Fibromyalgia is a chronic debilitating musculoskeletal pain syndrome. Pregabalin is the only medication that has been approved to treat fibromyalgia in China. Currently, there has been a growing interest in the development of non-pharmacological therapies. Ba-Duan-Jin is an ancient Chinese exercise for health promotion yet easy to learn. Findings from our previous study showed an effectiveness and good safety of Ba-Duan-Jin in patients with fibromyalgia. This study is to evaluate the effectiveness comparison of Ba-Duan-Jin and pregabalin in managing fibromyalgia symptoms experienced by Chinese patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
104
Ba-Duan-Jin is a common form of "self-health-care" Qigong exercise that has been practiced by Chinese people for at least eight hundred years. It consists of eight sets of simple movements. By combining meditation with slow, graceful movements, deep breathing, and relaxation, Ba-Duan-Jin practitioners believe it has the ability to move vital energy (Qi) throughout the body. Ba-Duan-Jin is also considered to be a multicomponent intervention that integrates physical, psychosocial, emotional, spiritual, and behavioral elements. While the biological mechanisms remain unclear, previous clinical trials have demonstrated that Ba-Duan-Jin can improve sleep quality, physical health, and mental health in patients with various chronic diseases
Pregabalin is one of the three medications (pregabalin, duloxetine, and milnacipran) that have been approved by the Food and Drug Administration (FDA) to treat fibromyalgia in US, and the only medicine that has been approved in China.
Jiao Juan
Beijing, Beijing Municipality, China
The change of the Visual Analogue Scale (VAS) for pain from baseline.
Pain VAS, range, 0 to 100 mm, where higher scores indicated the perceived pain to be more severe.
Time frame: up to 1 week
The change of the revised Fibromyalgia Impact Questionnaire (FIQR) from baseline.
A self-administered questionnaire with 10 subscales, measuring fibromyalgia symptoms and function domains. FIQR total score ranges from 0 to 100, with higher scores indicating more severe symptoms.
Time frame: Baseline, week 4, week 8, and week 12.
The change of the Multidimensional Fatigue Inventory-20 (MFI-20) from baseline.
The Multidimensional Fatigue Inventory-20 (MFI-20) measures fatigue severity. The MFI-20 total score ranges from 0 to 80, with higher scores indicate more severe fatigue.
Time frame: Baseline, week 4, week 8, and week 12.
The change of the Pittsburgh Sleep Quality Index (PSQI) from baseline.
Scores on the Pittsburgh Sleep Quality Index (PSQI) range from 0 to 21, with higher scores indicating worse sleep quality.
Time frame: Baseline, week 4, week 8, and week 12.
The Beck II Depression Inventory (BDI)
The Beck II Depression Inventory (BDI) assesses the severity of depressive symptoms. Scores range from 0 to 39, with higher scores indicate a greater degree of depression severity.
Time frame: Baseline, week 4, week 8, and week 12.
The change of the Perceived Stress Scale (PSS) from baseline.
The Perceived Stress Scale (PSS) is for measuring the perception of stress and current levels of experienced stress. Scores range from 0 to 56, with higher total score indicating a greater degree of symptom severity.
Time frame: Baseline, week 4, week 8, and week 12.
Global Impression of Change (PGIC) questionnaire evaluated at week 12.
A questionnaire determine any change in overall symptom status from the beginning of the study to its conclusion (score range, 1 \[very much improved\] to 7 \[very much worse).
Time frame: Week 12.
The change of the Short Form-36 Health Status Questionnaire (SF-36) from baseline.
The Short Form-36 Health Status Questionnaire (SF-36), which measured health-related quality of life (range, 0 to 100, with higher scores indicating better perceived health status).
Time frame: Baseline, week 4, week 8, and week 12.
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