Robert B. Saper, MD, MPH; Chelsey Lemaster, MS, MPH; Anthony Delitto, PhD, PT; Karen J. Sherman, PhD, MPH; Patricia M. Herman, ND, PhD; Ekaterina Sadikova, MPH; Joel Stevans, PhD, DC; Julia E. Keosaian, MPH; Christian J. Cerrada, BS; Alexandra L. Femia, MS; Eric J. Roseen, DC; Paula Gardiner, MD, MPH; Katherine Gergen Barnett, MD; Carol Faulkner, BS; Janice Weinberg, ScD
Presented in part at the following events: International Congress on Complementary Medicine Research, Jeju, Republic of Korea, 14 May 2015; International Congress on Integrative Medicine and Health, Henderson, Nevada, 17 May 2016; International Back and Neck Pain Forum, Buxton, United Kingdom, 1 June 2016; Academy of Integrative Pain Management, San Antonio, Texas, 24 September 2016; and North American Spine Society, Boston, Massachusetts, 28 October 2016.
Note: Drs. Saper and Weinberg had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.
Disclaimer: The contents of this publication are solely the responsibility of the authors and do not necessarily represent the official views of the National Center for Complementary and Integrative Health.
Acknowledgment: The authors thank the study yoga instructors (Deidre Alessio, Julie Aronis, Sylvia Baedorf Kassis, Lisa Cahill, Karen Cullen, Danielle Ciofani, Monica Delgado Chafee, Victoria Garcia Drago, Amy Goh, Beth Kacel, Robert Montgomery), Boston Medical Center Department of Physical Therapy (Jenn Blake, Daniel Chapman, Alysse Ferranto, Karen Mattie, James Mergel), New England Physical Therapy Plus (Bill Sullivan, Anisha Patel, Megan Poletto, Steven Smith, David Cunningham), study site champions (Aram Kaligian, Stephen Tringale, Yen Loh, Nandini Sengupta, Barbara Lottero, Dan Simpson), the Data and Safety Monitoring Board (Deborah Cotton, Bei-Hung Chang, John Denninger, Maya Breuer), and the research staff at Boston Medical Center (Sarah Baird, Katelin Blackburn, Sheba Ebhote, Shayna Egan, Calvin Fong, Elvin Fontana-Martinez, Shirley Gillies, Margo Godersky, Sarah Marchese, Alison Marshall, Matthew Mcgrath, Marilly Palettas, Dorothy Plumb, Bryan Rodriguez, Michael Roxas, Kaori Sato, Alison Smith, Huong Tran, Kristen Trimble, Jon Wardle). They also thank the study participants and staff of Boston Medical Center, Codman Square Health Center, Dimock Center, DotHouse Health, Greater Roslindale Medical & Dental Center, South Boston Community Health Center, South End Community Health Center, and Upham's Corner Health Center.
Grant Support: By grant 5R01-AT005956 from the National Center for Complementary and Integrative Health of the National Institutes of Health.
Disclosures: Dr. Saper reports grants from the National Center for Complementary and Integrative Health of the National Institutes of Health during the conduct of the study. Dr. Sherman reports grants from National Institutes of Health during the conduct of the study. Dr. Herman reports grants from the National Center for Complementary and Integrative Health during the conduct of the study. Dr. Weinberg reports grants from the National Institutes of Health during the conduct of the study. Authors not named here have disclosed no conflicts of interest. Disclosures can also be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M16-2579.
Editors' Disclosures: Christine Laine, MD, MPH, Editor in Chief, reports that she has no financial relationships or interests to disclose. Darren B. Taichman, MD, PhD, Executive Deputy Editor, reports that he has no financial relationships or interests to disclose. Cynthia D. Mulrow, MD, MSc, Senior Deputy Editor, reports that she has no relationships or interests to disclose. Deborah Cotton, MD, MPH, Deputy Editor, reports that she has no financial relationships or interest to disclose. Jaya K. Rao, MD, MHS, Deputy Editor, reports that she has stock holdings/options in Eli Lilly and Pfizer. Sankey V. Williams, MD, Deputy Editor, reports that he has no financial relationships or interests to disclose. Catharine B. Stack, PhD, MS, Deputy Editor for Statistics, reports that she has stock holdings in Pfizer and Johnson & Johnson.
Reproducible Research Statement:Study protocol: See Supplement 1. Statistical code: Not available. Data set: Available to approved individuals through a written data-sharing agreement with Dr. Saper (e-mail, email@example.com).
Requests for Single Reprints: Robert B. Saper, MD, MPH, Department of Family Medicine, Boston Medical Center, 1 Boston Medical Center Place, Dowling 5 South, Boston, MA 02118; e-mail, firstname.lastname@example.org.
Current Author Addresses: Drs. Saper, Roseen, Gardiner, and Gergen Barnett; Ms. Lemaster; Ms. Femia; and Ms. Faulkner: Department of Family Medicine, Boston Medical Center, 1 Boston Medical Center Place, Dowling 5 South, Boston, MA 02118.
