Simplified Tai Chi for Reducing Fibromyalgia Pain

Study Overview
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Brief Summary
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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.

Detailed Description
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120 males and females with fibromyalgia were randomized to participate in a modified 8 form Yang-Style Tai Chi program or a standard group education program. Both programs met in a small group format for twice weekly 60 minute sessions lasting for 12 weeks. 99 subjects completed the protocol. Primary outcomes from the Fibromyalgia Impact Questionnaire were assessed at baseline and 12 weeks. Secondary measures included pain intensity and interference, sleep, coping, and fitness tests.

Official Title
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Simplified Tai Chi for Reducing Fibromyalgia Pain

Conditions
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Fibromyalgia

Intervention / Treatment
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* Behavioral: 8-form Yang-style Tai chi
* Behavioral: Group education


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group education<br>The control condition received standard group education, which met in small groups two times weekly for 60 minutes over 12 weeks. | Behavioral: Group education<br>* Standard group education was delivered to participants in a small group format twice weekly for 60 minutes over 12 weeks.<br>|
| Experimental: 8-form Yang-style Tai chi program<br>This arm tested a modified 8-form Yang-style Tai chi program in subjects with fibromyalgia. Participants met in small groups two times weekly for 60 minutes over 12 weeks. | Behavioral: 8-form Yang-style Tai chi<br>* This study tested a modified 8-form Yang-style Tai chi program in subjects with fibromyalgia. Participants met in a small group two times weekly for 60 minutes over 12 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fibromyalgia Impact Questionnaire |  | Assessed following 12 week intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brief Pain Inventory |  | Assessed following 12 week intervention |