Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
Healthy Volunteers
NCT06410430

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

Led by Guang'anmen Hospital of China Academy of Chinese Medical Sciences · Updated on 2024-05-13

40

Participants Needed

1

Research Sites

21 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
  • Signed informed consent
Not Eligible

You will not qualify if you...

  • Pain Visual Analogue Scale (VAS) score less than 40mm
  • Received any treatments for fibromyalgia or probiotic bacteria within 2 weeks
  • Received antibiotics within 4 weeks
  • Practiced Ba-Duan-Jin, Tai Chi, yoga, or other forms of Qigong within previous 12 months
  • Severe depression or anxiety
  • Pregnancy or planned pregnancy within the study period
  • Poorly-controlled comorbid medical conditions such as dementia, cancer, thyroid disease, inflammatory arthritis
  • History of head trauma, cerebral infarction or cerebral hemorrhage
  • Contraindications for MRI, including metal implants, cardiac pacemaker, false tooth, surgical artery clips, metal tattoos, or claustrophobia

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Guang'anmen Hospital

Beijing, Beijing Municipality, China, 100053

Actively Recruiting

Loading map...

Research Team

S

Shiya Wu, MD

CONTACT

J

Juan Jiao, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

BASIC_SCIENCE

Number of Arms

2

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here