TRISMUS study: Randomised Pilot Study of Therabite® versus Wooden Spatula in the Amelioration of Trismus in Head and Neck Cancer Patients
NIHR Research for Patient Benefit (RfPB)
Clinicaltrials.gov number: NCT01733797
Professor Nick Slevin, Christie Hospital NHS Foundation Trust
This is a randomised, open-label, controlled, 2-centre pilot study assessing the objective and subjective effectiveness and cost-effectiveness of Therabite use compared with wooden spatula in ameliorating trismus in patients treated for stage 3 and 4 oral and oropharyngeal cancer. This study is supported by NIHR Research for Patient Benefit (RfPB) Programme. The principal objective assessment is measurement of maximum jaw opening. The objectives of the pilot study are to monitor patient compliance and tolerability, logistics of intervention and outcome sensitivity in terms of jaw exercises, quality of life (QOL) assessments and health economics assessments.