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The effect of lidocaine injection in tender points of head in patients with chronic daily headaches

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History
# Registration date Revision Id
2 2020-08-15, 1399/05/25 148685
1 2020-03-11, 1398/12/21 125144
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  • General information

    empty
    Correcting the code of ethics and changing the person responsible
    empty
    تصحیح کد اخلاق و تغییر مجری طرح

  • Ethics committees

    #1
    IR.AJUMS.1398.890
    IR.AJUMS.REC.1398.890

  • Person responsible for general inquiries


    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Maryam mohammadi
    Full name of responsible person - Persian: مریم محمدی
    Position - English: Resident
    Position - Persian: رزیدنت
    Latest degree: med_doctor
    Area of specialty/work: 40
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Farvardin street
    Street address - Persian: خیابان فروردین
    City - English: Ahvaz
    City - Persian: اهواز
    Province: Khouzestan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 6136753133
    Phone: +98 61 3374 3012
    Mobile: +98 913 166 7398
    Fax:
    Email: mry.mohammadimd@yahoo.com
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Davood Kashipazha
    Full name of responsible person - Persian: داوود کاشی پزها
    Position - English: Associate professor
    Position - Persian: استادیار
    Latest degree: specialist
    Area of specialty/work: 86
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Department of Neurology,Golestan Hospital,Farvardin St,Golestan,Ahvaz
    Street address - Persian: اهواز گلستان خیابان فروردین بیمارستان گلستان بخش نورولوژی
    City - English: Ahvaz
    City - Persian: اهواز
    Province: Khouzestan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 6135733118
    Phone: +98 61 3374 3012
    Mobile: +98 912 386 6210
    Fax:
    Email: dakashi47@gmail.com
    Web page address:

  • Person responsible for scientific inquiries


    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Maryam mohammadi
    Full name of responsible person - Persian: مریم محمدی
    Position - English: Resident
    Position - Persian: رزیدنت
    Latest degree: med_doctor
    Area of specialty/work: 40
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Farvardin street
    Street address - Persian: خیابان فروردین
    City - English: Ahvaz
    City - Persian: اهواز
    Province: Khouzestan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 6136753133
    Phone: +98 61 3374 3012
    Mobile: +98 913 166 7398
    Fax:
    Email: mry.mohammadimd@yahoo.com
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Davood Kashipazha
    Full name of responsible person - Persian: داوود کاشی پزها
    Position - English: Associate professor
    Position - Persian: استادیار
    Latest degree: specialist
    Area of specialty/work: 86
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Department of Neurology,Golestan Hospital,Farvardin St,Golestan,Ahvaz
    Street address - Persian: اهواز گلستان خیابان فروردین بیمارستان گلستان بخش نورولوژی
    City - English: Ahvaz
    City - Persian: اهواز
    Province: Khouzestan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 6135733118
    Phone: +98 61 3374 3012
    Mobile: +98 912 386 6210
    Fax:
    Email: dakashi47@gmail.com
    Web page address:

Protocol summary

Study aim
The effect of lidocaine injection in tender points of head in patients with chronic daily headaches
Design
Two arm parallel group randomised trial with blinded postoperative care and outcome assessment
Settings and conduct
Patients are examined for points of tenderness in the head and points of tenderness are identified in the patient. Then the patients in the intervention group were subcutaneously treated with topical injection of 1% lidocaine 2% in the areas of high tension. Patients in the control group were also given 1–2 cc normal saline.Patients are then reassessed one week, one month, two months and three months after the injection and the mean of headache severity and number of days of headache per week are assessed at each patient visit.
Participants/Inclusion and exclusion criteria
patients with chronic daily headaches
Intervention groups
patients with chronic daily headaches
Main outcome variables
Average daily headache severity; The number of days a week a patient has a headache;Average daily headache severity

General information

Reason for update
Correcting the code of ethics and changing the person responsible
Acronym
IRCT registration information
IRCT registration number: IRCT20200305046704N1
Registration date: 2020-03-11, 1398/12/21
Registration timing: registered_while_recruiting

Last update: 2020-08-27, 1399/06/06
Update count: 1
Registration date
2020-03-11, 1398/12/21
Registrant information
Name
maryam mohammadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3374 3012
Email address
mry.mohammadimd@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-03-10, 1398/12/20
Expected recruitment end date
2020-03-19, 1398/12/29
Actual recruitment start date
2020-03-10, 1398/12/20
Actual recruitment end date
2020-03-19, 1398/12/29
Trial completion date
2020-06-18, 1399/03/29
Scientific title
The effect of lidocaine injection in tender points of head in patients with chronic daily headaches
Public title
The effect of lidocaine injection in tender points of head in patients with chronic daily headaches
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
chronic daily headache
Exclusion criteria:
Head injury history Head Surgery Brain tumors depression and anxiety
Age
From 18 years old to 55 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Investigator
  • Outcome assessor
Sample size
Target sample size: 64
Actual sample size reached: 64
Randomization (investigator's opinion)
Randomized
Randomization description
By the method of randomized block
Blinding (investigator's opinion)
Double blinded
Blinding description
Researcher and participant with 4-block method
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Ahvaz Jundishapur University of Medical Sciences
Street address
Golestan Hospital, Farvardin Street
City
ahvaz
Province
Khouzestan
Postal code
6136753133
Approval date
2020-02-15, 1398/11/26
Ethics committee reference number
IR.AJUMS.REC.1398.890

Health conditions studied

1

Description of health condition studied
chronic daily headache
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Average daily headache severity
Timepoint
One week, one month, two months and three months after injection
Method of measurement
HIT6 , VAS score

Secondary outcomes

1

Description
The number of days a week a patient has a headache
Timepoint
One week, one month, two months and three months after injection
Method of measurement
Headache Impact Test Questionnaire(HIT6)

Intervention groups

1

Description
Intervention group: headache patients with tenderness points
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Golestan Hospital
Full name of responsible person
Mryam mohammadi
Street address
Farvardin street
City
Ahvaz
Province
Khouzestan
Postal code
6136753133
Phone
+98 61 3374 3012
Email
mry.mohammadimd@yahoo.com
Web page address

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
محمد بدوی
Street address
Golestan highway
City
Ahvaz
Province
Khouzestan
Postal code
1579461357
Phone
+98 61 3373 8383
Email
info@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Davood Kashipazha
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
Department of Neurology,Golestan Hospital,Farvardin St,Golestan,Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6135733118
Phone
+98 61 3374 3012
Email
dakashi47@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Davood Kashipazha
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
Department of Neurology,Golestan Hospital,Farvardin St,Golestan,Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6135733118
Phone
+98 61 3374 3012
Email
dakashi47@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Maryam mohammadi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Farvardin street
City
Ahvaz
Province
Khouzestan
Postal code
6136753133
Phone
+98 61 3374 3012
Email
mry.mohammadimd@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
All potential data can be shared after unidentifiable people
When the data will become available and for how long
Start access period after printing results
To whom data/document is available
It will be available to researchers working in academic and scientific institutions
Under which criteria data/document could be used
Meta-analysis
From where data/document is obtainable
mry.mohammadimd@yahoo.com
What processes are involved for a request to access data/document
send mail
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