A randomised, double-blind, placebo controlled, cross-over trial with low dose amitriptyline in the management of midfacial segment pai

Not Applicable

Completed

• Conditions: Signs and Symptoms: Facial pain; Signs and Symptoms; Facial pain

• Registration Number: ISRCTN72397670
• Lead Sponsor: Department of Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-09-30
• Study Completion: 2015-12-31
• Last Update Posted: 11 February 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 50

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified