RecruitingPhase IIIInterventional

MiTiGate trial: Is Botox more effective than lidocaine and treatment as usual in myalgia temporomandibular disorder (TMD)?

Myalgia temporomandibular disorder (M-TMD) causes persistent ache and stiffness in the chewing muscles of the jaw, making daily activities like talking and eating difficult. When basic self-care does not bring relief, doctors usually prescribe nerve-pain tablets such as amitriptyline or gabapentin. However, it remains unclear how well these pills work compared to targeted injections. The MiTiGate study is an NHS-funded clinical trial taking place across 12 UK hospital sites. It compares standard tablet treatments against jaw muscle injections using either Botox or lidocaine (a local anaesthetic). Over 36 weeks, researchers will monitor pain levels, side effects, and daily wellbeing in adults who have had jaw pain for three months or longer. The findings will help the NHS determine which therapy gives the best balance of pain relief, quality of life, and value for money.

At a glance

Status

Recruiting

Phase

Phase III

Sponsor

Newcastle upon Tyne Hospitals NHS Foundation Trust

Enrolment target

663

Start

04 Sep 2024

Estimated completion

31 Mar 2027

Myalgia temporomandibular disorder (M TMD)

What is this study about?

Temporomandibular disorders affecting the muscles (M-TMD) cause painful, tight chewing muscles around the jaw and temples. Affecting around 1 in 15 people in the UK, the condition can turn everyday actions like yawning, eating, and speaking into painful chores. Initial care usually involves resting the jaw, gentle heat, or exercises. When pain lasts longer than three months despite these self-care steps, finding reliable relief can become frustrating for both patients and clinicians.

Currently, the standard NHS treatment prescribed by specialists is a course of tablets such as amitriptyline or gabapentin. While these medications can calm pain signals, they do not work for everyone and can cause unwanted side effects such as drowsiness or dry mouth. Early research suggests that injections directly into the painful jaw muscles—using either a numbing medicine called lidocaine or botulinum toxin (Botox)—might offer equal or better relief with fewer whole-body side effects. However, doctors need clear, high-quality evidence before deciding which approach works best.

The MiTiGate trial has been designed to answer this question directly. Led by Newcastle University and funded by the National Institute for Health and Care Research (NIHR), the study compares standard daily tablets against both types of injections. By tracking patients over nine months, the research team hopes to give the NHS solid guidance on which treatment delivers the most effective, lasting pain relief while keeping side effects and healthcare costs as low as possible.

Key takeaways

The MiTiGate trial compares standard nerve-pain tablets against Botox or lidocaine injections for long-term jaw muscle pain.
It is open to UK adults who have lived with jaw pain for at least three months and found little relief from self-care.
Participation lasts for 36 weeks and includes five appointments, some of which may be completed from home.
The study aims to establish which treatment offers the best pain relief, safety, and value for the NHS.
Joining is completely voluntary, and you can withdraw at any time without altering your standard NHS care.

Who may be eligible?

You may be able to take part if you are aged 18 or over and have had jaw muscle pain as your main symptom for at least three months. To be eligible, you must have already tried basic self-care methods for at least six weeks without getting enough pain relief, and your current jaw pain must still be moderately troublesome.

You will not be able to join if you are pregnant, planning a pregnancy, or breastfeeding, because the study medications are not safe for unborn babies or infants. You must also agree to use reliable contraception during the study. If you have recently received any of the trial medications or had acupuncture in the past three months, you will need to wait before joining.

People with certain health conditions cannot take part for safety reasons. These include severe liver disease, kidney failure, bleeding disorders, connective tissue conditions such as Ehlers-Danlos syndrome, fibromyalgia, nerve-damage pain, uncontrolled overactive thyroid, or a known allergy or intolerance to lactose.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

I am aged 18 or older.
My jaw muscle pain has lasted for three months or longer.
I have tried self-care (such as jaw rest, exercises, or heat) for at least six weeks without enough improvement.
I am not pregnant, planning a pregnancy, or breastfeeding.
I have not had Botox, lidocaine injections, amitriptyline, gabapentin, or acupuncture in the past three months.
I do not have fibromyalgia, kidney failure, severe liver disease, or a lactose intolerance.

Answer every question to see your result.

What does participation involve?

Taking part in the MiTiGate trial lasts for 36 weeks (around nine months) and involves five clinic visits in total. If you join, a computer will place you at random into one of three treatment groups: standard daily tablets (amitriptyline or gabapentin), lidocaine injections into the jaw muscles, or Botox injections into the jaw muscles. You cannot choose your group, and your doctor cannot choose it for you.

If you are placed in the tablet group, you will take your medicine daily and can attend your later check-ups remotely from home. If you are in an injection group, you will receive treatment at the clinic and attend follow-up visits in person. Some participants in the North East of England will also be invited to have an optional MRI scan to take detailed pictures of their jaw joint.

Across the study, you will complete online questionnaires every three months about your jaw pain, daily activities, and general mood. You will also take part in a short sensory test where mild, brief pressure is applied to a fingernail to help researchers understand how your nervous system processes pain signals. If you take tablets, any unused medicine must be returned to the clinic at the end of the trial.

Potential risks and benefits

Taking part offers the possibility of improved jaw pain and gives you regular, close monitoring by hospital specialists. Your involvement will also help improve NHS care for thousands of people with chronic jaw pain in the future. However, there are potential risks and side effects. Injections may cause temporary soreness, bruising, or facial weakness. The tablets can cause side effects such as tiredness, dizziness, or dry mouth. There is also a small, unproven concern that Botox might cause minor bony changes in the jaw joint, which the study is monitoring closely. The fingernail pressure test may feel momentarily uncomfortable. Your participation is entirely voluntary, and you can leave the trial at any point without it affecting your regular NHS medical or dental care.

Locations (11)

Newcastle University
Approximate
Newcastle upon Tyne, England
Cardiff University
Approximate
Cardiff, Wales
University of Leeds
Approximate
Leeds, England
University of Liverpool
Approximate
Liverpool, England
Barts and The London
Approximate
London, England
University Dental Hospital of Manchester & North Manchester General Hospital
Unverified
Manchester, England
The James Cook University Hospital
Unverified
Middlesbrough, England
University of Sheffield
Unverified
Sheffield, England
University of Sunderland
Unverified
Sunderland, England
University Hospitals Bristol and Weston NHS Foundation Trust
Unverified
Bristol, England
NHS Greater Glasgow and Clyde
Unverified
Glasgow, Scotland

Common questions

Can I choose whether I receive injections or tablets?

No. To ensure fair and accurate results, a computer randomly assigns you to one of the three treatment groups. Neither you nor the study team can choose your treatment.

Do the jaw injections hurt?

You may feel a brief pinch or stinging sensation during the injection, followed by mild tenderness or bruising around the jaw for a few days. The team will do everything possible to keep you comfortable.

What is the fingernail pain test?

It is a short assessment where researchers apply brief, controlled pressure to your fingernail up to 12 times. It helps standardise how pain is reported across the study and ensures that trial results are consistent.

Will taking part cost me anything?

No, the trial treatments and tests are provided free of charge. You can ask the hospital team whether help is available to cover your travel expenses for clinic visits.

Can I stay on my existing pain relief while on the trial?

You can usually continue other helpful jaw therapies, provided they do not clash with the study drugs. However, you cannot take any of the trial medications outside the study or have acupuncture during the trial.

How to find out more

Charlotte Currie

Charlotte.currie@newcastle.ac.uk - Official trial record

Always speak to your GP or specialist before deciding to take part in a study.