare.

Background Positive patient expectations are often believed to be associated with greater benefits from complementary and alternative medicine (CAM) treatments. However, clinical studies of CAM treatments for chronic pain have not consistently supported this assumption, possibly because of differences in definitions and measures of expectations. The goal of this qualitative paper is to provide new perspectives on the outcome expectations of patients prior to receiving CAM therapies for chronic low back pain. Methods We conducted semi-structured interviews with 64 individuals receiving massage, chiropractic, acupuncture or yoga for chronic low back pain. Interviews were recorded and transcribed. Transcripts were analyzed by a team of experienced qualitative researchers using an immersion/crystallization approach to coding and analysis. Results Overall, participants’ expectations of treatment outcomes tended to cluster in four key domains: pain relief, improved function (including an increase in ability to engage in meaningful activities), improved physical fitness, and improved overall well-being (including mental well-being). Typically, patients had modest expectations for outcomes from treatment. Furthermore, outcome expectations were complex on several levels. First, the concept of expectations overlapped with several related concepts; in particular, hopes. Participants sometimes used expectations and hopes interchangeably and at other times made clear distinctions between these two terms depending on context. A related finding was that participants were cautious about stating that they expected positive outcomes. Finally, participants articulated strong interrelationships among the four key domains and often discussed how changes in one domain might affect other domains. Conclusions Overall, these findings contribute to a growing body of literature exploring the role of expectations in patient outcomes. This paper provides important guidance that may help refine the way treatment expectations are studied in the future. In particular, participants’ statements indicate that standardized measures of patient expectations should include items that capture hesitancy to articulate overly optimistic outcomes as well as interrelationships among different outcomes.

Background: Evidence suggests yoga is a safe and effective intervention for the management of physical and psychosocial symptoms associated with musculoskeletal conditions. However, heterogeneity in the components and reporting of clinical yoga trials impedes both the generalization of study results and the replication of study protocols. The aim of this Delphi survey was to address these issues of heterogeneity, by developing a list of recommendations of key components for the design and reporting of yoga interventions for musculoskeletal conditions.\ud \ud Methods: Recognised experts involved in the design, conduct, and teaching of yoga for musculoskeletal conditions were identified from a systematic review, and invited to contribute to the Delphi survey. Forty-one of the 58 experts contacted, representing six countries, agreed to participate. A three-round Delphi was conducted via electronic surveys. Round 1 presented an open-ended question, allowing panellists to individually identify components they considered key to the design and reporting of yoga interventions for musculoskeletal conditions. Thematic analysis of Round 1 identified items for quantitative rating in Round 2; items not reaching consensus were forwarded to Round 3 for re-rating.Results: Thirty-six panellists (36/41; 88%) completed the three rounds of the Delphi survey. Panellists provided 348 comments to the Round 1 question. These comments were reduced to 49 items, grouped under five themes, for rating in subsequent rounds. A priori group consensus of ≥80% was reached on 28 items related to five themes concerning defining the yoga intervention, types of yoga practices to include in an intervention, delivery of the yoga protocol, domains of outcome measures, and reporting of yoga interventions for musculoskeletal conditions. Additionally, a priori consensus of ≥50% was reached on five items relating to minimum values for intervention parameters.\ud \ud Conclusions: Expert consensus has provided a non-prescriptive reference list for the design and reporting of yoga interventions for musculoskeletal conditions. It is anticipated future research incorporating the Delphi guidelines will facilitate high quality international research in this field, increase homogeneity of intervention components and parameters, and enhance the comparison and reproducibility of research into the use of yoga for the management of musculoskeletal conditions.

