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:

  1. Usual treatment - Amitriptyline (Antidepressant) or Gabapentin (Anti epileptic)

  2. Lidocaine injections

  3. 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:

  1. Daily medication: Amitriptyline (Antidepressant) or Gabapentin (Anti epileptic)

    OR

  2. 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.