Drs. Delitto and Stevans: School of Health and Rehabilitation Sciences, University of Pittsburgh, 4029 Forbes Tower, Pittsburgh, PA 15260.
Dr. Sherman: Center for Health Studies, Group Health Cooperative, 1730 Minor Avenue, Suite 1600, Seattle, WA 98101.
Dr. Herman: RAND Corporation, 1776 Main Street, PO Box 2138, Santa Monica, CA 90407.
Ms. Sadikova: Department of Health Care Policy, Harvard Medical School, 180 Longwood Avenue, Boston, MA 02115.
Ms. Keosaian: Section of General Internal Medicine, Boston Medical Center, Crosstown Center, 801 Massachusetts Avenue, 2nd Floor, Boston, MA 02118.
Mr. Cerrada: Soto Street Building, SSB 1, 2001 North Soto Street, Los Angeles, CA 90032.
Dr. Weinberg: Department of Biostatistics, Boston University School of Public Health, Crosstown Center, 801 Massachusetts Avenue, 3nd Floor, Boston, MA 02118.
Author Contributions: Conception and design: R.B. Saper, A. Delitto, K.J. Sherman, P.M. Herman, J.E. Keosaian, P. Gardiner, C. Faulkner, J. Weinberg.
Analysis and interpretation of the data: R.B. Saper, C. Lemaster, A. Delitto, K.J. Sherman, P.M. Herman, E. Sadikova, A.L. Femia, E.J. Roseen, J. Weinberg.
Drafting of the article: R.B. Saper, C. Lemaster, A. Delitto, A.L. Femia, P. Gardiner, K. Gergen Barnett, J. Weinberg.
Critical revision of the article for important intellectual content: R.B. Saper, C. Lemaster, A. Delitto, K.J. Sherman, P.M. Herman, J. Stevans, J.E. Keosaian, E.J. Roseen, P. Gardiner, J. Weinberg.
Final approval of the article: R.B. Saper, C. Lemaster, A. Delitto, K.J. Sherman, P.M. Herman, E. Sadikova, J. Stevans, J.E. Keosaian, C.J. Cerrada, A.L. Femia, E.J. Roseen, P. Gardiner, K. Gergen Barnett, C. Faulkner, J. Weinberg.
Provision of study materials or patients: J. Stevans, J.E. Keosaian, K. Gergen Barnett.
Statistical expertise: E. Sadikova, J. Weinberg.
Obtaining of funding: R.B. Saper, A. Delitto, J.E. Keosaian.
Administrative, technical, or logistic support: C. Lemaster, J. Stevans, J.E. Keosaian, A.L. Femia, E.J. Roseen, P. Gardiner, K. Gergen Barnett.
Collection and assembly of data: C. Lemaster, C.J. Cerrada, E.J. Roseen.
Yoga is effective for mild to moderate chronic low back pain (cLBP), but its comparative effectiveness with physical therapy (PT) is unknown. Moreover, little is known about yoga's effectiveness in underserved patients with more severe functional disability and pain.
To determine whether yoga is noninferior to PT for cLBP.
12-week, single-blind, 3-group randomized noninferiority trial and subsequent 40-week maintenance phase. (ClinicalTrials.gov: NCT01343927)
Academic safety-net hospital and 7 affiliated community health centers.
320 predominantly low-income, racially diverse adults with nonspecific cLBP.
Participants received 12 weekly yoga classes, 15 PT visits, or an educational book and newsletters. The maintenance phase compared yoga drop-in classes versus home practice and PT booster sessions versus home practice.
Primary outcomes were back-related function, measured by the Roland Morris Disability Questionnaire (RMDQ), and pain, measured by an 11-point scale, at 12 weeks. Prespecified noninferiority margins were 1.5 (RMDQ) and 1.0 (pain). Secondary outcomes included pain medication use, global improvement, satisfaction with intervention, and health-related quality of life.
One-sided 95% lower confidence limits were 0.83 (RMDQ) and 0.97 (pain), demonstrating noninferiority of yoga to PT. However, yoga was not superior to education for either outcome. Yoga and PT were similar for most secondary outcomes. Yoga and PT participants were 21 and 22 percentage points less likely, respectively, than education participants to use pain medication at 12 weeks. Improvements in yoga and PT groups were maintained at 1 year with no differences between maintenance strategies. Frequency of adverse events, mostly mild self-limited joint and back pain, did not differ between the yoga and PT groups.
Participants were not blinded to treatment assignment. The PT group had disproportionate loss to follow-up.
A manualized yoga program for nonspecific cLBP was noninferior to PT for function and pain.
National Center for Complementary and Integrative Health of the National Institutes of Health.
Saper RB, Lemaster C, Delitto A, et al. Yoga, Physical Therapy, or Education for Chronic Low Back Pain: A Randomized Noninferiority Trial. Ann Intern Med. 2017;167:85–94. [Epub ahead of print 20 June 2017]. doi: 10.7326/M16-2579
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Published: Ann Intern Med. 2017;167(2):85-94.
Published at www.annals.org on 20 June 2017
Back Pain, Rheumatology.
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