Fibromyalgia Clinical Trial
— POYSEOfficial title:
Pain Outcomes Comparing Yoga Versus Structured Exercise (POYSE) Trial
Verified date | February 2020 |
Source | VA Office of Research and Development |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The Pain Outcomes comparing Yoga versus Structured Exercise (POYSE) Trial is a 2-arm parallel group, randomized clinical trial to compare the effectiveness of a yoga-based intervention (YOGA) with that of a structured exercise program (SEP) for subjects with fibromyalgia. The study aims are: 1) to compare the interventions' (YOGA vs. SEP) effects on overall fibromyalgia severity at 1 month (early response), 3 months (immediate post-intervention) and at 6 and 9 months (sustained effects); 2) to compare the interventions effects on specific fibromyalgia symptoms (pain, sleep, and fatigue), functional impairment, and related outcomes (quality of life, psychological symptoms); and 3) to compare the cost-effectiveness of the interventions.
Status | Completed |
Enrollment | 256 |
Est. completion date | December 31, 2018 |
Est. primary completion date | July 2, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: Veterans will be eligible if they have: - Widespread Pain Index (WPI) greater than 7 and Symptom Severity Scale (SS) greater than 5 or WPI 3-6 and SS greater than 9. - Symptoms have been present at a similar level for at least 3 months - The subject does not have a disorder that would otherwise explain the pain - Moderate pain severity (pain severity score greater than 5) - No changes in fibromyalgia medications for last 4 weeks - Access to a working telephone Exclusion Criteria: Exclusion criteria includes: - Severe medical conditions in which exercise is contraindicated (such as significant cardiovascular disease, COPD or asthma needing home oxygen, stroke or TIA in last 6 months, cancer (other than skin cancer) and receiving treatment for it - Active psychosis - Hospitalized for psychiatric reasons within the last 6 months - Active suicidal ideation - Moderate to severe cognitive impairment - Involvement in ongoing yoga classes or moderately intense exercise program in the last 3 months |
Country | Name | City | State |
---|---|---|---|
United States | Richard L. Roudebush VA Medical Center, Indianapolis, IN | Indianapolis | Indiana |
Lead Sponsor | Collaborator |
---|---|
VA Office of Research and Development |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Fibromyalgia Impact Questionnaire Revised (FIQR) Total Score | This measure will be assessed at Baseline, 1, 3, 6 and 9 months. The 3 month is the primary end point and the 6 and 9 month assessments are for sustained effect. Min:0, Max: 90. Higher Score = Worse Outcome. | 3 month | |
Secondary | Fibromyalgia Impact Questionnaire-Revised Difficulty Subscale | This represents a subscale of the FIQr and measures patient perceived difficulty related to fibromyalgia. Min:0, Max: 20. Higher Score = Worse Outcome. | 3 Month | |
Secondary | Fibromyalgia Impact Questionnaire-Revised Impact Subscale | This is a subscale of the FIQr and measures the overall impact of fibromyalgia symptoms. Min:0, Max: 100. Higher Score = Worse Outcome. | 3 Month | |
Secondary | Fibromyalgia Impact Questionnaire Revised Symptoms Subscale | This subscale of the FIQr provides an overall fibromyalgia symptom score. Min:0, Max: 100. Higher Score = Worse Outcome | 3 Month | |
Secondary | Brief Pain Inventory (BPI) Severity Subscale | is an 11-item, multidimensional pain measurement tool with demonstrated reliability in patients with arthritis as well as other pain conditions. The BPI rates the intensity of pain as well as the interference of pain with mood, physical activity, work, social activity, relations with others, sleep, and enjoyment of life.Min:0, Max: 40. Higher Score = Worse Outcome. | 3 month | |
Secondary | PHQ-9 for Depression | will be used to assess depression severity. Several studies have validated the PHQ-9 as a diagnostic measure with excellent psychometric properties. Internal consistency has consistently been shown to be high (Cronbach's alpha > 0.80) and test-retest assessment showed the PHQ-9 to be a responsive and reliable measure of depression treatment outcomes. Min:0, Max: 27. Higher Score = Worse Outcome. | 3 Month | |
Secondary | GAD-7 Anxiety Scale | This 7-item scale represent a measure of anxiety symptom severity and provides a score from 0 to 21 with higher scores representing more severe anxiety | 3 Month | |
Secondary | PTSD Checklist of Symptoms | This 17-item scale assess PTSD symptom severity and provides a severity score; with higher scores representing more severe PTSD. Min: 0, Max: 85 with higher scores representing more severity. | 3 Month | |
Secondary | SF-12 Physical Score (Health-related Quality of Life) | The SF-12 is a well-validate measure of health-related quality of life; providing a physical and mental health component summary score. Min:0, Max: 100. Higher Score = Worse Outcome. | 3 Month | |
Secondary | SF-12 Mental Score (Health-related Quality of Life) | The SF-12 is a well-validate measure of health-related quality of life; providing a physical and mental health component summary score. Min:0, Max: 100. Higher Score = Worse Outcome. | 3 Month | |
Secondary | Multi-dimensional Fatigue Inventory | This scale assesses overall fatigue and has been well-validated and used in other fibromyalgia trials. Min:0, Max: 100. Higher Score = Worse Outcome. | 3 Month | |
Secondary | MOS Sleep Scale - Problems Index | This scale assesses different aspects of sleep quality and provides an overall index with higher scores representing more severe sleep problems. Min:0, Max: 100. Higher Score = Worse Outcome. | 3 Month | |
Secondary | Pain Catastrophizing Scale | This 13-item scale assesses pain catastrophizing which has been found to be a predictor of poor treatment response. Min: 0. Max: 52. Higher Score = Worse Outcome. | 3 Month | |
Secondary | Arthritis Self-efficacy Scale | This scale has been well-validated to assess self-efficacy or confidence in a person's ability to complete a task. Min: 0, Max: 60. Higher score represents improvement. | 3 Month |
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