Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Yoga for Fibromyalgia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00966732
Recruitment Status : Completed
First Posted : August 27, 2009
Last Update Posted : October 16, 2014
Sponsor:
Information provided by (Responsible Party):
James W Carson, PhD, Oregon Health and Science University

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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.

Condition or disease Intervention/treatment Phase
Fibromyalgia Behavioral: Yoga of Awareness Program Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Yoga of Awareness Program for Fibromyalgia: A Randomized Clinical Trial
Study Start Date : October 2009
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Fibromyalgia Impact Questionnaire Revised (FIQR) [ Time Frame: baseline, 3 months, 6 months ]

Secondary Outcome Measures :
  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 ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes 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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00966732


Locations
Layout table for location information
United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97239
Sponsors and Collaborators
Oregon Health and Science University
Investigators
Layout table for investigator information
Principal Investigator: James W Carson, PhD Oregon Health and Science University
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: James W Carson, PhD, Associate Professor, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT00966732    
Other Study ID Numbers: Yoga for Fibromyalgia
First Posted: August 27, 2009    Key Record Dates
Last Update Posted: October 16, 2014
Last Verified: October 2014
Additional relevant MeSH terms:
Layout table for MeSH terms
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
 Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases