Efficacy of Botox Injection of the Masticatory Muscles in Head &Neck Cancer Patients with Trismus After Radiotherapy
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Maximal Incisal Opening
研究概览
简要总结
Trismus is a common side effect in head and neck cancer patients after radiation therapy. This project aims to explore the therapeutic effect of Botulinum toxin (Botox) injection to the masticatory muscles in the above-mentioned patients.
In this project, Botulinum toxin will be injected into the masticatory muscles (medial pterygoid and masticatory muscles), combined with oral rehabilitation exercises, to reduce the patient's masticatory muscle tension and spasm. Patient's mouth opening range, quality of life, trismus condition and pain will be evaluated to understand its efficacy.
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
- Triple (Participant, Care Provider, 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
- •Aged over 18 years old;
- •Head and neck cancer patients must have completed radiotherapy for at least 3 months;
- •Those whose mouth-opening distance is less than or equal to 3.5 cm (the functional cut-off point of trismus) and who have tightness or pain in the masticatory muscles;
- •Medical condition is stable;
排除标准
- •Those who have undergone surgery on their masticatory muscles;
- •Patients with obvious muscle atrophy or complete fibrosis of masticatory muscles ;
- •Those with tumor recurrence at the time of admission;
- •Those whose vital signs are unstable due to acute illness.
研究组 & 干预措施
Botox injection
干预措施: Echo-guided Botox injection (Drug)
Normal Saline Injection
干预措施: echo-guided normal saline injection (Procedure)
结局指标
主要结局
Maximal Incisal Opening
时间窗: From enrollment to the end of treatment at 6 months
次要结局
未报告次要终点