Tai Chi Mind-Body Therapy for Fibromyalgia - Full Text View

Sponsor:	Tufts Medical Center
Collaborators:	National Center for Complementary and Alternative Medicine (NCCAM) American College of Rheumatology Research and Education Foundation
Information provided by:	Tufts Medical Center
ClinicalTrials.gov Identifier:	NCT00515008

Purpose

The purpose of this study is to obtain preliminary data on the effects of Tai Chi on musculoskeletal pain, fatigue, sleep quality, psychological distress, physical performance,and health status in 60 patients with fibromyalgia.

Condition	Intervention
Fibromyalgia	Behavioral: 12-week Tai Chi Program. Behavioral: 12-week Stretching and Wellness Education Program

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Tai Chi Mind-Body Therapy for Fibromyalgia: a Pilot Single-Blind Randomized Controlled Trial.

Resource links provided by NLM:

MedlinePlus related topics: Fibromyalgia

U.S. FDA Resources

Further study details as provided by Tufts Medical Center:

Primary Outcome Measures:

Fibromyalgia Impact Questionnaire score [ Time Frame: wks 12 and 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Tender Point Count, Fibromyalgia Intensity Score, Physicians' Assessments of Fibromyalgia Severity, Sleep Quality, Depression Index, Physical Performance, Self-Efficacy and Health Related Quality of Life [ Time Frame: Wks 12 and 24 ] [ Designated as safety issue: No ]

Estimated Enrollment:	60
Study Start Date:	June 2007
Estimated Study Completion Date:	May 2009
Estimated Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1	Behavioral: 12-week Tai Chi Program. 12-week Tai Chi classes
Placebo Comparator: 2	Behavioral: 12-week Stretching and Wellness Education Program Non-TC informational program

Detailed Description:

Fibromyalgia (FM) is a common, complex chronic condition marked by diffuse musculoskeletal pain, fatigue, functional impairment, disability, and psychological distress that affects 6-10 million people in the United States (US). There are currently no satisfactory pharmacological or non-pharmacological treatments for FM. New cost-effective strategies that reduce musculoskeletal pain and improve emotional and physical functioning as well as quality of life in people with FM are urgently needed.

Tai Chi is a traditional Chinese discipline with both physical and mental components that appears to benefit a variety of chronic conditions. The physical component provides exercise that is consistent with that recommended for FM (muscle conditioning and aerobic cardiovascular exercise), while the mental component has the potential to improve psychological well-being. These effects are especially pertinent for the treatment of individuals with FM.

This is a pilot randomized controlled trial of Tai Chi for fibromyalgia. We plan to enroll 60 patients with fibromyalgia over a two year period. Participants are randomized to either a Tai Chi program or an attention control intervention. Assessments are performed at baseline, week 12 and week 24. This study will provide preliminary data on the potential acceptability and safety of Tai Chi for FM and will help guide the design of a future large-scale study of the efficacy of this alternative therapy.

Eligibility

Ages Eligible for Study:	21 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Age 21 or older
Fulfills the American College of Rheumatology (ACR) 1990 diagnostic criteria for FM. (1) a history of widespread musculoskeletal pain on the right and left sides of the body as well as above and below the waist for a minimum duration of 3 months, and (2) pain in 11 or more of 18 specific tender points with moderate or greater tenderness reported upon digital palpation.
Physically able to participate in both the Tai Chi and stretching and education programs according to their primary care physician.
Willing to complete the 12-week study, including twice-a-week Tai Chi or stretching and education sessions

Exclusion Criteria

Prior experience with Tai Chi or other similar types of Complementary and Alternative Medicine in the past 6 months such as Qi gong and yoga since these share some of the principles of Tai Chi
Any health condition limiting the ability to participate as determined by a primary care physician
Any other diagnosed medical condition that is known to contribute to FM symptomatology that is not under adequate control or cannot be expected to remain under adequate control for the study period such as thyroid disease, inflammatory arthritis, scleroderma, systemic lupus erythematosus, systemic sclerosis, rheumatoid arthritis, myositis and vasculitis or Sjogren's syndrome
Not English-Speaking
Positive pregnancy test or planning pregnancy within the study period
Inability to pass the Mini-Mental Status examination (score below 24)
Enrollment in any other clinical trial within the last 30 days
Plan to permanently relocate from the region during the trial period

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00515008

Locations

United States, Massachusetts
Tufts Medical Center, Division of Rheumatology
Boston, Massachusetts, United States, 02111

Sponsors and Collaborators

Tufts Medical Center

National Center for Complementary and Alternative Medicine (NCCAM)

American College of Rheumatology Research and Education Foundation

Investigators

Principal Investigator:

Chenchen Wang, MD, MSc

Tufts Medical Center

More Information

Additional Information:

(Click here for the Department of Rheumatology, Tufts - New England Medical Center's web site) This link exits the ClinicalTrials.gov site

Publications:

Wang C, Collet JP, Lau J. The effect of Tai Chi on health outcomes in patients with chronic conditions: a systematic review. Arch Intern Med. 2004 Mar 8;164(5):493-501. Review.

Wang C, Roubenoff R, Lau J, Kalish R, Schmid CH, Tighiouart H, Rones R, Hibberd PL. Effect of Tai Chi in adults with rheumatoid arthritis. Rheumatology (Oxford). 2005 May;44(5):685-7. Epub 2005 Mar 1. No abstract available.

Wang C. Tai Chi improves pain and functional status in adults with rheumatoid arthritis: results of a pilot single-blinded randomized controlled trial. Med Sport Sci. 2008;52:218-29.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Wang C, Schmid CH, Rones R, Kalish R, Yinh J, Goldenberg DL, Lee Y, McAlindon T. A randomized trial of tai chi for fibromyalgia. N Engl J Med. 2010 Aug 19;363(8):743-54.

Responsible Party:	Chenchen Wang, Principal Investigator, New England Medical Center Hospitals, Inc. Dept of Medicine
ClinicalTrials.gov Identifier:	NCT00515008 History of Changes
Other Study ID Numbers:	R21 AT003621, R21AT003621
Study First Received:	August 9, 2007
Last Updated:	December 16, 2009
Health Authority:	United States: Federal Government

Additional relevant MeSH terms:

Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases

Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on February 02, 2012