Clinical trial NCT00966732: Yoga for Fibromyalgia
Official title: Yoga of Awareness Program for Fibromyalgia: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
First posted: 2009-08-27
Enrollment: 68
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Fibromyalgia is a common, costly and debilitating illness which affects mostly women. Fibromyalgia patients report widespread musculoskeletal pain, fatigue, stiffness, and distress. Several consensus statements indicate that optimal care combines medication, exercise, and psychology. Yoga is a popular mind/body discipline which holds promise for reducing fibromyalgia symptoms. The aim of this pilot study is to evaluate the effects of an innovative program, Yoga of Awareness, in which yoga poses are complemented by meditation and breathing exercises, presentations on healthy coping, and group discussions. Fifty-six women with fibromyalgia will be recruited and randomly divided into two groups. One group will receive the yoga program right away, and the other group will wait 3 months before receiving the program. Information about fibromyalgia symptoms and functioning will be collected from both groups before and immediately after the first group receives the yoga program. When results from the 2 groups are compared, the investigators expect patients who received the yoga program will have greater gains in fibromyalgia symptoms, physical function and pain coping capacities then those waiting to receive the program. If this study shows the yoga program is effective, the investigators will use this data in 2010 to apply to the National Institutes of Health for a more complete study of its benefits.


Eligibility criteria: Inclusion Criteria:

* women ≥21 years of age
* diagnosed with fibromyalgia by ACR criteria for at least 1 year
* on a stable regimen of pharmacologic and/or non-pharmacologic treatment for FM ≥3 months

Exclusion Criteria:

* reside \>70 miles from the research site
* unavailable to attend the intervention at one of the scheduled times
* currently engaged in intensive yoga practice (practice \>3 days/wk)
* score \>29 on the Beck depression scale modified for fibromyalgia
* currently undergoing disability application or involved in litigation
* elective surgery scheduled during the study period
* physically disabled in a manner that precludes meaningful participation in the intervention (eg, quadriplegic paralysis)
* do not speak English

Primary outcomes:
measure: Fibromyalgia Impact Questionnaire Revised (FIQR)
timeFrame: baseline, 3 months, 6 months
Secondary outcomes:
measure: Vanderbilt Multidimensional Pain Coping Inventory (VMPCI)
timeFrame: baseline, 3 months, 6 months
measure: Chronic Pain Acceptance Questionnaire (CPAQ)
timeFrame: baseline, 3 months, 6 months
measure: Coping Strategies Questionnaire Catastrophizing Subscale (CSQCAT)
timeFrame: baseline, 3 months, 6 months
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: James W Carson, PhD
role: PRINCIPAL_INVESTIGATOR
References: