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
-
-
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
-
Ethics committees
1
-
Ethics committee
-
-
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
1
-
Sponsor
-
-
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
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
-
Comments
-