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OpenTrials
Completed

NCT Number: NCT00966732

Yoga for Fibromyalgia

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.

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Key information

Age range

21 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Yoga of Awareness Program

Behavioral

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.

Primary outcomes

  1. Fibromyalgia Impact Questionnaire Revised (FIQR)

    Time frame: baseline, 3 months, 6 months

Secondary outcomes

  1. Vanderbilt Multidimensional Pain Coping Inventory (VMPCI)

    Time frame: baseline, 3 months, 6 months

  2. Chronic Pain Acceptance Questionnaire (CPAQ)

    Time frame: baseline, 3 months, 6 months

  3. Coping Strategies Questionnaire Catastrophizing Subscale (CSQCAT)

    Time frame: baseline, 3 months, 6 months

Sponsors and collaborators

Lead sponsor

Oregon Health and Science University

Other

Registry information

Official study title

Yoga of Awareness Program for Fibromyalgia: A Randomized Clinical Trial

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Aug 27, 2009
Registry last updated
Oct 16, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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