Burgos-Mansilla Barbara, Schneeberger-Hitschfeld Pilar, Astete-Barra Krishna, Méndez-Rojas Antonia, Ortiz-Comino Lucía
Departamento de Ciencias de la Rehabilitación, Universidad de La Frontera, Temuco, Chile.
Departamento de Cirugía, Universidad de La Frontera, Temuco, Chile.
BMJ Open. 2025 Sep 2;15(9):e097131. doi: 10.1136/bmjopen-2024-097131.
Head and neck cancer (HNC) accounts for over 4% of global cancer incidence, yet the oncological treatment induces several sequelae such as oral dysfunction, cervical and shoulder impairments or pain that are not well addressed. Thus, survivors of HNC (sHNC) perceive a decrease in their quality of life (QoL). This study protocol aims to investigate the effects of manual therapy (MT) to determine the effectiveness and safety on oral opening, swallow function and upper quarter mobility, cervical muscle strength, pain, functionality and QoL of sHNC.
A randomised controlled trial will include 70 sHNC over 18 years of age and will be divided into two groups. Intervention will last for 6 weeks with a total of 18 sessions, including MT targeting mastication and head and neck muscles. The control group will receive motor control exercises. The main outcomes will be oral opening and swallow function. An intention-to-treat analysis will be performed to evaluate the effectiveness of the intervention, which will be further determined with the calculation of effect sizes expressed in Cohen's d.
The study was approved by the Ethics Committee of the Universidad de La Frontera (File 001_24) according to the Helsinki Declaration for Biomedical Research. All participants will provide informed consent. Study results will be published in open access peer-reviewed journals and may be shared at relevant meetings and research meetings.
This trial was registered with ClinicalTrials.gov on 28 November 2023 (code: NCT06148077).
头颈癌(HNC)占全球癌症发病率的4%以上,然而肿瘤治疗会引发多种后遗症,如口腔功能障碍、颈部和肩部损伤或疼痛,这些问题并未得到妥善解决。因此,头颈癌幸存者(sHNC)的生活质量(QoL)有所下降。本研究方案旨在调查手法治疗(MT)对头颈癌幸存者的口腔开口度、吞咽功能、上肢活动度、颈部肌肉力量、疼痛、功能和生活质量的有效性和安全性。
一项随机对照试验将纳入70名18岁以上的头颈癌幸存者,并分为两组。干预为期6周,共18次治疗,包括针对咀嚼肌和头颈部肌肉的手法治疗。对照组将接受运动控制训练。主要结局指标将是口腔开口度和吞咽功能。将进行意向性分析以评估干预的有效性,并通过计算科恩d值表示的效应量进一步确定。
该研究已根据《赫尔辛基生物医学研究宣言》获得弗龙特拉大学伦理委员会批准(文件编号:001_24)。所有参与者将提供知情同意书。研究结果将发表在开放获取的同行评审期刊上,并可能在相关会议和研究会议上分享。
本试验于2023年11月28日在ClinicalTrials.gov注册(编号:NCT06148077)。