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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.

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

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...

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.

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.

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.

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.

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.

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.

Physicians were surveyed regarding their beliefs about treatment efficacy for patients with low back pain.To document physician beliefs about the efficacy of specific treatments and the extent to which these beliefs correspond to current knowledge.Little is known about physician beliefs regarding the efficacy of specific back pain treatments.A national random sample of 2897 physicians were mailed questionnaires that asked about 1) the treatments they would order for hypothetical patients with low back pain and 2) the treatments they believed were effective for back pain. Responses were compared with guidelines suggested by the Quebec Task Force on Spinal Disorders.Almost 1200 physicians responded. More than 80% of these physicians believed physical therapy is effective, but this consensus was lacking for other treatments. Fewer than half of the physicians believed that spinal manipulation is effective for acute or chronic back pain or that epidural steroid injections, traction, and corsets are effective for acute back pain. Bed rest and narcotic analgesics were recommended by substantial minorities of physicians for patients with chronic pain. The Quebec Task Force found little scientific support for the effectiveness of most of the treatments found to be in common use.The lack of consensus among physicians could be attributable to the absence of clear evidence-based clinical guidelines, ignorance or rejection of existing scientific evidence, excessive commitment to a particular mode of therapy, or a tendency to discount the efficacy of competing treatments.

Health care costs associated with use of complementary and alternative medicine (CAM) by patients with spine problems have not been studied in a national sample.To estimate the total and spine-specific medical expenditures among CAM and non-CAM users with spine problems.Analysis of the 2002-2008 Medical Expenditure Panel Survey.Adults (above 17 y) with self-reported neck and back problems who did or did not use CAM services.Survey-weighted generalized linear regression and propensity matching to examine expenditure differences between CAM users and non-CAM users while controlling for patient, socioeconomic, and health characteristics.A total of 12,036 respondents with spine problems were included, including 4306 (35.8%) CAM users (40.8% in weighted sample). CAM users had significantly better self-reported health, education, and comorbidity compared with non-CAM users. Adjusted annual medical costs among CAM users was $424 lower (95% confidence interval: $240, $609; P0.001) for spine-related costs, and $796 lower (95% confidence interval: $121, $1470; P = 0.021) for total health care cost than among non-CAM users. Average expenditure for CAM users, based on propensity matching, was $526 lower for spine-specific costs (P0.001) and $298 lower for total health costs (P = 0.403). Expenditure differences were primarily due to lower inpatient expenditures among CAM users.CAM users did not add to the overall medical spending in a nationally representative sample with neck and back problems. As the causal associations remain unclear in these cross-sectional data, future research exploring these cost differences might benefit from research designs that minimize confounding.

Background Despite the growing popularity of massage, its effectiveness for treating neck pain remains unclear, largely because of the poor quality of research. A major deficiency of previous studies has been their use of low “doses” of massage that massage therapists consider inadequate. Unfortunately, the number of minutes per massage session, sessions per week, or weeks of treatment necessary for massage to have beneficial or optimal effects are not known. This study is designed to address these gaps in our knowledge by determining, for persons with chronic neck pain: 1) the optimal combination of number of treatments per week and length of individual treatment session, and 2) the optimal number of weeks of treatment. Methods/design In this study, 228 persons with chronic non-specific neck pain will be recruited from primary health care clinics in a large health care system in the Seattle area. Participants will be randomized to a wait list control group or 4 weeks of treatment with one of 5 different dosing combinations (2 or 3 30-min treatments per week or 1, 2, or 3 60-min treatments per week). At the end of this 4-week primary treatment period, participants initially receiving each of the 5 dosing combinations will be randomized to a secondary treatment period of either no additional treatment or 6 weekly 60-min massages. The primary outcomes, neck-related dysfunction and pain, will be assessed by blinded telephone interviewers 5, 12, and 26 weeks post-randomization. To better characterize the trajectory of treatment effects, these interview data will be supplemented with outcomes data collected by internet questionnaire at 10, 16, 20 and 39 weeks. Comparisons of outcomes for the 6 groups during the primary treatment period will identify the optimal weekly dose, while comparisons of outcomes during the secondary treatment period will determine if 10 weeks of treatment is superior to 4 weeks. Discussion A broad dosing schedule was included in this trial. If adherence to any of these doses is poor, those doses will be discontinued. Trial registration This trial is registered in ClinicalTrials.gov, with the ID number of NCT01122836