The self-reported health and functional status of persons with back pain in the United States have declined in recent years, despite greatly increased medical expenditures due to this problem. Although patient psychosocial factors such as pain-related beliefs, thoughts and coping behaviors have been demonstrated to affect how well patients respond to treatments for back pain, few patients receive treatments that address these factors. Cognitive-behavioral therapy (CBT), which addresses psychosocial factors, has been found to be effective for back pain, but access to qualified therapists is limited. Another treatment option with potential for addressing psychosocial issues, mindfulness-based stress reduction (MBSR), is increasingly available. MBSR has been found to be helpful for various mental and physical conditions, but it has not been well-studied for application with chronic back pain patients. In this trial, we will seek to determine whether MBSR is an effective and cost-effective treatment option for persons with chronic back pain, compare its effectiveness and cost-effectiveness compared with CBT and explore the psychosocial variables that may mediate the effects of MBSR and CBT on patient outcomes. In this trial, we will randomize 397 adults with nonspecific chronic back pain to CBT, MBSR or usual care arms (99 per group). Both interventions will consist of eight weekly 2-hour group sessions supplemented by home practice. The MBSR protocol also includes an optional 6-hour retreat. Interviewers masked to treatment assignments will assess outcomes 5, 10, 26 and 52 weeks postrandomization. The primary outcomes will be pain-related functional limitations (based on the Roland Disability Questionnaire) and symptom bothersomeness (rated on a 0 to 10 numerical rating scale) at 26 weeks. If MBSR is found to be an effective and cost-effective treatment option for patients with chronic back pain, it will become a valuable addition to the limited treatment options available to patients with significant psychosocial contributors to their pain. Clinicaltrials.gov Identifier: NCT01467843 .

PURPOSE This trial was designed to evaluate the optimal dose of massage for individuals with chronic neck pain. METHODS We recruited 228 individuals with chronic nonspecific neck pain from an integrated health care system and the general population, and randomized them to 5 groups receiving various doses of massage (a 4-week course consisting of 30-minute visits 2 or 3 times weekly or 60-minute visits 1, 2, or 3 times weekly) or to a single control group (a 4-week period on a wait list). We assessed neck-related dysfunction with the Neck Disability Index (range, 0–50 points) and pain intensity with a numerical rating scale (range, 0–10 points) at baseline and 5 weeks. We used log-linear regression to assess the likelihood of clinically meaningful improvement in neck-related dysfunction (≥5 points on Neck Disability Index) or pain intensity (≥30% improvement) by treatment group. RESULTS After adjustment for baseline age, outcome measures, and imbalanced covariates, 30-minute treatments were not significantly better than the wait list control condition in terms of achieving a clinically meaningful improvement in neck dysfunction or pain, regardless of the frequency of treatments. In contrast, 60-minute treatments 2 and 3 times weekly significantly increased the likelihood of such improvement compared with the control condition in terms of both neck dysfunction (relative risk = 3.41 and 4.98, P = .04 and .005, respectively) and pain intensity (relative risk = 2.30 and 2.73; P = .007 and .001, respectively). CONCLUSIONS After 4 weeks of treatment, we found multiple 60-minute massages per week more effective than fewer or shorter sessions for individuals with chronic neck pain. Clinicians recommending massage and researchers studying this therapy should ensure that patients receive a likely effective dose of treatment.

Study design A subanalysis of data derived from a randomized clinical trial was performed. Objective To evaluate the association of a patient's expectation for benefit from a specific treatment with improved functional outcome. Summary of background data Psychosocial factors, ambiguous diagnoses, and lack of a clearly superior treatment have complicated the management of patients with chronic low back pain. The authors hypothesized that patient expectation for benefit from a specific treatment is associated with improved functional outcomes when that treatment is administered. Methods In a randomized trial, 135 patients with chronic low back pain who received acupuncture or massage were studied. Before randomization, study participants were asked to describe their expectations regarding the helpfulness of each treatment on a scale of 0 to 10. The primary outcome was level of function at 10 weeks as measured by the modified Roland Disability scale. Results After adjustment for baseline characteristics, improved function was observed for 86% of the participants with higher expectations for the treatment they received, as compared with 68% of those with lower expectations (P = 0.01). Furthermore, patients who expected greater benefit from massage than from acupuncture were more likely to experience better outcomes with massage than with acupuncture, and vice versa (P = 0.03). Conclusions The results of this study suggest that patient expectations may influence clinical outcome independently of the treatment itself. In contrast, general optimism about treatment, divorced from a specific treatment, is not strongly associated with outcome. These results may have important implications for clinical trial design and recruitment, and may help to explain the apparent success of some conventional and alternative therapies in trials that do not control for patient expectations. The findings also may be important for therapy choices made in the clinical setting.

