Trials / Completed
CompletedNCT03890133
Exploration the Mechanism of Ba-Duan-Jin Therapy in the Management of Fibromyalgia
Exploration the Therapeutic Mechanism of Ba-Duan-Jin in the Treatment of Fibromyalgia by Improving Intestinal Microecology
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 60 (actual)
- Sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical Sciences · Academic / Other
- Sex
- Female
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2019-04-01
- Primary completion
- 2022-05-31
- Completion
- 2022-12-31
- First posted
- 2019-03-26
- Last updated
- 2024-10-21
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT03890133. Inclusion in this directory is not an endorsement.