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

Phase 3

• Conditions: Myalgia temporomandibular disorder (M TMD); Musculoskeletal Diseases

• Registration Number: ISRCTN12054536
• Lead Sponsor: ewcastle upon Tyne Hospitals NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-03-22
• Last Update Posted: 2 September 2024
• Study Completion: 2027-01-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 663

Inclusion Criteria

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.

Exclusion Criteria

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
10. Uncontrolled hyperthyroidism
11. Renal failure
12. Severe liver disease
13. Connective tissue disorders e.g. Ehlers-Danlos syndrome, Epidermolysis bullosa, Marfan syndrome, Osteogenesis imperfecta, Rheumatoid arthritis, Poly/dermatomyositis, Scleroderma, Sjogren’s syndrome, Systemic lupus erythematosus, Vasculitis
14. Any (previous) substance use disorder
15. Concerns from the research or clinical team over patient safety due to psychosocial distress, previous or current mental health illness*
16. Taking any of the following groups of medications:
16.1. Aminoglycoside antibiotics
16.2. Anticholinesterases
16.3. Non-depolarising and depolarising muscle relaxants
16.4. Opiates
16.5. Monoamine oxidase inhibitors (MAOIs)
17. Allergy or intolerance to any trial intervention
18. For the MRI sub-study group:
18.1. Cardiac pacemaker, defibrillator or pacing wires.
18.2. Cochlear implant, an aneurysm clip or a hydrocephalus shunt.
18.3. ustained injuries involving metal fragments to the eye.
18.4. Pregnancy.
18.5. Any other non-MRI-compatible implant or device.
For participants who would receive amitriptyline as treatment as usual, were they to be randomised to this arm, the following exclusions (19-24) also apply, and they would therefore be offered gabapentin instead:
19. Significant cardiovascular history as indicated by recent (less than 12 calendar months) myocardial infarction, any cardiac rhythm disorder, degree of heart block, prolonged QT interval, or coronary artery insufficiency.
20. Ileus
21. Urinary retention
22. Glaucoma
23. Orthostatic hypotension
24. Taking any of the following groups of medications:
24.1. Selective serotonin and or norepinephrine uptake inhibitors
24.2. Triptans
*If the chronology of events allows, the potentially eligible patient can be booked to be rescreened for a place on the trial at an appropriate point in the future.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The trial’s two co-primary outcomes for effectiveness are:<br>1. Characteristic pain intensity (CPI) assessed by a composite average, worst and current numerical rating scale of pain (0-100 scale) at 36 weeks of treatment examining the last 12 weeks’ pain intensity<br>2. Disorder-specific related quality of life measured using the Oral Health Impact Profile for TMDs (OHIP-TMD) at 36 weeks of treatment examining the last 4 weeks’ quality of life<br><br>The trial’s primary economic outcome is:<br>1. Incremental cost per quality-adjusted life year gained of the most effective treatment compared to other treatments at 36 weeks, calculated using data from the use of services and productivity questionnaire (USPQ administered baseline, 12 & 36 weeks), the time and travel questionnaire (T&TQ administered at census date of 24 weeks), the EQ-5D-5L (administered at baseline, 12, 24 & 36 weeks), and routine sources and study specific estimates for unit costs