Study design A randomized trial of 100 patients with low back pain who were potential surgical candidates. Objectives To determine whether an interactive videodisc with a booklet is superior to a booklet alone for informing patients about back surgery. Summary of background data Substantial geographic variation has been observed in lumbar spine surgery. Informed patient preferences should play an important role in decisions about surgery. However, little is known about optimal strategies for informing patients. Methods Subjects were randomized to receive an interactive videodisc (with a booklet) or a booklet alone. A knowledge test administered at baseline and follow-up was used to measure improvement in knowledge about treatment options for lumbar spine problems. Patients' reactions to the videodisc and booklet and preferences for treatment were also assessed. Results The patients' knowledge improved after exposure to either intervention. Multivariate analyses adjusted for baseline score, age, education, gender, and diagnosis showed a significant advantage for the videodisc with booklet over the booklet alone. The videodisc-booklet group showed significantly greater gains in knowledge among subjects with the worst baseline knowledge scores. A larger proportion of subjects in the videodisc-booklet group rated the materials easy to understand (93% vs.- 72%,P = 0.04), containing the right amount of information (93% vs.- 80%,P = 0.3), and adequate to assist in choice of treatment (75% vs.- 51%,P = 0.2). Those who viewed the videodisc expressed a somewhat lower preference for surgery than those who received the booklet alone (23% vs.- 42%,P = 0.4). Conclusions Both the booklet alone and the combination of videodisc and booklet improved knowledge. The combination produced greater knowledge gains than the booklet alone for the subgroup with the least knowledge at baseline. Patients preferred the combination and had a slightly lower preference for surgery if they had viewed the video presentation. For some patients, the video may enhance involvement in clinical decisions.

Back pain is a significant health care problem that has been managed unsatisfactorily in primary care settings. Providers typically address medical issues but do not adequately address patient concerns or functional limitations related to back pain. We evaluated a brief intervention for primary care back pain patients designed to provide accurate information about back pain, instill attitudes favorable towards self care, reduce fears and worries, assist patients in developing personalized action plans to manage their back pain, and improve functional outcomes. Patients enrolled in a large health maintenance organization were invited to participate in an educational program to improve back pain self care skills 6-8 weeks after a primary care back pain visit. Patients (n=226) were randomly assigned to a Self Care intervention or to Usual Care, and were assessed at baseline, 3-, 6-, and 12-months. The intervention involved a two-session Self Care group and an individual meeting and telephone conversation with the group leader, a psychologist experienced in chronic pain management. The intervention was supplemented by educational materials (book and videos) supporting active management of back pain. The control group received usual care supplemented by a book on back pain care. Participants assigned to the Self Care intervention showed significantly greater reductions in back-related worry and fear-avoidance beliefs than the control group. Modest, but statistically significant, effects on pain ratings and interference with activities were also observed.

Back surgery rates are rapidly rising in the United States. This surgery is usually elective, so patient preferences are important in the treatment decision.The objective of this study was to determine the impact on outcomes and surgical choices of an interactive, diagnosis-specific videodisk program for informing patients about treatment choices.This was a randomized, controlled trial at 2 sites comparing the interactive video plus a booklet with the booklet alone.Elective surgery candidates (n = 393) included 171 patients with herniated disks, 110 with spinal stenosis, and 112 with other diagnoses.Mailed questionnaires were used to assess outcomes and satisfaction; surgery rates were determined by questionnaires and automated records.Symptom and functional outcomes at 3 months and 1 year were similar between study groups. The overall surgery rate was 22% lower in the videodisk group (26% versus 33%, P = 0.08). Among patients with herniated disks, those in the video group underwent significantly less surgery (32% versus 47%, P = 0.05 by Kaplan-Meier test). Among patients with spinal stenosis, surgery rates in the video group were higher (39% for the video group, 29% for the booklet group; P = 0.4). There was little effect on patient satisfaction, but patients in the video group felt better informed.The program appears to facilitate decision making and may help to ensure informed consent. For patients with herniated disks, it reduced the surgery rate without diminishing patient outcomes. Its impact on costs of care depends on the proportion of patients with various diagnoses and on local surgery rates.

