Trial Overview
The trial will recruit 663 participants across the UK. Participants may be identified by a site, primary care, or self-referral. Participants must be 18 years old or older with m-TMD pain for 3 months or longer that is not controlled by self-management.
Participants will be randomly split equally into one of the 3 arms:
Usual treatment - Amitriptyline (Antidepressant) or Gabapentin (Anti epileptic)
Lidocaine injections
Botox® injections
Participants will not be able to choose the treatment they receive - this will be randomly selected by a computer.
There are up to 5 visits within a 36-week treatment period with either:
Daily medication: Amitriptyline (Antidepressant) or Gabapentin (Anti epileptic)
OR
An injectable treatment to the sore muscles every twelve weeks. Either lidocaine (numbing injection like at the dentist) OR Botox® .
Participants will be asked to complete questionnaires 4 times over 36 weeks and attend up to 5 in person visits for check ups or injection treatment.
Living in the North East?
Some participants in North-East England will also be invited to take part in MRI scanning to explore if there are changes in the jaw joint.
Can I claim back travel?
Reasonable travel expenses up to a total of £27/visit will be reimbursed. Please retain your receipts.
If you’d like to ask questions or self-refer for an eligibility assessment, please email nuth.mitigate@nhs.net with your name, age, and your nearest major town.