MiTiGate
Research type
Research Study
Full title
Managing chronic Myalgia Temporomandibular Disorder (M-TMD): a pragmatic phase III definitive three-arm parallel-group, co-primary outcome, individually randomised open-label controlled superiority trial comparing the clinical and cost-effectiveness and safety of Botulinum toxin type A, Lidocaine, and Amitriptyline/Gabapentin, with internal pilot and cost-effectiveness analysis (MiTiGate)
IRAS ID
1008152
Contact name
Justin Durham
Contact email
Sponsor organisation
Newcastle upon Tyne Hospitals NHS Foundation Trust
Clinicaltrials.gov Identifier
NA
Research summary
Myalgia Temporomandibular disorder (M-TMD) affects the muscles that move the jaw, causing pain. It affects 1 in every 15 people, and impacts on daily activities such as talking, eating, and chewing. Currently, there is no clear evidence about the best treatment, and first line therapy is self-management for at least 6 weeks.
If M-TMD pain lasts more than 3 months, then a referral to a specialist may be needed. They will usually prescribe NICE-recommended medicines amitriptyline or gabapentin (’usual treatment’). There is no clear evidence whether these are effective or which, if either, works better. Studies in other conditions that affect the pain system or muscles in the face/head show some evidence that lidocaine or botulinum toxin (Botox) injections might be helpful for M-TMD and have less side effects than usual treatment. This research will compare usual treatment (amitriptyline and gabapentin) against lidocaine and Botox injections to determine the best balance between effectiveness, side effects and cost. This NIHR-funded research is important to provide evidence about the most effective treatment to reduce pain and improve quality of life for people living with M-TMD, and which is cost-effective.
The trial will include 663 participants involving 12 hospitals across the UK. Participants may be identified by one of the 12 hospitals, by primary care or self-referral. They 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. 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 5 visits with a 36-week treatment period, with flexibility for some remote visits for non-injection patients. For further details please contact (nuth.mitigate@nhs.net).REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
24/NE/0019
Date of REC Opinion
7 Mar 2024
REC opinion
Further Information Favourable Opinion