Pragmatic Randomized Controlled Trial of Acupuncture Effectiveness in the Treatment of Fibromyalgia
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Fibromyalgia Impact Questionnaire (FIQ) score
研究概览
简要总结
Fibromyalgia is a medical condition characterized by musculoskeletal pain, fatigue, sleep disturbances and depression. It affects population at a socioeconomically active age and represents a burden for the patients and the health care system due to its personal and functional implications. At this moment, there is no completely effective treatment for fibromyalgia, and acupuncture has been a promising alternative. This trial aims to evaluate if addition of acupuncture to standard care represents an improvement in comparison with standard care only. Thus, patients enrolled in this trial will be randomly allocated into one of two groups: group A, who besides standard treatment will receive 12 sessions of acupuncture; and group B, who will receive standard care with monthly orientation sessions for the same period. Patients will be evaluated at baseline, after completion of acupuncture treatment or orientation, and after an additional 12-week follow up. Evaluation will be based on diaries of pain and medication, and standard scales of pain, quality of life and disability.
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
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American College of Rheumatology criteria for fibromyalgia
- •elementary school
- •drug treatment for at least 30 days (if any)
排除标准
- •disabling mental condition
- •other rheumatic conditions
- •other chronic medical conditions with musculoskeletal symptoms
- •pregnancy
- •conditions that impair walking
- •conditions that impair weekly consultations
- •acupuncture treatment in the twelve-month period prior to enrollment
- •diabetes mellitus
结局指标
主要结局
Fibromyalgia Impact Questionnaire (FIQ) score
时间窗: Twelve weeks from baseline
次要结局
- Weekly Likert scale in pain diary(Twenty-four weeks from baseline)
- Visual Analog Scale (VAS) for pain(Twenty-four weeks from baseline)
- Short Form 36 (SF-36) score for quality of life(Twenty-four weeks from baseline)
- Health Assessment Questionnaire - Disability Index (HAQ-DI) score(Twenty-four weeks from baseline)
- Hospital Anxiety and Depression (HAD) Scale(Twenty-four weeks from baseline)
- Fibromyalgia Impact Questionnaire (FIQ) score(Twenty-four weeks from baseline)