Yoga for Fibromyalgia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2009 by Oregon Health and Science University.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT00966732
First received: August 26, 2009
Last updated: January 19, 2010
Last verified: October 2009
  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

Resource links provided by NLM:


Further study details as provided by Oregon Health and Science University:

Primary Outcome Measures:
  • Fibromyalgia Impact Questionnaire Revised (FIQR) [ Time Frame: baseline, 3 months, 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 56
Study Start Date: October 2009
Estimated Study Completion Date: June 2010
Estimated Primary Completion Date: June 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
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00966732

Locations
United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97239
Sponsors and Collaborators
Oregon Health and Science University
Investigators
Principal Investigator: James W Carson, PhD Oregon Health and Science University
  More Information

No publications provided

Responsible Party: James W Carson, PhD, Oregon Health & Science University
ClinicalTrials.gov Identifier: NCT00966732     History of Changes
Other Study ID Numbers: Yoga for Fibromyalgia
Study First Received: August 26, 2009
Last Updated: January 19, 2010
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on September 30, 2014