There is growing recognition in the treatment of back pain that patient perspectives are essential in judging the results of treatment. Improving the patient's "quality of life" is often the main goal of therapy. Thus, although clinical research in the past has focused on physiologic outcomes, such as range of motion, muscle strength, or neurologic deficits, increasing attention is being given to the rigorous measurement of symptoms, functional status, role function, satisfaction with treatment, and health care costs. In many cases, these so-called "soft" outcomes can be measured with a level of reproducibility similar to more conventional clinical data such as imaging test results. Because symptoms and functional outcomes are sometimes only loosely associated with physiologic phenomena, the former outcomes should be measured directly. Modern questionnaires for measuring patient quality of life combine the expertise of social scientists and clinicians and have demonstrated validity. Furthermore, they have some important advantages over simple ratings of "excellent, good, fair, and poor" outcomes, or work status alone. Several modern instruments for measuring health-related quality of life in patients with low back pain are reviewed briefly, describing their content and length. Wider use of these instruments would help to increase clinician familiarity with their meaning and avoid duplication of effort in questionnaire development.

STUDY DESIGN This study describes recent United States trends and regional variations in the management of low back pain. OBJECTIVES The authors investigated recent temporal trends and compared practices in different geographic regions. SUMMARY OF BACKGROUND DATA Controversy exists concerning the appropriate medical and surgical management of patients with low back pain. METHODS National Hospital Discharge Survey data from 1979 through 1990 were analyzed. Case selection was based on previously developed algorithms intended to exclude nonmechanical causes of back pain. RESULTS Over the period of study, nonsurgical hospitalizations for low back pain decreased dramatically. In contrast, low back operation rates, particularly for fusion surgery, increased substantially. In recent years, surgery and hospitalization rates were highest in the South and lowest in the West. CONCLUSIONS Rapidly increasing surgical rates and wide geographic variations suggest the need for a more consistent approach to back problems.

Objective. This study examined patterns of diagnostic test use for patients with low back pain. Three specific questions were addressed: 1) What tests do physicians recommend for patients with 3 common types of low back pain? 2) Do physicians in various specialties differ in the tests they would order? and 3) How appropriate are physicians' choices of tests, based on current medical knowledge and expert recommendations? Methods. A stratified national random sample of 2,604 physicians in 8 specialties was mailed questionnaires asking about the tests they would order for hypothetical patients with acute back pain, sciatica, or chronic low back pain. Physicians were also asked which procedures they generally used to evaluate suspected lumbar nerve root compression. These responses were compared with guidelines that have been suggested by the Quebec Task Force on Spinal Disorders, based on comprehensive evaluation of the scientific literature. Results. Approximately 1,100 physicians responded to the survey (43% response rate). Magnetic resonance imaging was the most frequently used procedure for evaluating suspected lumbar nerve root compression, although a majority of neurosurgeons would still use myelography. Neurosurgeons and neurologists were twice as likely as other specialists to order an imaging study for patients with acute nonradiating pain or chronic back pain. Physiatrists and neurologists were more than 3 times as likely as other specialists to order electromyograms for acute back pain with sciatica or chronic back pain. Rheumatologists were almost twice as likely as other specialists to order laboratory tests for both acute and chronic back pain. The reported use of imaging and electrodiagnostic tests was generally premature and more extensive than that recommended by the Quebec Task Force. Conclusion. There is little consensus, either within or among specialties, on the use of diagnostic tests for patients with back pain. Thus, the diagnostic evaluation depends heavily on the individual physician and his or her specialty, and not just the patient's symptoms and findings. Furthermore, many physicians may be ordering imaging studies too early and for patients who do not have the appropriate clinical indications. These results suggest a need for additional clinical guidelines as well as better adherence to existing guidelines.

