Exploring Ba-Duan-Jin for treating fibromyalgia
Exploration the Therapeutic Mechanism of Ba-Duan-Jin in the Treatment of Fibromyalgia by Improving Gut Microbiota and Brain Magnetic Resonance Imaging
This study is testing if a traditional Chinese exercise called Ba-Duan-Jin can help women with fibromyalgia feel less pain and improve their overall health over 12 weeks.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Guang'anmen Hospital of China Academy of Chinese Medical Sciences Academic / other |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT06410430 on ClinicalTrials.gov |
What this trial studies
This study investigates how Ba-Duan-Jin, a traditional Chinese exercise, may help treat fibromyalgia by focusing on the brain-gut axis. Twenty eligible female patients will participate in a 12-week program, receiving online training from an experienced instructor, with sessions held twice a week. The study will evaluate changes in pain levels and tender point counts at multiple time points, while also analyzing blood, feces, and brain fMRI data to assess changes in gut microbiota, metabolites, and brain function networks. The findings aim to provide insights into the underlying mechanisms of this intervention.
Who should consider this trial
Good fit: Ideal candidates are right-handed females over 18 years old who meet the diagnostic criteria for fibromyalgia.
Not a fit: Patients with severe depression, anxiety, or poorly-controlled comorbid conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could offer a novel, non-pharmacological treatment option for patients suffering from fibromyalgia.
How similar studies have performed: While the specific approach of using Ba-Duan-Jin for fibromyalgia is novel, other studies have explored the benefits of mind-body interventions in similar conditions.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Meet the 1990 American College of Rheumatology (ACR) Research Classification Criteria for fibromyalgia or 2016 Revisions to the 2010/2011 fibromyalgia diagnostic criteria; * Be over 18 years of age; * Female; * Right-handedness; * Sign informed consent. Exclusion Criteria: * be less than 40mm of pain VAS score; * had received any treatments for fibromyalgia or probiotic bacteria within 2 weeks; * had received antibiotics within 4 weeks; * had practiced Ba-Duan-Jin, Tai Chi, yoga, or other forms of Qigong within previous 12 months; * had severe depression or anxiety; * pregnancy or planned pregnancy within the study period; * had any poorly-controlled comorbid medical conditions, such as dementia, cancer, thyroid disease, inflammatory arthritis; * patients with a history of head trauma, cerebral infarction or cerebral haemorrhage * contraindications for MRI,including metal implants, cardiac pacemaker,false tooth, surgical artery clips, metal tattoos or claustrophobia;
Where this trial is running
Beijing, Beijing Municipality
- Guang'anmen Hospital — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Study coordinator: Shiya Wu, MD
- Email: 2778823398@qq.com
- Phone: +86 010-88001060
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.