Simplified Tai Chi for Reducing Fibromyalgia Pain

Fibromyalgia Clinical Trial

Official title:

Simplified Tai Chi for Reducing Fibromyalgia Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01311427
• Other study ID #: NIAMS 5R21 AR053506
• Status: Completed
• Phase: N/A
• First received: February 9, 2011
• Last updated: March 7, 2011
• Start date: August 2006
• Est. completion date: July 2008

Study information

• Verified date: March 2011
• Source: Oregon Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: July 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

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.
• Group education
Standard group education was delivered to participants in a small group format twice weekly for 60 minutes over 12 weeks.

Locations

Country	Name	City	State
United States	Oregon Research Institute	Eugene	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Oregon Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fibromyalgia Impact Questionnaire		Assessed following 12 week intervention	No
Secondary	Brief Pain Inventory		Assessed following 12 week intervention	No