Pain Outcomes Comparing Yoga Versus Structured Exercise (POYSE) Trial

Conditions:Fibromyalgia, Pain
Therapuetic Areas:Musculoskeletal, Rheumatology
Age Range:18 - Any
Start Date:August 1, 2013
End Date:December 31, 2018

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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

This study sample will include 306 Veterans with fibromyalgia. Patients will be randomized to
one of two treatment arms. The YOGA arm will involve a standardized 12-week, yoga-based
intervention. The yoga intervention will consist of three treatment components: 1) in-person
group yoga taught by a certified yoga therapist; 2) a relaxation audio recording for
home-use; and 3) a DVD recording to reinforce concepts taught during in-person yoga sessions.
Patients randomized to the structured exercise program (SEP) arm will participate in a
12-week exercise program delivered in a group/class format and supervised by a fitness
instructor. In addition, SEP patients will receive a DVD (for home use) describing the
benefits of aerobic exercise for fibromyalgia, a one-on-one consultation session with the
fitness instructor, an individualized exercise prescription, and supervised exercise sessions
for 12 weeks.

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
We found this trial at
Indianapolis, Indiana 46202
Principal Investigator: Matthew J. Bair, MD MS
Phone: 317-988-3838
Indianapolis, IN
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