Yoga for Fibromyalgia
Primary Purpose
Fibromyalgia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Yoga of Awareness Program
Sponsored by
About this trial
This is an interventional treatment trial for Fibromyalgia
Eligibility 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
Sites / Locations
- Oregon Health & Science University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
yoga condition
wait-list control condition
Arm Description
assigned to start the yoga program right away
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.
Outcomes
Primary Outcome Measures
Fibromyalgia Impact Questionnaire Revised (FIQR)
Secondary Outcome Measures
Vanderbilt Multidimensional Pain Coping Inventory (VMPCI)
Chronic Pain Acceptance Questionnaire (CPAQ)
Coping Strategies Questionnaire Catastrophizing Subscale (CSQCAT)
Full Information
NCT ID
NCT00966732
First Posted
August 26, 2009
Last Updated
October 14, 2014
Sponsor
Oregon Health and Science University
1. Study Identification
Unique Protocol Identification Number
NCT00966732
Brief Title
Yoga for Fibromyalgia
Official Title
Yoga of Awareness Program for Fibromyalgia: A Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oregon Health and Science University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
68 (Actual)
8. Arms, Groups, and Interventions
Arm Title
yoga condition
Arm Type
Experimental
Arm Description
assigned to start the yoga program right away
Arm Title
wait-list control condition
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Yoga of Awareness Program
Intervention Description
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 Outcome Measure Information:
Title
Fibromyalgia Impact Questionnaire Revised (FIQR)
Time Frame
baseline, 3 months, 6 months
Secondary Outcome Measure Information:
Title
Vanderbilt Multidimensional Pain Coping Inventory (VMPCI)
Time Frame
baseline, 3 months, 6 months
Title
Chronic Pain Acceptance Questionnaire (CPAQ)
Time Frame
baseline, 3 months, 6 months
Title
Coping Strategies Questionnaire Catastrophizing Subscale (CSQCAT)
Time Frame
baseline, 3 months, 6 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James W Carson, PhD
Organizational Affiliation
Oregon Health and Science University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Yoga for Fibromyalgia
We'll reach out to this number within 24 hrs