Few studies have evaluated the effectiveness of massage for chronic low back pain.To compare the effectiveness of 2 types of massage and usual care for chronic back pain.Parallel-group randomized, controlled trial. Randomization was computer-generated, with centralized allocation concealment. Participants were blinded to massage type but not to assignment to massage versus usual care. Massage therapists were unblinded. The study personnel who assessed outcomes were blinded to treatment assignment. (ClinicalTrials.gov registration number: NCT00371384)An integrated health care delivery system in the Seattle area.401 persons 20 to 65 years of age with nonspecific chronic low back pain.Structural massage (n = 132), relaxation massage (n = 136), or usual care (n = 133).Roland Disability Questionnaire (RDQ) and symptom bothersomeness scores at 10 weeks (primary outcome) and at 26 and 52 weeks (secondary outcomes). Mean group differences of at least 2 points on the RDQ and at least 1.5 points on the symptom bothersomeness scale were considered clinically meaningful.The massage groups had similar functional outcomes at 10 weeks. The adjusted mean RDQ score was 2.9 points (95% CI, 1.8 to 4.0 points) lower in the relaxation group and 2.5 points (CI, 1.4 to 3.5 points) lower in the structural massage group than in the usual care group, and adjusted mean symptom bothersomeness scores were 1.7 points (CI, 1.2 to 2.2 points) lower with relaxation massage and 1.4 points (CI, 0.8 to 1.9 points) lower with structural massage. The beneficial effects of relaxation massage on function (but not on symptom reduction) persisted at 52 weeks but were small.Participants were not blinded to treatment.Massage therapy may be effective for treatment of chronic back pain, with benefits lasting at least 6 months. No clinically meaningful difference between relaxation and structural massage was observed in terms of relieving disability or symptoms.National Center for Complementary and Alternative Medicine.

In 1988, the Diagnosis-Related Group for "Medical Back Problems" was the seventh leading reason for all U.S. hospitalizations. The authors sought to describe the content of these hospitalizations and consider the potential for shifting nonsurgical care to the outpatient setting. Three complementary data sources (the 1988 National Hospital Discharge Survey, a statewide Washington hospital discharge registry, and medical records) were used to examine the diagnoses, tests, treatments, resource use, and subsequent care associated with these hospitalizations. Nationally, nonspecific back pain and herniated discs were the most common diagnoses. Nearly half the hospitalizations were for diagnostic tests (especially myelography) and the other half for pain control. In Washington state, 43% of patients were admitted by family physicians or internists, and 40% by orthopedic or neurologic surgeons. Twenty percent of patients underwent subsequent back surgery within 1 year (most within 3 months), suggesting that many hospitalizations were "presurgical." Most of the tests and treatments identified are known to be safe in the outpatient setting. Focused medical record review indicated frequent psychosocial problems or complicating factors, including obesity, substance abuse, prior back surgery, psychologic diagnoses, or lack of a caregiver at home. The findings support other evidence that many hospitalizations for "medical back problems" are unnecessary, but also suggest a need for improved outpatient and home-based alternatives to hospitalization.

Outcomes of primary care back pain patients (N = 1128) were studied at 1 year after seeking care. Changes in depression depending on outcome, and predictors of poor outcome were evaluated. Less than one back pain patient in five reported recent onset (first onset within the previous 6 months). One year after seeking care, the large majority of both recent and nonrecent-onset patients reported having back pain in the previous month (69% vs. 82%). A significant minority of both recent and nonrecent-onset patients had either a poor functional outcome (14% vs. 21%) or continuing high intensity pain without appreciable disability (10% vs. 16%). Predictors of poor outcome included pain-related disability, days in pain, lower educational attainment, and female gender. Among initially dysfunctional patients with persistent pain, one half were improved and one third had a good outcome at the 1-year follow-up. Among initially dysfunctional patients who experienced a good outcome, elevated depressive symptoms improved to normal levels at follow-up. The outcome of back pain was predicted by pain-related disability and days in pain rather than by recency of onset, so it may be more meaningful to distinguish characteristic levels of pain intensity, pain-related disability, and pain persistence than to classify patients as acute or chronic.

