Does Spinal Cord Stimulation (SCS) Have an Effect Beyond Patients' Expectations? An Investigation of Treatment and Placebo Effects
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Patients' subjective pain intensity evaluated on a 0-10 Mechanical Visual Analogue Scale (M-VAS)
研究概览
简要总结
The aim of the study is to evaluate treatment outcomes of Spinal Cord Stimulation. In the study each patient participates in four test sessions of 4-5 hours. Patients arrive for test days with their stimulation on. In each test session, baseline pain is first evaluated. Then, SCS is regulated (on/off) and patients evaluate their pain intensity immidiately and every 15 minutes during the test sessions. Patients are blinded to the treatment conditions during their participation in the study. At all times, patients can resume their usual treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •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
Placebo condition
The patient is incorrectly told that stimulation is on
干预措施: Stimulation OFF (Device)
Placebo condition
The patient is incorrectly told that stimulation is on
干预措施: Told ON (Device)
Total treatment
The patient is correctly told that stimulation is on
干预措施: Stimulation ON (Device)
Total treatment
The patient is correctly told that stimulation is on
干预措施: Told ON (Device)
Stimulation treatment
The patient is incorrectly told that stimulation is off
干预措施: Stimulation ON (Device)
Stimulation treatment
The patient is incorrectly told that stimulation is off
干预措施: Told OFF (Device)
Control condition
The patient is correctly told that stimulation is off
干预措施: Stimulation OFF (Device)
Control condition
The patient is correctly told that stimulation is off
干预措施: Told OFF (Device)
结局指标
主要结局
Patients' subjective pain intensity evaluated on a 0-10 Mechanical Visual Analogue Scale (M-VAS)
时间窗: From enrollment to completion of four test sessions scheduled with a minimum interval of one week between each session.
次要结局
未报告次要终点
研究者
Christina Emborg
Postdoc
University of Aarhus