Karen J. Sherman

Acupuncture for chronic pain: individual patient data meta-analysis

BACKGROUND Although acupuncture is widely used for chronic pain, there remains considerable controversy as to its value. We aimed to determine the effect size of acupuncture for 4 chronic pain conditions: back and neck pain, osteoarthritis, chronic headache, and shoulder pain. METHODS We conducted a systematic review to identify randomized controlled trials (RCTs) of acupuncture for chronic pain in which allocation concealment was determined unambiguously to be adequate. Individual patient data meta-analyses were conducted using data from 29 of 31 eligible RCTs, with a total of 17 922 patients analyzed. RESULTS In the primary analysis, including all eligible RCTs, acupuncture was superior to both sham and no-acupuncture control for each pain condition (P < .001 for all comparisons). After exclusion of an outlying set of RCTs that strongly favored acupuncture, the effect sizes were similar across pain conditions. Patients receiving acupuncture had less pain, with scores that were 0.23 (95% CI, 0.13-0.33), 0.16 (95% CI, 0.07-0.25), and 0.15 (95% CI, 0.07-0.24) SDs lower than sham controls for back and neck pain, osteoarthritis, and chronic headache, respectively; the effect sizes in comparison to no-acupuncture controls were 0.55 (95% CI, 0.51-0.58), 0.57 (95% CI, 0.50-0.64), and 0.42 (95% CI, 0.37-0.46) SDs. These results were robust to a variety of sensitivity analyses, including those related to publication bias. CONCLUSIONS Acupuncture is effective for the treatment of chronic pain and is therefore a reasonable referral option. Significant differences between true and sham acupuncture indicate that acupuncture is more than a placebo. However, these differences are relatively modest, suggesting that factors in addition to the specific effects of needling are important contributors to the therapeutic effects of acupuncture.

A Review of the Evidence for the Effectiveness, Safety, and Cost of Acupuncture, Massage Therapy, and Spinal Manipulation for Back Pain

Back pain and its sequelae place an enormous burden on society, health care systems, and the economies of developed countries (1). More than 50% of Americans experience back pain each year; most have pain for more than 1 week (2). In the United States,

Lessons from a trial of acupuncture and massage for low back pain: Patient expectations and treatment effects

25 billion is spent annually on medical care services for back problems and another

A Randomized Trial Comparing Acupuncture, Simulated Acupuncture, and Usual Care for Chronic Low Back Pain

