NCT04668482已完成不适用
Sweat Gland Function in Patients With Failed Back Surgery Syndrome, Treated With Spinal Cord Stimulation
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- Sweat gland function by measuring Electrochemical Skin Conductances (ESC)
研究概览
简要总结
This study is investigating sweat gland function during on and off states of the spinal cord stimulator, in patients with failed back surgery syndrome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Basic Science
- 盲法
- None
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
- •Subject is at least 18 years old.
- •Diagnosis of FBSS (Failed conservative treatments for pain including but not limited to pharmacological therapy and physical therapy) and currently being treated with spinal cord stimulation.
- •Cognitive and language functioning enabling coherent communication between the examiner and the participant.
排除标准
- •Patients with major psychiatric problems.
结局指标
主要结局
Sweat gland function by measuring Electrochemical Skin Conductances (ESC)
时间窗: The change between the measurement while SCS is switched off and while SCS is switched on. Total study duration lasts one day.
The investigators will examine the difference in sweat gland function between both measurements (SCS on versus SCS off), measured with the Sudoscan.
次要结局
- Pain intensity scores using the Visual Analogue Scale(Two times on the same day; once while SCS is switched off and once while SCS is switched on. Total study duration lasts one day.)
研究者
Moens Maarten
principal investigator
Universitair Ziekenhuis Brussel
研究点 (2)
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