A Multimodal Evaluation of the Comparative Efficacy of Yoga Versus a Patient Centered Support Group for Treating Chronic Pain in Gulf War Illness
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 75
- Locations
- 2
- Primary Endpoint
- Pain (Brief Pain Inventory - Short Form) - Pain Severity
Study Overview
Brief Summary
The purpose of this study is to determine whether yoga is effective for the treatment of chronic pain in Gulf War Illness.
Detailed Description
Background:
Many military personnel who participated in the Gulf War in 1990-1991 reported negative health consequences subsequent to their deployment. The most prevalent of these health consequences involves a triad of symptoms that include fatigue, pain and cognitive disturbances, commonly referred to as "Gulf War Illness" (GWI). No clear, unifying patho-physiological disease process or effective treatment has yet been identified for GWI. Results from a diverse spectrum of research studies support the view that veterans with GWI are medically ill, but the physiological abnormalities that contribute to their illness are not currently well understood nor sufficiently treated by conventional medicine. While the cause of GWI remains unknown, a potential link between GWI and autonomic nervous system (ANS) dysregulation has been suggested.
Yoga has been suggested to exert its therapeutic effects through adjusting imbalances in the ANS. In addition, yoga has been shown to be clinically effective in treating many of the physical symptoms typically found in GWI, including chronic pain and fatigue. As chronic pain is perhaps the most prevalent and debilitating symptom of GWI, we propose to target pain. Significantly for this application, no improvements in pain have yet been reported in any clinical trial involving GWI. Furthermore, no published studies have investigated yoga as an intervention in GWI.
Objectives:
The primary objective is to investigate yoga for the treatment of chronic pain in veterans with GWI. A secondary objective is to provide veterans with skills in yoga breathing, postures, and meditation that can be used to promote health and well-being.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 42 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Served in the military in 1990-1991, regardless of deployment.
- •History of chronic pain.
- •Able to attend weekly visits at the study center for 10 weeks.
- •If on a psychotropic medication, the regimen will be stable for at least 4 weeks, prior to entry in the study.
Exclusion Criteria
- •Participation in another clinical trial.
- •Unable to visit the study center.
- •Unable to stand or walk.
Outcomes
Primary Outcomes
Pain (Brief Pain Inventory - Short Form) - Pain Severity
Time Frame: Week 10 minus Week 0
Model - estimated change in the Pain Severity subscale of the Brief Pain Inventory - Short Form from baseline to end of treatment. The subscale's minimum score is 0; maximum is 10; more negative change scores indicate greater improvement from baseline to end of treatment
Pain (Brief Pain Inventory - Short Form) - Pain Interference
Time Frame: Week 10 minus Week 0
Model - estimated change in the Pain Interference subscale of the Brief Pain Inventory - Short Form from baseline to end of treatment. The subscale's minimum score is 0; maximum is 10; more negative change scores indicate greater improvement from baseline to end of treatment.
Secondary Outcomes
- Change in Number of Participants Who Used Analgesic Medication(Week 0, Week 10)
- Fatigue (6-Minute Walk Test)(Week 0, Week 10)
- Change in Number of Participants Who Used Nonsteroidal Anti-inflammatory Drugs(Week 0, Week 10)
- Change in Number of Participants Who Used Opiate Medication(Week 0, Week 10)
Investigators
Peter Bayley
Associate Director of Cognitive Neuroscience
Palo Alto Veterans Institute for Research