N/A
Completed N=256
Pain Outcomes Comparing Yoga Versus Structured Exercise (POYSE) Trial
Source: ClinicalTrials.gov NCT01797263 ↗Enrolled (actual)
256
Serious AEs
2.3%
Results posted
Feb 2020
Primary outcomePrimary: Fibromyalgia Impact Questionnaire Revised (FIQR) Total Score — 41.5; 42.2 units on a scale
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Fibromyalgia Impact Questionnaire Revised (FIQR) Total Score |
41.5; 42.2 | — |
| SECONDARY Fibromyalgia Impact Questionnaire-Revised Difficulty Subscale |
10.8; 10.5 | — |
| SECONDARY Fibromyalgia Impact Questionnaire-Revised Impact Subscale |
7.3; 7.9 | — |
| SECONDARY Fibromyalgia Impact Questionnaire Revised Symptoms Subscale |
23.5; 23.8 | — |
| SECONDARY Brief Pain Inventory (BPI) Severity Subscale |
5.6; 5.9 | — |
| SECONDARY PHQ-9 for Depression |
8.6; 9.8 | — |
| SECONDARY GAD-7 Anxiety Scale |
6.5; 6.6 | — |
| SECONDARY PTSD Checklist of Symptoms |
48.3; 49.0 | — |
| SECONDARY SF-12 Physical Score (Health-related Quality of Life) |
17.8; 18.6 | — |
| SECONDARY SF-12 Mental Score (Health-related Quality of Life) |
46.4; 46.4 | — |
| SECONDARY Multi-dimensional Fatigue Inventory |
49.2; 51.4 | — |
| SECONDARY MOS Sleep Scale - Problems Index |
48.5; 44.8 | — |
| SECONDARY Pain Catastrophizing Scale |
17.8; 18.6 | — |
| SECONDARY Arthritis Self-efficacy Scale |
37.2; 37.0 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01797263). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.