50 billion is spent on lost productivity and disability payments (3). Despite the high prevalence of back pain and the numerous conventional medical treatments used for this problem, few treatments are supported by strong scientific evidence (4, 5). The limited effectiveness of conventional treatments has contributed to a high level of patient dissatisfaction with medical care for back pain (6). Thus, it is not surprising that back and neck problems are the main reasons why complementary and alternative medical (CAM) therapies are used and CAM providers are consulted (7, 8). Spinal manipulation, performed mostly by chiropractors in the United States (9), is the most popular CAM therapy for back pain in this country (7). Chiropractic has been licensed in all 50 states since 1974 (10) and is covered by most insurance plans (11). Massage therapy has become increasingly popular over the past decade and is currently licensed, or otherwise regulated, in 30 states (12). In 1997, 11% of Americans used massage, making 114 million visits to massage therapists (7). Although less common than chiropractic and massage, acupuncture, which is licensed in 39 states, is the third most frequently used CAM therapy for back pain in the United States. A recent study found that back pain is the most common reason for visiting chiropractors (40% of visits), massage therapists (20% of visits), and acupuncturists (about 14% of visits) (8). Few studies have evaluated the many other CAM therapies used for back pain; these include mindbody therapies (such as yoga, meditation, and tai chi), physical treatments (such as magnets, spa therapy, the Feldenkrais method, the Alexander technique, and Pilates-based exercises), botanicals (such as willow bark and Devils claw), and supplements (such as glucosamine sulfate and chondroitin sulfate). Over the past quarter century, numerous randomized, controlled trials (RCTs) have evaluated CAM therapies for back pain; in the past decade, reviews and meta-analyses of these trials have proliferated. The poor quality, inconsistent conclusions, and biases of many studies and reviews have led to confusion. We attempt to provide clinicians, patients, and health plans with a clear and balanced understanding of the current evidence about the effectiveness, safety, and cost of the CAM therapies most often used by Americans to treat low back pain: acupuncture, massage therapy, and spinal manipulation. Methods Data Sources We identified systematic reviews of RCTs that evaluated acupuncture, massage therapy, and spinal manipulation for nonspecific back pain published since 1995. In addition, we identified original articles that described results of RCTs published since the reviews were conducted. In accordance with the Cochrane Collaboration Back Review Groups guidelines for systematic reviews for spinal disorders (13), both the reviews and the subsequent original articles were identified by using a computerized search of MEDLINE (from 1966 to April 2002), EMBASE (from 1988 to 1 September 2001), and the Cochrane Controlled Trials Register (through September 2001). We used the specific therapies (acupuncture, massage, or manipulation) and back pain, low back pain, and backache as search terms. We also retrieved reference lists from recent original publications to identify additional trials. We searched MEDLINE for articles on the safety of acupuncture, massage, and lumbar manipulation. Because observational data on the relative costs of CAM and conventional care are subject to substantial bias as a result of the noncomparability of patients seeking care from CAM and conventional providers (14, 15), we extracted cost data only from the few effectiveness RCTs that measured cost. Two authors independently extracted descriptive data characterizing the reviews and original articles. Discrepancies were resolved after we jointly reviewed the original documents. Role of the Funding Sources The funding sources had no role in the design, conduct, or reporting of the study or in the decision to submit the manuscript for publication. Results Acupuncture Effectiveness In 1997, a nonadvocate, multidisciplinary panel was convened by the National Institutes of Health to evaluate the effectiveness of acupuncture. The panel concluded that, although basic research has begun to elucidate the mechanisms of action of acupuncture and promising results have emerged from clinical studies of acupuncture for emesis and postoperative dental pain, the value of acupuncture for other conditions (including back pain) was inconclusive and worthy of further study (16). Since this report, one meta-analysis (17) and two best-evidence syntheses (19, 20) have evaluated acupuncture for back pain (Table 1). A total of 14 RCTs were identified in these reviews; 11 were included in all 3. Most trials focused on nonspecific chronic back pain. The trials had serious limitations, including small sample sizes, inadequate acupuncture treatment, and high dropout rates. Table 1. Recent Systematic Reviews of Randomized, Controlled Trials Evaluating the Effectiveness of Acupuncture, Massage, or Spinal Manipulation for Back Pain Ernst and White [17], who considered 9 trials suitable for a meta-analysis, concluded that 1) acupuncture was superior to various control interventions and 2) evidence was insufficient to determine whether acupuncture was superior to placebo. Ernst and White asserted that their conclusions were based largely on rigorous research; however, the other reviews (19, 20), which used different quality rating scales, rated the studies less favorably and believed that meta-analysis would be inappropriate because the trials were heterogeneous in terms of design, type and duration of back pain, acupuncture treatment protocols, and outcome measures. Furthermore, van Tulder and colleagues (19) noted that most of the studies did not meet the current standards for conducting and reporting of RCTs. They concluded that the review did not clearly indicate that acupuncture is effective in the management of back pain and that high-quality RCTs were needed. Smith and colleagues (20) also concluded that more high-quality primary trials would be needed before clinically meaningful conclusions could be reached. Since the publication of these 3 reviews, we identified 6 additional published RCTs (Table 2) (27-32). In the largest trial, 262 patients with low back pain that had persisted for at least 6 weeks after a physician visit were randomly assigned to receive individualized Traditional Chinese Medical acupuncture, therapeutic massage, or self-care educational materials (30). Most patients had pain persisting for more than 1 year. Both treatment protocols proscribed use of herbs and oriental massage. After an average of 8 treatments over a 10-week period, acupuncture was found to be less effective than massage but equal to self-care educational materials in decreasing pain and improving function. Because there was no untreated comparison group, this study could not determine whether acupuncture was ineffective or merely less effective than massage. Table 2. Recent Randomized, Controlled Trials Evaluating Acupuncture, Massage, or Spinal Manipulation for Back Pain Published Too Late To Be Included in Systematic Reviews Summarized in Table 1 An Australian study randomly assigned 130 patients with chronic spinal pain (82% had low back pain) to receive acupuncture, chiropractic spinal manipulation, or nonsteroidal anti-inflammatory medication (27). Among the 77 patients who completed the study, neither back dysfunction nor pain significantly improved by the end of the 4-week treatment period in the acupuncture group. A Scottish study randomly assigned 60 elderly patients with chronic back pain to receive 4 weeks (2 sessions/week) of treatment with transcutaneous electrical nerve stimulation (TENS) or acupuncture (28). Acupuncture and TENS had similar effects on the severity of pain and use of analgesic medication. The acupuncture group, but not the TENS group, had a small but statistically significant short-term improvement in spinal flexion. Because a Cochrane Review has concluded that there is no evidence for the efficacy of TENS, it remains unclear whether either treatment was more effective than placebo (35). A Swedish study randomly assigned 50 patients with chronic lumbar pain to 8 weekly treatments of acupuncture or a placebo control in which a disconnected TENS unit was used (29). At the 1-month and 6-month follow-up evaluations, patients receiving acupuncture were significantly more likely to improve than were those receiving placebo. A Norwegian study randomly assigned 60 patients with acute low back pain to receive standardized acupuncture treatment for 2 weeks or enterosoluble naproxen at 500 mg twice daily for 10 days (31). Patients receiving acupuncture used substantially less analgesic medication after the first week of treatment and had fewer recurrences of low back pain after 6 and 18 months. However, pain relief between the groups did not differ. Finally, a German study randomly assigned 131 consecutive outpatients of an orthopedic department who had chronic low back pain to receive 12 weeks of active physical therapy alone (the control treatment) or in conjunction with real acupuncture or sham acupuncture (32). Real acupuncture was found to be superior to the control treatment but not to sham acupuncture in reducing pain intensity and disability. Safety Although tens of millions of acupuncture needles are used annually in the United States (36), only about 50 cases of complications resulting from acupuncture have be

