Choosing the right surgery method for carpal tunnel syndrome
Design
In this study, 50 patients have been assigned to two groups of intervention and control by using random numbers table.
Settings and conduct
In this clinical trial, all patients who undergo surgery in Shahid Beheshti Hospital with carpal tunnel syndrome diagnosis include the study.
Participants/Inclusion and exclusion criteria
Inclusion criteria includes patients diagnosed with carpal tunnel syndrome. Exclusion criteria include failure to follow the patient after surgery, recurrence of carpal tunnel syndrome after CTR surgery, patients whose symptoms are severe, such as trauma, fracture, bleeding, and injury during surgery.
Intervention groups
One group was treated with double incision and another group with minimal incision.
Main outcome variables
Pain, Paresthesia, Numbness, Weakness, Return to daily activities
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160508027797N5
Registration date:2019-03-11, 1397/12/20
Registration timing:registered_while_recruiting
Last update:2019-03-11, 1397/12/20
Update count:0
Registration date
2019-03-11, 1397/12/20
Registrant information
Name
Masoud Bahrami Ferydoni
Name of organization / entity
Babol University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3225 6285
Email address
m.bahrami@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-11-18, 1397/08/27
Expected recruitment end date
2019-11-18, 1398/08/27
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Double Incision and Comparison of the outcomes of Minimal Incision technique in treatment of carpal tunnel syndrome
Public title
Double Incision and Comparison of the outcomes of Minimal Incision technique in treatment of carpal tunnel syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with carpal tunnel syndrome
Exclusion criteria:
Failure to follow the patient after surgery
Carpal tunnel syndrome recurs after CTR surgery
Patients whose symptoms are severe, such as trauma, fracture, bleeding, and damage during surgery.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
These patients are divided into 2 groups of 25 Minimal Incision and Double Incision according to the random numbers table.
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 Babol University of Medical Sciences
Street address
Babol University of Medical Sciences, Ganjafrooz Street, Babol, Mazandaran, Iran
City
Babol
Province
Mazandaran
Postal code
4716681451
Approval date
2018-11-18, 1397/08/27
Ethics committee reference number
IR.MUBABOL.HRI.REC.1397.207
Health conditions studied
1
Description of health condition studied
Carpal tunnel syndrome
ICD-10 code
G56.0
ICD-10 code description
Carpal tunnel syndrome
Primary outcomes
1
Description
Pain
Timepoint
Before surgery and six month of surgery
Method of measurement
Visual Analogue Scale
2
Description
Paresthesia
Timepoint
Before surgery and six month of surgery
Method of measurement
Based on patient response
3
Description
Numbness
Timepoint
Before surgery and six month of surgery
Method of measurement
Based on boston form
4
Description
weakness
Timepoint
Before surgery and six month of surgery
Method of measurement
Based on boston form
Secondary outcomes
1
Description
Return to daily activities
Timepoint
Before surgery and six month of surgery
Method of measurement
Based on boston form
Intervention groups
1
Description
Intervention group: Minimal Incision Surgery
Category
Treatment - Surgery
2
Description
Control group: Double Incision Surgery
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Babol Shahid Beheshti Hospital
Full name of responsible person
Dr. Masoud Bahrami Ferydoni
Street address
Babol University of Medical Sciences; Ganjafrooz Street; Babol; Iran
City
Babol
Province
Mazandaran
Postal code
4716681451
Phone
+98 11 3225 6285
Email
Drbahrami865@gmail.com
Web page address
http://www.mubabol.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr. Reza Ghadimi
Street address
Babol University of Medical Sciences; Ganjafrooz Street; Babol; Iran
City
Babol
Province
Mazandaran
Postal code
4716681451
Phone
+98 11 3219 7667
Email
rezaghadimi@yahoo.com
Web page address
http://www.mubabol.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol 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
Babol University of Medical Sciences
Full name of responsible person
Dr. Ilia Roshani
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Orthopedics
Street address
Babol University of Medical Sciences; Ganjafrooz street; Babol; Iran
City
Babol
Province
Mazandaran
Postal code
4716681451
Phone
+98 11 3225 6285
Email
iliaroshani@yahoo.com
Web page address
http://www.mubabol.ac.ir/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr. Masoud Bahrami Ferydoni
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
Babol University of Medical Sciences; Ganjafrooz street; Babol; Iran
City
Babol
Province
Mazandaran
Postal code
4716681451
Phone
+98 11 3225 6285
Email
Drbahrami865@gmail.com
Web page address
http://www.mubabol.ac.ir/
Person responsible for updating data
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr. Masoud Bahrami Ferydoni
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
Babol University of Medical Sciences; Ganjafrooz Street; Babol; Iran
City
Babol
Province
Mazandaran
Postal code
4716681451
Phone
+98 11 3225 6585
Email
Drbahrami865@gmail.com
Web page address
http://www.mubabol.ac.ir/
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD