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

Fibromyalgia Clinical Trial

Official title:

Exploration the Therapeutic Mechanism of Ba-Duan-Jin in the Treatment of Fibromyalgia by Improving Intestinal Microecology

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03890133
• Other study ID #: 81873294
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2019
• Est. completion date: December 31, 2022

Study information

• Verified date: November 2021
• Source: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
• Contact: Li yan ting, MD
• Phone: 13120032955
• Email: liyanting0816[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 .

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2022
• Est. primary completion date: May 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

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.

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.

Locations

Country	Name	City	State
China	GAMhospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Country where clinical trial is conducted

China, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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, week24
Secondary	Gut microbiota sequencing results by analyzing metagenomes of microbial genes	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
Secondary	Serum Brain Derived Neurotrophic Factor (BDNF) levels	Serum BDNF levels were measured in healthy control group and FM patients	Baseline, week12
Secondary	The change of the revised Fibromyalgia Impact Questionnaire (FIQR) from baseline.	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.
Secondary	Global Impression of Change (PGIC) questionnaire evaluated at 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.
Secondary	fMRI of the brain in patients with fibromyalgia	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
Secondary	Serum Tyrosine kinase B (TrkB) levels	Serum TrkB levels were measured in healthy control group and FM patients	Baseline, week12

External Links

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