Comparison of the effectiveness of open surgery versus ultrasound guided median nerve dissection with injection of methyl prednisolone acetate in treatment of carpal tunnel syndrome
Determine the comparison of the effectiveness of open surgery versus ultrasound guided median nerve dissection with injection of methyl prednisolone acetate in treatment of carpal tunnel syndrome
Design
In this study, 40 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 age 20-65 years old with patients with carpal tunnel syndrome Informed consent of patient in the study. Exclusion criteria include neuropathy or an old nerve injury; Patients with systemic disease, such as disease, arthritis, diabetes, hypothyroidism ; dissatisfaction to fill consent paper.
Intervention groups
One group was treated with open surgery and the other group was treated by injection of Depo- Mdrol under sonographic guidance.
Main outcome variables
Pain, Paresthesia, Numbness, Weakness, Return to daily activities، sonographic improvement
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200629047948N1
Registration date:2020-06-29, 1399/04/09
Registration timing:registered_while_recruiting
Last update:2020-06-29, 1399/04/09
Update count:0
Registration date
2020-06-29, 1399/04/09
Registrant information
Name
Amir Hossein Zohrehvand
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3225 6285
Email address
a.zohrehvand@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-03-18, 1398/12/28
Expected recruitment end date
2021-03-14, 1399/12/24
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of open surgery versus ultrasound guided median nerve dissection with injection of methyl prednisolone acetate in treatment of carpal tunnel syndrome
Public title
Comparison of the effectiveness of open surgery versus ultrasound guided median nerve dissection with injection of methyl prednisolone acetate in treatment of carpal tunnel syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 20-65 years patients with carpal tunnel syndrome Informed consent of patient in the study.
Exclusion criteria:
Neuropathy or an old nerve injury
Patients with systemic disease, such as disease, arthritis, diabetes, hypothyroidism
Dissatisfaction to fill consent paper
Age
From 20 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Samples will be divided into two groups of Control and intervention using Permuted Block Randomization. Number will be selected for allocation concealment by one of the colleagues and by another, that assignment chain is chosen.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
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
2020-03-14, 1398/12/24
Ethics committee reference number
IR.MUBABOL.HRI.REC.1398.372
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 one and three month of surgery
Method of measurement
Visual Analogue Scale
2
Description
Paresthesia
Timepoint
Before surgery and one and three month of surgery
Method of measurement
Based on patient response
3
Description
Numbness
Timepoint
Before surgery and one and three month of surgery
Method of measurement
Based on boston form
4
Description
weakness
Timepoint
Before surgery and one and three month of surgery
Method of measurement
Based on boston form
Secondary outcomes
1
Description
Return to daily activities
Timepoint
Before surgery and one and three month of surgery
Method of measurement
Based on boston form
2
Description
Sonographic improvement
Timepoint
Before surgery and one and three month of surgery
Method of measurement
Median nerve cross sectional area on ultrasound
Intervention groups
1
Description
Intervention group: Undergoes open surgery using the Fallen method.
Category
Treatment - Surgery
2
Description
Control group: patient lies prone an wrist sets in supine position. median nerve is visualized by sonographic guidance at wrist area.after local analgesia a 22 gauge needle will be entered from ulnar side of median nerve and carpal ligament starts to be fenestrated. at the end 20 miligram of Bupivacaine with 40 miligram Depomedrol and 3-5 cc normal saline is injected and needle is removed.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Babol Shahid Beheshti Hospital
Full name of responsible person
Dr. Amir Hossien Zohrehvand
Street address
Babol University of Medical Sciences; Ganjafrooz Street; Babol; Iran
City
Babol
Province
Mazandaran
Postal code
4716681451
Phone
+98 11 3225 6285
Email
ahzt9dr@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
Parmida abdavy
Position
General Medicine
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Babol University of Medical Sciences; Ganjafrooz Street; Babol; Iran
City
Babol
Province
Mazandaran
Postal code
4716681451
Phone
+98 11 3225 6285
Email
abdavyparmida@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. Amir hossein Zohrehvand
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Neurosurgery
Street address
Babol University of Medical Sciences; Ganjafrooz street; Babol; Iran
City
Babol
Province
Mazandaran
Postal code
4716681451
Phone
+98 11 3225 6285
Email
ahzt9dr@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. Amir Hossein Zohrehvand
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Neurosurgery
Street address
Babol University of Medical Sciences; Ganjafrooz street; Babol; Iran
City
Babol
Province
Mazandaran
Postal code
4716681451
Phone
+98 11 3225 6285
Email
ahzt9dr@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