跳至主要内容
临床试验/EUCTR2011-004682-32-IT
EUCTR2011-004682-32-IT进行中(未招募)不适用

Intra-articular injection of botulinum toxin type A in hemiplegic shoulder pain: a multicentric, double blind randomised, versus steroid study. - BTX-A in HSP

FONDAZIONE ISTITUTO SAN RAFFAELE-G.GIGLIO0 个研究点开始时间: 2012年3月8日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
进行中(未招募)
发起方

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • Patients with hemiparesis and shoulder pain due to first stroke (ischemic or hemorrhagic) admitted in a rehabilitative department to carry out a standard post-acute rehabilitative program.
  • Age 18-70 years.
  • Pain score of 45 or greater on a 0-100 mm pain visual analog scale (VAS; 0 = no pain, 100 = worst possible pain).
  • Duration of HSP for at least one month.
  • Pain refractoriness to conventional treatment i.e. common analgesics (such as paracetamol and NSAIDs), slings, strapping and handling of the arm, functional electrical stimulation of shoulder muscles.
  • Are the trial subjects under 18? no
  • Number of subjects for this age range: 0
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 26
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 26

排除标准

  • Significant spasticity in the upper shoulder joint, defined as a score of 2 or more at the modified Ashworth scale.
  • History of shoulder pain or shoulder diseases.
  • History of neurological diseases (i.e. Parkinson disease, dystonia).
  • History of botulinum toxin treatment.

研究者

发起方
FONDAZIONE ISTITUTO SAN RAFFAELE-G.GIGLIO

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