NCT04900324Unknown不适用
Intramuscular Injections of Botulinum Toxin in Lateral Pterygoid Muscle in the Treatment of Temporomandibular Dysfunctions: Studying the Interest of MRI Guidance and Ultrasound Guidance
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Pain improvement
研究概览
简要总结
The main hypothesis is that a significant pain improve (measured with Visual Analogic Scale [VAS]) can be observed after injection of botulinum toxin A, meaning the success of the guidance device.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients suffering from muscular TemporoMandibular Dysfunctions (TMD) with clinical diagnosis: myofascial pain, limited opening of the mouth, articular noise.
- •>= 18 years old
- •with signed informed consent form
排除标准
- •articular TMD: arthritis or other inflammatory disease of temporomandibular joint, arthrosis, bone deformation, previous fracture of condylar area ;
- •electromyographic hypoactivity, pure muscular diseases ;
- •oro-mandibular dystonia ;
- •botulinum toxin allergy,
- •risk of bleeding
- •recent or active infection
- •intercurrent antibiotic treatment (drug interaction) ;
- •vaccination during the 15 days preceding the injection.
结局指标
主要结局
Pain improvement
时间窗: Month 2
Significant improvement of the pain measured with VAS (0 to 10), corresponding to at least 30% decrease of the pain after injection of botulinum toxin A
次要结局
未报告次要终点
研究者
研究点 (1)
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