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Completed

NCT Number: NCT01311427

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.

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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oregon Research Institute

Eugene, Oregon, 97403, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

8-form Yang-style Tai chi

Behavioral

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

Behavioral

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

Primary outcomes

  1. Fibromyalgia Impact Questionnaire

    Time frame: Assessed following 12 week intervention

Secondary outcomes

  1. Brief Pain Inventory

    Time frame: Assessed following 12 week intervention

Sponsors and collaborators

Lead sponsor

Oregon Research Institute

Other

Registry information

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Mar 9, 2011
Registry last updated
Mar 9, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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