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Fibromyalgia (FM) is a chronic debilitating musculoskeletal pain syndrome. "Central sensitization" is an important mechanism of the disease. Recent studies have shown that "microbiome-gut-brain axis" imbalance may be one of the important mechanisms of "central sensitization". The purpose of this study was to investigate the therapeutic mechanism of Ba-Duan-Jin therapy in the treatment of fibromyalgia by improving intestinal microecology. The mechanism was evaluated by comparing the results of brain functional MRI (fMRI) and microbacterial analysis of the patients' stool pre and post treatment .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ba-Duan-Jin group | Experimental | 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; 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. |
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| Pregabalin group | Active Comparator | 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. |
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| Healthy control group | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ba-Duan-Jin | Behavioral | Ba-Duan-Jin is a common form of "self-healthcare" 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. |
| Measure | Description | Time Frame |
|---|---|---|
| The change of the Visual Analogue Scale (VAS) for pain from baseline. | Pain VAS, range from 0 to 100 mm with higher score indicating more severe pain. | Baseline, week4, week8, week12, week24 |
| Measure | Description | Time Frame |
|---|---|---|
| Gut microbiota sequencing results by analyzing metagenomes of microbial genes | Fecal samples are obtained from the experimental group and control group. After extracting DNA from fecal samoles, high-throughput Illumina sequencing, gene classification, abundance calculation, functional and metabolic annotation will be performed on the extracted DNA. The Bowtie2, BWA and Soap2 will be selected for the comparison software. The condition of comparison is to obtain the comparison results of 95% identity (and above). |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GAMhospital | Beijing | Beijing Municipality | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30789154 | Background | Jiao J, Russell IJ, Wang W, Wang J, Zhao YY, Jiang Q. Ba-Duan-Jin alleviates pain and fibromyalgia-related symptoms in patients with fibromyalgia: results of a randomised controlled trial. Clin Exp Rheumatol. 2019 Nov-Dec;37(6):953-962. Epub 2019 Feb 15. | |
| 40589353 | Derived | Wu S, Jing B, Wang Y, Long M, Li Y, Li Z, Jiao J. Two Neuroanatomical Subtypes in Fibromyalgia Patients: Distinct Morphological Patterns and Treatment Outcomes. CNS Neurosci Ther. 2025 Jul;31(7):e70500. doi: 10.1111/cns.70500. |
| Label | URL |
|---|---|
| Ba-Duan-Jin alleviates pain and fibromyalgia-related symptoms in patients with fibromyalgia: results of a randomised controlled trial. | View source |
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| ID | Term |
|---|---|
| D005356 | Fibromyalgia |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009468 | Neuromuscular Diseases |
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| ID | Term |
|---|---|
| D000069583 | Pregabalin |
| ID | Term |
|---|---|
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
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| Pregabalin capsule | Drug | 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. |
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| Baseline, week12 |
| Serum Brain Derived Neurotrophic Factor (BDNF) levels | Serum BDNF levels were measured in healthy control group and FM patients | Baseline, week12 |
| 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. |
| 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).](streamdown:incomplete-link) | Week 12. |
| fMRI of the brain in patients with fibromyalgia | To compare the changes in structure, connectivity and metabolic function of the brain in patients with fibromyalgia before and after treatment by fMRI. | Baseline, week12 |
| Serum Tyrosine kinase B (TrkB) levels | Serum TrkB levels were measured in healthy control group and FM patients | Baseline, week12 |
| D009422 |
| Nervous System Diseases |
| D002264 |
| Carboxylic Acids |
| D009930 | Organic Chemicals |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |