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

ISRCTN	ISRCTN72397670
DOI	https://doi.org/10.1186/ISRCTN72397670
Protocol serial number	N0192151055, 12892/001/001/DDX13911
Sponsor	Department of Health
Funders	Nottingham University Hospitals NHS Trust, NHS R&D Support Funding

Submission date: 30/09/2005
Registration date: 30/09/2005
Last edited: 23/01/2019

Recruitment status: Stopped
Overall study status: Stopped
Condition category: Signs and Symptoms

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof A Sama
Scientific

Department of Otorhinolaryngology
Queens Medical Centre
University Hospital NHS Trust
Nottingham
NG7 2UH
United Kingdom

Email	Anshul.Sama@nottingham.ac.uk

Study information

Primary study design	Interventional
Study design	Randomised double-blind placebo-controlled cross-over trial
Secondary study design	Randomised cross over trial
Study type	Participant information sheet
Scientific title	A randomised, double-blind, placebo controlled, cross-over trial with low dose amitriptyline in the management of midfacial segment pain
Study objectives	Do patients who have Midfacial Segment Pain (a version of tension type headache that affects the midface) respond to low dose amitriptyline?
Ethics approval(s)	Ethics committee approval 12/07/2004 but trial not started until 26/07/2006 because of delay in provision of a placebo
Health condition(s) or problem(s) studied	Signs and Symptoms: Facial pain
Intervention	1. Amitriptyline 20mg 2. Placebo
Intervention type	Drug
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Amitriptyline
Primary outcome measure(s)	Response to pain
Key secondary outcome measure(s)	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
Completion date	31/12/2015
Reason abandoned (if study stopped)	Participant recruitment issue

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	65 Years
Sex	All
Target sample size at registration	50
Key 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
Key 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
Date of first enrolment	26/07/2004
Date of final enrolment	31/12/2015

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Queens Medical Centre

Nottingham
NG7 2UH
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

23/01/2019: Study abandoned
21/06/2013: The overall trial end date for this trial was changed from 01/12/2010 to 31/12/2015.