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)

ewcastle upon Tyne Hospitals NHS Foundation Trust0 sites663 target enrollmentMarch 22, 2024

Overview

No summary available.

Registry

who.int

Start Date

March 22, 2024

End Date

January 31, 2027

Last Updated

last year

Study Type

Interventional

Sex

All

Sponsor

ewcastle upon Tyne Hospitals NHS Foundation Trust

•1\. Adults \=18 years old
•2\. Willing and able to give informed consent before trial procedures occurring
•3\. DC/TMD derived diagnosis of M\-TMD with pain for \=3 months identified as the primary complaint of familiar pain
•4\. Self\-management trialled for \=6 weeks and not controlled the pain to the patient’s satisfaction
•5\. Minimum pain intensity of 30 on CPI over the last 3 months
•6\. For people of childbearing potential: an agreement to use at least an acceptable effective method of contraception or to practise sexual abstinence to avoid pregnancy for the duration of trial involvement.

•A documented diagnosis or the patient reports any, of the following:
•1\. Current use of any of the trial interventions or has used any within the last 12 weeks\*. Patients can continue any other treatment modality they currently find helpful for their TMD subject to no absolute contraindications to its use alongside the interventions under investigation.
•2\. Any other subtype of TMD that is the primary cause of familiar pain detected on clinical examination; familiar pain is pain provoked by clinical exam or testing/movement of a structure that matches the patient’s primary complaint e.g., for M\-TMD familiar pain is provoked from examination or use of the muscles of mastication. Patients can have other forms of (painful) TMD comorbid with M\-TMD, but these should not be the primary cause of familiar pain determined by DC/TMD\-derived diagnostic procedures.
•3\. Enrolled in another interventional research trial which could affect the outcome of this trial.
•4\. People who are pregnant, planning pregnancy, or breastfeeding during the time of the study participation\*.
•5\. Current or planned acupuncture within the trial period or 3 months before the trial period\*.
•6\. Lactose intolerance or lactose allergy
•7\. Fibromyalgia
•8\. Neuropathic pain
•9\. Coagulopathy