Clinical trial NCT06410430: Exploration the Mechanism of Ba-Duan-Jin in the Treatment of Fibromyalgia Based on Brain-gut Axis
Official title: Exploration the Therapeutic Mechanism of Ba-Duan-Jin in the Treatment of Fibromyalgia by Improving Gut Microbiota and Brain Magnetic Resonance Imaging
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Fibromyalgia
Lead sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Sponsor class: OTHER
First posted: 2024-05-13
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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).


Eligibility 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;

Primary outcomes:
measure: The change of the Visual Analogue Scale (VAS) for pain from baseline
timeFrame: Baseline, week4, week8, week12
measure: The change of Tender Point Count (TPC) from baseline
timeFrame: Baseline, week4, week8, week12
Secondary outcomes:
measure: Gut microbiota sequencing results by analyzing metagenomes of microbial genes
timeFrame: Baseline, week12
measure: Serum fatty acids metabolism results by UPLC-MS/MS
timeFrame: Baseline, week12
measure: Brain morphology in fibromyalgia patients measured by structural MRI
timeFrame: Baseline, week12
measure: Brain functional connectivity in fibromyalgia patients measured by function MRI
timeFrame: Baseline, week12
measure: The change of the revised Fibromyalgia Impact Questionnaire (FIQR) from baseline
timeFrame: Baseline, week4, week8, week12
measure: The change of the Short Form-36 Health Status Questionnaire (SF-36) from baseline
timeFrame: Baseline, week4, week8, week12
Other outcomes:
measure: The change of the Minimum Mental State Examination(MMSE) from baseline
timeFrame: Baseline, week4, week8, week12
measure: The change of the Hamilton Anxiety Scale#HAMA# from baseline
timeFrame: Baseline, week4, week8, week12
measure: The change of the Multidimensional Fatigue Inventory-20 (MFI-20) from baseline
timeFrame: Baseline, week4, week8, week12
measure: The change of the Perceived Stress Scale (PSS) from baseline
timeFrame: Baseline, week4, week8, week12
measure: The change of the Pittsburgh Sleep Quality Index (PSQI) from baseline
timeFrame: Baseline, week4, week8, week12
measure: The change of the Montreal Cognitive Assessment (MOCA) from baseline
timeFrame: Baseline, week4, week8, week12
measure: The change of the Hospital anxiety and depression scale(HADS) from baseline
timeFrame: Baseline, week4, week8, week12
Locations:
city: Beijing
country: China
facility: Guang'anmen Hospital
state: Beijing
Study officials:
References:
citation: Jiao J, Russell IJ, Wang W, Wang J, Zhao YY, Jiang Q. Ba-Duan-Jin alleviates pain and fibromyalgia-related symptoms in patients with fibromyalgia: results of a randomised controlled trial. Clin Exp Rheumatol. 2019 Nov-Dec;37(6):953-962. Epub 2019 Feb 15.