Comparison of the efficacy of steroid injection via proximal and distal approach on the symptoms and function in patients with mild and moderate Carpat Tunnel Syndrome
Red color represents old content. It may be empty showing addition in the new version.
Green color represents new content. It may be empty showing deletion in the new version.
Inline
Side by side
Added new contents,
deleted old contents,contents that are not changed.
New table contents
New table contents
Old table contents
Old table contents
Unchanged contents
Unchanged contents
Added new contents, contents that are not changed.
Deleted old contents, contents that are not changed.
Old table contents
Old table contents
Unchanged contents
Unchanged contents
New table contents
New table contents
Unchanged contents
Unchanged contents
General information
34
32
3432
empty
60
60
empty
2019-01-22, 1397/11/02
2019-01-22 00:00:00
empty
2019-12-11, 1398/09/20
2019-12-11 00:00:00
empty
2020-03-11, 1398/12/21
2020-03-11 00:00:00
empty
Record the actual sample size, the start and end date of the actual sampling and the end date of the trial
Record the actual sample size, the start and end date of the actual sampling and the end date of the trial
empty
ثبت حجم نمونه تحقق یافته ، تاریخ شروع و پایان نمونه گیری تحقق یافته و تاریخ خاتمه کارآزمایی
ثبت حجم نمونه تحقق یافته ، تاریخ شروع و پایان نمونه گیری تحقق یافته و تاریخ خاتمه کارآزمایی
Sponsors / Funding sources
#1
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Ahmad Rezaei
Full name of responsible person - Persian: احمد رضایی
Street address - English: No.1, Northern gate of the university, Poursina St, Enghelab St
Street address - Persian: خیابان انقلاب ؛خیابان پورسینا ؛ درب شمالی دانشگاه ؛ ساختمان شماره ۱
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1417653761
Phone: +98 21 6405 3491
Fax:
Email: deanmed@tums.ac.ir
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Mohammad Ali Sahraeian
Full name of responsible person - Persian: محمدعلی صحرائیان
Street address - English: No.1, Northern gate of the university, Poursina St, Enghelab St
Street address - Persian: خیابان انقلاب ؛خیابان پورسینا ؛ درب شمالی دانشگاه ؛ ساختمان شماره ۱
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1417653761
Phone: +98 21 6405 3491
Fax:
Email: deanmed@tums.ac.ir
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Ahmad RezaeiMohammad Ali Sahraeian Full name of responsible person - Persian: احمد رضاییمحمدعلی صحرائیان Street address - English: No.1, Northern gate of the university, Poursina St, Enghelab St Street address - Persian: خیابان انقلاب ؛خیابان پورسینا ؛ درب شمالی دانشگاه ؛ ساختمان شماره ۱ City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 1417653761 Phone: +98 21 6405 3491 Fax: Email: deanmed@tums.ac.ir Web page address:
Protocol summary
Study aim
Determination of the results of steroid injection by proximal and distal methods on the symptoms and function of patients with mild to moderate carpal tunnel syndrome
Design
Two arm parallel group randomised clinical trial , design for 34 hands in each group, enrolled between
Settings and conduct
Population under study will include patients suspected of Carpal Tunnel Syndrome (CTS) referred to Iran Rehabilitation Center, from physical medicine and rehabilitation, orthopedic, and rheumatology clinics during 2018 time period
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1) Mild to moderate CTS based on Electrodiagnostic findings;
2) Older than 18 years old;
Exclusion criteria:
1) severe CTS with persistent pain & numbness;
2) a previous history of CTS injection 6 months ago;
3) a previous history of using CTS night splint;
4)a previous history of Carpal Tunnel Release surgry;
5) corticosteroid contraindication;
6) corticosteroid allergy;
7) Malignancy;
8) inflammation;
9) Pregnancy;
10) the presence of neurologic disorders;
11) Patients who have a surgical indication;
Intervention groups
Patients will be divided into two groups. First group will be injected by 40mg methyl prednisolone (proximal to crease); and, second group will be injected by 40mg methyl prednisolone (distal to crease) (palmar). It should be mentioned that both groups will use wrist static splint as a confirmed
and standard treatment for a period of 3 months, just at nights
Main outcome variables
1.Electrodignostic findings
2. Comparison of symptom severity
3. Comparison of functional status
General information
Reason for update
Record the actual sample size, the start and end date of the actual sampling and the end date of the trial
Acronym
CTS
IRCT registration information
IRCT registration number:IRCT20180804040685N1
Registration date:2018-11-07, 1397/08/16
Registration timing:prospective
Last update:2021-02-25, 1399/12/07
Update count:1
Registration date
2018-11-07, 1397/08/16
Registrant information
Name
Hamid Reza Fateh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8490 2110
