Fibromyalgia Clinical Trial
Official title:
A Randomized Controlled Trial of Eight Brocades (Ba Duan Jin) to Improve Quality of Life in Patients With Fibromyalgia
Verified date | January 2018 |
Source | Guang'anmen Hospital of China Academy of Chinese Medical Sciences |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
In this randomized, usual therapy-controlled study, 62 patients with fibromyalgi (FM) were recruited with a ratio of 1:1. Trained and guided by Eight Brocades (EB) certified physicians, participant practiced EB one hour, twice a week for 12 weeks. Evaluation will be based on standard scales of pain, FM symptoms severity, degree of fatigue, depression, sleep quality and quality of life.
Status | Completed |
Enrollment | 62 |
Est. completion date | August 2017 |
Est. primary completion date | February 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: - • Age 18 years or older. - Fulfills the American College of Rheumatology (ACR) 1990 classification criteria for FM. - On a stable variety and dosage of pharmacologic for FM =4 weeks Exclusion Criteria: - • Prior experience with EB or other similar types of Complementary and Alternative Medicine in the past 1 year such as Qi gong, Tai Chi and yoga since these share some of the principles of EB. - Dementia, cancer, or other serious medical conditions limiting ability to participate in the Eight Brocades or strength training, as determined by the study physicians. - Any other diagnosed medical condition known to contribute to FM symptomatology that is not under adequate control for the study period such as thyroid disease, inflammatory arthritis, systemic lupus erythematosus, rheumatoid arthritis, myositis, vasculitis or Sjogren's syndrome. - Positive urine pregnancy test at baseline or planning pregnancy within the study period. - Reside >70 miles from the research site. |
Country | Name | City | State |
---|---|---|---|
China | Guang'anmen Hospital of China Academy of Chinese Medical Sciences | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
Guang'anmen Hospital of China Academy of Chinese Medical Sciences | Beijing Municipal Science & Technology Commission |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The change of Visual Analogue Scales for pain (PVAS) from baseline to 12 weeks. | baseline, 4 weeks, 8 weeks, 12 weeks | ||
Primary | The change of Fibromyalgia Impact Questionnaire (FIQ) from baseline to 12 weeks | baseline, 4 weeks, 8 weeks, 12 weeks | ||
Secondary | The change of the Short Form-36 Health Status Questionnaire (SF-36) from baseline to 12 weeks | baseline, 4 weeks, 8 weeks, 12 weeks | ||
Secondary | The change of Multidimensional Assessment Fatigue (MAF) from baseline to 12 weeks | baseline, 4 weeks, 8 weeks, 12 weeks | ||
Secondary | The change of Beck depression inventory (BDI) from baseline to 12 weeks | baseline, 4 weeks, 8 weeks, 12 weeks | ||
Secondary | The change of Perceived Stress Scale (PSS) from baseline to 12 weeks | baseline, 4 weeks, 8 weeks, 12 weeks | ||
Secondary | The change of Pittsburgh sleep quality index (PSQI) from baseline to 12 weeks | baseline, 4 weeks, 8 weeks, 12 weeks |
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