Objectives: To describe the federal initiative in outcomes research, the organization and structor of a Patient Outcomes Research Team [PORT] concerned with low back pain, and the early progress of this research team. Findings: Back pain is a leading reason for physician visits, hospitalization, and work disability. However, there is a paucity of valid evidence to support most current methods of treating spine disorders. This PORT was funded to study geographic variation in the use of back surgery and to better characterize its outcomes; evaluate the reasons for nonsurgical hospitalization for back pain; examine the accuracy and optimal sequencing of expensive diagnostic tests; and disseminate information to clinicians and patients to improve the process of care. This effort requires a multidisciplinary team of clinicans and methodologist, and a network of government and professional organizations concerned about the problem of low back pain. The team has documented wide geographic variations in rates of ...

Belief that positive patient expectations could enhance treatment benefits has been widespread for many years and a major rationale for masking clinical trial participants to their assigned treatment.1–3 However, the most clear and compelling evidence that patients’ beliefs about treatment can enhance or attenuate the results of treatment comes from experimental studies of placebo analgesia wherein expectations are manipulated via visual and auditory cues.4,5 In fact, relatively few clinical studies have explicitly evaluated the influence of patient expectations on treatment outcomes, 6 although some have included measures of pre-treatment patient expectations or preferences for medical treatment to explore this relationship (e.g., Crow, 1999 7, Torgerson et al., 1996 8, Myers, et al., 2008 9, Greenberg 2006 10). Despite the paucity of evidence, some researchers assert that positive patient expectations for treatment efficacy are responsible for much of the success of some treatments, including many complementary and alternative medical (CAM) therapies.11–13 If true, this would suggest that patients’ expectations might help guide choice of effective therapy and that encouraging positive expectations of therapy might result in better outcomes. Three studies of patients with chronic back pain have examined whether patient beliefs about the helpfulness of acupuncture were predictive of treatment outcomes.14–16 These studies reported inconsistent results. As part of a large trial evaluating the efficacy of acupuncture for back pain among acupuncture naive persons, we collected information that allowed us to explore the relationship between patients’ pre-treatment preferences and expectations of improvement (in general and from acupuncture treatment) and actual treatment outcomes. Our pre-planned analyses hypothesized that greater improvement would be more likely among participants with: Higher baseline expectations that their back pain would improve. Higher baseline expectations of the helpfulness of acupuncture. A preference for acupuncture over other back pain treatments. Both a preference for acupuncture and high expectations regarding acupuncture. Methods Both the design 17 and main trial results 18 for this institutional review board-approved trial have been described elsewhere. The pertinent components of the trial design are briefly reviewed here. 638 participants 20 to 70 years of age with chronic non-specific low back pain were recruited from integrated health care systems in the Seattle and Oakland metropolitan areas. Participants were randomized to one of four treatment groups: individualized acupuncture, standardized acupuncture, simulated acupuncture (non-insertive stimulation of acupuncture points), and usual care. This report includes data only for the 477 participants randomized to one of the three treatment groups, who received 10 treatments over 7 weeks -- twice a week for 3 weeks followed by weekly treatments for 4 weeks. Participants were informed that the study was evaluating “different methods of stimulating acupuncture points”. In all three treatment groups, participants rated the skills and caring of the provider and their perceptions of the treatment almost identically. A Diagnostician acupuncturist, who was unaware of treatment assignment, saw each patient at the beginning of each visit and recommended an individualized treatment, which was only given to those randomized to that treatment group. The real or simulated acupuncture treatments were administered by a Therapist acupuncturist who interacted only minimally with the patient. Telephone interviewers masked to type of acupuncture interviewed participants at baseline and at 8, 26 and 52 weeks post-randomization. In addition, participants completed short questionnaires immediately after their first and fifth treatments. Outcome variable(s) Primary trial outcomes were the modified Roland Morris Disability Scale score (Roland score) and symptom bothersomeness score at 8 weeks. The modified Roland is a 23-item questionnaire that measures back-specific functional status.19 Participants were also asked to rate how bothersome their back pain was during the past week on a 0 to 10 scale where 0 indicated not at all bothersome and 10 extremely bothersome. This measure was highly correlated with pain intensity (r=0.8, p

