Yoga for Fibromyalgia
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Fibromyalgia |
Behavioral: Yoga of Awareness Program |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Yoga of Awareness Program for Fibromyalgia: A Randomized Clinical Trial |
- Fibromyalgia Impact Questionnaire Revised (FIQR) [ Time Frame: baseline, 3 months, 6 months ] [ Designated as safety issue: No ]
- Vanderbilt Multidimensional Pain Coping Inventory (VMPCI) [ Time Frame: baseline, 3 months, 6 months ] [ Designated as safety issue: No ]
- Chronic Pain Acceptance Questionnaire (CPAQ) [ Time Frame: baseline, 3 months, 6 months ] [ Designated as safety issue: No ]
- Coping Strategies Questionnaire Catastrophizing Subscale (CSQCAT) [ Time Frame: baseline, 3 months, 6 months ] [ Designated as safety issue: No ]
| Enrollment: | 68 |
| Study Start Date: | October 2009 |
| Study Completion Date: | December 2010 |
| Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: yoga condition
assigned to start the yoga program right away
|
Behavioral: Yoga of Awareness Program
The 8 week yoga program will meet in groups of about 8-10 persons. Each 2-hour session will include gentle stretching, strengthening, and balance poses; meditation exercises; breathing techniques; study of pertinent topics (eg, mind/body stress reactivity), and group discussions (eg, experiences while practicing yoga). Participants will be asked to practice yoga methods at home, guided by a DVD (or audio recordings). The program will be taught by a certified yoga teacher (RYT) who has extensive experience in teaching yoga to medical patients.
|
|
No Intervention: wait-list control condition
This condition will control for any effects of symptom measurement reactivity in patients receiving routine fibromyalgia medical care. After the 3-month assessment, the yoga intervention program will be provided to these patients.
|
Eligibility| Ages Eligible for Study: | 21 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00966732
| United States, Oregon | |
| Oregon Health & Science University | |
| Portland, Oregon, United States, 97239 | |
| Principal Investigator: | James W Carson, PhD | Oregon Health and Science University |
More Information
No publications provided
| Responsible Party: | James W Carson, PhD, Associate Professor, Oregon Health and Science University |
| ClinicalTrials.gov Identifier: | NCT00966732 History of Changes |
| Other Study ID Numbers: | Yoga for Fibromyalgia |
| Study First Received: | August 26, 2009 |
| Last Updated: | October 14, 2014 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Fibromyalgia Myofascial Pain Syndromes Muscular Diseases Musculoskeletal Diseases |
Nervous System Diseases Neuromuscular Diseases Rheumatic Diseases |
ClinicalTrials.gov processed this record on February 26, 2015