Yoga for Fibromyalgia

Fibromyalgia Clinical Trial

Official title:

Yoga of Awareness Program for Fibromyalgia: A Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00966732
• Other study ID #: Yoga for Fibromyalgia
• Status: Completed
• Phase: N/A
• First received: August 26, 2009
• Last updated: October 14, 2014
• Start date: October 2009
• Est. completion date: December 2010

Study information

• Verified date: October 2014
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

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.

Locations

Country	Name	City	State
United States	Oregon Health & Science University	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Oregon Health and Science University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fibromyalgia Impact Questionnaire Revised (FIQR)		baseline, 3 months, 6 months	No
Secondary	Vanderbilt Multidimensional Pain Coping Inventory (VMPCI)		baseline, 3 months, 6 months	No
Secondary	Chronic Pain Acceptance Questionnaire (CPAQ)		baseline, 3 months, 6 months	No
Secondary	Coping Strategies Questionnaire Catastrophizing Subscale (CSQCAT)		baseline, 3 months, 6 months	No