Electrodermal Activity and Respiration in Patients Treated With Spinal Cord Stimulation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 3
- 主要终点
- Respiration rate
研究概览
简要总结
This study is investigating skin conductance and respiration 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 impaired skin integrity at the fingers.
- •Patients with major psychiatric problems.
结局指标
主要结局
Respiration rate
时间窗: 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.]
The investigators will examine the difference in respiration rate between both measurements (SCS on versus SCS off)
Skin conductance changes
时间窗: 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.]
The investigators will examine the difference in skin conductance between both measurements (SCS on versus SCS off)
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