Clinical trial NCT03890133: Exploration the Mechanism of Ba-Duan-Jin Therapy in the Management of Fibromyalgia
Official title: Exploration the Therapeutic Mechanism of Ba-Duan-Jin in the Treatment of Fibromyalgia by Improving Intestinal Microecology
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Keywords: Fibromyalgia
Ba-Duan-Jin
Gut microbiota
Mechanism
Lead sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Sponsor class: OTHER
First posted: 2019-03-26
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: 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 .


Eligibility criteria: 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.

Primary outcomes:
measure: The change of the Visual Analogue Scale (VAS) for pain from baseline.
timeFrame: Baseline, week4, week8, week12, week24
Secondary outcomes:
measure: Gut microbiota sequencing results by analyzing metagenomes of microbial genes
timeFrame: Baseline, week12
measure: Serum Brain Derived Neurotrophic Factor (BDNF) levels
timeFrame: Baseline, week12
measure: The change of the revised Fibromyalgia Impact Questionnaire (FIQR) from baseline.
timeFrame: Baseline, week 4, week 8, and week 12.
measure: Global Impression of Change (PGIC) questionnaire evaluated at week 12.
timeFrame: Week 12.
measure: fMRI of the brain in patients with fibromyalgia
timeFrame: Baseline, week12
measure: Serum Tyrosine kinase B (TrkB) levels
timeFrame: Baseline, week12
Other outcomes:
Locations:
city: Beijing
country: China
facility: GAMhospital
state: Beijing
Study officials:
References:
citation: 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.