Clinical trial NCT03797560: Comparison of Ba-Duan-Jin and Pregabalin in Patients with Fibromyalgia
Official title: Comparison the Treatment Effects Between Ba-Duan-Jin and Pregabalin in Patients with Fibromyalgia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Keywords: Eight Brocades; Ba-Duan-Jin; Baduanjin; Qigong; Pain
Lead sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Sponsor class: OTHER
First posted: 2019-01-09
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: The change of the Visual Analogue Scale (VAS) for pain from baseline.
timeFrame: up to 1 week
Secondary outcomes:
measure: The change of the revised Fibromyalgia Impact Questionnaire (FIQR) from baseline.
timeFrame: Baseline, week 4, week 8, and week 12.
measure: The change of the Multidimensional Fatigue Inventory-20 (MFI-20) from baseline.
timeFrame: Baseline, week 4, week 8, and week 12.
measure: The change of the Pittsburgh Sleep Quality Index (PSQI) from baseline.
timeFrame: Baseline, week 4, week 8, and week 12.
measure: The Beck II Depression Inventory (BDI)
timeFrame: Baseline, week 4, week 8, and week 12.
measure: The change of the Perceived Stress Scale (PSS) from baseline.
timeFrame: Baseline, week 4, week 8, and week 12.
measure: Global Impression of Change (PGIC) questionnaire evaluated at week 12.
timeFrame: Week 12.
measure: The change of the Short Form-36 Health Status Questionnaire (SF-36) from baseline.
timeFrame: Baseline, week 4, week 8, and week 12.
Other outcomes:
Locations:
city: Beijing
country: China
facility: Jiao Juan
state: Beijing
Study officials:
References:
citation: Yang Y, Li YT, Sun YR, Wang J, Li Y, Zhang JH, Jiao J, Jiang Q. Therapeutic Effects of Ba-Duan-Jin versus Pregabalin for Fibromyalgia Treatment: Protocol for a Randomized Controlled Trial. Rheumatol Ther. 2021 Sep;8(3):1451-1462. doi: 10.1007/s40744-021-00341-9. Epub 2021 Jul 22.