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Simplified Tai Chi for Reducing Fibromyalgia Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01311427
Recruitment Status : Completed
First Posted : March 9, 2011
Last Update Posted : March 9, 2011
Sponsor:
Information provided by:
Oregon Research Institute

Tracking Information
First Submitted Date  ICMJE February 9, 2011
First Posted Date  ICMJE March 9, 2011
Last Update Posted Date March 9, 2011
Study Start Date  ICMJE August 2006
Actual Primary Completion Date July 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 7, 2011)
Fibromyalgia Impact Questionnaire [ Time Frame: Assessed following 12 week intervention ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: March 7, 2011)
Brief Pain Inventory [ Time Frame: Assessed following 12 week intervention ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Simplified Tai Chi for Reducing Fibromyalgia Pain
Official Title  ICMJE Simplified Tai Chi for Reducing Fibromyalgia Pain
Brief Summary 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 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Fibromyalgia
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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
Publications * 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.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 7, 2011)
99
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2008
Actual Primary Completion Date July 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01311427
Other Study ID Numbers  ICMJE NIAMS 5R21 AR053506
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Kim D. Jones, Associate Professor, Oregon Health & Sciences University
Study Sponsor  ICMJE Oregon Research Institute
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Kim D Jones, PhD Oregon Health and Science University
PRS Account Oregon Research Institute
Verification Date March 2011

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