Exploration the Mechanism of Ba-Duan-Jin in the Treatment of Fibromyalgia Based on Brain-gut Axis
- Conditions
- Fibromyalgia
- Interventions
- Behavioral: Ba-Duan-Jin
- Registration Number
- NCT06410430
- Brief 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 40
- 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.
- 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;
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Ba-Duan-Jin group Ba-Duan-Jin 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.
- Primary Outcome Measures
Name Time Method The change of Tender Point Count (TPC) from baseline Baseline, week4, week8, week12 TPC, the 18 body points of the 1990 American College of Rheumatology (ACR) Research Classification Criteria for fibromyalgia, which in healthy subjects do not cause pain, whereas in patients with fibromyalgia no fewer than 11 are painful
The change of the Visual Analogue Scale (VAS) for pain from baseline Baseline, week4, week8, week12 Pain VAS, range from 0 to 100 mm with higher score indicating more severe pain
- Secondary Outcome Measures
Name Time Method Brain morphology in fibromyalgia patients measured by structural MRI Baseline, week12 To compare the changes in brain structure and morphology in patients with fibromyalgia before and after treatment by structural MRI. The images were acquired by a Siemens 3.0T Skyra scanner (Siemens; Munich, Germany) using fast spoiled gradient-echo sequence. Images contain whole brain, grey matter, white matter, atlas-based regions of interest for the patient group and healthy controls. The structural MRI images were processed with CAT 12 software (Version12.7, r1700). In detail, the voxel-based morphometry pipeline includes initial and refined voxel-based processing.
The change of the Short Form-36 Health Status Questionnaire (SF-36) from baseline Baseline, week4, week8, week12 The Short Form-36 Health Status Questionnaire (SF-36), which measured health-related quality of life (range, 0 to 100, with higher scores indicating better perceived health status
Serum fatty acids metabolism results by UPLC-MS/MS Baseline, week12 Blood samples are obtained from the Ba-Duan-Jin group and control group. Ultra Performance Liquid Chromatography Tandem Mass Spectrometry will be performed. The SIMCA will be selected for Orthogonal Partial Least Squares-Discriminant Analysis. The Kyoto encyclopedia of genes and genomes will be selected for functional enrichment analysis of differential metabolites.
The change of the revised Fibromyalgia Impact Questionnaire (FIQR) from baseline Baseline, week4, week8, week12 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.
Brain functional connectivity in fibromyalgia patients measured by function MRI Baseline, week12 To compare the changes in connectivity and metabolic function of the brain in patients with fibromyalgia before and after treatment by function MRI. The scanning sequence is set up under the guidance of an imaging professional, while ensuring that the participants undergo the MRI scans with their eyes closed but awake; head movements do not exceed 1.5 mm in translation in any direction and 1.5° in rotation in any direction.
Gut microbiota sequencing results by analyzing metagenomes of microbial genes Baseline, week12 Fecal samples are obtained from the Ba-Duan-Jin 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).
Trial Locations
- Locations (1)
Guang'anmen Hospital
🇨🇳Beijing, Beijing, China