Title:Prophylactic Effect of Greater Occipital Nerve Block on intensity and frequency of Migraine Headaches
Study design: Randomized Controlled Trial
Purposes:Assessment of Greater Occipital Nerve Block on intensity of migraine Headaches
Assessment of Greater Occipital Nerve Block on frequency of migraine headaches
Method:The patients are randomized to receive GONB using lidocaine 2%
+ either saline or triamcinolone 40 mg. In the Experimental group (group A), 1 mL 2% lidocaine plus 0.5 mL 40 mg triamcinolone injected to each Greater Occipital Nerve at the medial third of the distance between the occipital protuberance and the mastoid process. In the Placebo group (group B), 1 mL 2% lidocaine plus 0.5 mL saline injected at the same sites. Inderal Tablets are also prescribed for both groups as 20 mg twice daily.
We are going to assess the frequency and severity of headaches 15 days, 1 month and 2 months after injection. Changes in symptom severity were compared between the two groups.
Headache severity is assessed on an 11-point scale before and after injection on visits. Each subject fills MIDAS query in each visit.
Non codein pain killers should not be used more than 2 times a week. The study is conducted double blinded.
General information
Acronym
GONB
IRCT registration information
IRCT registration number:IRCT2013031212781N1
Registration date:2013-05-05, 1392/02/15
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-05-05, 1392/02/15
Registrant information
Name
ِِDavood Kashipazha
Name of organization / entity
Ahvaz JodndiShapour University of Medical Sciencs
Country
Iran (Islamic Republic of)
Phone
+98 61 1374 3012
Email address
kashi-d@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahvaz, Jundishapur University of Medical SciencesVice of Research And Technology
Expected recruitment start date
2013-01-20, 1391/11/01
Expected recruitment end date
2013-09-22, 1392/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Prophylactic Effect of Greater Occipital Nerve Block on intensity and frequency of Migraine Headaches
Public title
Prophylactic Effect of Greater Occipital Nerve Block on intensity and frequency of Migraine Headaches
Purpose
Treatment
Inclusion/Exclusion criteria
Criteria
Inclusion Criteria:
• Age 18-75 years.
• Migraine with or without tenderness.
• At least 1 attack per week.
• MIDAS score >11
Exclusion Criteria:
• Pregnant or lactating.
• Continuous headache.
• Maintenance opioid medication.
• Started migraine prophylactic medication within the past 2 months.
• Hypersensitivity to study ingredients.
• Injection site infection at injection visit.
• Systemic infection at injection visit.
• Cranial bone defect.
• Chronic cluster headache, new daily persistent headache.
• Chronic tension type headache.
• Medication overuse headache.
• Injection phobia.
• Headache due to secondary causes.
Age
From 18 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ahvaz, Jundishapur University of Medical Sciences
Street address
Ahwaz
City
Ahwaz
Postal code
6135715794
Approval date
2012-12-22, 1391/10/02
Ethics committee reference number
ETH-680
Health conditions studied
1
Description of health condition studied
migraine
ICD-10 code
G43
ICD-10 code description
migraine
Primary outcomes
1
Description
headache severity and frequency
Timepoint
Days 0 - 15 - 30 - 60 of study
Method of measurement
self report of patient
Secondary outcomes
empty
Intervention groups
1
Description
1 mL 2% lidocaine plus 0.5 mL 40 mg triamcinolone injected to each Greater Occipital Nerve at the medial third of the distance between the occipital protuberance and the mastoid process. Inderal Tablets are also prescribed as 20 mg twice daily.
Category
Treatment - Drugs
2
Description
1 mL 2% lidocaine plus 0.5 mL saline injected at the same sites bilaterally. Inderal Tablets are also prescribed as 20 mg twice daily.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Golestan Hospital
Full name of responsible person
Ali Nakhostin Mortazavi
Street address
Dept Neurology, Golestan Hospital, Golestan Ave
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences Vice of Research And Technology
Full name of responsible person
Davood Kashipazha
Street address
AJUMS, Golestan Ave
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz Jundishapur University of Medical Sciences Vice of Research And Technology
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
Ahvaz Jundishapour University of Medical Science
Full name of responsible person
Ali Nakhostin Mortazavi
Position
Neurology Resident
Other areas of specialty/work
Street address
Dept Neurology, Golestan Hospital, Golestan Ave
City
Ahvaz
Postal code
6135733118
Phone
+98 61 1374 3012
Fax
+98 61 1374 3012
Email
anmortazavi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz Jundishapour University of Medical Science
Full name of responsible person
Davood Kashipazha
Position
Assistant Professor
Other areas of specialty/work
Street address
Dept Neurology, Golestan Hospital, Golestan Ave
City
Ahvaz
Postal code
6135733118
Phone
+98 61 1374 3012
Fax
+98 61 1374 3012
Email
kashi-d@ajums.ac.ir, dakashi47@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz Jundishapour University of Medical Science
Full name of responsible person
Ali Nakhostin Mortazavi
Position
Neurology Resident
Other areas of specialty/work
Street address
Dept Neurology, Golestan Hospital, Golestan Ave
City
Ahvaz
Postal code
6135733118
Phone
+98 61 1374 3012
Fax
+98 61 1374 3012
Email
anmortazavi@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)