Eight Brocades (Ba Duan Jin) for Treating Patients With Fibromyalgia
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|ClinicalTrials.gov Identifier: NCT02401386|
Recruitment Status : Completed
First Posted : March 27, 2015
Last Update Posted : January 23, 2018
|Condition or disease||Intervention/treatment||Phase|
|Fibromyalgia||Behavioral: The Eight Brocades||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||62 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||A Randomized Controlled Trial of Eight Brocades (Ba Duan Jin) to Improve Quality of Life in Patients With Fibromyalgia|
|Actual Study Start Date :||March 2015|
|Actual Primary Completion Date :||February 2017|
|Actual Study Completion Date :||August 2017|
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.
Behavioral: The Eight Brocades
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.
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.
- The change of Visual Analogue Scales for pain (PVAS) from baseline to 12 weeks. [ Time Frame: baseline, 4 weeks, 8 weeks, 12 weeks ]
- The change of Fibromyalgia Impact Questionnaire (FIQ) from baseline to 12 weeks [ Time Frame: baseline, 4 weeks, 8 weeks, 12 weeks ]
- 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 ]
- The change of Multidimensional Assessment Fatigue (MAF) from baseline to 12 weeks [ Time Frame: baseline, 4 weeks, 8 weeks, 12 weeks ]
- The change of Beck depression inventory (BDI) from baseline to 12 weeks [ Time Frame: baseline, 4 weeks, 8 weeks, 12 weeks ]
- The change of Perceived Stress Scale (PSS) from baseline to 12 weeks [ Time Frame: baseline, 4 weeks, 8 weeks, 12 weeks ]
- The change of Pittsburgh sleep quality index (PSQI) from baseline to 12 weeks [ Time Frame: baseline, 4 weeks, 8 weeks, 12 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02401386
|Guang'anmen Hospital of China Academy of Chinese Medical Sciences|
|Beijing, Beijing, China, 100053|
|Principal Investigator:||Juan Jiao, M.D.,PhD||Guang'anmen Hospital of China Academy of Chinese Medical Sciences|