Does Addition of Medial Pterygoid Muscle Injection Improve the Outcome of Botulinum Toxin Therapy for Masticatory Myofascial Pain Syndrome? A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 111
- 试验地点
- 1
- 主要终点
- pain intensity
研究概览
简要总结
Masticatory myofascial pain syndrome (MMPS) is a common and debilitating orofacial pain condition characterized by localized or referred pain originating from trigger points in the masticatory muscles. The condition significantly impairs quality of life, affecting mastication, speech, and psychosocial well-being. The masseter and temporalis muscles are the most frequently targeted muscles in conventional botulinum toxin type A (BoNT-A) therapy for MMPS; however, the medial pterygoid muscle, a primary jaw-closing muscle, is often overlooked due to its deep anatomical location and the technical challenges associated with its injection.
详细描述
Current evidence supports the efficacy of BoNT-A in reducing pain and improving mandibular function in patients with localized MMPS. However, the specific contribution of targeted medial pterygoid injection to overall treatment outcomes remains unclear. This study aims to address this gap by evaluating whether the addition of targeted medial pterygoid injection enhances the clinical efficacy of conventional masseter and temporalis BoNT-A therapy.
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 (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
- •Diagnosis of myogenous TMD/myalgia according to DC/TMD.
- •Pain modified by jaw movement, function, or parafunction.
- •Familiar pain reproduced during standardized masseter/temporalis examination.
- •Clinical evidence of medial pterygoid involvement.
- •Medial pterygoid provocation reproduces the patient's familiar pain.
- •Symptoms present for at least 3 months.
- •No major competing odontogenic cause for the patient's pain.
排除标准
- •Predominantly arthrogenous TMD.
- •Trigeminal neuralgia or other neuropathic facial pain.
- •Active systemic inflammatory or infectious disease affecting the masticatory muscles.
- •Significant neuromuscular disease.
- •Pregnancy or breastfeeding.
- •Previous BoNT-A injection into the relevant masticatory muscles during the predefined washout period.
- •Known hypersensitivity to the study medication or formulation components.
- •Local infection at the injection site.
- •Significant bleeding disorder.
- •Clinically significant uncontrolled anticoagulation.
- •Previous major surgery involving the medial pterygoid region that could alter anatomy.
结局指标
主要结局
pain intensity
时间窗: 6 months
a 10-point visual analogue scale (VAS), where 0 revealed no pain and 10 represented the worst imaginable pain
次要结局
未报告次要终点
研究者
Alshaimaa Ahmed shabaan
Prof.
Fayoum University