NCT00917176已完成2 期
Subcutaneous C2 Stimulation: Treatment of Fibromyalgia
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 试验地点
- 2
- 主要终点
- Pain scores on Visual Analogue Scale (VAS), pain Catastrophizing Scale (PCS), pain vigilance and awareness questionnaire (PVAQ)
研究概览
简要总结
The aim of this study is to investigate whether greater occipital nerve stimulation is effective in the treatment of fibromyalgia related pain. The study uses sub sensory threshold stimulation and placebo stimulation in order to investigate whether sub-threshold stimulation is feasible in a placebo controlled study.
研究设计
- 研究类型
- Interventional
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Diagnosed according to the criteria of the American College of Rheumatology (ACR-90)
- •Minimally treated with adequate trials during 3 months
- •Insight of the patient in her disease and capable of understanding and signing an informed consent
排除标准
- •History of severe illness or suffering from severe chronic disease
- •History of substance abuse, unless treated and in remission during 6 months
- •Cardiac disease
- •History of epileptic insults
- •Psychiatric disorders with psychotic symptoms
- •Pace maker / defibrillator
- •Pregnancy
结局指标
主要结局
Pain scores on Visual Analogue Scale (VAS), pain Catastrophizing Scale (PCS), pain vigilance and awareness questionnaire (PVAQ)
时间窗: at a weekly base during 10 weeks
次要结局
- Scores on Fatigue and Mood(at a weekly base, during 10 weeks)
研究者
研究点 (2)
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