Bedford VA Edith Nourse Rogers Memorial VA Hospital
Bedford, Massachusetts, 01730, United States
NCT Number: NCT02224183
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Bedford, Massachusetts, 01730, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: Baseline, 6 weeks, 12 weeks, 24 weeks
Measured using the Defense and Veterans Pain Rating Scale (DVPRS) which rates pain on a 0-10 scale
Time frame: Baseline, 6 weeks, 12 weeks, 24 weeks
Back-related function will be measured using the 23-point modified Roland Morris Disability Questionnaire (RMDQ).
Time frame: Baseline, 6 weeks, 12 weeks, 24 weeks
Pain medication use in the previous 7 days will be measured
Time frame: Baseline, 6 weeks, 12 weeks, 24 weeks
Measured using the VR-12
Time frame: 6 weeks, 12 weeks, 24 weeks
Time frame: Baseline, 6 weeks, 12 weeks, 24 weeks
Measured using a single question that asks patients' overall satisfaction with their treatment
Time frame: Baseline, 6 weeks, 12 weeks, 24 weeks
Measured using PTSD Checklist - Civilian version (PCL-C)
Time frame: Baseline, 12 weeks, 24 weeks
Measured using the Neurobehavioral Symptom Inventory (NSI)
Time frame: Baseline, 12 weeks, 24 weeks
Measured using the Pittsburgh Sleep Quality Index (PSQI)
Time frame: Baseline, 12 weeks, 24 weeks
Measured using 9-item Patient Health Questionnaire (PHQ-9)
Time frame: Baseline, 12 weeks, 24 weeks
Measured using the 7-item General Anxiety Disorder (GAD-7) questionnaire
Time frame: Baseline, 12 weeks, 24 weeks
Measured using the Coping Strategies Questionnaire (CSQ)
Time frame: Baseline, 12 weeks, 24 weeks
Measured using the Patient Self-Efficacy Questionnaire (PSEQ)
Time frame: Baseline, 12 weeks, 24 weeks
Measured using the Dyadic Adjustment Scale (DAS)
Time frame: Baseline, 12 weeks, 24 weeks
Measured using the Work Productivity and Activity Impairment questionnaire
Time frame: 6 weeks, 12 weeks, 24 weeks
Medical record review and self-reported utilization data (medications, doctor visits, etc) will inform the cost effectiveness analysis of the interventions
Boston Medical Center
Other
Veterans Back to Health: A Study Comparing Yoga and Education for Veterans With Chronic Low Back Pain
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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