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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

February 9, 2011
March 7, 2011
August 2006
July 2008   (final data collection date for primary outcome measure)
Fibromyalgia Impact Questionnaire [ Time Frame: Assessed following 12 week intervention ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01311427 on ClinicalTrials.gov Archive Site
Brief Pain Inventory [ Time Frame: Assessed following 12 week intervention ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Simplified Tai Chi for Reducing Fibromyalgia Pain
Simplified Tai Chi for Reducing Fibromyalgia Pain

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Fibromyalgia
  • 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.
  • 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.
    Intervention: Behavioral: Group education
  • 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.
    Intervention: Behavioral: 8-form Yang-style Tai chi
Jones KD, Sherman CA, Mist SD, Carson JW, Bennett RM, Li F. A randomized controlled trial of 8-form Tai chi improves symptoms and functional mobility in fibromyalgia patients. Clin Rheumatol. 2012 Aug;31(8):1205-14. doi: 10.1007/s10067-012-1996-2. Epub 2012 May 13.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
99
July 2008
July 2008   (final data collection date for primary outcome measure)

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.
Both
40 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01311427
NIAMS 5R21 AR053506
Yes
Kim D. Jones, Associate Professor, Oregon Health & Sciences University
Oregon Research Institute
Not Provided
Study Chair: Kim D Jones, PhD Oregon Health and Science University
Oregon Research Institute
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP