Clinical trial NCT02224183: Yoga vs. Education for Veterans With Chronic Low Back Pain
Official title: Veterans Back to Health: A Study Comparing Yoga and Education for Veterans With Chronic Low Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Recurrent Low Back Pain
Keywords: low back pain
yoga
education
Veterans
cost-effectiveness
military
back pain
Lead sponsor: Boston Medical Center
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2014-08-25
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Chronic low back pain (cLBP) is the most common pain condition in the military, causing substantial physical and psychological suffering, reduction in force readiness, and high economic cost. Yoga has been studied in 10 RCTs in civilian populations with cLBP suggesting it may be effective in reducing pain intensity, improving back-related function, and lowering pain medication use. Multiple differences exist between civilian and military populations with cLBP, making it necessary to adapt and test yoga for cLBP in military populations. This study's primary aim is to evaluate the effectiveness of yoga for reducing pain in military personnel and Veterans with cLBP through a structured, reproducible 12-week series of hatha yoga classes, supplemented with home practice, compared to an education group. Additionally, the enormous mental health burden often shouldered by returning military personnel presents another important distinguishing factor. Thus, the study's secondary aim is to assess yoga's capacity to reduce post-traumatic stress symptoms (PTSS). The third aim is to evaluate the cost-effectiveness of yoga for cLBP at 3 months and 6 months from the perspective of the provider, the Veteran, and the Veterans Health Administration. The fourth and final aim is to evaluate the effect of back pain and yoga on marital and family functioning. The proposed RCT will (1) establish a structured reproducible yoga protocol uniquely suited to Veterans populations with cLBP; (2) develop web-based delivery systems to assist Veterans in yoga home practice; (3) increase our knowledge of the feasibility and impact of yoga for Veterans' cLBP and psychological comorbidities. These results will help determine whether yoga is an effective modality for addressing cLBP in a Veteran population.


Eligibility criteria: Inclusion Criteria:

* Veteran of any branch of military service
* Current low-back pain present for at least half the days over the past 6 months mean pain intensity for the previous week ≥4 on 0-10 rating scale

Exclusion Criteria:

* Significant yoga practice in the previous 6 months
* Have read The Back Pain Helpbook in the previous 6 months
* New LBP treatments started within the previous month or anticipated to begin in the next 3 months
* Known pregnancy
* Known inflammatory or systemic causes of LBP
* Severe and/or progressive medical, neurological, or psychiatric comorbidities
* Inability to understand/speak English
* Plans to move out of the area in the next 6 months
* Lack of informed consent
* Unwillingness to be randomized

Primary outcomes:
measure: Change from baseline in low back pain
timeFrame: Baseline, 6 weeks, 12 weeks, 24 weeks
measure: Change from baseline in back-related function
timeFrame: Baseline, 6 weeks, 12 weeks, 24 weeks
Secondary outcomes:
measure: Change from baseline in pain medication use
timeFrame: Baseline, 6 weeks, 12 weeks, 24 weeks
measure: Change from baseline in health-related quality of life
timeFrame: Baseline, 6 weeks, 12 weeks, 24 weeks
measure: Self-rated global improvement
timeFrame: 6 weeks, 12 weeks, 24 weeks
measure: Patient satisfaction
timeFrame: Baseline, 6 weeks, 12 weeks, 24 weeks
measure: Change in post-traumatic stress symptoms
timeFrame: Baseline, 6 weeks, 12 weeks, 24 weeks
Other outcomes:
measure: Change from baseline in post-concussive symptoms
timeFrame: Baseline, 12 weeks, 24 weeks
measure: Change from baseline in sleep quality
timeFrame: Baseline, 12 weeks, 24 weeks
measure: Change from baseline in depressive symptoms
timeFrame: Baseline, 12 weeks, 24 weeks
measure: Change from baseline in anxiety symptoms (GAD-7)
timeFrame: Baseline, 12 weeks, 24 weeks
measure: Change from baseline in coping skills
timeFrame: Baseline, 12 weeks, 24 weeks
measure: Change from baseline in self-efficacy
timeFrame: Baseline, 12 weeks, 24 weeks
measure: Marital/family functioning
timeFrame: Baseline, 12 weeks, 24 weeks
measure: Change in work status
timeFrame: Baseline, 12 weeks, 24 weeks
measure: Cost-effectiveness
timeFrame: 6 weeks, 12 weeks, 24 weeks
Locations:
city: Bedford
country: United States
facility: Bedford VA Edith Nourse Rogers Memorial VA Hospital
state: Massachusetts
Study officials:
affiliation: Boston Medical Center
name: Robert B Saper, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Saper RB, Lemaster CM, Elwy AR, Paris R, Herman PM, Plumb DN, Sherman KJ, Groessl EJ, Lynch S, Wang S, Weinberg J. Yoga versus education for Veterans with chronic low back pain: study protocol for a randomized controlled trial. Trials. 2016 Apr 29;17(1):224. doi: 10.1186/s13063-016-1321-5.