Comparison of Ba-Duan-Jin and Pregabalin in Patients With Fibromyalgia

Study Overview
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Brief Summary
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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.

Official Title
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Comparison the Treatment Effects Between Ba-Duan-Jin and Pregabalin in Patients With Fibromyalgia

Conditions
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Fibromyalgia

Intervention / Treatment
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* Other: Ba-Duan-Jin
* Drug: Pregabalin capsule


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: meet the 1990 American College of Rheumatology (ACR) Research Classification Criteria for fibromyalgia; be between the ages of 18 to 70 years. Exclusion Criteria: had practiced Ba-Duan-Jin, Tai Chi, yoga or other forms of Qigong exercise within 12 months of their recruitment to the study; be less than 40mm of pain VAS score; had renal failure, and severe depression or anxiety; had any poorly-controlled comorbid medical conditions, such as dementia, cancer, thyroid disease, inflammatory arthritis; pregnancy or planned pregnancy within the study period; patients residing more than 70 miles from the research site.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ba-Duan-Jin group<br>Ba-Duan-Jin therapy: The participants will be guided by a research staff to do the Ba-Duan-Jin therapy for 50 minutes twice weekly for 12 weeks, in the outpatient section of the hospital. Placebo pregabalin capsules: Pregabalin placebo treatment will be administered at bedtime once a day, starting at 150 mg for the first week, and increase to the dose of 300 mg from the second week. After one week, if 300 mg dose is tolerable, then maintain it for 10 additional weeks, if not, then go back to the 150 mg dose for 10 additional weeks. | Other: Ba-Duan-Jin<br>* 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<br>* Other names: Baduanjin; Eight Brocades; Eight-Section Brocade;|
| Active Comparator: Pregabalin group<br>Wellness education and muscle relaxation exercise program: This program will be held for 50 minutes twice weekly for twelve weeks, containing 10-minute wellness education, 10-minute doctor-patient discussion, and 30-minute guided muscle relaxation exercise. Active pregabalin capsules: As same usage as the placebo pregabalin capsules. | Drug: Pregabalin capsule<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | up to 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | 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). | 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). | Baseline, week 4, week 8, and week 12. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Eight Brocades; Ba-Duan-Jin; Baduanjin; Qigong; Pain