NCT00947622Unknown1 期
Occipital Transcranial Direct Current Stimulation in Fibromyalgia
适应症
试验速览
- 阶段
- 1 期
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Decrease on Visual Analogue Scale (VAS) score for Fibromyalgia related pain and pain scales of the Fibromyalgia Impact Questionnaire
研究概览
简要总结
The aim of this study is to investigate whether transcranial direct current stimulation is effective in the treatment of fibromyalgia related pain. The study provides a placebo arm and the design is a cross-over design.
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
- Triple (Participant, Care Provider, Investigator)
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
- •Patients suffering from Fibromyalgia, diagnosed according to the criteria of the ACR-90, with exclusion of other pathologies mimicking the FMS related symptoms by a M.D. of the department of Physical Medicine and Rehabilitation (UZA, Belgium)
- •Dutch speaking
- •Stability of medication during the study
排除标准
- •History of substance abuse, unless treated and in remission during 6 months
- •Cardiac disease, implanted pace-maker or defibrillator
- •History of epileptic insults
- •Severe organic comorbidity
- •Psychiatric comorbidity with psychotic symptoms
- •Pregnancy
结局指标
主要结局
Decrease on Visual Analogue Scale (VAS) score for Fibromyalgia related pain and pain scales of the Fibromyalgia Impact Questionnaire
时间窗: baseline, directly after treatment, 3 weeks after treatment
次要结局
- Changes in scores of the pain vigilance and awareness questionnaire, pain catastrophizing scale, fibromyalgia impact questionnaire and modified Fatigue Impact Scale(base line, directly after treatment and 3 weeks after treatment)
研究者
研究点 (2)
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