Chronic Pain Clinical Trial
Official title:
A Multimodal Evaluation of the Comparative Efficacy of Yoga Versus a Patient Centered Support Group for Treating Chronic Pain in Gulf War Illness
Verified date | May 2020 |
Source | Palo Alto Veterans Institute for Research |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to determine whether yoga is effective for the treatment of chronic pain in Gulf War Illness.
Status | Completed |
Enrollment | 75 |
Est. completion date | March 2018 |
Est. primary completion date | March 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 42 Years to 85 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United States | VA Palo Alto Health Care System | Palo Alto | California |
Lead Sponsor | Collaborator |
---|---|
Palo Alto Veterans Institute for Research | United States Department of Defense |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pain (Brief Pain Inventory - Short Form) - Pain Severity | 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 | Week 10 minus Week 0 | |
Primary | Pain (Brief Pain Inventory - Short Form) - Pain Interference | 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. | Week 10 minus Week 0 | |
Secondary | Fatigue (6-Minute Walk Test) | Increase from baseline to end of treatment in distance walked during 6-Minute Walk Test. Greater values indicate more increase and therefore a more positive outcome. | Week 0, Week 10 | |
Secondary | Change in Number of Participants Who Used Analgesic Medication | Change in number of participants who self-reported use of analgesic medication(s) from Week 0 to Week 10. | Week 0, Week 10 | |
Secondary | Change in Number of Participants Who Used Nonsteroidal Anti-inflammatory Drugs | Change in number of participants who self-reported use of Nonsteroidal Anti-inflammatory Drug(s) from Week 0 to Week 10. | Week 0, Week 10 | |
Secondary | Change in Number of Participants Who Used Opiate Medication | Change in number of participants who self-reported use of Opiate Medication(s) from Week 0 to Week 10. | Week 0, Week 10 |
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