Botox blokkering av dyp nerveknute hos pasienter med Persisterende idiopatiske ansiktssmerter

Å delta i en klinisk studie er ingen rettighet. Det blir stilt strenge krav til hvem som blir valgt ut til å delta. For at du skal bli vurdert som deltaker i en klinisk studie, må vanligvis din behandlende lege sende en forespørsel til det sykehuset som er ansvarlig for studien. Du må også passe inn i de kriteriene som forskerne har satt for å velge ut pasienter til sine studier. 1 Inclusion and exclusion criteria 1.1 Inclusion criteria: 1. Written informed consent from the patient 2.Male or female aged 18 to 80 years 3. Persistent Idiopathic Facial Pain fulfilling diagnostic criteria as classified in The International Classification of Headache Disorders, 3rd edition (ICHD-3 beta version)[2] as modified by the authors of this trial. See below. Modified diagnostic criteria for PIFP according to The International Classification of Headache Disorders, 3rd edition (ICHD-3 beta version) A. Facial and/or oral pain fulfilling criteria B and C B. Recurring daily for >2 hr per day for >3 months C. Pain has both of the following characteristics: 1. Poorly localized and may radiate beyond the trigeminal nerve distribution 2. Dull, aching or nagging quality D. Clinical neurological examination is normal, however patient may denote paresthesia or a mild degree of gain or loss of sensory function in the affected area E. A dental cause has been excluded by appropriate investigations;signs of structural pathology or other specific causes of pain are not identified. Minor operation and injury (insignificant trauma e.g. tooth extraction) to the face, maxilla, teeth and gums without a direct causal relationship with the pain regarding both time and site is accepted. See table 3. Page 13. A symptomatic cause of pain has been ruled out by MRI of the brain and facial structures. F. Not better accounted for by another ICHD-3 diagnosis. 4. Unsatisfactory effect of available treatment methods as evaluated by a neurologist, ENT specialist or maxillofacial surgeon. The patient should have failed treatment with both antidepressant as tricyclic antidepressants and anticonvulsant as carbamazepine (Tegretol, Carbatrol) 5. Average Pain intensity =4 (0-10) in Numeric Pain Rating Scale (NRS) on the affected side during the 4-week baseline period (Questionnaire 1) 6. WOCBP must be using highly effective contraception. Such methods include: combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal or transdermal); progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable or implantable); intrauterine device (IUD); intrauterine hormone-releasing system (IUS); bilateral tubal occlusion; vasectomized partner; sexual abstinence. This group of patients should not be using other drugs that might interact and reduce the efficacy of the used anticonceptive drug. WOCBP is defined as fertile women, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilization methods include: hysterectomy, bilateral salpingectomy and bilateral oophorectomy. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. WOCBP will have to agree to take a pregnancy test before inclusion and before the injection. 1.2 Exclusion criteria: 1. Bilateral symmetrically affected (³80 % of the pain must be located on the affected side, whereas <20 % pain may be located on the contralateral side) 2. neurological or temporomandibular joint disorders, or other related systemic diseases that can explain the pain 3. mri ct examination confirming intracranial pathology explaining the pain. 4. systemic or local disease or condition that can give a significantly increased risk of complications to the particular procedure 5. infection on injection site 6. not competent to asses informed consent based on neurological assessment 7. psychiatric disorder that prevents the completion of the study 8. pregnancy 9. inappropriate use of contraception 10. breastfeeding 11. abuse or unauthorized use of medication, drugs or alcohol 12. allergy or other hypersensitivity reactions to marcaine, lidocaine, xylocaine, or adrenaline, possibly similar related drugs 13. anatomical factors that prevent or impede the injection 14. known hypersensitivity to bta or to any of the excipients 15. treatment with drugs that can interact with bta: aminoglycoside antibiotics, spectinomycin, neuromuscular blockers, both depolarizing (succinylcholine) and non-depolarizing (tubokurarinderivater), lincosamides, polymyxins, quinidine, magnesium sulfate, anticholinesterases.>