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

Not Applicable

Completed

• Conditions: Fibromyalgia
• Interventions: Other: Ba-Duan-Jin; Drug: Pregabalin capsule

• Registration Number: NCT03797560
• Lead Sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-01-06
• Study First Submitted QC: 2019-01-06
• Study First Posted: 2019-01-09
• Study Start: 2019-03-22
• Primary Completion: 2021-10-31
• Study Completion: 2022-10-31
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-22
• Last Update Posted: 2024-10-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 104

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ba-Duan-Jin group	Ba-Duan-Jin	Ba-Duan-Jin therapy: 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. Placebo pregabalin capsules: 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.
Pregabalin group	Pregabalin capsule	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.

Primary Outcome Measures

Name	Time	Method
The change of the Visual Analogue Scale (VAS) for pain from baseline.	up to 1 week	Pain VAS, range, 0 to 100 mm, where higher scores indicated the perceived pain to be more severe.

Secondary Outcome Measures

Name	Time	Method
The change of the revised Fibromyalgia Impact Questionnaire (FIQR) from baseline.	Baseline, week 4, week 8, and week 12.	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.
The change of the Multidimensional Fatigue Inventory-20 (MFI-20) from baseline.	Baseline, week 4, week 8, and week 12.	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.
The change of the Pittsburgh Sleep Quality Index (PSQI) from baseline.	Baseline, week 4, week 8, and week 12.	Scores on the Pittsburgh Sleep Quality Index (PSQI) range from 0 to 21, with higher scores indicating worse sleep quality.
The Beck II Depression Inventory (BDI)	Baseline, week 4, week 8, and week 12.	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.
The change of the Perceived Stress Scale (PSS) from baseline.	Baseline, week 4, week 8, and week 12.	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.
Global Impression of Change (PGIC) questionnaire evaluated at week 12.	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).
The change of the Short Form-36 Health Status Questionnaire (SF-36) from baseline.	Baseline, week 4, week 8, and week 12.	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).

Trial Locations

Locations (1)

Jiao Juan; 🇨🇳 Beijing, Beijing, China