ISRCTN12054536进行中（未招募）3 期
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 个研究点目标入组 663 人开始时间: 2024年3月22日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 663
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •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.
排除标准
- •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.
- •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.
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