EUCTR2017-001709-33-FR进行中（未招募）1 期
Randomized, Double-blind, Placebo-controlled Trial on the Efficacy of the Botulinum Toxin for the Treatment of Lateral Epicondylitis - EPITOX
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 150
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
入选标准
- •1) Males or females aged from 18 to 60 years;
- •2) Whether or not having a professional activity;
- •3) Whether or not having a motor disability;
- •4) Unilateral lateral epicondylitis, persistent for more than 3 months, or recurrent and not having responded to at least one reference treatment: local injection of corticosteroids, physical therapy, rest, or NSAIDs;
- •5) Signing of an informed consent form;
- •6) Affiliation to a health insurance organism.
- •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 150
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1) Central nervous system disorder, which is responsible for spasticity in the limb suffering from epicondylitis;
- •2) History of severe psychiatric disorder;
- •3) History of myasthenia gravis;
- •4) Pregnant or nursing women;
- •5) Inability to understand or to answer questions;
- •6) Contra-indication to botulinum toxin or corticosteroids;
- •7) Injection of botulinum toxin within 3 months prior to inclusion;
- •8) Taking any anticoagulant drugs;
- •9) Predictable difficulties of follow-up;
- •10) Patient under guardianship or curatorship.
研究者
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