NCT01261650终止4 期
Influence of Transcranial Direct Current Stimulation of the Primary Motor Cortex on Pain Sensation in Patients Suffering From Fibromyalgia Syndrome
Karl Landsteiner Institute of Remobilization and Functional Health2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2010年12月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Visual Analoge Scale
研究概览
简要总结
Fibromyalgia is a common chronic pain syndrome characterized by bad treatable chronic widespread pain present at a similar level for at least 3 months. The aim of this study is to examine if 3 weeks of transcranial direct current stimulation is a suitable therapy to reduce chronic pain.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who have an established diagnosis of fibromyalgia according to the 1990 criteria of the "American College of Rheumatology"
- •Symptoms have been present at a similar level for at least 3 months
- •Stable medication for at least 2 months
- •visual analog scale ≥ 3 (0=no pain; 10=worst possible pain)
- •The patient does not have a disorder that would otherwise explain the pain
排除标准
- •Alcohol/substance abuse
- •Pregnancy
- •Neuropsychiatric disorders
- •Metal implants near stimulation area
- •Cardiac pace maker
- •Local injuries
- •Inflammatory rheumatic disease
- •Acute tumor
- •Acute fracture
- •Well-defined neuropathic induced pain
研究组 & 干预措施
transcranial direct current stimulation
Active Comparator
transcranial direct current stimulation of the primary motor cortex
干预措施: transcranial direct current stimulation (Device)
sham treatment
Sham Comparator
干预措施: sham treatment (Device)
结局指标
主要结局
Visual Analoge Scale
时间窗: Difference Baseline - after treatment
次要结局
- Quality of Life - SF-36(baseline / after treatment / 1 , 2, 3 months after treatment)
- IL-6 ELISA(baseline / after treatment / 1,2,3, months after treatment)
- Fibromyalgia Impact Questionaire(baseline / after treatment / 1,2,3, months after treatment)
- IL-10 ELISA(baseline / after treatment / 1,2,3, months after treatment)
- Visual analog scale(1,2,3 months after treatment)
- TNF-alpha ELISA(baseline / after treatment / 1,2,3, months after treatment)
- IL-4 ELISA(baseline / after treatment / 1,2,3, months after treatment)
研究者
研究点 (2)
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