Yoga vs. Education for Veterans With Chronic Low Back Pain

Study Overview
=================
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.

Official Title
-----------------
Veterans Back to Health: A Study Comparing Yoga and Education for Veterans With Chronic Low Back Pain

Conditions
-----------------
Recurrent Low Back Pain

Intervention / Treatment
-----------------
* Behavioral: Education
* Behavioral: Yoga


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Education<br>Individuals randomized to the education group will receive The Back Pain Helpbook, an educational book with strategies for self-care including an exercise program, lifestyle modification, and tips for managing flare-ups. In addition, they will receive an assignment sheet outlining specific chapters to read over the course of the 12-weeks. In addition, participants receive at 3, 6, 9, and 12 weeks newsletters highlighting main points from the assigned chapters. | Behavioral: Education<br>* Individuals randomized to the education group will receive The Back Pain Helpbook, an educational book with strategies for self-care including an exercise program, lifestyle modification, and tips for managing flare-ups. In addition, they will receive an assignment sheet outlining specific chapters to read over the course of the 12-weeks. In addition, participants receive at 3, 6, 9, and 12 weeks newsletters highlighting main points from the assigned chapters.<br>|
| Active Comparator: Yoga<br>Weekly yoga classes will each be taught by two yoga instructors. Classes will be 75 minutes long. Mats and props will be provided. Yoga participants will be encouraged to practice for 30 minutes on days when they do not have class. They will be provided free of charge with a participant handbook, mat, block, and strap to aid home practice. Yoga home practice videos will be placed online for home practice and the website will track time spent using the videos for home practice. DVDs will be provided for those that do not have consistent access to the internet at home. | Behavioral: Yoga<br>* Weekly yoga classes will each be taught by two yoga instructors. Classes will be 75 minutes long. Mats and props will be provided. Yoga participants will be encouraged to practice for 30 minutes on days when they do not have class. They will be provided free of charge with a participant handbook, mat, block, and strap to aid home practice. Yoga home practice videos will be placed online for home practice and the website will track time spent using the videos for home practice. DVDs will be provided for those that do not have consistent access to the internet at home.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in low back pain | Measured using the Defense and Veterans Pain Rating Scale (DVPRS) which rates pain on a 0-10 scale | Baseline, 6 weeks, 12 weeks, 24 weeks | 
| Change from baseline in back-related function | Back-related function will be measured using the 23-point modified Roland Morris Disability Questionnaire (RMDQ). | Baseline, 6 weeks, 12 weeks, 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in pain medication use | Pain medication use in the previous 7 days will be measured | Baseline, 6 weeks, 12 weeks, 24 weeks | 
| Change from baseline in health-related quality of life | Measured using the VR-12 | Baseline, 6 weeks, 12 weeks, 24 weeks | 
| Self-rated global improvement |  | 6 weeks, 12 weeks, 24 weeks | 
| Patient satisfaction | Measured using a single question that asks patients' overall satisfaction with their treatment | Baseline, 6 weeks, 12 weeks, 24 weeks | 
| Change in post-traumatic stress symptoms | Measured using PTSD Checklist - Civilian version (PCL-C) | Baseline, 6 weeks, 12 weeks, 24 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
low back pain, yoga, education, Veterans, cost-effectiveness, military, back pain