NCT03797560

Comparison of Ba-Duan-Jin and Pregabalin in Patients with Fibromyalgia

Comparison the Treatment Effects Between Ba-Duan-Jin and Pregabalin in Patients with Fibromyalgia

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 104 (actual)
• Sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Fibromyalgia is a chronic debilitating musculoskeletal pain syndrome. Pregabalin is the only medication that has been approved to treat fibromyalgia in China. Currently, there has been a growing interest in the development of non-pharmacological therapies. Ba-Duan-Jin is an ancient Chinese exercise for health promotion yet easy to learn. Findings from our previous study showed an effectiveness and good safety of Ba-Duan-Jin in patients with fibromyalgia. This study is to evaluate the effectiveness comparison of Ba-Duan-Jin and pregabalin in managing fibromyalgia symptoms experienced by Chinese patients.

Conditions

• Fibromyalgia

Interventions

Type	Name	Description
OTHER	Ba-Duan-Jin	Ba-Duan-Jin is a common form of "self-health-care" 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, previous clinical trials have demonstrated that Ba-Duan-Jin can improve sleep quality, physical health, and mental health in patients with various chronic diseases
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: 2019-03-22
• Primary completion: 2021-10-31
• Completion: 2022-10-31
• First posted: 2019-01-09
• Last updated: 2024-10-24

Locations

1 site across 1 country: China