Evaluation of the transient pressure effect on the middle part of external carotid artery for terminating an acute attack of migraine
Design
Interventional study without a control limb
Settings and conduct
Patients with migraine headache who come to urgent department and the intervention will be applied in this unit. Pain intensity was evaluated by Universal Pain Assessment Tools (UPAT). In safe position, applying vital signs monitoring and ipsilateral type of headache, a gentle pressure was applied on the carotid artery, lateral to the cricothyroid membrane and medial border of the Sterno- Cleido- Mastoid (SCM), by using both index and middle fingers, till the headache was relieved, following which the pressure was maintained for a period of 15 seconds. Then the middle finger was maintained at its position and the index finger slid caudally with the same pressure as far a distance of four centimeters and the pressure withdrawn slowly. After 2 minutes, patients were asked to report any change in headache which was recorded.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients in range of 18 -45 years old, with established migraine based on International Classification of Headache Disorders (ICDH) guidelines, who had no atheromatous plaque in their carotid arteries.
Exclusion criteria: Patients with histories of syncopal attacks, sensitivity of carotid sinus, cardiac dysrhythmia, neurologic disease, basilar migraine and patients with another non migraine headache symptoms
Intervention groups
Patients with migraine headache who come to urgent department.
This study has not control group.
Main outcome variables
Reduction in pain intensity score.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150116020676N4
Registration date:2019-07-21, 1398/04/30
Registration timing:registered_while_recruiting
Last update:2019-07-21, 1398/04/30
Update count:0
Registration date
2019-07-21, 1398/04/30
Registrant information
Name
Farhad Tavakoli
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2226 9950
Email address
ftavakoli@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-07-21, 1398/04/30
Expected recruitment end date
2019-09-21, 1398/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of employing direct tactile pressure on the external carotid artery to relieve acute episode attack of migraine: An interventional study
Public title
Effect of pressure on external carotid artery in treatment of acute migraine headache
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Established migraine, based on International Classification of Headache Disorders (ICDH) guidelines، in whom color doppler sonography of the carotid arteries depicted no narrowing of the carotid arteries or any atheromatous plaque.
Exclusion criteria:
Patients with histories of syncopal attacks
Sensitivity of carotid sinus
Cardiac dysrhythmia
History of any neurologic disease
Patients with another non migraine headache symptoms
Basilar migraine
Age
From 18 years old to 45 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Central organization of Tehran of medical sciences, Ghods St. , keshavarz Blv.
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2018-05-20, 1397/02/30
Ethics committee reference number
IR.TUMS.IKHC.REC.1397.182
Health conditions studied
1
Description of health condition studied
Migraine headache
ICD-10 code
G43
ICD-10 code description
Migraine
Primary outcomes
1
Description
Reduction in pain score evaluated by universal pain assessment tools (UPAT)
Timepoint
2 minutes after removing the pressure on carotid artery
Method of measurement
Universal Pain Assessment Tools
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In safe position, applying vital signs monitoring and ipsilateral type of headache, a gentle pressure was applied on the carotid artery, lateral to the cricothyroid membrane and medial border of the Sterno- Cleido- Mastoid (SCM), by using both index and middle fingers, till the headache was relieved, following which the pressure was maintained for a period of 15 seconds. Then the middle finger was maintained at its position and the index finger slid caudally with the same pressure as far a distance of four centimeters and the pressure withdrawn slowly. After 2 minutes, patients were asked to report any change in headache which was recorded.