Randomised feasibility study to compare the use of Therabite ® with wooden spatulas to relieve and prevent trismus in patients with cancer of the head and neck

Abstract

Our aim was to compare the efficacy of the Therabite® jaw motion rehabilitation system (Atos Medical) with that of wooden spatulas to relieve and prevent trismus in patients who have had radiotherapy for stage three and four oral and oropharyngeal cancer. Secondary aims were to assess the feasibility and the impact of exercise on health-related quality of life (QoL), and the use of health services after treatment. We designed a randomised, open-label, controlled, three-centre feasibility study to compare the effectiveness and cost of the Therabite® and wooden spatulas. We studied compliance with exercises and health-related QoL, assessed cost using three health economics measures, and conducted semistructured interviews with patients. Patients were randomised into two groups: the Therabite® group (n = 37) and the wooden spatula group (n = 34). All patients had some sense of jaw tightening before the study started. Mean mouth opening after six months increased in both groups, but the difference between the groups was not significant (p = 0.39). Completion rates for the three economic measures were good. There was no significant difference between the two groups in frequency of contact with care services or in QoL. Exercises during and after radiotherapy can ameliorate trismus in patients with stage three and four oral and oropharygeal cancers, but differences between groups in efficacy, compliance, QoL, or use of hospital or community health services, were not significant.

A Systematic Review of the Feasibility and Psychometric Properties of the ICEpop CAPability Measure for Adults and Its Use So Far in Economic Evaluation

“…Most of the studies were conducted in the United Kingdom [17][18][19][20][21][22][23][24][25][26][27][28][29][30][31][32][33][34] ; 1 was conducted in Canada, 35 and 1 across both Australia and the United Kingdom. 36 Seven studies were considered multi-country, because they involved participants from several of the following countries: Australia, Canada, Germany, Norway, the United States, and the United Kingdom.…”

“…23 The area of drug addiction and opiate dependence was investigated by Goranitis et al 21,22 Other populations were women with lower urinary tract symptoms, 17 people with visual impairment, 20,27 patients with diabetes, 24 Huntington disease patients, 26 people with spinal cord injury, 35 and patients with cancer (oral/oropharyngeal and gynecological). 28,29 Some studies involved carers, 1 evaluating the family impact of meningitis 32 and 1 exploring the quality of life among people receiving hospice care. 34 Four studies recruited participants from the general UK population.…”

Use of a novel atlas for muscles of mastication to reduce inter observer variability in head and neck radiotherapy contouring

“…Trismus is defined as a maximum inter-incisor distance of 35 mm and is caused by impaired function of the masticatory muscles [13]. Trismus can manifest in poor dental hygiene, impaired chewing, malnutrition and psychological difficulties including low self-esteem, depression and suicidal intentions, which all reduce health-related quality-of-life [14,15]. Clinical assessment of patients is challenging due to a restricted ability to assess disease status.…”

The use of stretching devices for treatment of trismus in head and neck cancer patients: a randomized controlled trial

“…High attrition rates are common in similar studies, ranging from 11 to 42% [6–11]. Most common reasons for drop-out are either related to other patient factors, such as mortality [6–9, 12], tumor progression (recurrent tumor or metastasis) [7, 8, 12], or lack need for treatment [7] or are related to stretching problems, such as pain during exercises [8, 10, 11], no perceived improvement [6], and fitting issues of stretching device [7, 10]. In future studies these factors influencing the progression of the stretching protocol need to be taken into account.…”