跳至主要内容
临床试验/NCT02425839
NCT02425839已完成不适用

Assessment of Correlation Between Changes of Shear Wave Elastography and Surface Electromyogram of the Masseter, in Rest and Maximal Voluntary Contraction

Centre Hospitalier Universitaire de Saint Etienne1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2015年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
1
主要终点
Elastic modulus using Supersonic Shear Imaging® technique on superficial and deep masseter parts at rest and maximal voluntary contraction.

研究概览

简要总结

Diagnoses and follow up of muscles diseases lack imaging. Severity assessment of masticatory dysfunction and follow up of treatment effectiveness is currently based only on clinical features. Supersonic ShearWave Imaging® is a new, non-invasive, non-irradiating and dynamic imaging technique that uses ultrasound and allows shear wave elastic modulus in a muscle in order to study its viscoelastic properties.

In this study, the investigators study the correlation between changes of shear wave elastography modulus and surface electromyogram features of the masseters between rest and maximal voluntary contraction.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
盲法
None

入排标准

年龄范围
20 Years 至 40 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •People with social security.
  • •People aged 20 to 40 years, of both sexes.
  • •People that gave and signed consent to participate in the study.

排除标准

  • •Any concomitant muscle disease (myopathy, myositis...)
  • •Botulinum toxin injections in the masseter in the last 3 months preceding the study.
  • •Any treatment that induces muscular effect (baclofen, benzodiazepine)
  • •Bruxism or any masticatory apparatus disease
  • •Any surgery of the masticatory apparatus

研究组 & 干预措施

Experimental group

Experimental
  • ultrasound exam by Supersonic Shear Imaging® technique
  • EMG examination by electromyograph Keypoint system.

干预措施: Ultrasound exam by Supersonic Shear Imaging® technique (Device)

Experimental group

Experimental
  • ultrasound exam by Supersonic Shear Imaging® technique
  • EMG examination by electromyograph Keypoint system.

干预措施: EMG examination by electromyograph Keypoint system (Device)

结局指标

主要结局

Elastic modulus using Supersonic Shear Imaging® technique on superficial and deep masseter parts at rest and maximal voluntary contraction.

时间窗: Day 1 (inclusion day)

次要结局

  • Thickness of the masseter deep part mesured by Supersonic Shear Imaging® technique(Day 1 (inclusion day))
  • Thickness of the whole masseter mesured by Supersonic Shear Imaging® technique(Day 1 (inclusion day))
  • Thickness of the masseter superficial part mesured by Supersonic Shear Imaging® technique(Day 1 (inclusion day))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验