Determining the effect of the percutaneous needle method on the amount of A1 release in trigger finger
Design
This study consists of two groups of 10 people who are assigned to one of the intervention groups which is to perform treatment with pink or green needle by simple random method and removing the type of intervention (code number 1 or 2) from inside the envelope. The study is double-blind, and the patients and the evaluator are unaware of the type of intervention
Settings and conduct
The study was conducted in Hazrat Fatemeh Hospital in Tehran, and after being assigned to the desired group, the patient was operated percutaneously with one of the types of needles, and after that, all patients underwent open surgery to determine the degree of tendon and vascular damage and the degree of release. find awareness
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with Trigger finger, People between 18 and 60 years old
Exclusion criteria: Diabetics, People with previous reconstructive surgery
Intervention groups
The first group (intervention) includes people whose A1 monetary release is treated with the percutaneous needle method with a pink needle, and the second group (control) includes people whose A1 monetary release is treated with the same method but with a green needle
Main outcome variables
The amount of poly release, The amount of tendon damage, The amount of vascular damage, The amount of tissue damage
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230222057488N1
Registration date:2023-02-26, 1401/12/07
Registration timing:prospective
Last update:2023-02-26, 1401/12/07
Update count:0
Registration date
2023-02-26, 1401/12/07
Registrant information
Name
Afsane Bagheri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8871 7272
Email address
dr.afsanehbagheri@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-21, 1402/02/01
Expected recruitment end date
2023-08-21, 1402/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of percutaneous needle on A1 poly release in trigger finger
Public title
Investigating the effect of percutaneous needle method in the repair of trigger finger
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
People between 18 and 60 years old
Having a Trigger finger
Exclusion criteria:
Diabetic people
No previous reconstructive surgery
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
We have 10 numbers of code number 1 and 10 numbers of code number 2, which we put in an envelope and draw lots for each patient before the operation, using a simple random method. Code number one is related to treatment with pink needle and code number two is green needle
Blinding (investigator's opinion)
Double blinded
Blinding description
We throw 20 pieces of paper into the envelope by a simple random method. We write code number 1 on 10 numbers and code number 2 on the other 10 numbers, and before the operation we take out a paper from the envelope, if the code number is one, the treatment will be done with a pink needle, and if it is number two, the treatment will be done with a green needle. became
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Iran University of Medical Sciences
Street address
Hemmad highway. Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2023-01-08, 1401/10/18
Ethics committee reference number
IR.IUMS.FMD.REC.1401.496
Health conditions studied
1
Description of health condition studied
Trigger finger
ICD-10 code
M65.3
ICD-10 code description
Trigger finger
Primary outcomes
1
Description
The amount of release of A1 poly
Timepoint
Immediately after surgery
Method of measurement
Observation in open surgery method
Secondary outcomes
1
Description
Tendon damage
Timepoint
Immediately after surgery
Method of measurement
Observation in open surgery method
2
Description
Vascular damage
Timepoint
Immediately after surgery
Method of measurement
Observation in open surgery method
3
Description
Tissue damage
Timepoint
Immediately after surgery
Method of measurement
Observation in open surgery method
Intervention groups
1
Description
Intervention group: A1 poly release by entering the poly at an angle of 45 degrees from the surface of the hand with a pink needle and then opening the skin of the hand and observing the amount of release and damage
Category
Treatment - Surgery
2
Description
Control group: A1 poly release by entering the poly at an angle of 45 degrees from the surface of the hand with a green needle and then opening the skin of the hand and observing the amount of release and damage
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Hazrate Fatemeh Hospital
Full name of responsible person
Mohamadreza Akhondinasab
Street address
Seyed Jamalodin Asadabadi St.
City
Tehran
Province
Tehran
Postal code
1433933111
Phone
+98 21 8871 7272
Email
akhondinasab@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Hossein Keyvani
Street address
Hemmad highway
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 8670 2504
Email
keyvani.h@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Hazrate Fatemeh Hospital
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
Iran University of Medical Sciences
Full name of responsible person
َAfsaneh Bagheri
Position
Specialist assistant
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Seyed Jamalodin Asadabadi St.
City
Tehran
Province
Tehran
Postal code
1433933111
Phone
+98 21 8871 7272
Email
dr.afsanehbagheri@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mohamadreza Akhondinasab
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Plastic and Reconstructive Surgery
Street address
Seyed Jmalodin Asadabadi St.
City
Tehran
Province
Tehran
Postal code
1433933111
Phone
+98 21 8871 7272
Email
akhondinasab@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
َAfsaneh Bagheri
Position
Specialist assistant
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Seyed Jamalodin Asadabadi St.
City
Tehran
Province
Tehran
Postal code
1433933111
Phone
+98 21 8871 7272
Email
dr.afsanehbagheri@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Yes - There is 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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The written informed consent form will be provided to the participants before the procedure, and then it will be included in the thesis. We have also published it in the researcher system. The data of the study also includes the results of the variables, including the amount of Poly release, the amount of vascular, tendon and tissue damage that is included in the thesis report
When the data will become available and for how long
The consent form will be placed in the attachments section after the thesis is printed. Also, the data of the participants is included in the thesis
To whom data/document is available
All people who have access to the full text of the thesis
Under which criteria data/document could be used
It can be modeled in similar studies
From where data/document is obtainable
Email to the general supervisor of the thesis Dr. Afsaneh Bagheri dr.afsanehbagheri@gmail.com
What processes are involved for a request to access data/document
After sending the email to the general supervisor, the thesis can be received within 1 week