Anwendung Von Elektromyographie Mit Gleichzeitigem Bio-Feedback Zur Behandlung Von Craniomandibulären Dysfunktionen Und/Oder Bruxismus.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Worst perceived pain
研究概览
简要总结
The treatment of craniomandibular disorders is a challenging task. Many different treatments are yet available with occlusal splints being one of the most commonly used. A relative new diagnostic and treatment alternative is the Grindcare device. This enables the electromyographic (EMG) assessment of the activity of the temporal muscle and the contigent electrical stimulation of this muscle as bio-feedback whenever the EMG activity exceeds a certain limit. This stimulation results to a sudden break of the muscle activity.
Aim of this study is to compare the therapeutic efficacy of the Grindcare device in pain reduction at female non-chronic CMD patients to that of a Michigan-type splint. Our null-hypothesis was that there is no difference between the device and the splint in the reduction of pain intensity.
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
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent form
- •Age between 18 and 70 years
- •Non-chronic painful CMD with/without mandibular movement restriction
排除标准
- •Pregnancy or breastfeeding
- •Chronic Pain Status higher than 2
- •Known allergic reaction against the gel pads
- •Electronic implants (pacemaker, defibrilator, insulin pump)
- •Facial pain of dental or neuropathic etiology
- •Traumatic injuries of the face / operations
- •Dental treatment need
- •Problems with swallowing reflex
研究组 & 干预措施
Michigan-type occlusal splint
Occlusal splint, Michigan-type
干预措施: Michigan-type occlusal splint (Device)
Grindcare
Biofeedback device
干预措施: Grindcare (Device)
结局指标
主要结局
Worst perceived pain
时间窗: 1 week
次要结局
未报告次要终点
研究者
Giannakopoulos Nikolaos
Dr.med.dent., M.Sc.
Heidelberg University