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临床试验/NCT05885061
NCT05885061招募中不适用

Effects of Spinal Cord Stimulation

University of Aarhus2 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2023年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
25
试验地点
2
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

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

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

申办方类型
Other
责任方
Sponsor

研究点 (2)

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