Study design Randomized, controlled trial. Objective To evaluate a four-session self-management group intervention for patients with pain in primary care, led by trained lay persons with back pain. The intervention was designed to reduce patient worries, encourage self-care, and reduce activity limitations. Background data Randomized trials of educational interventions suggest that activating interventions may improve back pain outcomes. Expert opinion increasingly regards effective self-management of back pain as important in achieving good outcomes. In this study, an educational intervention designed to activate patients and support effective self-management was evaluated. Methods Six to 8 weeks after a primary care visit for back pain, patients were invited to participate in an educational program to improve back pain self-management. Those showing interest by returning a brief questionnaire became eligible for the study. Participants (n = 255) randomly were assigned to either a self-management group intervention or to a usual care control group. The effect of the intervention, relative to usual care, was assessed 3, 6, and 12 months after randomization, controlling for baseline values. The intervention consisted of a four-session group applying problem-solving techniques to back pain self-management, supplemented by educational materials (book and videos) supporting active management of back pain. The groups were led by lay persons trained to implement a fully structured group protocol. The control group received usual care, supplemented by a book on back pain care. Results Participants randomly assigned to the self-management groups reported significantly less worry about back pain and expressed more confidence in self-care. Roland Disability Questionnaire Scores were significantly lower among participants in the self-management groups relative to the usual care controls at 6 months (P = 0.007), and this difference was sustained at 12 months at borderline significance levels (P = 0.09). Among self-management group participants, 48% showed a 50% or greater reduction in Roland Disability Questionnaire Score at 6 months, compared with 33% among the usual care controls. Conclusions Self-management groups led by trained lay persons following a structured protocol were more effective than usual care in reducing worries, producing positive attitudes toward self-care, and reducing activity limitations among patients with back pain in primary care.

There are few data on the relative effectiveness and costs of treatments for low back pain. We randomly assigned 321 adults with low back pain that persisted for seven days after a primary care visit to the McKenzie method of physical therapy, chiropractic manipulation, or a minimal intervention (provision of an educational booklet). Patients with sciatica were excluded. Physical therapy or chiropractic manipulation was provided for one month (the number of visits was determined by the practitioner but was limited to a maximum of nine); patients were followed for a total of two years. The bothersomeness of symptoms was measured on an 11-point scale, and the level of dysfunction was measured on the 24-point Roland Disability Scale.After adjustment for base-line differences, the chiropractic group had less severe symptoms than the booklet group at four weeks (P=0.02), and there was a trend toward less severe symptoms in the physical therapy group (P=0.06). However, these differences were small and not significant after transformations of the data to adjust for their non-normal distribution. Differences in the extent of dysfunction among the groups were small and approached significance only at one year, with greater dysfunction in the booklet group than in the other two groups (P=0.05). For all outcomes, there were no significant differences between the physical-therapy and chiropractic groups and no significant differences among the groups in the numbers of days of reduced activity or missed work or in recurrences of back pain. About 75 percent of the subjects in the therapy groups rated their care as very good or excellent, as compared with about 30 percent of the subjects in the booklet group (P0.001). Over a two-year period, the mean costs of care were $437 for the physical-therapy group, $429 for the chiropractic group, and $153 for the booklet group.For patients with low back pain, the McKenzie method of physical therapy and chiropractic manipulation had similar effects and costs, and patients receiving these treatments had only marginally better outcomes than those receiving the minimal intervention of an educational booklet. Whether the limited benefits of these treatments are worth the additional costs is open to question.

The past few years have witnessed an explosion of primary care-relevant research on low back pain. The descriptive studies have helped elucidate the diagnostic and therapeutic interventions that are in current use. The literature syntheses have clarified what is known about the usefulness of these interventions. The randomized trials have pushed the frontiers of knowledge in several important areas. The quality of research in this field is mixed but has improved significantly in recent years. If research is to lead to substantial improvements in primary care for low back pain, however, the focus must be broadened to embrace an existing but neglected paradigm, the biopsychosocial model. It must be understood how the physician can become a more effective healer and counselor for the patient with back pain. This will require that greater attention be paid to literature outside of the field and that communication and collaboration with researchers in other disciplines increase. Modern distractions such as technology, litigation, and disability compensation have interfered with the ability of physicians to meet their patients' needs. If physicians are to become more effective managers of such common problems as low back pain, they must rediscover their ability to help their patients cope with illness and suffering.

