Actively Recruiting
Exploration the Mechanism of Ba-Duan-Jin in the Treatment of Fibromyalgia Based on Brain-gut Axis
Led by Guang'anmen Hospital of China Academy of Chinese Medical Sciences · Updated on 2024-05-13
40
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is 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).
CONDITIONS
Official Title
Exploration the Mechanism of Ba-Duan-Jin in the Treatment of Fibromyalgia Based on Brain-gut Axis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
- Signed informed consent
You will not qualify if you...
- Pain Visual Analogue Scale (VAS) score less than 40mm
- Received any treatments for fibromyalgia or probiotic bacteria within 2 weeks
- Received antibiotics within 4 weeks
- Practiced Ba-Duan-Jin, Tai Chi, yoga, or other forms of Qigong within previous 12 months
- Severe depression or anxiety
- Pregnancy or planned pregnancy within the study period
- Poorly-controlled comorbid medical conditions such as dementia, cancer, thyroid disease, inflammatory arthritis
- History of head trauma, cerebral infarction or cerebral hemorrhage
- Contraindications for MRI, including metal implants, cardiac pacemaker, false tooth, surgical artery clips, metal tattoos, or claustrophobia
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Guang'anmen Hospital
Beijing, Beijing Municipality, China, 100053
Actively Recruiting
Research Team
S
Shiya Wu, MD
CONTACT
J
Juan Jiao, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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