A randomized clinical trial of acupuncture compared with sham acupuncture in fibromyalgia

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.

Paradoxes in Acupuncture Research: Strategies for Moving Forward

BACKGROUND 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. METHODS 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. RESULTS 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). CONCLUSIONS 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 acupunctures 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.

A Randomized Trial Comparing Yoga, Stretching, and a Self-care Book for Chronic Low Back Pain

Context A substantial number of patients use acupuncture to treat the symptoms of fibromyalgia, but previous randomized trials of this intervention are inconclusive, in part because of control groups that did not permit adequate blinding of the patients. Contribution This study randomly assigned 100 patients with fibromyalgia to 12 weeks of either true acupuncture treatment or one of 3 types of sham acupuncture. No differences in pain were identified between acupuncture and sham acupuncture. Cautions The study had too few patients to detect small differences between the groups. Patients could use other fibromyalgia therapies, so this study evaluates acupuncture as adjunctive treatment. The Editors Fibromyalgia is a condition of unknown cause that is characterized by chronic, diffuse pain and tenderness to palpation at specific musculoskeletal sites (1). It is the second most common rheumatologic condition after osteoarthritis, afflicting 2% to 4% of the U.S. population (2). Most randomized, controlled trials of allopathic interventions have not demonstrated sustained benefit, and use of complementary and alternative medicine for fibromyalgia is common (3). For example, 60% to 90% of patients with fibromyalgia report using 1 or more complementary or alternative treatments (4, 5), and 22% of these patients have tried acupuncture (6). Despite skepticism in western cultures, the literature suggests that acupuncture may alleviate chronic pain (7). Randomized, controlled trials of acupuncture face many methodologic challenges, including the identification of appropriate treatment and control groups, blinding of study participants, and the inability to blind practitioners (8). Needle placement and the extent to which needle insertion and stimulation is necessary are also controversial (7-9). In the only rigorous randomized, controlled trial of acupuncture for fibromyalgia, 7 of 8 outcome measures significantly improved after 3 weeks of treatment with electroacupuncture (10). However, because blinding was not assessed and electroacupuncture involves perceptible current, these promising results could reflect a lack of blinding to treatment condition. Moreover, the study followed patients only during treatment. Because fibromyalgia is a chronic condition, longer-term outcomes should be examined. To address these methodologic problems, we performed a randomized, controlled trial of acupuncture to treat fibromyalgia that included 3 sham acupuncture treatments to account for the effects of needle insertion and placement. The adequacy of participant blinding was carefully evaluated. We sought to determine whether directed acupuncture that is designed to treat fibromyalgia relieves pain better than does sham acupuncture in adults with fibromyalgia. On the basis of the scant literature and our clinical experience, we hypothesized a priori that directed acupuncture would result in the greatest clinical improvement. Methods Participants Participants were recruited from the greater Seattle, Washington, metropolitan area between January 2001 and September 2002. Recruitment strategies included dissemination of information on the study through newspapers, television, advertisements, signs posted at university-affiliated hospitals, and letters to local fibromyalgia support groups and health care providers with large caseloads of patients with fibromyalgia. Potential participants were told that they had an equal chance of being assigned to 1 of 4 acupuncture interventions, none of which have been proven but 1 of which was believed to have the most potential to improve the symptoms of fibromyalgia. The institutional review boards at the participating institutions approved the study, and participants provided written informed consent. Eligible participants were English-speaking adults 18 years of age or older in whom fibromyalgia was diagnosed by a physician and who had a prerandomization global pain score of 4 or greater on a visual analogue scale (0 = no pain, 10 = worst pain ever). Participants agreed to undergo randomization and kept use of any fibromyalgia-related pharmacologic and nonpharmacologic therapies constant throughout the study. At the baseline evaluation before randomization, a research coordinator trained in tender-point examination confirmed the diagnosis of fibromyalgia by using the 1990 criteria of the American College of Rheumatology (1). Participants were excluded if they reported other pain-related medical conditions or potential contraindications to acupuncture treatment (such as bleeding disorders or severe needle phobia), were pregnant or breastfeeding, used narcotics (which could blunt the effects of acupuncture), were involved in litigation related to fibromyalgia (which might reduce their incentive for improvement), or had previously received acupuncture (to maximize blinding). Randomization Procedure A research coordinator screened and enrolled participants at an academic research center. After participants completed a baseline evaluation, another research coordinator who was uninvolved with data collection randomly assigned them to 1 of 4 treatment groups by using a computer-generated, blocked random-allocation sequence with a block size of 4. This research coordinator informed the acupuncture clinic of the treatment assignment. Intervention Eight U.S.