Effects of manual therapy on oral opening, swallow function and upper quarter mobility in Chilean survivors of head and neck cancer: a study protocol for a controlled, randomised study (MAnual ThErapy for Oral Opening (MATEO) study).

Abstract

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).