NCT00697398已完成不适用
Repetitive Trans-cranial Magnetic Stimulation of the Motor Cortex in Fibromyalgia: A Prospective Randomized Blinded Placebo-controlled Study Evaluating the Clinical Efficiency and the Metabolic Correlate in 18FDG-PET
适应症
干预措施
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
- Analgesic efficiency
研究概览
简要总结
Fibromyalgia (FM) syndrome is a chronic pain condition.Repetitive trans-cranial magnetic stimulation (rTMS) was thus suggested in this indication.
详细描述
We recently demonstrated that these patients exhibit significant perfusion abnormalities in regions of the brain known to be involved in sensory and affective-attentional dimensions of pain processing. These results, in agreement with previous functional magnetic resonance imaging reports, confirm the hypothesis of central sensitization, which provides the rationale for prescription of centrally acting analgesic agents in patients with severe FM.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Female or male patient, aged from 18 to 65 years
- •Patient presenting a primary fibromyalgia answering the criteria of the ACR
- •At present painful patient with a digital echelle of the briefing inventory bread superior or equal to 4/10
- •Patient presenting a stable treatment since at least 1 less
排除标准
- •Patient minor
- •pregnant woman
- •women in age to procreate without contraception
- •patient deprived of freedom further to a court or administrative order
- •patient presenting a secondary fibromyalgia
研究组 & 干预措施
1
Placebo Comparator
Sound placebo
干预措施: Transcranial stimulation (Other)
2
Experimental
Sound
干预措施: Transcranial stimulation (Other)
结局指标
主要结局
Analgesic efficiency
时间窗: 36 months
次要结局
- Evaluation of the tolerance of the treatment(36 months)
- Additional evaluation of the pain(36 months)
- Evaluation of the quality of life(36 months)
研究者
研究点 (1)
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