The comparison of treatment effect between acupuncture and botox injection effects on prevention of chronic migraine among patients referred to pain clinic of Poursina hospital in 2014
In this study we compare the therapeutic outcome of two method acupuncture and botox injection in prevention of chronic migraine, the probable benefits and disadvantages of these methods is measured and used of them to true conduct the patient to select the best method in prevention of chronic migraine. Include criteria: the patient with chronic migraine (IHS criteria) that have 20 to 60 years old. The exclusion criteria: the other migraine reasons, pregnant women, psychotic disorder or mental retardation, epilepsy, history of neurologic disorder heart disease and trauma, arterial hypertension and non tendency for being in study. In this study the patient suffering chronic migraine that received the prophylaxis treatment for more than 3 months and had no betterment in migraine symptoms based on their tendency select one of acupuncture or botox injection. Total number of patients is 100 people, 50 people in each group. In this study intervention is one part of patient treatment and we don’t new intervention. Primary outcome is reduction in severity and days of headache and improvement in life quality.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201404146186N3
Registration date:2014-04-30, 1393/02/10
Registration timing:prospective
Last update:
Update count:0
Registration date
2014-04-30, 1393/02/10
Registrant information
Name
Bahram Naderi Nabi
Name of organization / entity
Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 3323 4600
Email address
naderi_bahram@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Guilan University of Medical Sciences
Expected recruitment start date
2014-05-05, 1393/02/15
Expected recruitment end date
2014-09-21, 1393/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of treatment effect between acupuncture and botox injection effects on prevention of chronic migraine among patients referred to pain clinic of Poursina hospital in 2014
Public title
Comparison of acupuncture and botox in prevention of chronic migraine
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:the patient aged 20 to 60 years old that have chronic migraine (with HIS criteria) that come to Rasht poursina hospital pain clinic in 2014.
Exclusion criteria: other reasons of headache such as brain tumor; the people that have other headache addition to migraine; pregnant women; psychotic disorder or mental retardation, epilepsy; history of neurological disorder, heart disease and trauma, arterial hypertension; patient dissatisfaction to enter in the study.
Age
From 20 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
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
Vice chancellor for research of Guilan University of Medical Sciences
Street address
Shahid Beheshti Hiway
City
Rasht
Postal code
Approval date
2014-02-22, 1392/12/03
Ethics committee reference number
1920422818
Health conditions studied
1
Description of health condition studied
Migraine
ICD-10 code
G43
ICD-10 code description
Migraine
Primary outcomes
1
Description
Pain intensity
Timepoint
Referral time, the end of first month, end of second month and the end of third month
Method of measurement
VAS score
Secondary outcomes
1
Description
Frecuancy of headache in month
Timepoint
Referral time,the end of first month, end of second month and the end of third month
Method of measurement
Incidence number of migraine headache with IHS
Intervention groups
1
Description
Intervention1: Botox, 155 unit Botulinum toxin XEOMIN, GERMANY, Merz Group Services GmbH, in one time injection
Category
Treatment - Drugs
2
Description
Intervention 2: Acupuncture, every other day up to 15 times in two period , one week interval, along 70 days from initial of treatment
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Porsina hospital pain clinic
Full name of responsible person
Dr Bahram Naderi Nabi
Street address
Namjoo Avenue
City
Rasht
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor of Guilan University of Medical Sciences
Full name of responsible person
Abtin Heidarzadeh
Street address
Shahid beheshti Highway
City
rasht
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor of Guilan 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
Guilan University of Medical Sciences
Full name of responsible person
Dr Bahram Naderi Nabi
Position
Assosiate professor /Anesthesiologist
Other areas of specialty/work
Street address
Poursina hospita
City
Rasht
Postal code
4193713189
Phone
+98 13 1321 0434
Fax
+98 13 1324 5140
Email
naderi_bahram@yahoo.com;arcguilan1392@gmail.com
Web page address
www.velaiat.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Dr Bahram Naderi Nabi
Position
Assosiate professor
Other areas of specialty/work
Street address
Poursina hospital, Poursina intersection.
City
Rasht
Postal code
Phone
+98 13 1321 0434
Fax
Email
naderi_bahram@yahoo.com; vbuhosp@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Dr Bahram Naderi Nabi
Position
Assosiate professor of Guilan university of medical sciences
Other areas of specialty/work
Street address
Poursina hospital, Poursina intersection
City
Rasht
Postal code
4193713189
Phone
+98 13 1321 0434
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)