A randomized clinical trial for comparison of two methods of BOTOX injection (FTP & FSFD) to improve headache frequency & quality of life of migrainous headache patients
Help to improve of quality of life of chronic migraine headache patients & lowering of complications & treatment cost
Design
Single popular based clinical trial
Settings and conduct
40 patients who their ages between 18 to 65 that refered & documented by neurologist of Ali ebne Abitaleb hospital divided to two groups then each one injected by one of mentioned method & follow them base on diary migraine chart & life style questionnaire at days 0, 30, 60, 90 & 120.
Participants/Inclusion and exclusion criteria
Inclusion criteria : all patients 18 to 65 years old with chronic migraine that suffering at least 4 hours of each days & for 15 days or more of month.
Exclusion criteria: pregnancy, drug sensivity, coagulopathy, infection of injection site, history of previous treatment with BOTOX, complicated migraine, Beck severity scale point more than 24, secondary migraine due to other reasons, psychologic disorders, neuromuscular junction disorders
Intervention groups
All patients 18 to 65 years old with chronic migraine that suffering at least 4 hours of each days & for 15 days or more of month.
Main outcome variables
Decrease of frequency & severety of migrainous headache & improvement of quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180203038600N1
Registration date:2019-04-09, 1398/01/20
Registration timing:retrospective
Last update:2019-04-09, 1398/01/20
Update count:0
Registration date
2019-04-09, 1398/01/20
Registrant information
Name
Mohadese Fekri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3433 9042
Email address
fekri.mhds@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-02-08, 1396/11/19
Expected recruitment end date
2018-04-07, 1397/01/18
Actual recruitment start date
2018-02-08, 1396/11/19
Actual recruitment end date
2018-04-07, 1397/01/18
Trial completion date
2018-07-19, 1397/04/28
Scientific title
A randomized clinical trial for comparison of two methods of BOTOX injection (FTP & FSFD) to improve headache frequency & quality of life of migrainous headache patients
Public title
Comparison of two methods of BOTOX injection (FTP & FSFD) to improve of chronic migrainous headache patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who have at least 15 days headache that maintain for 4 hour or more
Patients who had no improvement in severity & frequency of headaches by using prophylactic drug agents like that Beta blockers, CCB, anti convulsive drugs & anti depressant
Exclusion criteria:
Pregnancy
History of BOTOX injection or other Botulinum serotypes
Neuromuscular junction disease
Psychologic disorders that have negative impact on clinical trial
Beck severity scale of depression more than 24
Primary or secondary headaches due to another reasons
Complicated migraine
Drug sensivity
Coagulopathy
Infection of injection skin site
Age
From 18 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
40
Actual sample size reached:
18
Randomization (investigator's opinion)
Randomized
Randomization description
randomization as simple randomized & individualization with using of locked pockets that data bases is hiding from neurologist who visits & evaluates patients & statistical consultant will analyses data bases, too.
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
Ethics committee of Rafsanjan university of medical science
Street address
Rafsanjan university of medical science, Imam Ali Blvd., Ali ebne Abi taleb square, Rafsanjan Town
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Approval date
2017-12-26, 1396/10/05
Ethics committee reference number
IR.rums.rec.1396.151
Health conditions studied
1
Description of health condition studied
chronic migraine
ICD-10 code
G43.0
ICD-10 code description
Migraine without aura [common migraine]
Primary outcomes
1
Description
Frequency of migraine headache attacks
Timepoint
The days 0, 30, 60, 90, 120 after injection
Method of measurement
Migraine diary chart
Secondary outcomes
1
Description
Quality of life improvement
Timepoint
Synchronous to first variable outcome evaluation
Method of measurement
Quality of life questionnaire approved by WHO
Intervention groups
1
Description
BOTOX injection for chronic migraine headache patients by FTP method
Category
Treatment - Drugs
2
Description
Intervention group: BOTOX injection for chronic migraine headache patients by FSFD method
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ali ebne Abitaleb hospital
Full name of responsible person
Dr.Salehi Hossein
Street address
Ali ebne Abitaleb hospital, Imam Ali Blvd., Ali ebne Abitaleb square, Rafsanjan Town
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Phone
+98 34 3428 0038
Fax
+98 34 3428 0071
Email
dr_hosseinsalehi@yahoo.com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Dr.shamsi Ali
Street address
Rafsanjan medical university, Imam Ali Blvd., Ali ebne Abitaleb square, Rafsanjan Town
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Phone
+98 34 3428 0097
Fax
Email
alishamsy@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rafsanjan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Dr.Fekri Mohadese
Position
Intern
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Ali ebne Abi taleb hospital, Imam Ali Blvd., Ali ebne Abi Taleb square, Rafsanjan Town
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Phone
+98 34 3428 0038
Email
fekri.mhds@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Dr.Salehi Hossein
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
plastic surgery
Street address
Ali ebne Abitaleb hospital, Imam Ali Blvd., Ali ebne Abitaleb Square, Rafsanjan Town
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Phone
+98 34 3428 0038
Email
dr_hosseinsalehi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Dr.Fekri Mohadese
Position
Intern
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Ali ebne Abitaleb hospital, Imam Ali Blvd, Ali ebne Abitaleb Square, Rafsanjan Town
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Phone
+98 34 3428 0038
Email
fekri.mhds@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All documents reveal based on approved international diary migraine chart & life style questionnaire.
When the data will become available and for how long
We can publish all result 6 month after data collection & analysis.
To whom data/document is available
All physicians & researchers can use data for research & treatment.
Under which criteria data/document could be used
All physicians & researchers can use data for research & treatment.
From where data/document is obtainable
they can contact with this E-mail : fekri.mhds@gmail.com.
What processes are involved for a request to access data/document