Official Title: “Yoga of Awareness Program for Fibromyalgia: A Randomized Clinical Trial”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Single Blind (Outcomes Assessor), Historical Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: June 2010

Intervention(s) in this Clinical Trial

• 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.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: yoga condition
  • assigned to start the yoga program right away
• 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.

Primary Measures

• Fibromyalgia Impact Questionnaire Revised (FIQR)
  • Time Frame: baseline, 3 months, 6 months
    Safety Issue?: No

Secondary Measures

• Vanderbilt Multidimensional Pain Coping Inventory (VMPCI)
  • Time Frame: baseline, 3 months, 6 months
    Safety Issue?: No
• Chronic Pain Acceptance Questionnaire (CPAQ)
  • Time Frame: baseline, 3 months, 6 months
    Safety Issue?: No
• Coping Strategies Questionnaire Catastrophizing Subscale (CSQCAT)
  • Time Frame: baseline, 3 months, 6 months
    Safety Issue?: 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

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 21 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Oregon Health and Science University

Overall Clinical Trial Officials and Contacts

James W Carson, PhD Principal Investigator Oregon Health and Science University  

Information obtained from ClinicalTrials.gov on February 04, 2010

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00966732

Study ID Number: Yoga for Fibromyalgia

ClinicalTrials.gov Identifier: NCT00966732

Health Authority: United States: Institutional Review Board