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

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Status: Enrolling

Conditions: Fibromyalgia

Treatments: Behavioral: Ba-Duan-Jin

Study type: Interventional

Funder types: Other

Identifiers

NCT06410430

CI2021A0151

Details and patient eligibility

About

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).

Enrollment: 40 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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;

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Ba-Duan-Jin group

Experimental group

Description:

The participants will be 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.

Treatment:

Behavioral: Ba-Duan-Jin

Healthy control group

No Intervention group