Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.
A study comparing the use of wooden spatulas to the Therabite device for head and neck cancer patients who have mouth opening problems (Trismus Trial)
Both wooden spatulas and a device called Therabite are used to help people who aren’t able to fully open their mouths after radiotherapy. This study compared these 2 methods for people who had radiotherapy for mouth cancer and cancer where the mouth joins the throat (oropharyngeal cancer).
More about this trial
Some people find it difficult to open their mouth properly after radiotherapy. This is because the muscles used to open and close the mouth are affected by the radiotherapy. This is called
Trismus can be treated by gently stretching the jaw muscles using wooden spatulas. The spatulas are placed in the mouth between the front teeth for a period of time each day. The jaw muscles are stretched by increasing the number of spatulas over time.
The Therabite device is another way to gently stretch the jaw muscles. It is a hand operated device that is put inside the mouth.
For this study people used the Therabite device or wooden spatulas before radiotherapy started and continued during treatment. Because the researchers thought starting the exercises before radiotherapy would be beneficial.
The aim of this trial was to compare Therabite with wooden spatulas to find which:
- was best to treat trismus
quality of lifethe most
- exercise routine people were most likely to follow
Summary of results
This was a feasibility study. 71 people took part.
It was a randomised study. The people taking part were put into 1 of 2 groups by a computer. Neither they or their doctor could choose which group they were in.
- 37 people used the Therabite device
- 34 people used the wooden spatulas.
After 6 months of usage there was no significant difference in trismus between the 2 groups. The acceptability of the exercises was the same for both groups.
There was also no significant difference in the number of times individuals from each group contacted health professionals such as their GP or a
The study team also used telephone interviews to ask the people about any issues that occurred and how these could be improved.
They said that the frequency of the exercises should be reduced from 5 times a day to 3 times. And that a break from the exercises of up to 6 weeks should be allowed when the side effects of radiotherapy are at their worst.
The team concluded that:
- exercises during and after radiotherapy can improve trismus
- both Therabite and wooden spatulas are acceptable to people
- a break when the side effects of radiotherapy are worst should be allowed
- regular contact with the participants is needed to encourage and support them
We have based this summary on information from the research team. The information they sent us has been reviewed by independent specialists (
How to join a clinical trial
Professor Nick Slevin
NIHR Clinical Research Network: Cancer
NIHR Research for Patient Benefit (RfPB) Programme
The Christie NHS Foundation Trust