-trained and licensed acupuncturists with a median of 10 years of experience (range, 4 to 18 years) provided study treatments in their private offices. One investigator trained the acupuncturists in the study procedures to increase their comfort with delivering all 4 treatments and monitored compliance with the protocol throughout the study. Participants were assigned an acupuncturist according to geographic convenience and schedule availability, and every effort was made to have them treated by the same acupuncturist for the entire 12 weeks. The primary acupuncturist was defined as the practitioner from whom a participant received the most treatments. In all groups, participants were asked to attend treatment sessions twice weekly for 12 weeks (24 treatments). We considered participants who attended 80% or more (19 of 24) of acupuncture appointments to have completed a full course of treatment. Outcome measures were collected at regularly scheduled time points from participants who discontinued treatment. Participants received directed acupuncture designed to treat fibromyalgia according to the practice of Traditional Chinese Medicine or 1 of 3 sham acupuncture treatments. One sham intervention, a control for acupoint specificity, involved acupuncture typically used to treat irregular menses or early menses due to Blood Heat (an unrelated condition) according to Traditional Chinese Medicine. Another sham intervention, which was also a control for acupoint specificity, used body locations not recognized as true acupoints or meridians for needling (sham needling). The third sham treatment, a control for needle insertion, consisted of noninsertive simulated acupuncture at the same acupoints used in directed acupuncture (simulated acupuncture). This technique, in which a toothpick in a needle guide-tube is used to mimic needle insertion and withdrawal, has been shown to be indistinguishable from true acupuncture in acupuncture-nave patients with back pain (9). Simulated acupuncture more closely duplicates the needle insertion experience than do techniques using placebo needles that require placing adhesive or plastic foam on the skin (11, 12). Acupoints and sham points (Appendix Figure) were chosen by a study acupuncturist with 15 years of experience in treating fibromyalgia and were approved by 3 other senior acupuncturists. In all groups that underwent needle insertion, needles were retained at standard depths (13) for 30 minutes at each acupoint. Disposable Chinese, Japanese, or Korean needles (34 to 40 gauge) were used, depending on the practitioners preference. In the simulated acupuncture group, participants remained on the table for 30 minutes after simulated insertion and then underwent simulated needle withdrawal. Efforts were made to imitate the sounds of opening needle packs and needle disposal. Acupuncturists were not blinded to the treatments they delivered. To maximize participant blinding, we included only acupuncture-nave persons who could not compare their treatment with previous experiences with acupuncture, limited contact among study participants, restricted conversation between acupuncturists and participants, and blindfolded participants during treatment. All research personnel who collected or analyzed data were unaware of treatment group. At the end of 12 weeks, we collected data to assess the adequacy of blinding. Outcome Measures Demographic measures collected at the baseline evaluation included age, sex, race, education, marital status, and duration of pain and diagnosis of fibromyalgia. Participants also listed the types of therapies they had previously tried for their pain. We grouped this information into manual therapies (physical, ergonometric, chiropractic, or massage therapy), mental health therapies (psychotherapy or cognitive behavioral therapy), dietary changes, or other therapies (nerve blocks, hypnosis, or biofeedback). Outcome measures were collected at baseline; after 1, 4, 8, and 12 weeks of acupuncture treatment; and 3 and 6 months after completion of treatment (weeks 24 and 36). The primary outcome was subjective pain, as measured by a standard 10-cm visual analogue scale (0 = no pain, 10 = worst pain ever). Other outcomes measured by using a visual analogue scale were intensity of fatigue (0 = none, 10 = worst ever), sleep quality (0 = worst ever, 10 = best ever), and overall well-being (0 = worst ever, 10 = best ever). We assessed physical and mental functioning by using the Medical Outcomes Study 36-item Short-Form Health Survey (14), which has high reliability and validity in many patient groups, including those