Email address
hr-fateh@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-23, 1397/07/01
Expected recruitment end date
2019-03-11, 1397/12/20
Actual recruitment start date
2019-01-22, 1397/11/02
Actual recruitment end date
2019-12-11, 1398/09/20
Trial completion date
2020-03-11, 1398/12/21
Scientific title
Comparison of the efficacy of steroid injection via proximal and distal approach on the symptoms and function in patients with mild and moderate Carpat Tunnel Syndrome
Public title
Distal jnjection in Carpal tunnel syndrome ; Effect of Proximal injection in treatment of Carpal tunnel syndrome ;
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Mild to moderate CTS based on Electrodiagnostic findings
Older than 18 years old
Exclusion criteria:
Severe CTS with persistent pain & numbness;
Previous history of CTS injection 6 months ago;
Previous history of using CTS night splint;
Previous history of Carpal Tunnel Release surgery ;
Corticosteroid contraindication;
Corticosteroid allergy;
Malignancy;
Inflammation;
Pregnancy;
Presence of neurologic disorders;
Patients who have a surgical indication;
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
32
Actual sample size reached:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Based on the quadruple number block ;
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 Tehran University of Medical Sciences
Street address
Jalal-Al-Ahmad Street; North Karegar Street;Tehran
City
Tehran
Province
Tehran
Postal code
1411713135
Approval date
2018-09-18, 1397/06/27
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1397.444
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
Electrodignostic findings
Timepoint
Assessment of changes in electrodiagnostic tests at the beginning of the study (before intervention) and 3 months after steroid injection
Method of measurement
EMG-NCV machine
Secondary outcomes
1
Description
Symptom severity
Timepoint
Beginning of the study (before intervention) and 3 months after steroid injection
Method of measurement
Visual Analogue Scale
2
Description
Functional status
Timepoint
Beginning of the study (before intervention) and 3 months after steroid injection
Method of measurement
Boston carpal tunnel questionnaire
Intervention groups
1
Description
Intervention group : Injection (40 mg Methyl prednisolone) distal to crease; All injections would be made via insulin needle (gauge 29, and length 2.1 inch). Distal method injection takes place on volar section under wrist crease (palmar) and needle entrance angle would be 5-10 degrees or parallel to the arm (In this case wrist would be placed at dorsiflexion state 40-50 degrees). One and three months after the injection, patients will be reevaluated in terms of severity of symptoms and three months after the injection, patients will be reevaluated in terms of severity of symptoms and functional status (VAS- Boston questionnaires) .
Category
Treatment - Drugs
2
Description
Control group:Injection (40 mg Methyl prednisolone) proximal to crease; . All injections would be made via insulin needle (gauge 29, and length 2.1 inch). proximal method injection takes place in volar section (upper part of wrist crease) and medial side of Palmaris longus tendon; while, needle entrance angle is 30-40 degrees. One and three months after the injection, patients will be reevaluated in terms of severity of symptoms and functional status (VAS- Boston questionnaires) .
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shariati hospital
Full name of responsible person
Mina Meshkini
Street address
Jalal-Al-Ahmad St; North karegar St; Tehran
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8490 2110
Email
meshkini83@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Ali Sahraeian
Street address
No.1, Northern gate of the university, Poursina St, Enghelab St
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 6405 3491
Fax
Email
deanmed@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Mina Meshkini
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
Jalal-Al-Ahmad St, North Karegar St,Tehran
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8490 2110
Email
meshkini83@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Hamid Reza Fateh
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Physical Medicine
Street address
Jalal-Al-Ahmad St, North Karegar St,Tehran
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8940 2110
Email
meshkini83@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mina Meshkini
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
Jalal-Al-Ahmad St, North Karegar St, Tehran
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8490 2110
Email
meshkini83@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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
No - There is not 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