NCT06410430

Exploration the Mechanism of Ba-Duan-Jin in the Treatment of Fibromyalgia Based on Brain-gut Axis

Exploration the Therapeutic Mechanism of Ba-Duan-Jin in the Treatment of Fibromyalgia by Improving Gut Microbiota and Brain Magnetic Resonance Imaging

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

To investigate the mechanism by Ba-Duan-Jin in the treatment of fibromyalgia. Twenty eligible fibromyalgia patients were selected, and were trained and guided online by an experienced Ba-Duan-Jin instructor with reference to the standard operating procedure (SOP) for a 12-week course of 1 hour twice a week. The evaluation points were 0, 4, 8, and 12 weeks. The change of pain Visual Analogue Score (VAS) and tener point count (TPC) post-treatment were evaluated. And blood, feces, and brain fMRI were collected from the patients at 0 and 12 weeks to compare the changes in gut microbiota, metabolites, and brain function networks before and after the intervention with the 16SrRNA sequencing, targeted metabolomics, and real-time Quantitative Polymerase Chain Reaction (PCR).

Conditions

• Fibromyalgia

Interventions

Type	Name	Description
BEHAVIORAL	Ba-Duan-Jin	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 ovements,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.

Timeline

• Start date: 2024-01-31
• Primary completion: 2024-05-31
• Completion: 2024-06-30
• First posted: 2024-05-13
• Last updated: 2024-05-13

Locations

1 site across 1 country: China