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

NCT ID: NCT03890133

Last Updated: 2024-10-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-01
• Study Completion Date: 2022-12-31

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 .

Conditions

Fibromyalgia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Ba-Duan-Jin

Intervention Type: 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 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.

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.

Group Type: ACTIVE_COMPARATOR

Pregabalin capsule

Intervention Type: DRUG

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.

Healthy control group

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: DRUG

Other Intervention Names

Baduanjin; Eight Brocades; Eight-Section Brocade

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Juan Jiao

Deputy chief physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

GAMhospital

Beijing, Beijing Municipality, China

Countries

China

References

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.

Reference Type: BACKGROUND

PMID: 30789154 (View on PubMed)

Wu S, Jing B, Wang Y, Long M, Li Y, Li Z, Jiao J. Two Neuroanatomical Subtypes in Fibromyalgia Patients: Distinct Morphological Patterns and Treatment Outcomes. CNS Neurosci Ther. 2025 Jul;31(7):e70500. doi: 10.1111/cns.70500.

Reference Type: DERIVED

PMID: 40589353 (View on PubMed)

Related Links

https://pubmed.ncbi.nlm.nih.gov/30789154/

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

Other Identifiers

81873294

Identifier Type: -

Identifier Source: org_study_id