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Simplified Tai Chi for Reducing Fibromyalgia Pain

Primary Purpose

Fibromyalgia

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

8-form Yang-style Tai chi

Group education

About this trial

This is an interventional treatment trial for Fibromyalgia

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Oregon Research Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Group education

8-form Yang-style Tai chi program

Arm Description

The control condition received standard group education, which met in small groups two times weekly for 60 minutes over 12 weeks.

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.

Outcomes

Primary Outcome Measures

Fibromyalgia Impact Questionnaire

Secondary Outcome Measures

Brief Pain Inventory

Full Information

NCT ID

NCT01311427

First Posted

February 9, 2011

Last Updated

March 7, 2011

Sponsor

Oregon Research Institute

1. Study Identification

Unique Protocol Identification Number

NCT01311427

Brief Title

Simplified Tai Chi for Reducing Fibromyalgia Pain

Official Title

Simplified Tai Chi for Reducing Fibromyalgia Pain

Study Type

Interventional

2. Study Status

Record Verification Date

March 2011

Overall Recruitment Status

Completed

Study Start Date

August 2006 (undefined)

Primary Completion Date

July 2008 (Actual)

Study Completion Date

July 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Oregon Research Institute

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Fibromyalgia

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

99 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group education

Arm Type

Active Comparator

Arm Description

The control condition received standard group education, which met in small groups two times weekly for 60 minutes over 12 weeks.

Arm Title

8-form Yang-style Tai chi program

Arm Type

Experimental

Arm Description

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 Type

Behavioral

Intervention Name(s)

8-form Yang-style Tai chi

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Group education

Intervention Description

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

Primary Outcome Measure Information:

Title

Fibromyalgia Impact Questionnaire

Time Frame

Assessed following 12 week intervention

Secondary Outcome Measure Information:

Title

Brief Pain Inventory

Time Frame

Assessed following 12 week intervention

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kim D Jones, PhD

Organizational Affiliation

Oregon Health and Science University

Official's Role

Study Chair

Facility Information:

Facility Name

Oregon Research Institute

City

Eugene

State/Province

Oregon

ZIP/Postal Code

97403

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

22581278

Citation

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.

Results Reference

derived

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Simplified Tai Chi for Reducing Fibromyalgia Pain

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