N/A
N=66
Tai Chi Mind-Body Therapy for Fibromyalgia
Fibromyalgia
Bottom Line
View on ClinicalTrials.gov: NCT00515008 ↗Enrolled (actual)
66
Serious AEs
0.0%
Results posted
Mar 2016
Primary outcome: Primary: Mean Change From Baseline of Fibromyalgia Impact Questionnaire Score — -27.8; -9.4 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Tai Chi Intervention (Behavioral); Control Intervention (Behavioral)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Tufts Medical Center
- Primary completion
- Jun 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change From Baseline of Fibromyalgia Impact Questionnaire Score |
-27.8; -9.4 | — |
| SECONDARY Mean Change From Baseline of VAS Physicians' Global Assessment of Fibromyalgia Severity |
-1.0; 0.02 | — |
| SECONDARY Mean Change From Baseline of Patient's Global Assessment Score |
-2.5; -0.6 | — |
| SECONDARY Mean Change From Baseline PSQI Score |
-3.6; -0.7 | — |
| SECONDARY Mean Change From Baseline of 6-Minute Walk Test |
60.6; 16.3 | — |
| SECONDARY Mean Change From Baseline SF-36 Score Physical Component |
8.5; 1.4 | — |
| SECONDARY Mean Change From Baseline SF-36 Score Mental Component |
7.7; 6.1 | — |
| SECONDARY Mean Change From Baseline CES-D Score |
-8.1; -2.3 | — |
| SECONDARY Mean Change From Baseline CPSS Score |
1.5; 0.5 | — |
Summary
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00515008). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.