This study identifies the key motivations of patients repeatedly seeking medical care for chronic back problems.We conducted one-on-one, in-depth interviews with patients to discuss their experiences with low back pain and its care. To validate our interpretation of the qualitative data, participants were mailed questionnaires listing the themes identified in the interviews and asked to rate the importance to them of each of the themes.Managed health care plans in Atlanta, Dallas, and Seattle.Fifty-four patients (37% male, 63% female) who were 25 to 65 years of age and had three or more medically attended episodes of low back pain during the 3 years preceding the study.In describing their motivations for seeking medical care for back pain, nearly all participants cited difficulty in performing normal activities and the desire to discover the cause of the pain. Other motivations for seeking medical care for back pain included increased pain and the desire for a diagnostic test or a new treatment. Many of the verbalized reasons for repeated medical visits among patients with chronic back pain are probably best understood as seeking validation of their suffering.Patients with chronic back pain report many unmet needs and expectations. Overall satisfaction might be improved if clinicians elicit patients' views of underlying causes and their expectations from office visits.

The use of chiropractors has increased substantially in recent years, and there is growing scientific evidence on the effectiveness of chiropractic treatment for common low back ailments. Despite the increased acceptance of chiropractic care, little is known about the prevalence of chiropractic coverage in employer health plans and the nature of such benefits when they are provided. This article reports on the extent and composition of chiropractic insurance among workers with employer-sponsored health insurance in 1993. The prevalence of the benefits in employer plans was examined, as was the extent to which plans are in compliance with state mandated benefits in this area. The authors also examined what the actual benefits consist of and how they compare with those for physician office visits and physical therapy.

Background: There is a need for more Comparative Effectiveness Research (CER) on Chinese medicine (CM) to inform clinical and policy decision-making. This document aims to provide consensus advice for the design of CER trials on CM for researchers. It broadly aims to ensure more adequate design and optimal use of resources in generating evidence for CM to inform stakeholder decision-making. Methods: The Effectiveness Guidance Document (EGD) development was based on multiple consensus procedures (survey, written Delphi rounds, interactive consensus workshop, international expert review). To balance aspects of internal and external validity, multiple stakeholders, including patients, clinicians, researchers and payers were involved in creating this document. Results: Recommendations were developed for “using available data” and “future clinical studies”. The recommendations for future trials focus on randomized trials and cover the following areas: designing CER studies, treatments, expertise and setting, outcomes, study design and statistical analyses, economic evaluation, and publication. Conclusion: The present EGD provides the first systematic methodological guidance for future CER trials on CM and can be applied to single or multi-component treatments. While CONSORT statements provide guidelines for reporting studies, EGDs provide recommendations for the design of future studies and can contribute to a more strategic use of limited research resources, as well as greater consistency in trial design.

Although yoga is an effective treatment for chronic low back pain, little is known about the mechanisms responsible for its benefits. In a trial comparing yoga to intensive stretching and self-care, we explored whether physical (hours of back exercise/week), cognitive (fear avoidance, body awareness, and self-efficacy), affective (psychological distress, perceived stress, positive states of mind, and sleep), and physiological factors (cortisol, DHEA) mediated the effects of yoga or stretching on back-related dysfunction (Roland-Morris Disability Scale (RDQ)). For yoga, 36% of the effect on 12-week RDQ was mediated by increased self-efficacy, 18% by sleep disturbance, 9% by hours of back exercise, and 61% by the best combination of all possible mediators (6 mediators). For stretching, 23% of the effect was mediated by increased self-efficacy, 14% by days of back exercise, and 50% by the best combination of all possible mediators (7 mediators). In open-ended questions, ≥20% of participants noted the following treatment benefits: learning new exercises (both groups), relaxation, increased awareness, and the benefits of breathing (yoga), benefits of regular practice (stretching). Although both self-efficacy and hours of back exercise were the strongest mediators for each intervention, compared to self-care, qualitative data suggest that they may exert their benefits through partially distinct mechanisms.

