Simplified Tai Chi for Reducing Fibromyalgia Pain

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: July 2008

Detailed Description

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.

Interventions

  • Behavioral: 8-form Yang-style Tai chi
    • 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.
  • Behavioral: Group education
    • Standard group education was delivered to participants in a small group format twice weekly for 60 minutes over 12 weeks.

Arms, Groups and Cohorts

  • Active Comparator: Group education
    • The control condition received standard group education, which met in small groups two times weekly for 60 minutes over 12 weeks.
  • Experimental: 8-form Yang-style Tai chi program
    • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Fibromyalgia Impact Questionnaire
    • Time Frame: Assessed following 12 week intervention

Secondary Measures

  • Brief Pain Inventory
    • Time Frame: Assessed following 12 week intervention

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 40 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Oregon Research Institute
  • Provider of Information About this Clinical Study
    • Kim D. Jones, Associate Professor, Oregon Health & Sciences University
  • Overall Official(s)
    • Kim D Jones, PhD, Study Chair, Oregon Health and Science University

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