NCT00807430终止不适用
A Single Centre, Randomised, Clinical Placebo Controlled Study of the Optimal Treatment and Long-term Effect of FES on Bruxism
Medotech A/S2 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2009年2月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Primary outcome is to reduce the EMG activity per hour per night
研究概览
简要总结
To investigate the effect of the treatment with Grindcare® on the muscles- and jaw symptoms and at the jaw muscle activity during sleep.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Signed and dated ICF
- •18 years or older
- •Fulfill the RDC-criteria for myofascial TMD diagnose (group 1a or 1b)
- •Average pain more that 3 on a Visual Analog scale (VAS) in the baseline period
排除标准
- •Contraindication of concommitant diseases for the study judged by investigator
- •Daily use of pain medication, e.g. prophylaxis against migraine or headache.
- •Patients who are using occlusal splints in the treatment period.
结局指标
主要结局
Primary outcome is to reduce the EMG activity per hour per night
时间窗: 10 weeks after start of treatment
次要结局
- Secondary outcome is to evaluate long-term effect of FES om EMG activity(after end of treatment with FES)
研究者
研究点 (2)
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