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
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