Randomised Pilot Study of Therabite® Versus Wooden Spatula in the Amelioration of Trismus in Head and Neck Cancer Patients. (Trismus Trial)
Trismus is defined as a tightening of jaw opening. The negative impact of Trismus on the
quality of life of head and neck cancer patients is well established. It affects eating,
drinking, speaking and social function and is often as debilitating as any disfigurement
resulting from treatment.
The use of jaw exercises using a Therabite appliance following treatment has been shown to
reduce the level of Trismus in small studies. Many UK centres, however, use stacked wooden
spatulas inserted between the incisors as a means of passive exercise. There is anecdotal
evidence that suggests the use of exercises prior to treatment may help reduce the severity
of the Trismus experienced by the patient.
This study will enrol 112 head and neck cancer patients allocated by chance to use either
the Therabite or wooden spatula and patients will be asked to perform mouth exercises on a
daily basis for 6 months.
There is a need to evaluate both the clinical effectiveness and cost-effectiveness of
Therabite as opposed to wooden spatulas to determine whether they should be adopted as
standard care in head and neck cancer patients.
In this pilot trial, the investigators will measure benefits of Therabite to patients, as
compared to usual care with wooden spatulas. Mouth opening will be the key outcome for the
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Change in Jaw measurement
Willis bite calliper will be used to measure the jaw opening at baseline, 3 and 6 months
Baseline, 3 months and 6 months at hopsital
The Christie NHS Foundation Trust
United Kingdom: Research Ethics Committee