Fibromyalgia Clinical Trial
Official title:
Simplified Tai Chi for Reducing Fibromyalgia Pain
Verified date | March 2011 |
Source | Oregon Research Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
Data from two recent Tai chi studies have found that Tai Chi yields symptomatic benefit in patients with fibromyalgia (FM). The purpose of this study is to confirm those findings in a larger randomized, controlled clinical trial in a community-based setting. We also sought to extend this line of inquiry by closely examining Tai chi's effect on physical function, specifically postural stability. Towards these ends, we conducted a single-blind, randomized controlled clinical trial of an FM modified 8-form Yang-style Tai chi program compared to standard education. Subjects in both conditions meet in small groups two times weekly for 60 minutes over 12 weeks.
Status | Completed |
Enrollment | 99 |
Est. completion date | July 2008 |
Est. primary completion date | July 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 40 Years and older |
Eligibility |
Inclusion Criteria: - Subjects included adults over 40 years of age or older who met 1990 ACR criteria for the classification of FM. Those criteria include pain in three or more body quadrants (above the waist, below the waist, left of midline and right of midline) including axial pain by self-report for a minimum of three consecutive months. - Additionally at least 11 of 18 muscle/tendon junction tender points were found to be painful via digital palpation of 4kg over 4 seconds by a trained examiner (Wolfe 1990). Exclusion Criteria: - Individuals were excluded if they practiced Tai chi within the past 6 months; - were exercising more than 30 minutes, three times weekly for past 3 months; - could not independently ambulate without assistive devices; - were unable to attain MD clearance for exercise within past 3 months; - were unwilling to undergo random assignment; had cognitive impairment based on score >3 Pfeiffer Mental Status; - had significant depressive symptoms based on a score of >27 on Beck Depression Inventory; - had BPI pain severity scores less than 3/10, had planned elective surgery during the study period; - were unwilling to keep all treatments/medications steady throughout the study period; - were currently enrolled in another study. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Oregon Research Institute | Eugene | Oregon |
Lead Sponsor | Collaborator |
---|---|
Oregon Research Institute |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Fibromyalgia Impact Questionnaire | Assessed following 12 week intervention | No | |
Secondary | Brief Pain Inventory | Assessed following 12 week intervention | No |
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