Myalgia temporomandibular disorder (M TMD) Musculoskeletal Diseases
Conditions
Interventions
Participants will be randomized and allocated to one of three arms:
1. Treatment as Usual (TAU): oral amitriptyline or oral gabapentin for 36 weeks
2. Lidocaine injections: three sets of injections,
either 100mg or 300mg of gabapentin once daily, then twice daily on day 2, and then three times daily on day 3.
2. Titration interval: the quickest allowed for gabapentin and amitriptyline is 1 week a
Sponsors
Newcastle upon Tyne Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The trial’s two co-primary outcomes for effectiveness are: 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 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 The trial’s primary economic outcome is: 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 | — |
Secondary
| Measure | Time frame |
|---|---|
| Measured between screening/baseline visit and 36 weeks: 1. Costs of care measured using the patient use of services and productivity questionnaire (USPQ) alongside the time and travel questionnaire (T&TQ) 2. Generic quality of life/utility measured using EQ-5D-5L 3. Jaw function measured using jaw function limitation questionnaire short-form 4. Psychosocial distress measured using the Patient Health Questionnaire-4 (PHQ-4) 5. Sleep quality measured using the Brief Pittsburgh Sleep Quality Index 6. Over-the-counter (OTC) analgesia measured using a daily diary 7. Structural changes and apparent diffusion coefficient (representing bone density) in the temporomandibular joint on MRI and serum biomarkers of bone turnover CTX and P1NP 8. Global impression of change in pain intensity, daily activities, emotional status, and overall status measured using a single global impression of change scale for each 9. Adverse effects measured using the Liverpool adverse effects profile 10. Longitudinal sequential qualitative data collection from a purposive sub-sample of participants using semi-structured interviews 11. A longer-term economic model will also be explored extrapolating costs and outcomes over a lifetime horizon | — |
Countries
England, Scotland, United Kingdom, Wales
Contacts
Public ContactCharlotte Currie
Outcome results
None listed