History
# Registration date Revision Id
2 2020-07-05, 1399/04/15 142927
1 2019-12-12, 1398/09/21 113692
Changes made to previous revision
This is the first revision

Protocol summary

Study aim
Comparison of the effectiveness of local corticosteroid injection with injection of dextrose 5% solution in patients with carpal tunnel syndrome.
Design
Double blinded randomized control trial.
Settings and conduct
This study will be conducted on physical medicine and rehabilitation department of Rasool Akram hospital, Tehran, Iran. Patients with mild to moderate carpal tunnel syndrome (based on electrodiagnostic study) will be included in the study. Patients will be categorized into one of the following groups, using block randomization method: A Group: Will receive ultrasound-guided injection of 1CC triamcinolone into carpal tunnel. B Group: Will receive ultrasound-guided injection of 5 CC dextrose 5% into carpal tunnel. Patients in the both groups will receive the conservative treatments for carpal tunnel syndrome including wrist splints for six weeks as well. Patients will be followed after 2 weeks, one month and 6 months after injections. The pain intensity (Visual analogue scale) and the electrodiagnostic parameters are the main outcomes.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1- Clinical diagnosis of carpal tunnel syndrome based on history (paresthesia over the distribution of median nerve) and possitive Tinnel and Phalen's tests. 2- Mild to moderate severity based on electrodiagnostic study. 3- Age between 18-65 years. exclusion criteria: Severe CTS, thenar atrophy, contraindication for injection, previous treatment , Neoplasm or trauma,tenderness and fracture of wrist, cervical radiculopathy, polyneuropathy.
Intervention groups
A Group: Ultrasound-guided injection of 1CC triamcinolone into carpal tunnel. B Group: Ultrasound-guided injection of 5 CC dextrose 5% into carpal tunnel.
Main outcome variables
Pain intensity (Visual analogue scale) and the electrodiagnostic parameters.

General information

Reason for update
Acronym
CTS
IRCT registration information
IRCT registration number: IRCT20180603039969N1
Registration date: 2019-12-12, 1398/09/21
Registration timing: registered_while_recruiting

Last update: 2019-12-12, 1398/09/21
Update count: 1
Registration date
2019-12-12, 1398/09/21
Registrant information
Name
Sara Moradnia
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3553 1210
Email address
moradnia.s@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-12-10, 1398/09/19
Expected recruitment end date
2020-06-08, 1399/03/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of ultrasound-guided local corticosteroid injection with dextrose 5% solution injection in carpal tunnel syndrome.
Public title
Comparison of effectiveness of corticosteroid with dextrose in treatment of carpal tunnel syndrome.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with clinical diagnosis of carpal tunnel syndrome (paresthesia over the median nerve territory in the hand). Mild to moderate severity of carpal tunnel syndrome, based on electrodiagnostic studies. Age between 18-65 years,
Exclusion criteria:
Severe CTS ( based on electrodiagnostic data). Signs of thenar atrophy. Contraindication for injection ( such as history of hypersensitivity to corticosteroid, signs of local infection, immune deficiency, needle phobia. Diseases that mimic symptoms of carpal tunnel syndrome such as polyneuropathy, radiculopathy, and thoracic outlet syndrome. Surgical treatment or local injection in the last six months. Neoplastic or traumatic origin. Tenderness and fracture of wrist bones.
Age
From 18 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
  • Participant
  • Investigator
Sample size
Target sample size: 54
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be categorized into one of the following groups, using block randomization method: Group A) Will receive ultrasound-guided injection of 1 ml triamcinolone (40 mg) into the carpal tunnel. Group B) Will receive ultrasound-guided injection of 5 ml dextrose 5% into the carpal tunnel.
Blinding (investigator's opinion)
Double blinded
Blinding description
The patient and the investigator are kept blinded. The injecting syringe is covered with sterile gas. Therefore, the investigator will be kept blinded to the type of injecting solution. Furthermore, the patient will be kept blinded to the type of injecting solution.
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
Ethics committee, medical school, Iran University of Medical Sciences, Hemmat autobahn
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2018-11-20, 1397/08/29
Ethics committee reference number
IR.IUMS.FMD.REC.1397.216

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 intensity (Visual analogue scale)
Timepoint
Baseline, and after 2 weeks, one month and 6 months after injection.
Method of measurement
10 point VAS scale.

2

Description
Electrodiagnosis parameters
Timepoint
Baseline, and after 2 weeks, one month and 6 months after injection.
Method of measurement
Electrodiagnostic study machine

Secondary outcomes

empty

Intervention groups

1

Description
One session of ultrasound-guided 1 CC Triamcinolone (Exir co, Tehran, Iran) injection into the carpal tunnel.
Category
Treatment - Drugs

2

Description
One session of ultrasound-guided 5 CC dextrose 5% solution (Ghazi co, Tehran, Iran) injection into the carpal tunnel.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Rasoul akram hospital
Full name of responsible person
ِDR Arash Babaei
Street address
Rasoul akram hospital, Niayesh street, Satarkhan Ave
City
Tehran
Province
Tehran
Postal code
۱۴۴۵۶۱۳۱۳۱
Phone
+98 21 6435 2683
Email
arashbabaie@gmail.com
Web page address
http://hrmc.iums.ac.ir/form_contact.php?sid=44&slc_lang=fa

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
ِDr seyed kazem malakooti
Street address
Iran university of medical sciences, hemmat autobahn
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 8670 2503
Email
research@iums.ac.ir
Web page address
http://vcr.iums.ac.ir/page/3340/%D9%85%D8%B9%D8%A7%D9%88%D9%86%D8%AA-%D8%AA%D8%AD%D9%82%DB%8C%D9%82%D8%A7%D8%AA-%D9%88-%D9%81%D9%86%D8%A7%D9%88%D8%B1%DB%8C
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences
Proportion provided by this source
80
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
Persons

Person responsible for general inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Sara moradnia
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
Physical medicine, Rasoul-akram hospital, Niayesh street, Satarkhan Ave, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6435 2683
Email
moradnia.s@ajums.ac.ir
Web page address
http://hrmc.iums.ac.ir/

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Sara Moradnia
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
Rasoul akram hospital, Niayesh street, Satarkhan Ave
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6435 2683
Email
moradnia.s@ajums.ac.ir
Web page address
http://hrmc.iums.ac.ir/

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Sara Moradnia
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
Physical medicine department, Rasoul-akram hospital, Niayesh street, Satarkhan Ave, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6435 2683
Email
moradnia.s@ajums.ac.ir
Web page address
http://hrmc.iums.ac.ir/

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All collected data can be shared after making patients anonymous.
When the data will become available and for how long
Starting 6 months after publication.
To whom data/document is available
Data will be available for researchers on the internet.
Under which criteria data/document could be used
Data will be shared based on the request of the researchers.
From where data/document is obtainable
Dr. Babaei, Physical medicine department, Rasoul-akram hospital, Satarkhan Street, Tehran, Iran.
What processes are involved for a request to access data/document
Data will be sent via Email.
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