In October 1995, an International Forum for Primary Care Research on Low Back Pain was held in Seattle, Washington. The Forum focused on the broad range of decisions that patients and their primary care providers make concerning how to best manage low back pain. In addition to providing a venue for summarizing the current state of knowledge about these issues, a major goal of the Forum was to draft an agenda for future primary care research on low back pain. Previous efforts to delineate priority areas for research in this field have emphasized the concerns of basic scientists, pain specialists, and surgeons while ignoring the major concerns of patients and providers in the primary care setting, where the majority of patients with back pain are seen. This article describes the group consensus process used to draft an agenda, presents the items included, and contrasts this primary care agenda with agendas for back pain research developed primarily by specialists. This agenda identifies for the first time the clinical and methodologic issues that primary care experts on back pain consider to be of highest priority. Hopefully, it will help focus future primary care research and encourage funding agencies to give priority to the issues identified.

Study Design. Low back pain patients seen in primary care were allocated randomly to one of two educational interventions or to usual care. Objective. To evaluate educational interventions designed to improve the outcomes of primary care for low back pain. Summary of Background Data. Patients with back pain are frequently dissatisfied with their medical care and identify lack of information as the most insufficient aspect. Methods. In a large Health Maintenance Organization clinic, 293 subjects were allocated randomly to receive usual care, an educational booklet, or a 15-minute session with a clinic nurse, including the booklet and a follow-up telephone call. Outcome measures included satisfaction with care, perceived knowledge, participation in exercise, functional status, symptom relief, and health care use. Outcomes were assessed 1, 3, 7, and 52 weeks after the intervention. Results. The nurse intervention resulted in higher patient satisfaction than usual care (P < 0.001) and higher perceived knowledge (P < 0.001). Self-reported exercise participation was also higher in the nurse intervention group after a 1-week follow-up period (97% vs. 65% in the other groups ; P< 0.0001). There were no significant differences among the three groups in worry, symptoms, functional status, or health care use at any follow-up interval. Differences in self-reported exercise and perceived knowledge were no longer significant after 7 weeks. Conclusions. These findings challenge the value of purely educational approaches in reducing functional impact or health care use related to back pain and also challenge the value of fitness exercise in the most acute phase of back pain.

To determine ways in which emergency physicians approach the diagnosis and treatment of the common presenting complaint of low back pain, responses of emergency physicians to a questionnaire dealing with three hypothetical patients with different types of low back pain were taken from a stratified national random sample of eight medical specialties. For severe acute (with and without sciatica) or chronic low back pain, physicians were asked which tests and consultants they would use in pursuit of the diagnosis, and which treatments and specialty referrals they would recommend in each of the three scenarios. For diagnosis in the acute cases (pain less than 1 week), up to 22% of emergency physicians recommended computed tomography (CT scan) and 36% recommended magnetic resonance imaging (MRI). Specialist consultation would be sought for 61% of the acute sciatica patients, 32% of the acute nonsciatica patients, and 47% of the chronic patients. In approaching treatment, over 75% of emergency physicians would advise bedrest for an average of 3.5 to 4.5 days. Between 16% and 40% suggested physical therapy for the acute patients. Referrals to surgical specialists (orthopedist or neurosurgeon) were highest (81%) for acute sciatica, compared with 52% for chonic low back pain, and 41% for acute nonsciatic low back pain. In conclusion, given that most cases of acute low back pain resolve with minimal intervention, diagnostic imaging, laboratory testing, and early specialist consultation favored by many emergency physicians would add little except expense to understanding its etiology. For treatment, emergency physician recommendations for bedrest were longer than necessary and, for physical therapy, of no proven benefit. The tendency to refer acute cases to orthopedists and neurosurgeons could set the stage for unnecessary operative intervention. Simpler, less costly, and more reassuring approaches to emergency department patients with low back pain should be considered.