NCT01311427

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
99

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2006

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2006

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

February 9, 2011

Completed
28 days until next milestone

First Posted

Study publicly available on registry

March 9, 2011

Completed
Last Updated

March 9, 2011

Status Verified

March 1, 2011

Enrollment Period

1.9 years

First QC Date

February 9, 2011

Last Update Submit

March 7, 2011

Conditions

Fibromyalgia

Outcome Measures

Primary Outcomes (1)

  • Fibromyalgia Impact Questionnaire

    Assessed following 12 week intervention

Secondary Outcomes (1)

  • Brief Pain Inventory

    Assessed following 12 week intervention

Study Arms (2)

Group education

ACTIVE COMPARATOR

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

Behavioral: Group education

8-form Yang-style Tai chi program

EXPERIMENTAL

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.

Behavioral: 8-form Yang-style Tai chi

Interventions

8-form Yang-style Tai chiBEHAVIORAL

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.

8-form Yang-style Tai chi program
Group educationBEHAVIORAL

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

Group education

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oregon Research Institute

Eugene, Oregon, 97403, United States

Location

Related Publications (1)

  • 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.

    PMID: 22581278DERIVED

MeSH Terms

Conditions

Fibromyalgia

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System Diseases

Study Officials

  • Kim D Jones, PhD

    Oregon Health and Science University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 9, 2011

First Posted

March 9, 2011

Study Start

August 1, 2006

Primary Completion

July 1, 2008

Study Completion

July 1, 2008

Last Updated

March 9, 2011

Record last verified: 2011-03

Locations

US(1)