NCT03768791已完成不适用
Heart Rate Variability in Patients With Failed Back Surgery Syndrome, Treated With Spinal Cord Stimulation
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
- 23
- 试验地点
- 1
- 主要终点
- Heart rate variability changes
研究概览
简要总结
This study is an observatory single center study investigating heart rate variability 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
- •The presence of one or more coexisting conditions known to affect HRV analysis (including but not limited to atrial fibrillation, numerous atrial or ventricular extra beats, paced rhythm, left ventricular bundle branch block, cancer, kidney or hepatic failure, and diabetes mellitus (autonomic nervous system dysfunction)).
- •The use of medication that directly modifies autonomic control (for example beta-blockers).
研究组 & 干预措施
SCS on
Experimental
干预措施: SCS is switched on (Other)
SCS off
Experimental
干预措施: SCS is switched off (Other)
结局指标
主要结局
Heart rate variability 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 heart rate variability between both measurements (SCS on versus SCS off)
次要结局
- Pain intensity scores(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 (1)
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