Fibromyalgia Clinical Trial
Official title:
Tai Chi Mind-Body Therapy for Fibromyalgia: a Pilot Single-Blind Randomized Controlled Trial.
Verified date | February 2016 |
Source | Tufts Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 66 |
Est. completion date | June 2011 |
Est. primary completion date | June 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 21 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Tufts Medical Center, Division of Rheumatology | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Tufts Medical Center | American College of Rheumatology Research and Education Foundation, National Center for Complementary and Integrative Health (NCCIH) |
United States,
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. — View Citation
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. — View Citation
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. doi: 10.1159/000134302. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Mean Change From Baseline of Fibromyalgia Impact Questionnaire Score | Fibromyalgia Impact Questionnaire (FIQ) is a well-validated, multidimensional measure of the overall severity of fibromyalgia as rated by patients. Categories include the intensity of pain, physical functioning, fatigue, morning tiredness, stiffness, depression, anxiety, job difficulty, and overall well-being.21 The total score ranges from 0 to 100, with higher scores indicating more severe symptoms. | wks 12 | No |
Secondary | Mean Change From Baseline of VAS Physicians' Global Assessment of Fibromyalgia Severity | Physicians' global assessment score was assessed separately by the study physician, who was unaware of the group assignment, with the use of a visual-analogue scale (VAS) (range, 0 to 10,with higher scores indicating greater pain). | Wks 12 | No |
Secondary | Mean Change From Baseline of Patient's Global Assessment Score | Patients' global assessment score was assessed separately by the participant, who was unaware of the group assignment, with the use of a visual-analogue scale (VAS) (range, 0 to 10,with higher scores indicating greater pain). | 12 weeks | No |
Secondary | Mean Change From Baseline PSQI Score | The Pittsburgh Sleep Quality Index (PSQI) is a self-report measure of sleep quality(range, 0 to 21, with higher scores indicating worse sleep quality) | 12 weeks | No |
Secondary | Mean Change From Baseline of 6-Minute Walk Test | 12 weeks | No | |
Secondary | Mean Change From Baseline SF-36 Score Physical Component | The Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) Physical Component is the summary score for the physical quality-of-life components (range, 0 to 100, with higher scores indicating better health status) | 12 weeks | No |
Secondary | Mean Change From Baseline SF-36 Score Mental Component | The Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) Mental Component is the summary score for the mental quality-of-life components (range, 0 to 100, with higher scores indicating better health status) | 12 weeks | No |
Secondary | Mean Change From Baseline CES-D Score | The Center for Epidemiologic Studies (CES-D) Depression Scale (range, 0 to 60, with higher scores indicating more severe depression), is a self-report measure of depressive symptoms. | 12 weeks | No |
Secondary | Mean Change From Baseline CPSS Score | The Chronic Pain Self-Efficacy Scale (CPSS) is a self-report score measuring self-efficacy with respect to chronic pain (range, 1 to 10, with higher scores indicating greater self-efficacy). | 12 weeks | No |
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