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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-31

Study Completion Date

2024-06-30

Brief Summary

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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).

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Detailed Description

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Conditions

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Fibromyalgia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Ba-Duan-Jin group

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.

Group Type EXPERIMENTAL

Ba-Duan-Jin

Intervention Type BEHAVIORAL

Ba-Duan-Jin is a common form of "self-healthcare" Qigong exercise that has been practiced by Chinese people for at least eight hundred years.It consists of eight sets of simple movements. By combining meditation with slow, graceful ovements,deep breathing, and relaxation, Ba-Duan-Jin practitioners believe it has the ability to move vital energy (Qi) throughout the body. Ba-Duan-Jin is also considered to be a multicomponent intervention that integrates physical, psychosocial, emotional, spiritual, and behavioral elements. While the biological mechanisms remain unclear.

Healthy control group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Ba-Duan-Jin

Ba-Duan-Jin is a common form of "self-healthcare" Qigong exercise that has been practiced by Chinese people for at least eight hundred years.It consists of eight sets of simple movements. By combining meditation with slow, graceful ovements,deep breathing, and relaxation, Ba-Duan-Jin practitioners believe it has the ability to move vital energy (Qi) throughout the body. Ba-Duan-Jin is also considered to be a multicomponent intervention that integrates physical, psychosocial, emotional, spiritual, and behavioral elements. While the biological mechanisms remain unclear.

Intervention Type BEHAVIORAL

Other Intervention Names

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Baduanjin Eight Brocades Eight-Section Brocade

Eligibility Criteria

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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;

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes