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Sponsors and Collaborators: |
National Center for Complementary and Alternative Medicine (NCCAM) American College of Rheumatology Research and Education Foundation |
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Information provided by: | National Center for Complementary and Alternative Medicine (NCCAM) |
ClinicalTrials.gov Identifier: | NCT00515008 |
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 |
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Fibromyalgia |
Behavioral: 12-week Tai Chi Program. Behavioral: 12-week Stretching and Wellness Education Program |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Tai Chi Mind-Body Therapy for Fibromyalgia: a Pilot Single-Blind Randomized Controlled Trial. |
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 |
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1: Active Comparator |
Behavioral: 12-week Tai Chi Program.
12-week Tai Chi classes
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2: Placebo Comparator |
Behavioral: 12-week Stretching and Wellness Education Program
Non-TC informational program
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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.
Ages Eligible for Study: | 21 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria
United States, Massachusetts | |
Tufts Medical Center, Division of Rheumatology | |
Boston, Massachusetts, United States, 02111 |
Principal Investigator: | Chenchen Wang, MD, MSc | Tufts Medical Center |
Responsible Party: | New England Medical Center Hospitals, Inc. Dept of Medicine ( Chenchen Wang, Principal Investigator ) |
Study ID Numbers: | R21 AT003621 |
Study First Received: | August 9, 2007 |
Last Updated: | October 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00515008 |
Health Authority: | United States: Federal Government |
Muscular Diseases Neuromuscular Diseases Musculoskeletal Diseases Myofascial Pain Syndromes |
Fibromyalgia Pain Rheumatic Diseases |
Nervous System Diseases |