- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02401386
Eight Brocades (Ba Duan Jin) for Treating Patients With Fibromyalgia
A Randomized Controlled Trial of Eight Brocades (Ba Duan Jin) to Improve Quality of Life in Patients With Fibromyalgia
Study Overview
Detailed Description
The EB, also written as Ba Duan Jin, or Baduanjin, or Eight-Section Brocade, is a set of Qigong exercises that originated in China and date back thousands of years. It is a mind-body practice that combines meditation with slow, gentle, graceful movements, as well as deep breathing and relaxation, to move vital energy (or qi) throughout the body and is practiced as a rehabilitation exercise for various kinds of diseases. It is considered a complex, multicomponent intervention that integrates physical, psychosocial, emotional, spiritual, and behavioral elements. Participants in the EB group received a modified EB adapted by Chinese Medicine Master Zhi-zheng Lu, which was added several joint exercise movements to the traditional EB forms to specifically tailor it for patients with rheumatic diseases.
FM is a common and complex clinical syndrome characterized by chronic and widespread musculoskeletal pain, fatigue, sleep disturbance, and physical and psychological impairment. Evidence-based guidelines suggest that exercise is beneficial for FM and has been advocated as a core component of its treatment. Because of EB's mind-body attributes and it is easy to learn, we assume that it could be well suited for the treatment of FM.
Patients enrolled in this trial will be randomly allocated into one of two groups: EB group and usual therapy-controlled group. Patients will be evaluated at baseline, at week 4, 8 and 12. The primary outcome measure was a Visual Analogue Scales for pain (PVAS). Secondary outcome measures included the following: the Revised FM Impact Questionnaire (FIQR), the Multidimensional Assessment of Fatigue (MAF), the Pittsburgh Sleep Quality Index (PSQI), the Beck Depression Inventory (BDI), the Perceived Stress Scale (PSS), and the Tender Points Count (TPC).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Beijing
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Beijing, Beijing, China, 100053
- Guang'anmen Hospital of China Academy of Chinese Medical Sciences
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: EB group
Trained and guided by EB certified physicians, patients in EB group received closely supervised, group-format EB program and practiced EB for one hour, twice weekly for 12 weeks in the Guang'anmen Hospital.
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Patients received closely supervised, group-format EB program and practiced EB revised by Chinese Medicine Master Zhi-zheng Lu for one hour, twice weekly for 12 weeksmovements, a review of principles, and breathing techniques in EB.
Participants will be asked to practice EB at home for at least 16 minutes each day which is how long it takes to complete an EB exercise, using an instructional Digital Video Disc.
The program will be taught by experienced EB masters.
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NO_INTERVENTION: Control group
The participants in usual therapy-controlled group will stay on their previous treatment through 12 weeks.
As compensation, they will be invited to receive LEB training for 12 weeks after the end of the study.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The change of Visual Analogue Scales for pain (PVAS) from baseline to 12 weeks.
Time Frame: baseline, 4 weeks, 8 weeks, 12 weeks
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baseline, 4 weeks, 8 weeks, 12 weeks
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The change of Fibromyalgia Impact Questionnaire (FIQ) from baseline to 12 weeks
Time Frame: baseline, 4 weeks, 8 weeks, 12 weeks
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baseline, 4 weeks, 8 weeks, 12 weeks
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The change of the Short Form-36 Health Status Questionnaire (SF-36) from baseline to 12 weeks
Time Frame: baseline, 4 weeks, 8 weeks, 12 weeks
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baseline, 4 weeks, 8 weeks, 12 weeks
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The change of Multidimensional Assessment Fatigue (MAF) from baseline to 12 weeks
Time Frame: baseline, 4 weeks, 8 weeks, 12 weeks
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baseline, 4 weeks, 8 weeks, 12 weeks
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The change of Beck depression inventory (BDI) from baseline to 12 weeks
Time Frame: baseline, 4 weeks, 8 weeks, 12 weeks
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baseline, 4 weeks, 8 weeks, 12 weeks
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The change of Perceived Stress Scale (PSS) from baseline to 12 weeks
Time Frame: baseline, 4 weeks, 8 weeks, 12 weeks
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baseline, 4 weeks, 8 weeks, 12 weeks
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The change of Pittsburgh sleep quality index (PSQI) from baseline to 12 weeks
Time Frame: baseline, 4 weeks, 8 weeks, 12 weeks
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baseline, 4 weeks, 8 weeks, 12 weeks
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Juan Jiao, M.D.,PhD, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Z141107002514094
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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