Condition category
Signs and Symptoms
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
21/06/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof A Sama

ORCID ID

Contact details

Department of Otorhinolaryngology
Queens Medical Centre
University Hospital NHS Trust
Nottingham
NG7 2UH
United Kingdom
+44
Anshul.Sama@nottingham.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0192151055, 12892/001/001/DDX13911

Study information

Scientific title

Acronym

Study hypothesis

Do patients who have Midfacial Segment Pain (a version of tension type headache that affects the midface) respond to low dose amitriptyline?

Please note that as of 21/06/2013, the anticipated end date for this trial was updated from 01/12/2010 to 31/12/2015

Ethics approval

Added June 2008: Ethics committee approval 12/07/04 but trial not started until 26/07/06 because of delay in provision of a placebo.

Study design

Randomised double-blind placebo-controlled cross-over trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Signs and Symptoms: Facial pain

Intervention

1. Amitriptyline 20mg
2. Placebo

Intervention type

Drug

Phase

Not Specified

Drug names

amitriptyline

Primary outcome measures

Response to pain to amitriptyline or placebo in randomised cross-over trial.

Secondary outcome measures

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 (ie proportion of patients with >50% reduction in headache days or headache duration

Overall trial start date

26/07/2004

Overall trial end date

31/12/2015

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Added June 2008: 50 patients

Participant 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

Recruitment start date

26/07/2004

Recruitment end date

31/12/2015

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Otorhinolaryngology
Nottingham
NG7 2UH
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

Nottingham University Hospitals NHS Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

NHS R&D Support Funding

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes