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

May 7, 2024 updated by: Juan Jiao, Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Exploration the Therapeutic Mechanism of Ba-Duan-Jin in the Treatment of Fibromyalgia by Improving Gut Microbiota and Brain Magnetic Resonance Imaging

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100053
        • Recruiting
        • Guang'anmen Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Healthy control group
Experimental: 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.
Behavioral: 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.
Other Names:
  • Baduanjin
  • Eight Brocades
  • Eight-Section Brocade

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The change of the Visual Analogue Scale (VAS) for pain from baseline
Time Frame: Baseline, week4, week8, week12
Pain VAS, range from 0 to 100 mm with higher score indicating more severe pain
Baseline, week4, week8, week12
The change of Tender Point Count (TPC) from baseline
Time Frame: 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
Baseline, week4, week8, week12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gut microbiota sequencing results by analyzing metagenomes of microbial genes
Time Frame: 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).
Baseline, week12
Serum fatty acids metabolism results by UPLC-MS/MS
Time Frame: 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.
Baseline, week12
Brain morphology in fibromyalgia patients measured by structural MRI
Time Frame: 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.
Baseline, week12
Brain functional connectivity in fibromyalgia patients measured by function MRI
Time Frame: 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.
Baseline, week12
The change of the revised Fibromyalgia Impact Questionnaire (FIQR) from baseline
Time Frame: 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.
Baseline, week4, week8, week12
The change of the Short Form-36 Health Status Questionnaire (SF-36) from baseline
Time Frame: 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
Baseline, week4, week8, week12

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
The change of the Minimum Mental State Examination(MMSE) from baseline
Time Frame: Baseline, week4, week8, week12
The Minimum Mental State Examination(MMSE) scores range from 0 to 30, with higher scores indicating better cognitive function
Baseline, week4, week8, week12
The change of the Hamilton Anxiety Scale#HAMA# from baseline
Time Frame: Baseline, week4, week8, week12
The Hamilton Anxiety Scale is used to assess the severity of anxiety symptoms and consists of 14 items, with higher scores indicating greater anxiety
Baseline, week4, week8, week12
The change of the Multidimensional Fatigue Inventory-20 (MFI-20) from baseline
Time Frame: Baseline, week4, week8, week12
The Multidimensional Fatigue Inventory-20 (MFI-20) measures fatigue severity. The MFI-20 total score ranges from 0 to 80, with higher scores indicate more severe fatigue.
Baseline, week4, week8, week12
The change of the Perceived Stress Scale (PSS) from baseline
Time Frame: Baseline, week4, week8, week12
The Perceived Stress Scale (PSS) is for measuring the perception of stress and The Perceived Stress Scale (PSS) is for measuring the perception of stress and current levels of experienced stress. Scores range from 0 to 56, with higher total score indicating a greater degree of symptom severity
Baseline, week4, week8, week12
The change of the Pittsburgh Sleep Quality Index (PSQI) from baseline
Time Frame: Baseline, week4, week8, week12
Scores on the Pittsburgh Sleep Quality Index (PSQI) range from 0 to 21, with higher scores indicating worse sleep quality.
Baseline, week4, week8, week12
The change of the Montreal Cognitive Assessment (MOCA) from baseline
Time Frame: Baseline, week4, week8, week12
The MOCA scale includes visuospatial function (maximum 5 points), naming (maximum 3 points), attention ability (maximum 6points), language skills (maximum 3 points), abstract thinking ability (maximum2points), memory ability (maximum 5 points), and orientation ability (maximum 6 points), with a total score of 30 points.
Baseline, week4, week8, week12
The change of the Hospital anxiety and depression scale(HADS) from baseline
Time Frame: Baseline, week4, week8, week12
The HADS is a 14-item, 4-point Likert scale-based self-report rating measure (with a range of 0-3). Seven questions on this scale are used to assess depression and anxiety. The sum of the 14 items determines the final score, while the specific seven items (ranging from 0 to 21) determine the final score for each subscale.
Baseline, week4, week8, week12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 31, 2024

Primary Completion (Estimated)

May 31, 2024

Study Completion (Estimated)

June 30, 2024

Study Registration Dates

First Submitted

April 24, 2024

First Submitted That Met QC Criteria

May 7, 2024

First Posted (Actual)

May 13, 2024

Study Record Updates

Last Update Posted (Actual)

May 13, 2024

Last Update Submitted That Met QC Criteria

May 7, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CI2021A0151

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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