Clinical Study on Efficacy and Safety of Warm Acupuncture in Treatment of Cold-sensitive Fibromyalgia Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- The change of the VAS score for item 10 (susceptibility to cold) of the modified fibromyalgia Impact Questionnaire from baseline.
研究概览
简要总结
Non-pharmaceutical therapies, such as acupuncture, hydrotherapy, and meditative exercises (such as Qigong (including Tai Chi and Ba-Duan-Jin), have been shown to reduce pain and improve physical function. The management recommendations of fibromyalgia issued by the European Union, Canada, Germany and Israel have all affirmed the "first-line" role of Non-pharmaceutical therapy. Because of its good efficacy and safety, acupuncture therapy has been recommended in the management guidelines and has broad application prospects. Warm acupuncture is a therapy combining acupuncture and moxibustion, which is widely used in the treatment of various painful diseases in China, especially for cold-sensitive patients . This study aims to observe the safety and effectiveness of warm acupuncture in the treatment of cold-sensitive fibromyalgia patients, in order to provide a more alternative non-drug therapy for this particular type of patients with fibromyalgia .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 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 over 18 years of age;
- •The type and dose of drugs used for fibromyalgia should be stable for at least 2 weeks;
- •The VAS score of item 10 (sensitivity to cold) in FIQR scale ≧4 points;
- •Sign informed consent.
排除标准
- •Patients suffering from systemic or local acute infectious diseases;
- •Patients with severe visceral diseases or physical weakness who cannot tolerate acupuncture treatment;
- •Pregnant women.
结局指标
主要结局
The change of the VAS score for item 10 (susceptibility to cold) of the modified fibromyalgia Impact Questionnaire from baseline.
时间窗: Baseline, week4, week8, week12, week16
range from 0 to 10 cm with higher score indicating more sensitive to cold.
次要结局
- The change of the Minimum Mental State Examination(MMSE) from baseline.(Baseline, week4, week8, week12, week16)
- The change of the revised Fibromyalgia Impact Questionnaire (FIQR) from baseline(Baseline, week4, week8, week12, week16)
- The change of the Multidimensional Fatigue Inventory-20 (MFI-20) from baseline.(Baseline, week4, week8, week12, week16)
- The change of the Perceived Stress Scale (PSS) from baseline.(Baseline, week4, week8, week12, week16)
- The change of the Visual Analogue Scale (VAS) for pain from baseline.(Baseline, week4, week8, week12, week16)
- The change of the Beck II Depression Inventory (BDI) from baseline.(Baseline, week4, week8, week12, week16)
- The change of the Hamilton Anxiety Scale（HAMA） from baseline.(Baseline, week4, week8, week12, week16)
- The change of the Short Form-36 Health Status Questionnaire (SF-36) from baseline.(Baseline, week4, week8, week12, week16)
- The change of the Pittsburgh Sleep Quality Index (PSQI) from baseline.(Baseline, week4, week8, week12, week16)
- Global Impression of Change (PGIC) questionnaire evaluated at week 16.(week16)
研究者
Juan Jiao
Investigator
Guang'anmen Hospital of China Academy of Chinese Medical Sciences