About

The MiTiGate trial is a non commercial trial funded by the National Institute of Health and Care Research (NIHR) on behalf of the NHS for people suffering with jaw pain.

MiTiGate is the largest randomised controlled trial of myalgia Temporomandibular Disorder (m-TMD) in the UK.

The trial is funded by the NIHR (excess of £2 million) and sponsored by The Newcastle Upon Tyne Hospitals NHS Foundation Trust.

The trial opened to recruitment in September 2024 and is expected to end recruitment in the summer of 2026.

Where can I take part?

The trial is being led by Chief Investigator Professor Justin Durham of Newcastle University and Newcastle Hospitals NHS Foundation Trust.

The trial is currently open to recruitment and will be recruiting from the following locations across the UK, which are shown below alongside their clinical leads:

  • Bristol - Dr Mark Gormley

  • Cardiff - Dr Charlotte Emanuel

  • Dundee - Professor Michaelina Macluskey

  • Leeds - Mr Alasdair McKechnie

  • Liverpool - Dr Francis O’Neill

  • London - QMUL - Dr Eleni Besi

  • Middlesbrough - Mr Chris Bridle

  • Newcastle upon Tyne - Dr Rachel Green

  • Sheffield - Dr Simon Atkins

  • Sunderland - Mr Michael Nugent

  • Glasgow - opening in 2025

  • Manchester - opening in 2025

    No matter where you live, please only email the study's central site at nuth.mitigate@nhs.net . You will then be directed accordingly.

More about MiTiGate

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, lidocaine injections, or Botox injections. Participants will not be able to choose the treatment they receive - this will be randomly selected by a computer.

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.

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.

Reasonable travel expenses up to a total of £27/visit will be reimbursed.

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.