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临床试验/EUCTR2019-004704-35-SE
EUCTR2019-004704-35-SE进行中(未招募)1 期

Masseter myofascial pain relief following an intra-muscular injection with botulinum toxin type A. A randomized double-blind controlled multicenter pilot study. - BTX1 - myalgia pain

Region Örebro0 个研究点目标入组 48 人开始时间: 2020年2月12日最近更新:
适应症
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
发起方
入组人数
48

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

  • age > 18 years
  • > 3-month complaints of jaw/face pain
  • the diagnose myalgia according to DC/TMD
  • understands Swedish verbally and in writing
  • in writing give his/her consent to participate
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 38
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 10

排除标准

  • polyarthritis/connective tissue disease
  • fibromyalgia or other generalized pain
  • neurological disorders
  • whiplash associated disorders
  • ongoing virus or bacterial infection
  • ongoing dental treatment
  • botulinum toxin injection in the jaw or face past six months
  • complex psychiatric/psychological profile, institutional residence
  • employee at the trial clinic, internal resident
  • hypersensitivity to botulinum toxin, human albumin
  • serious health conditions according to the examiner's assessment
  • in the presence of infection at the proposed injection site(s)
  • pregnancy or lactating
  • fertile women not on contraception

研究者

发起方
Region Örebro

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