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

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Status: Completed

Conditions: Fibromyalgia

Treatments: Other: Ba-Duan-Jin; Drug: Pregabalin capsule

Study type: Interventional

Funder types: Other

Identifiers

NCT03797560

Z181100001718153

Details and patient eligibility

About

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.

Enrollment: 104 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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104 participants in 2 patient groups

Ba-Duan-Jin group

Experimental group

Description:

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.

Treatment:

Other: Ba-Duan-Jin

Pregabalin group

Active Comparator group

Description:

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.

Treatment:

Drug: Pregabalin capsule