Fibromyalgia Clinical Trial
Official title:
A Randomized Controlled Trial of Eight Brocades (Ba Duan Jin) to Improve Quality of Life in Patients With Fibromyalgia
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.
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).
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