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

NCT06410430 | Recruiting

• 1 other identifier: CI2021A0151
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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).

Conditions

Fibromyalgia

Outcome Measures

Primary Outcomes (2)

• The change of the Visual Analogue Scale (VAS) for pain from baseline

  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

  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 Outcomes (6)

• Gut microbiota sequencing results by analyzing metagenomes of microbial genes

  Baseline, week12

• Serum fatty acids metabolism results by UPLC-MS/MS

  Baseline, week12

• Brain morphology in fibromyalgia patients measured by structural MRI

  Baseline, week12

• Brain functional connectivity in fibromyalgia patients measured by function MRI

  Baseline, week12

• The change of the revised Fibromyalgia Impact Questionnaire (FIQR) from baseline

  Baseline, week4, week8, week12

Other Outcomes (7)

• The change of the Minimum Mental State Examination(MMSE) from baseline

  Baseline, week4, week8, week12

• The change of the Hamilton Anxiety Scale#HAMA# from baseline

  Baseline, week4, week8, week12

• The change of the Multidimensional Fatigue Inventory-20 (MFI-20) from baseline

  Baseline, week4, week8, week12

Study Arms (2)

Ba-Duan-Jin group

EXPERIMENTAL

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

Healthy control group

NO INTERVENTION

Interventions

Ba-Duan-Jin 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.

Also known as: Baduanjin, Eight Brocades, Eight-Section Brocade

Ba-Duan-Jin group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Guang'anmen Hospital of China Academy of Chinese Medical Sciences: lead

Study Sites (1)

Guang'anmen Hospital

Beijing, Beijing Municipality, 100053, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 30789154 BACKGROUND

Related Links

• Ba-Duan-Jin alleviates pain and fibromyalgia-related symptoms in patients with fibromyalgia: results of a randomised controlled trial.

MeSH Terms

Conditions

Fibromyalgia

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Central Study Contacts

Shiya Wu, MD

CONTACT

+86 010-88001060; 2778823398@qq.com

Juan Jiao, PhD

CONTACT

+86 010-88001060; jiao.juan@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician

Study Record Dates

• First Submitted: April 24, 2024
• First Posted: May 13, 2024
• Study Start: January 31, 2024
• Primary Completion: May 31, 2024
• Study Completion: June 30, 2024
• Last Updated: May 13, 2024

Record last verified: 2024-05

Locations

CN (1)