NCT01400282Unknown4 期
Analgesic Efficacy of High Frequency Spinal Cord Stimulation: a Placebo-controlled Study
适应症
试验速览
- 阶段
- 4 期
- 入组人数
- 30
- 试验地点
- 3
- 主要终点
- Patient's Global Impression of Change (PGIC)
研究概览
简要总结
The aim of the study is to compare the efficacy of high frequency (HF SCS) stimulation and sham stimulation (Sham SCS - i.e. no stimulation) and conventional spinal cord stimulation (Conv SCS) on the patient reported global impression of change, pain intensity and health related quality of life.
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, Care Provider, Investigator)
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
- •signed informed consent
- •treated with spinal cord stimulation
- •stable pain relief achieved
排除标准
- •failure to give informed consent
- •unable to use or understand how to handle the equipment, PGIC,VAS score or EQ-5D questionnaires.
结局指标
主要结局
Patient's Global Impression of Change (PGIC)
次要结局
- Intensity of Pain
- Quality of Life (EQ-5D)
研究者
研究点 (3)
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