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临床试验/NCT03251521
NCT03251521已完成不适用

Evaluation of Pain Intensity in Different Steps of Injection With Botulinum Toxin in the Treatment of Spasticity in Post-stroke Patients

University Hospital, Grenoble0 个研究点目标入组 46 人开始时间: 2012年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
46
主要终点
Evolution of pain intensity during injection with botulinum toxin

研究概览

简要总结

The aim of the study was to analyze which step of the procedure of toxin botulinum injection is the most painful between skin break-in, electric stimulation, injection and needle withdrawal.

详细描述

Post-stroke spasticity management by botulinum toxin injections may be limited by pain or discomfort at the injection side.

Particularly tracking by electrostimulation, but also skin puncture, toxin injection or needle withdrawal may be painful.

The objective of this study is to define an individual injection strategy in order to limit pain.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • severe upper or lower limb spasticity (Ashworth score ≥ 2 for at least one muscle)
  • patients requiring a treatment by botulinum toxin
  • patients refusing analgesia for injections.

排除标准

  • severe aphasia (severity subscore of the BDAE <3)
  • cognitive impairment or psychiatric disease altering the reliability of pain evaluation
  • patient medically unstable.

结局指标

主要结局

Evolution of pain intensity during injection with botulinum toxin

时间窗: 30 min

Pain intensity in different steps of the procedure of toxin botulinum injection: skin break-in, electric stimulation, injection and needle withdrawal.

次要结局

  • Hypoesthesia(30 min)
  • Neuropathic pain(30 min)

研究者

发起方
University Hospital, Grenoble
申办方类型
Other
责任方
Sponsor

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