跳至主要内容
临床试验/NL-OMON43640
NL-OMON43640已完成不适用

Spinal Cord Stimulation in Small Fibre Neuropathy: A pilot study - SFN-SCS Study

Medisch Universitair Ziekenhuis Maastricht0 个研究点目标入组 20 人开始时间: 待定最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
20

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

年龄范围
18 至 99(—)

入选标准

  • SFN-diagnosis
  • age between 18 and 75 years
  • mean pain intensity 5 or higher on the 11 points numeric rating scale (NRS
  • pain present for more than 12 months
  • previous treatment unsuccessful with drugs from the following drugs: tricyclic antidrepressant agent, alpha 2 adrenergic calcium channel agonist/anti-epileptic drug, serotonin-norepinephrine reuptake inhibitor, tramadol or strong opioids
  • Steady state medication use for at least 2 months

排除标准

  • neuromodulation in history
  • neuropathic pain prevalent in upper limbs exceeding NRS 3
  • neuropathy or chronic pain of other origin than SFN (NRS >3)
  • insufficient cooperation from the patient
  • bloth clothing disorder
  • immune deficiency
  • known peripheral vascular disease
  • life expextancy < 1 year
  • local infection or other skin disorders at site of incision
  • other clinical or unstable, or severe acute or chronic medical or psychiatric/psychological condition or laboratory abnormality that may increase the risk associated with study participation or procedure or may interfere with the interpretation of study results and, in the judgement of the investigator, would make the subject inappropriate for entry into this study
  • severe cardiac or pulmonary failure
  • use of opioids

研究者

发起方
Medisch Universitair Ziekenhuis Maastricht

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