Magnesium Sulphate Injection in Treatment of Myofascial Trigger Points in Masseter Muscle
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- pain score
研究概览
简要总结
This is a prospective, single- center, randomized (1:1) clinical trial comparing the effectiveness of magnesium sulphate injections in treatment of myofascial trigger points in the masseter muscle versus the saline injection.
详细描述
The proposal presents the magnesium sulphate (MgSO4) as a possible injection treatment for TrPs. The MgSO4 prevents the release of pre-synaptic acetylcholine from neuromuscular and sympathetic junctions that could explain the ability of the MgSO4 to relax the muscle and reduce pain Specific aim: evaluate the effectiveness of magnesium sulphate injections in treatment of myofascial trigger points in the masseter muscle versus the saline injection.
Hypothesis
the injection of masseter muscle trigger points with magnesium sulphate is more effective than saline injection in pain relief.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Definite diagnosis of myofascial pain with a referral, based on the DC/TMD criteria
- •the presence of one or more trigger points in the unilateral or bilateral masseter muscle
- •no history of any invasive procedures in the related masseter muscle.
排除标准
- •Factors that can cause pain in the orofacial region other than MTPs (decayed tooth, TMJ internal disorder).
- •Any systemic disease that possibly affects the masticatory system such as rheumatoid arthritis and epilepsy
- •pregnancy and lactation.
研究组 & 干预措施
group II
each patient injected 0.5ml in each TrPs of magnesium sulphate by the same operator
干预措施: Magnesium sulfate (Drug)
group I
each patient injected 0.5ml in each TrPs of saline by the same operator
干预措施: Saline (Drug)
结局指标
主要结局
pain score
时间窗: 6 months postoperative
pain score measured on a 10-point visual analogue scale (VAS), the 0 indicating no pain and 10 indicating the worst pain ever.
次要结局
- quality-of-life in an Oral Health Impact Profile questionnaire (OHIP-14)(six months postoperative)
研究者
Alshaimaa Ahmed shabaan
associate professor in oral & maxillofacial Surgery Department
Fayoum University