Exploration the Mechanism of Ba-Duan-Jin Therapy in the Management of Fibromyalgia

November 6, 2021 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 Intestinal Microecology

Fibromyalgia (FM) is a chronic debilitating musculoskeletal pain syndrome. "Central sensitization" is an important mechanism of the disease. Recent studies have shown that "microbiome-gut-brain axis" imbalance may be one of the important mechanisms of "central sensitization". The purpose of this study was to investigate the therapeutic mechanism of Ba-Duan-Jin therapy in the treatment of fibromyalgia by improving intestinal microecology. The mechanism was evaluated by comparing the results of brain functional MRI (fMRI) and microbacterial analysis of the patients' stool pre and post treatment .

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

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 Locations

  • China
    • Beijing
      • Beijing, Beijing, China
        • Recruiting
        • GAMHospital
        • Contact:
        • 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

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • meet the 1990 American College of Rheumatology (ACR) Research Classification Criteria for fibromyalgia and 2016 Revisions to the 2010/2011 fibromyalgia diagnostic criteria;
  • be between the ages of 18 to 70 years;
  • not taking medication for FM for at least 4 weeks;
  • no special eating habits.

Exclusion Criteria:

  • had practiced Ba-Duan-Jin, Tai Chi, yoga or other forms of Qigong exercise within 12 months of their recruitment to the study;
  • be less than 40mm of pain VAS score;
  • had renal failure, severe depression or anxiety;
  • had any poorly-controlled comorbid medical conditions, such as dementia, cancer, thyroid disease, inflammatory arthritis;
  • pregnancy or planned pregnancy within the study period;
  • patients residing more than 70 miles from the research site;
  • patients with a history of head trauma;
  • a smoker or drinker;
  • contraindications for MRI,including metal implants, cardiac pacemaker,false tooth, surgical artery clips, metal tattoos or claustrophobia;
  • patients with cerebral infarction or cerebral hemorrhage.

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Pregabalin group

Wellness education and muscle relaxation exercise program: This program will be held for 50 minutes twice weekly for twelve weeks, containing 10-minute wellness education, 10-minute doctor-patient discussion, and 30-minute guided muscle relaxation exercise.

Active pregabalin capsules: As same usage as the placebo pregabalin capsules.
Drug: Pregabalin capsule
Pregabalin is one of the three medications (pregabalin, duloxetine, and milnacipran) that have been approved by the Food and Drug Administration (FDA) to treat fibromyalgia in US, and the only medicine that has been approved in China.
No Intervention: Healthy control group
Experimental: Ba-Duan-Jin group
The participants will be guided by a research staff to do the Ba-Duan-Jin therapy for 50 minutes twice weekly for 12 weeks, in the outpatient section of the hospital; Pregabalin placebo treatment will be administered at bedtime once a day, starting at 150 mg for the first week, and increase to the dose of 300 mg from the second week. After one week, if 300 mg dose is tolerable, then maintain it for 10 additional weeks, if not, then go back to the 150 mg dose for 10 additional weeks.
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 movements,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, week24
Pain VAS, range from 0 to 100 mm with higher score indicating more severe pain.
Baseline, week4, week8, week12, week24

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Global Impression of Change (PGIC) questionnaire evaluated at week 12.
Time Frame: Week 12.
A questionnaire determine any change in overall symptom status from the beginning of the study to its conclusion (score range, 1 [very much improved] to 7 [very much worse).
Week 12.
Gut microbiota sequencing results by analyzing metagenomes of microbial genes
Time Frame: Baseline, week12
Fecal samples are obtained from the experimental 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 Brain Derived Neurotrophic Factor (BDNF) levels
Time Frame: Baseline, week12
Serum BDNF levels were measured in healthy control group and FM patients
Baseline, week12
The change of the revised Fibromyalgia Impact Questionnaire (FIQR) from baseline.
Time Frame: Baseline, week 4, week 8, and week 12.
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, week 4, week 8, and week 12.
fMRI of the brain in patients with fibromyalgia
Time Frame: Baseline, week12
To compare the changes in structure, connectivity and metabolic function of the brain in patients with fibromyalgia before and after treatment by fMRI.
Baseline, week12
Serum Tyrosine kinase B (TrkB) levels
Time Frame: Baseline, week12
Serum TrkB levels were measured in healthy control group and FM patients
Baseline, 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)

April 1, 2019

Primary Completion (Anticipated)

May 31, 2022

Study Completion (Anticipated)

December 31, 2022

Study Registration Dates

First Submitted

March 17, 2019

First Submitted That Met QC Criteria

March 25, 2019

First Posted (Actual)

March 26, 2019

Study Record Updates

Last Update Posted (Actual)

November 9, 2021

Last Update Submitted That Met QC Criteria

November 6, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 81873294

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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