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

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

Recruiting
18 years and older
Female
Phase N/A

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Overview

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

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;

Study details
    Fibromyalgia

NCT06410430

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

20 May 2024

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