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Simplified Tai Chi for Reducing Fibromyalgia Pain

This study has been completed.
Sponsor:
Information provided by:
Oregon Research Institute
ClinicalTrials.gov Identifier:
NCT01311427
First received: February 9, 2011
Last updated: March 7, 2011
Last verified: March 2011
History of Changes
  Purpose

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.


Condition Intervention
Fibromyalgia
 Behavioral: 8-form Yang-style Tai chi
Behavioral: Group education

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Simplified Tai Chi for Reducing Fibromyalgia Pain

Resource links provided by NLM:

MedlinePlus related topics: Fibromyalgia
U.S. FDA Resources

Further study details as provided by Oregon Research Institute:

Primary Outcome Measures:
  • Fibromyalgia Impact Questionnaire [ Time Frame: Assessed following 12 week intervention ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Brief Pain Inventory [ Time Frame: Assessed following 12 week intervention ] [ Designated as safety issue: No ]

Enrollment: 99
Study Start Date: August 2006
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
 Behavioral: Group education
Standard group education was delivered to participants in a small group format twice 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.
 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.

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.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01311427

Locations
United States, Oregon
Oregon Research Institute
Eugene, Oregon, United States, 97403
Sponsors and Collaborators
Oregon Research Institute
Investigators
Study Chair: Kim D Jones, PhD Oregon Health and Science University
  More Information

No publications provided by Oregon Research Institute

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Kim D. Jones, Associate Professor, Oregon Health & Sciences University
ClinicalTrials.gov Identifier: NCT01311427     History of Changes
Other Study ID Numbers: NIAMS 5R21 AR053506
Study First Received: February 9, 2011
Last Updated: March 7, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
 Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on June 18, 2013