Comparison the Treatment Effects Between Ba-Duan-Jin and Pregabalin in Patients with Fibromyalgia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- The change of the Visual Analogue Scale (VAS) for pain from baseline.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •meet the 1990 American College of Rheumatology (ACR) Research Classification Criteria for fibromyalgia;
- •be between the ages of 18 to 70 years.
排除标准
- •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.
研究组 & 干预措施
Ba-Duan-Jin group
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.
干预措施: Ba-Duan-Jin (Other)
Pregabalin group
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.
干预措施: Pregabalin capsule (Drug)
结局指标
主要结局
The change of the Visual Analogue Scale (VAS) for pain from baseline.
时间窗: up to 1 week
Pain VAS, range, 0 to 100 mm, where higher scores indicated the perceived pain to be more severe.
次要结局
- The change of the revised Fibromyalgia Impact Questionnaire (FIQR) from baseline.(Baseline, week 4, week 8, and week 12.)
- The change of the Multidimensional Fatigue Inventory-20 (MFI-20) from baseline.(Baseline, week 4, week 8, and week 12.)
- The change of the Pittsburgh Sleep Quality Index (PSQI) from baseline.(Baseline, week 4, week 8, and week 12.)
- The Beck II Depression Inventory (BDI)(Baseline, week 4, week 8, and week 12.)
- The change of the Perceived Stress Scale (PSS) from baseline.(Baseline, week 4, week 8, and week 12.)
- Global Impression of Change (PGIC) questionnaire evaluated at week 12.(Week 12.)
- The change of the Short Form-36 Health Status Questionnaire (SF-36) from baseline.(Baseline, week 4, week 8, and week 12.)
研究者
Juan Jiao
Deputy chief physician
Guang'anmen Hospital of China Academy of Chinese Medical Sciences