Analyses were adjusted for age, sex, education, baseline pain duration (<1 y vs ≥1 y since experiencing a week without back pain), and baseline values of the outcome measures: the RDQ score (range 0 to 23, higher values indicate greater function limitations) and the pain bothersomeness score (range 0 to 10, higher scores indicate worse pain bothersomeness). Error bars indicate 95% CIs. Baseline data were adjusted to the same baseline score in all groups to simplify comparisons of the data over time.
eAppendix. Study Protocol
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Cherkin DC, Anderson ML, Sherman KJ, et al. Two-Year Follow-up of a Randomized Clinical Trial of Mindfulness-Based Stress Reduction vs Cognitive Behavioral Therapy or Usual Care for Chronic Low Back Pain. JAMA. 2017;317(6):642–644. doi:10.1001/jama.2016.17814
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The need for effective treatment options for chronic low back pain has spurred interest in “mind-body” approaches including cognitive behavioral therapy (CBT) and mindfulness-based stress reduction (MBSR). We previously reported that, compared with usual care, MBSR and CBT reduced functional limitations and pain bothersomeness for up to 1 year among adults with chronic low back pain.1,2 We now report 2-year outcomes.
We conducted an interviewer-blind, randomized clinical trial. All participants provided oral informed consent for trial participation and written informed consent for participation in MBSR or CBT. Adults aged 20 through 70 years with chronic low back pain (n = 342) were assigned randomly to MBSR (n = 116), CBT (n = 113), or usual care (n = 113). MBSR and CBT were delivered in 8 weekly 2-hour group sessions. Because treatment effects were observed at 26 weeks, we revised the study protocol (Supplement) and obtained approval from the Group Health institutional review board to add another assessment of functional limitations (the modified Roland Disability Questionnaire [RDQ]) and back pain bothersomeness at about 2 years from randomization. Group differences were estimated by a repeated measures regression model that included outcome measures at 4, 8, 26, and 52 weeks and a mean follow-up time of 2 years after randomization. Outcome measures were analyzed both as mean change and percentage of participants with clinically meaningful improvement (≥30%) from baseline. Models were fit using generalized estimating equations adjusting for age, sex, education, baseline pain duration, and baseline score on the outcome measure. Missing outcome data were imputed with a 2-step generalized estimating equations approach for nonignorable nonresponse.3 We used the statistical package R (R Foundation), version 3.0.2, and followed an intention-to-treat approach. All tests and CIs were 2-sided and statistical significance was defined as a P value of less than .05.
The mean interval between randomization and 2-year follow-up was 1.9 years (range, 1.4 to 2.8 years). At 2 years, 276 participants (81%) provided outcome data. Follow-up rates were 78% for MBSR, 75% for CBT, and 89% for usual care. Adjusted mean RDQ scores at 2 years in each group were similar to those at 1 year (Figure). The 3 groups differed significantly on mean change from baseline on the RDQ at 2 years (omnibus P = .04; Table). Participants randomized to CBT compared with usual care showed greater improvement in function (adjusted mean difference in change, −1.84 [95% CI, −3.32 to −0.37]). MBSR did not differ significantly from usual care or CBT at 2 years. The percentages of participants with 30% or more improvement from baseline on the RDQ remained higher in the MBSR and CBT groups than in usual care at 2 years (55.4%, 62.0%, and 42.0%, respectively), but the overall difference among groups was no longer statistically significant. There were no significant differences between MBSR and CBT on any measure examined. Treatment effects on pain bothersomeness were small and not statistically significant.
Although mean within-group improvements from baseline were largely maintained at 2 years (at least for functional limitations), the only statistically significant between-group differences were between CBT and usual care. This benefit was modest. Previous trials of CBT-based interventions for chronic low back pain also found effects persisting for at least 2 years.4,5 To our knowledge, this is the first trial to evaluate 2-year effects of MBSR for chronic low back pain; our results suggest some diminution of effects relative to usual care after 1 year. Study limitations included differential follow-up rates in the intervention and control groups, recruitment from a single state, fewer than 60% of MBSR and CBT participants attended at least 6 of the 8 sessions, and potential reduction of statistical power due to a lower response rate at 2 years (80.7%) vs 1 year (84.8%). Imputation was used to minimize the effect of potential loss of statistical power. Research is needed to determine whether strategies to increase adherence or “booster sessions” after the 8 weekly sessions result in greater short-term and long-term benefits.
Corresponding Author: Daniel C. Cherkin, PhD, Group Health Research Institute, 1730 Minor Ave, Suite 1600, Seattle, WA 98101 (email@example.com).
Author Contributions: Dr Cook had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.
Concept and design: Cherkin, Sherman, Balderson, Cook, Turner.
Acquisition, analysis, or interpretation of data: All authors.
Drafting of the manuscript: Cherkin, Sherman, Balderson, Hansen, Turner.
Critical revision of the manuscript for important intellectual content: Cherkin, Anderson, Sherman, Balderson, Cook, Turner.
Statistical analysis: Anderson, Cook.
Obtained funding: Cherkin.
Administrative, technical, or material support: Cherkin, Anderson, Sherman, Balderson, Hansen.
Supervision: Cherkin, Hansen.
Conflict of Interest Disclosures: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest and none were reported.
Funding/Support: Research reported in this publication was supported by grant R01AT006226 from the National Center for Complementary and Integrative Health (NCCIH) of the National Institutes of Health.
Role of the Funder/Sponsor: The study funder had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; or decision to submit the manuscript for publication.
Disclaimer: This content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.
Additional Contributions: We thank the following individuals from Group Health Research Institute who received salary support from the NCCIH grant: Kristin Delaney, MPH, for extracting information from data systems and preparing data for analyses; John Ewing, BFA, for conducting patient follow-up interviews; Natalia Charamand, BA, for administrative support.
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