Signs and Symptoms: Facial pain Signs and Symptoms Facial pain
Conditions
Interventions
1. Amitriptyline 20mg
2. Placebo
Sponsors
Department of Health
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male and females 18-65 at entry into trial 2. Total history of 6 months or more for bilateral symmetrical facial pain (pressure, tight, ache in quality) affecting any of the following in isolation or combination: bridge of nose, periorbital, retro-orbital, either side of the nose, maxilla and forehead 3. Episodes last more than 4 hours, occurring with a frequency of >15 days/month or more 4. No association with changes in ambient pressure 5. Absence of migraninous aura, absence of rhinological symptoms, absence of facial flushing or lacrimation, absence of nasal endoscopic evidence of middle meatal disease, absence of computed topographic evidence of sinonasal inflammatory changes, absence of temporomandibular joint dysfucntion or dental disease 6. Absence of a history of other headache syndromes unless attacks distinguished by patient and frequency less than or equal to 1 month, absences of a history of a history of facial trauma 7. No evidence of an affective disorder on the Hamilton rating scale, not taking an antidepressant or psychotropic drug, no substance abuse 8. No contraindication to taking amitriptyline, no comcomitant drug use of drugs for the prophylactic treatment of headache, alcohol abuse, analgesic abuse
Exclusion criteria
Exclusion criteria: Added June 2008: 1. No association with changes in ambient pressure (diving, flying) 2. Absence of migrainous aura 3. Absence of rhinological symptoms (nasal obstruction, rhinorrhoea, hyposmia/anosmia, discoloured mucus) 4. Absence of facial flushing or lacrimation 5. Absence of nasal endoscopic evidence of middle meatal disease (mucopus, mucosal swelling or oedema) 6. Absence of computed topographic evidence of sinonasal inflammatory changes (mucosal thickening of >3mm) 7. Absence of temporomandibular joint dysfunction or dental disease 9. Absence of a history of other headache syndromes (eg migraine) unless attacks distinguished by patient and frequency less than or equal to 1/month 9. Absence of a history of facial trauma 10. No evidence of an affective disorder on the Hamilton rating scale 11. Not taking an antidepressant or psychotropic drug 12. No substance abuse 13. No contraindication to taking amitriptyline 14. No concomitant drug use of : drugs for the prophylactic treatment of headache, alcohol abuse, analgesic abuse
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response to pain | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Analgesic intake 2. Change in headache/facial pain days per week 1 month before trial and on week 8 of study and the same after cross-over 3. Change in mean week severity scores per week 1 week before trial and on week 8 of study and the same after cross-over 4. Change in mean headache/facial pain duration per day 5. Change in number of analgeasic doses or change in number of days analgesic taken 6. Response rate (i.e., proportion of patients with >50% reduction in headache days or headache duration | — |
Countries
United Kingdom
Outcome results
None listed