Tai Chi Mind-Body Therapy for Fibromyalgia

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
American College of Rheumatology Research and Education Foundation
Information provided by (Responsible Party):
Tufts Medical Center
ClinicalTrials.gov Identifier:
NCT00515008
First received: August 9, 2007
Last updated: December 9, 2013
Last verified: December 2013
  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:


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 2016
Estimated Primary Completion Date: May 2015 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
American College of Rheumatology Research and Education Foundation
Investigators
Principal Investigator: Chenchen Wang, MD, MSc Tufts Medical Center
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Tufts Medical Center
ClinicalTrials.gov Identifier: NCT00515008     History of Changes
Other Study ID Numbers: R21 AT003621, R21AT003621
Study First Received: August 9, 2007
Last Updated: December 9, 2013
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 September 18, 2014