Effect of Mindfulness-Based Stress Reduction vs Cognitive Behavioral Therapy or Usual Care on Back Pain and Functional Limitations in Adults With Chronic Low Back Pain: A Randomized Clinical Trial

In November 2007, the Society for Acupuncture Research (SAR) held an international symposium to mark the 10th anniversary of the 1997 NIH Consensus Development Conference on Acupuncture. The symposium presentations revealed the considerable maturation of the field of acupuncture research, yet two provocative paradoxes emerged. First, a number of well-designed clinical trials have reported that true acupuncture is superior to usual care, but does not significantly outperform sham acupuncture, findings apparently at odds with traditional theories regarding acupuncture point specificity. Second, although many studies using animal and human experimental models have reported physiological effects that vary as a function of needling parameters (e.g., mode of stimulation) the extent to which these parameters influence therapeutic outcomes in clinical trials is unclear. This White Paper, collaboratively written by the SAR Board of Directors, identifies gaps in knowledge underlying the paradoxes and proposes strategies for their resolution through translational research. We recommend that acupuncture treatments should be studied (1) “top down” as multi-component “whole-system” interventions and (2) “bottom up” as mechanistic studies that focus on understanding how individual treatment components interact and translate into clinical and physiological outcomes. Such a strategy, incorporating considerations of efficacy, effectiveness and qualitative measures, will strengthen the evidence base for such complex interventions as acupuncture.

Effects of yoga on mental and physical health: a short summary of reviews.

