Yoga for veterans with chronic low back pain: Design and methods of a randomized clinical trial.
Chronic low back pain (CLBP) afflicts millions of people worldwide, with particularly high prevalence in military veterans. Many treatment options exist for CLBP, but most have limited effectiveness and some have significant side effects. In general populations with CLBP, yoga has been shown to improve health outcomes with few side effects. However, yoga has not been adequately studied in military veteran populations. In the current paper we will describe the design and methods of a randomized clinical trial aimed at examining whether yoga can effectively reduce disability and pain in US military veterans with CLBP. A total of 144 US military veterans with CLBP will be randomized to either yoga or a delayed treatment comparison group. The yoga intervention will consist of 2× weekly yoga classes for 12weeks, complemented by regular home practice guided by a manual. The delayed treatment group will receive the same intervention after six months. The primary outcome is the change in back pain-related disability measured with the Roland-Morris Disability Questionnaire at baseline and 12-weeks. Secondary outcomes include pain intensity, pain interference, depression, anxiety, fatigue/energy, quality of life, self-efficacy, sleep quality, and medication usage. Additional process and/or mediational factors will be measured to examine dose response and effect mechanisms. Assessments will be conducted at baseline, 6-weeks, 12-weeks, and 6-months. All randomized participants will be included in intention-to-treat analyses. Study results will provide much needed evidence on the feasibility and effectiveness of yoga as a therapeutic modality for the treatment of CLBP in US military veterans.
VA San Diego Healthcare System, CA, USA; Department of Family Medicine and Public Health, University of California San Diego, CA, USA. Electronic address: egroessl@ucsd.edu.
Erik J
EJ
Groessl
VA San Diego Healthcare System, CA, USA; Department of Family Medicine and Public Health, University of California San Diego, CA, USA.
Laura
L
Schmalzl
VA San Diego Healthcare System, CA, USA; Department of Family Medicine and Public Health, University of California San Diego, CA, USA.
Meghan
M
Maiya
VA San Diego Healthcare System, CA, USA; Department of Family Medicine and Public Health, University of California San Diego, CA, USA.
Lin
L
Liu
VA San Diego Healthcare System, CA, USA; Department of Family Medicine and Public Health, University of California San Diego, CA, USA.
Debora
D
Goodman
VA San Diego Healthcare System, CA, USA; Department of Orthopaedic Surgery, University of California San Diego, CA, USA.
Douglas G
DG
Chang
VA San Diego Healthcare System, CA, USA; Department of Psychiatry, University of California San Diego, CA, USA.
Julie L
JL
Wetherell
VA San Diego Healthcare System, CA, USA; School of Nursing, University of San Diego, CA, USA.
Jill E
JE
Bormann
VA San Diego Healthcare System, CA, USA; Department of Psychiatry, University of California San Diego, CA, USA.
J Hamp
JH
Atkinson
VA San Diego Healthcare System, CA, USA; Department of Medicine, University of California San Diego, CA, USA.
Sunita
S
Baxi
D001007:Anxiety / Q000523:psychology; D059350:Chronic Pain / Q000523:psychology / Q000628:therapy*; D003863:Depression / Q000523:psychology; D005221:Fatigue; D018737:Hand Strength; D006801:Humans; D017116:Low Back Pain / Q000523:psychology / Q000628:therapy*; D053580:Muscle Strength; D010147:Pain Measurement; D016059:Range of Motion, Articular; D020377:Self Efficacy; D012720:Severity of Illness Index; D012890:Sleep; D014728:Veterans; D015013:Yoga
Complementary and integrative health; Randomized controlled trial; Veterans; Veterans affairs; Yoga