This study aims to determine the effect of superficial scalp arteries' compression compare with 8 mg intravenous Dexamethason in acute attack of migraine in patients come to neurologist clinic of Ayatollah Kashani hospital, Shahrekord, Iran. The study is a randomized clinical trial and the subjects are 200 ambulatory patients with migraine according to International Headache Society (IHS) criteria. Patients are divided to two groups randomly. The first group takes only 8mg IV Dexamethason and in the second group takes 8mg IV Dexamethason and compress the superficial scalp arteries' for 5-minute dependent to pain site.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201012265470N1
Registration date:2011-06-29, 1390/04/08
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-06-29, 1390/04/08
Registrant information
Name
Mahmood Mirzaei
Name of organization / entity
Shahrekord University of Medical Scinces
Country
Iran (Islamic Republic of)
Phone
+98 38 1226 4834
Email address
mirzaei@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellery for research, Shahrekord University of Medical Sciences
Expected recruitment start date
2011-06-20, 1390/03/30
Expected recruitment end date
2012-02-13, 1390/11/24
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of superficial scalp arteries compression and intravenous Dexamethason in acute attack of migraine
Public title
The effect of superficial scalp arteries compression in acute attack of migraine
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: migraine according to International Headache Society (IHS) criteria; Patient's consciousness; headache is not due to life threatening factors. Exclusion criteria: Headaches which are due to anxiety and depression and psychiatric disorders; Headaches which are induced by head trauma; regurgitation resistance to treatment; background on neurofibromatose with convulsion and oblivion.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
200
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shshrekord University of Medicla Sciences
Street address
Kashani Bld
City
Shahrekord
Postal code
Approval date
2008-04-20, 1387/02/01
Ethics committee reference number
87-2-1
Health conditions studied
1
Description of health condition studied
acute attack of migraine
ICD-10 code
G43
ICD-10 code description
Migraine
Primary outcomes
1
Description
pain
Timepoint
30 minutes
Method of measurement
IHS criteria
Secondary outcomes
empty
Intervention groups
1
Description
Intevention group: takes 8 mg IV Dexamethason and compress the superficial scalp arteries' for 5 minute dependent on pain site
Category
Treatment - Other
2
Description
Control: takes only 8 mg IV Dexamethason
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Kashani Hospital of Shahrekord
Full name of responsible person
Mahmood Mirzaei
Street address
Neurology department, Kashani hospital, Parastar St.
City
Shahrekord
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellery for research, Sahrekord University of medical sciences
Full name of responsible person
Mahmoud Mobasheri
Street address
Kashani St.
City
Shahrekord
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellery for research, Sahrekord University of medical sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Shahrekord University of Medical Sciences
Full name of responsible person
Mahmood Mirzaei
Position
Assistant professor, Neurology department
Other areas of specialty/work
Street address
Neurology department, Kashani hospital, Parastar St.
City
Shahrekord
Postal code
Phone
+98 38 1222 0016
Fax
Email
ghmirzaei@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahrekord University of Medical Sciences
Full name of responsible person
Mahmood Mirzaei
Position
neurologist
Other areas of specialty/work
Street address
Neurology department, Kashani hospital, Parastar St.
City
Shahrekord
Postal code
Phone
+98 38 1226 4825
Fax
Email
ghmirzaei@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahrekord University of Medical Sciences
Full name of responsible person
Mahmood Mirzaei
Position
neuorologist
Other areas of specialty/work
Street address
Nerology department, Kashani hospital, Parastar St.
City
Shahrekord
Postal code
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)