Background Back pain, one of the most prevalent conditions afflicting American adults, is the leading reason for using complementary and alternative medicine (CAM) therapies. Yoga is an increasingly popular "mind-body" CAM therapy often used for relieving back pain and several small studies have found yoga effective for this condition. This study will assess whether yoga is effective for treating chronic low back pain compared with self care and exercise and will explore the mechanisms responsible for any observed benefits. Methods/Design A total of 210 participants with low back pain lasting at least 3 months will be recruited from primary care clinics of a large healthcare system based in Seattle. They will be randomized in a 2:2:1 ratio to receive 12 weekly yoga classes, 12 weekly conventional therapeutic exercise classes of comparable physical exertion, or a self-care book. Interviewers masked to participants' treatment group will assess outcomes at baseline and 6, 12 and 26 weeks after randomization. Primary outcomes will be back-related dysfunction and symptom bothersomeness. In addition, data will be collected on physical measurements (e.g., flexion) at baseline and 12 weeks and saliva samples will be obtained at baseline, 6 and 12 weeks. Information will be collected on specific physical, psychological, and physiological factors to allow exploration of possible mechanisms of action through which yoga could relieve back pain and dysfunction. The effectiveness of yoga will be assessed using analysis of covariance (using general estimating equations - GEE) within an intention-to-treat context. If yoga is found effective, further analyses will explore whether yoga's benefits are attributable to physical, psychological and/or physiological factors. Conclusions This study will provide the clearest evidence to date about the value of yoga as a therapeutic option for treating chronic back pain, and if the results are positive, will help focus future, more in-depth, research on the most promising potential mechanisms of action identified by this study. Trial registration This trial is registered in ClinicalTrials.gov, with the ID number of NCT00447668.

Background Meeting recruitment goals is challenging for many clinical trials conducted in primary care populations. Little is known about how the use of different recruitment strategies affects the types of individuals choosing to participate or the conclusions of the study. Methods A secondary analysis was performed using data from participants recruited to a clinical trial evaluating acupuncture for chronic back pain among primary care patients in a large integrated health care organization. We used two recruitment methods: mailed letters of invitation and an advertisement in the health plan's magazine. For these two recruitment methods, we compared recruitment success (% randomized, treatment completers, drop outs and losses to follow-up), participant characteristics, and primary clinical outcomes. A linear regression model was used to test for interaction between treatment group and recruitment method. Results Participants recruited via mailed letters closely resembled those responding to the advertisement in terms of demographic characteristics, most aspects of their back pain history and current episode and beliefs and expectations about acupuncture. No interaction between method of recruitment and treatment group was seen, suggesting that study outcomes were not affected by recruitment strategy. Conclusion In this trial, the two recruitment strategies yielded similar estimates of treatment effectiveness. However, because this finding may not apply to other recruitment strategies or trial circumstances, trials employing multiple recruitment strategies should evaluate the effect of recruitment strategy on outcome. Trial registration Clinical Trials.gov NCT00065585.

Background Although many clinicians believe there are clinically important subgroups of persons with "non-specific" low back pain, such subgroups have not yet been clearly identified. As part of a large trial evaluating acupuncture for chronic low back pain, we sought to identify subgroups of participants that were particularly responsive to acupuncture. Methods We performed a secondary analysis of data for the 638 participants in our clinical trial comparing different types of acupuncture to usual care to identify baseline characteristics that predicted responses to individualized, standardized, or simulated acupuncture treatments. After identifying factors that predicted improvements in back-related function or symptoms, we determined if these factors were more likely to predict improvement for those receiving the acupuncture treatments than for those receiving usual care. This was accomplished by testing for an interaction between the prognostic factors and treatment group in four models: functional outcomes (measured by the Roland-Morris Disability Scale) at 8 and 52 weeks post-randomization and symptom outcomes (measured with a numerical rating scale) at 8 and 52 weeks. Results Overall, the strongest predictors of improvement in back function and symptoms were higher baseline levels of these measures, receipt of an acupuncture treatment, and non-use of narcotic analgesics. Benefit from acupuncture compared to usual care was greater with worse pre-treatment levels of back dysfunction (interaction p < 0.004 for the functional outcome, Roland Morris Disability Scale at 8 weeks). No other consistent interactions were observed. Conclusion This secondary analysis found little evidence for the existence of subgroups of patients with chronic back pain that would be especially likely to benefit from acupuncture. However, persons with chronic low back pain who had more severe baseline dysfunction had the most short-term benefit from acupuncture.

