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

Fibromyalgia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03797560
• Other study ID #: Z181100001718153
• Status: Completed
• Phase: N/A
• Start date: March 22, 2019
• Est. completion date: October 31, 2022

Study information

• Verified date: December 2022
• Source: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: October 31, 2022
• Est. primary completion date: October 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• meet the 1990 American College of Rheumatology (ACR) Research Classification Criteria for fibromyalgia;
• be between the ages of 18 to 70 years.

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, and 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.

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

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.

Locations

Country	Name	City	State
China	Jiao Juan	Beijing	Beijing

Sponsors (1)

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

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change of the Visual Analogue Scale (VAS) for pain from baseline.	Pain VAS, range, 0 to 100 mm, where higher scores indicated the perceived pain to be more severe.	up to 1 week
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	The change of the Multidimensional Fatigue Inventory-20 (MFI-20) from baseline.	The Multidimensional Fatigue Inventory-20 (MFI-20) measures fatigue severity. The MFI-20 total score ranges from 0 to 80, with higher scores indicate more severe fatigue.	Baseline, week 4, week 8, and week 12.
Secondary	The change of the Pittsburgh Sleep Quality Index (PSQI) from baseline.	Scores on the Pittsburgh Sleep Quality Index (PSQI) range from 0 to 21, with higher scores indicating worse sleep quality.	Baseline, week 4, week 8, and week 12.
Secondary	The Beck II Depression Inventory (BDI)	The Beck II Depression Inventory (BDI) assesses the severity of depressive symptoms. Scores range from 0 to 39, with higher scores indicate a greater degree of depression severity.	Baseline, week 4, week 8, and week 12.
Secondary	The change of the Perceived Stress Scale (PSS) from baseline.	The Perceived Stress Scale (PSS) is for measuring the perception of stress and current levels of experienced stress. Scores range from 0 to 56, with higher total score indicating a greater degree of symptom severity.	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	The change of the Short Form-36 Health Status Questionnaire (SF-36) from baseline.	The Short Form-36 Health Status Questionnaire (SF-36), which measured health-related quality of life (range, 0 to 100, with higher scores indicating better perceived health status).	Baseline, week 4, week 8, and week 12.