Efficacy of Botox Injection of the Masticatory Muscles in Head and Neck Cancer Patients with Trismus After Radiotherapy

What this Trial Is About

This research aims to explore the therapeutic effect of Botulinum toxin (Botox) injections in patients with trismus, a common side effect of radiation therapy for head and neck cancer. The study evaluates how Botox injections combined with oral rehabilitation exercises may help reduce muscle tension and spasms in the masticatory muscles, potentially improving mouth opening, quality of life, trismus condition, and pain. Participants will be randomly assigned to receive either echo-guided Botox injections or echo-guided normal saline injections into the masticatory muscles, including the medial pterygoid muscle. The study uses a triple-masked design to compare these treatments. The treatment period lasts up to six months, during which patients also perform oral rehabilitation exercises to support muscle function. During the trial, participants' maximal mouth opening will be measured from enrollment through the six-month treatment period. Researchers will also assess quality of life, trismus symptoms, and pain levels. The study monitors the patients' health conditions to ensure stability and safety throughout the treatment. Overall participation lasts at least six months, with close observation of treatment effects and any side effects.

Efficacy of Botox Injection of the Masticatory Muscles in Head &Neck Cancer Patients with Trismus After Radiotherapy