Acupuncture is a popular complementary and alternative treatment for chronic back pain. Recent European trials suggest similar short-term benefits from real and sham acupuncture needling. This trial addresses the importance of needle placement and skin penetration in eliciting acupuncture effects for patients with chronic low back pain.A total of 638 adults with chronic mechanical low back pain were randomized to individualized acupuncture, standardized acupuncture, simulated acupuncture, or usual care. Ten treatments were provided over 7 weeks by experienced acupuncturists. The primary outcomes were back-related dysfunction (Roland-Morris Disability Questionnaire score; range, 0-23) and symptom bothersomeness (0-10 scale). Outcomes were assessed at baseline and after 8, 26, and 52 weeks.At 8 weeks, mean dysfunction scores for the individualized, standardized, and simulated acupuncture groups improved by 4.4, 4.5, and 4.4 points, respectively, compared with 2.1 points for those receiving usual care (P.001). Participants receiving real or simulated acupuncture were more likely than those receiving usual care to experience clinically meaningful improvements on the dysfunction scale (60% vs 39%; P.001). Symptoms improved by 1.6 to 1.9 points in the treatment groups compared with 0.7 points in the usual care group (P.001). After 1 year, participants in the treatment groups were more likely than those receiving usual care to experience clinically meaningful improvements in dysfunction (59% to 65% vs 50%, respectively; P = .02) but not in symptoms (P.05).Although acupuncture was found effective for chronic low back pain, tailoring needling sites to each patient and penetration of the skin appear to be unimportant in eliciting therapeutic benefits. These findings raise questions about acupuncture's purported mechanisms of action. It remains unclear whether acupuncture or our simulated method of acupuncture provide physiologically important stimulation or represent placebo or nonspecific effects.

Objectives Little is known about the effectiveness of therapeutic massage, one of the most popular complementary medical treatments for neck pain. A randomized controlled trial was conducted to evaluate whether therapeutic massage is more beneficial than a self-care book for patients with chronic neck pain. Methods Sixty-four such patients were randomized to receive up to 10 massages over 10 weeks or a self-care book. Follow-up telephone interviews after 4, 10, and 26 weeks assessed outcomes including dysfunction and symptoms. Log-binomial regression was used to assess whether there were differences in the percentages of participants with clinically meaningful improvements in dysfunction and symptoms (ie, >5-point improvement on the Neck Disability Index; >30% improvement from baseline on the symptom bothersomeness scale) at each time point. Results At 10 weeks, more participants randomized to massage experienced clinically significant improvement on the Neck Disability Index [39% vs. 14% of book group; relative risk (RR)=2.7; 95% confidence interval (CI), 0.99-7.5] and on the symptom bothersomeness scale (55% vs. 25% of book group; RR=2.2; 95% CI, 1.04-4.2). After 26 weeks, massage group members tended to be more likely to report improved function (RR=1.8; 95% CI, 0.97-3.5), but not symptom bothersomeness (RR=1.1; 95% CI, 0.6-2.0). Mean differences between groups were strongest at 4 weeks and not evident by 26 weeks. No serious adverse experiences were reported. Conclusions This study suggests that massage is safe and may have clinical benefits for treating chronic neck pain at least in the short term. A larger trial is warranted to confirm these results.

Study Design. Review of oral and poster presentations and of workshop summaries from the Ninth International Forum for Primary Care Research on Low Back Pain held in Majorca, Spain, October 4-6, 2007. Objective. Summarize highlights of the conference. Summary of Background Data. The International Forum for Primary Care Research on Low Back Pain has become the primary conference for presenting research on the advances in primary care for back pain. Methods. Distillation of the key themes and findings of the research presented at the Forum. Results. Presentations at the forum included intervention studies, psychosocial aspects of low back pain, and epidemiological, clinical, and pathologic studies. Conclusion. The research presented at the forum has contributed to the advancement of understanding of how to improve primary care for low back pain. The Tenth International Forum will occur on June 14-17, 2009, in Boston.