title: Yoga versus education for Veterans with chronic low back pain: study protocol for a randomized controlled trial.
abstract: BACKGROUND
  Chronic low back pain is the most frequent pain condition in Veterans and causes substantial suffering, decreased functional capacity, and lower quality of life. Symptoms of post-traumatic stress, depression, and mild traumatic brain injury are highly prevalent in Veterans with back pain. Yoga for low back pain has been demonstrated to be effective for civilians in randomized controlled trials. However, it is unknown if results from previously published trials generalize to military populations.
  
  
  METHODS
  This study is a parallel randomized controlled trial comparing yoga to education for 120 Veterans with chronic low back pain. Participants are Veterans ≥18 years old with low back pain present on at least half the days in the past six months and a self-reported average pain intensity in the previous week of ≥4 on a 0-10 scale. The 24-week study has an initial 12-week intervention period, where participants are randomized equally into (1) a standardized weekly group yoga class with home practice or (2) education delivered with a self-care book. Primary outcome measures are change at 12 weeks in low back pain intensity measured by the Defense and Veterans Pain Rating Scale (0-10) and back-related function using the 23-point Roland Morris Disability Questionnaire. In the subsequent 12-week follow-up period, yoga participants are encouraged to continue home yoga practice and education participants continue following recommendations from the book. Qualitative interviews with Veterans in the yoga group and their partners explore the impact of chronic low back pain and yoga on family relationships. We also assess cost-effectiveness from three perspectives: the Veteran, the Veterans Health Administration, and society using electronic medical records, self-reported cost data, and study records.
  
  
  CONCLUSIONS
  This study will help determine if yoga can become an effective treatment for Veterans with chronic low back pain and psychological comorbidities.
  
  
  BACKGROUND
  ClinicalTrials.gov: NCT02224183.
authors.affiliation: Department of Family Medicine, Boston University School of Medicine and Boston Medical Center, Boston, MA, USA. robert.saper@bmc.org.
authors.forename: Robert B
authors.initials: RB
authors.lastname: Saper
authors.affiliation: Department of Family Medicine, Boston University School of Medicine and Boston Medical Center, Boston, MA, USA.
authors.forename: Chelsey M
authors.initials: CM
authors.lastname: Lemaster
authors.affiliation: Center for Information Dissemination and Education Resources, VA Boston Healthcare System, Boston, MA, USA.|Department of Health Policy and Management, Boston University School of Public Health, Boston, MA, USA.
authors.forename: A Rani
authors.initials: AR
authors.lastname: Elwy
authors.affiliation: Boston University School of Social Work, Boston, MA, USA.
authors.forename: Ruth
authors.initials: R
authors.lastname: Paris
authors.affiliation: RAND Corporation, Santa Monica, CA, USA.
authors.forename: Patricia M
authors.initials: PM
authors.lastname: Herman
authors.affiliation: Center for Healthcare Organization and Implementation Research, Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA, USA.
authors.forename: Dorothy N
authors.initials: DN
authors.lastname: Plumb
authors.affiliation: Group Health Research Institute, Seattle, WA, USA.|Department of Epidemiology, University of Washington, Seattle, WA, USA.
authors.forename: Karen J
authors.initials: KJ
authors.lastname: Sherman
authors.affiliation: VA San Diego Healthcare System, San Diego, CA, USA.|Department of Family and Preventive Medicine, University of California San Diego School of Medicine, San Diego, CA, USA.
authors.forename: Erik J
authors.initials: EJ
authors.lastname: Groessl
authors.affiliation: There & Back Again, Inc., Wakefield, MA, USA.
authors.forename: Susan
authors.initials: S
authors.lastname: Lynch
authors.affiliation: Center for Healthcare Organization and Implementation Research, Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA, USA.
authors.forename: Shihwe
authors.initials: S
authors.lastname: Wang
authors.affiliation: Department of Biostatistics, Boston University School of Public Health, Boston, MA, USA.
authors.forename: Janice
authors.initials: J
authors.lastname: Weinberg
mesh_terms: D001900:Boston; D059350:Chronic Pain / Q000175:diagnosis / Q000191:economics / Q000503:physiopathology / Q000628:therapy*; D002985:Clinical Protocols; D003362:Cost-Benefit Analysis; D004185:Disability Evaluation; D057286:Electronic Health Records; D017048:Health Care Costs; D005102:Health Expenditures; D007722:Health Knowledge, Attitudes, Practice; D006801:Humans; D017116:Low Back Pain / Q000175:diagnosis / Q000191:economics / Q000503:physiopathology / Q000628:therapy*; D010147:Pain Measurement; D010353:Patient Education as Topic / Q000191:economics; D020127:Recovery of Function; D012107:Research Design; D016037:Single-Blind Method; D013997:Time Factors; D016896:Treatment Outcome; D058014:Veterans Health; D015013:Yoga
keywords: Cost-effectiveness; Low back pain; Military families; Randomized controlled trial; Veterans; Yoga