NCT05885061招募中不适用
Effects of Spinal Cord Stimulation
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Pain intensity, Visual Analogue Scale
研究概览
简要总结
The goal of this interventional study is to test effects of spinal cord stimulation in patients receiving treatment for their chronic pain. The main question of the study is:
• What is the effect of spinal cord stimulation when compared to placebo? Participants will rate their pain with their usual spinal cord stimulation on and off.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients (>18 years of age) with SCS implanted to treat chronic pain.
- •Patients who consent to participation and can cooperate in the study.
- •Use of continuous paresthesia-free SCS for minimum 6 months prior to participation in the study.
- •Pain score of 7 or less on a 0-10 scale in the most painful area treated with SCS, rated upon inclusion.
- •Patients not receiving other neuromodulation treatment.
- •Patients who have not undergone changes in their (pain relevant) medication during the last 30 days (pro necessitate medication allowed).
排除标准
- 未提供
研究组 & 干预措施
Spinal cord stimulation turned on
Active Comparator
干预措施: Spinal cord stimulation turned on (suggestions: off) (Device)
Spinal cord stimulation turned off
Placebo Comparator
干预措施: Spinal cord stimulation turned off (suggestions: on) (Device)
Spinal cord stimulation turned on and suggestions
Active Comparator
干预措施: Spinal cord stimulation turned on with suggestions (suggestions on) (Device)
Control
No Intervention
结局指标
主要结局
Pain intensity, Visual Analogue Scale
时间窗: Every 30 minutes during study session (max 5 hours)
0-10 (0=no pain, 10=worst imaginable pain). Continual assessments to register changes.
次要结局
未报告次要终点
研究者
研究点 (1)
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