BACKGROUND Chronic low back pain is a common problem lacking highly effective treatment options. Small trials suggest that yoga may have benefits for this condition. This trial was designed to determine whether yoga is more effective than conventional stretching exercises or a self-care book for primary care patients with chronic low back pain. METHODS A total of 228 adults with chronic low back pain were randomized to 12 weekly classes of yoga (92 patients) or conventional stretching exercises (91 patients) or a self-care book (45 patients). Back-related functional status (modified Roland Disability Questionnaire, a 23-point scale) and bothersomeness of pain (an 11-point numerical scale) at 12 weeks were the primary outcomes. Outcomes were assessed at baseline, 6, 12, and 26 weeks by interviewers unaware of treatment group. RESULTS After adjustment for baseline values, 12-week outcomes for the yoga group were superior to those for the self-care group (mean difference for function, -2.5 [95% CI, -3.7 to -1.3]; P < .001; mean difference for symptoms, -1.1 [95% CI, -1.7 to -0.4]; P < .001). At 26 weeks, function for the yoga group remained superior (mean difference, -1.8 [95% CI, -3.1 to -0.5]; P < .001). Yoga was not superior to conventional stretching exercises at any time point. CONCLUSION Yoga classes were more effective than a self-care book, but not more effective than stretching classes, in improving function and reducing symptoms due to chronic low back pain, with benefits lasting at least several months. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT00447668.

Unanticipated Benefits of CAM Therapies for Back Pain: An Exploration of Patient Experiences

IMPORTANCE Mindfulness-based stress reduction (MBSR) has not been rigorously evaluated for young and middle-aged adults with chronic low back pain. OBJECTIVE To evaluate the effectiveness for chronic low back pain of MBSR vs cognitive behavioral therapy (CBT) or usual care. DESIGN, SETTING, AND PARTICIPANTS Randomized, interviewer-blind, clinical trial in an integrated health care system in Washington State of 342 adults aged 20 to 70 years with chronic low back pain enrolled between September 2012 and April 2014 and randomly assigned to receive MBSR (n = 116), CBT (n = 113), or usual care (n = 113). INTERVENTIONS CBT (training to change pain-related thoughts and behaviors) and MBSR (training in mindfulness meditation and yoga) were delivered in 8 weekly 2-hour groups. Usual care included whatever care participants received. MAIN OUTCOMES AND MEASURES Coprimary outcomes were the percentages of participants with clinically meaningful (≥30%) improvement from baseline in functional limitations (modified Roland Disability Questionnaire [RDQ]; range, 0-23) and in self-reported back pain bothersomeness (scale, 0-10) at 26 weeks. Outcomes were also assessed at 4, 8, and 52 weeks. RESULTS There were 342 randomized participants, the mean (SD) [range] age was 49.3 (12.3) [20-70] years, 224 (65.7%) were women, mean duration of back pain was 7.3 years (range, 3 months-50 years), 123 (53.7%) attended 6 or more of the 8 sessions, 294 (86.0%) completed the study at 26 weeks, and 290 (84.8%) completed the study at 52 weeks. In intent-to-treat analyses at 26 weeks, the percentage of participants with clinically meaningful improvement on the RDQ was higher for those who received MBSR (60.5%) and CBT (57.7%) than for usual care (44.1%) (overall P = .04; relative risk [RR] for MBSR vs usual care, 1.37 [95% CI, 1.06-1.77]; RR for MBSR vs CBT, 0.95 [95% CI, 0.77-1.18]; and RR for CBT vs usual care, 1.31 [95% CI, 1.01-1.69]). The percentage of participants with clinically meaningful improvement in pain bothersomeness at 26 weeks was 43.6% in the MBSR group and 44.9% in the CBT group, vs 26.6% in the usual care group (overall P = .01; RR for MBSR vs usual care, 1.64 [95% CI, 1.15-2.34]; RR for MBSR vs CBT, 1.03 [95% CI, 0.78-1.36]; and RR for CBT vs usual care, 1.69 [95% CI, 1.18-2.41]). Findings for MBSR persisted with little change at 52 weeks for both primary outcomes. CONCLUSIONS AND RELEVANCE Among adults with chronic low back pain, treatment with MBSR or CBT, compared with usual care, resulted in greater improvement in back pain and functional limitations at 26 weeks, with no significant differences in outcomes between MBSR and CBT. These findings suggest that MBSR may be an effective treatment option for patients with chronic low back pain. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT01467843.