This study aims to examine the effect of median nerve hydrodissection and to acquire data on the added value of corticosteroid injection when using hydrodissection as a treatment for patients with carpal tunnel syndrome.
Design
prospective, block randomized allocation clinical trial with 2 arm parallel and control groups, double masked (Participant, Outcomes Assessor)
Settings and conduct
The study population are patients with clinical and electrophysiological symptoms of mild to moderate CTS who referred to the physical medicine and rehabilitation clinics of Imam Khomeini and Sina hospitals. After examining the inclusion and exclusion criteria, 60 patients are randomly assigned to one of three study groups.
Each patient is evaluated initially (before injection) and at intervals of two weeks, 1, 3 and 6 months after injection. Assessments will include visual analog (VAS), Boston Carpal Tunnel Questionnaire, Electrodiagnostic test data, dynamometer, and median nerve cross-section (CSA) measurements by ultrasound.
Participants/Inclusion and exclusion criteria
Adult men or women aged 18 - 80 years with clinical and electromyographic diagnosis of Carpal Tunnel Syndrome any accompanying orthopedic or neurologic disorders that could mimic CTS.
Intervention groups
Group A: Corticosteroid Hydrodissection Injection
Ultrasound-guided hydrodissection using 1ml of 40mg triamcinolone acetonide mixed with 1ml of 2% lidocaine hydrochloride and 3cc Normal Saline.
Group B: Hydrodissection Injection without Corticosteroid
Ultrasound-guided hydrodissection using 1ml of 2% lidocaine mixed with 4cc Normal Saline.
Group C: control group
Ultrasound in-plane ulnar approach injection using 1 mL of triamcinolone is
as per current treatment practices.
Main outcome variables
Change from baseline of severity of symptoms and functional status after Hydrodissection injection
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210613051566N1
Registration date:2021-12-17, 1400/09/26
Registration timing:prospective
Last update:2021-12-17, 1400/09/26
Update count:0
Registration date
2021-12-17, 1400/09/26
Registrant information
Name
sahar ghorbanpour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8870 1551
Email address
sahar.ghorbanpour@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-12-22, 1400/10/01
Expected recruitment end date
2022-03-20, 1400/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Ultrasound‐Guided Median nerve Hydrodissection with Corticosteroid Injection in the treatment of mild to moderate Carpal Tunnel Syndrome
Public title
Comparison of Ultrasound‐Guided Median nerve Hydrodissection with Corticosteroid Injection in the treatment of mild to moderate Carpal Tunnel Syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Confirmed clinical and Electrophysiological diagnosis of Carpal Tunnel Syndrome with mild to moderate degree
Exclusion criteria:
Confirmed clinical and Electrophysiological diagnosis of CTS with severe degree
Patients with suspicious of CTS mimic condition, including cervical radiculopathy, polyneuropathy, brachial plexopathy, thoracic outlet syndrome
Recent corticosteroid injection to the carpal tunnel within 6 months
Previous history of carpal tunnel surgical release
Steroid injection contraindications
Pregnancy
Cancer
Coagulopathy
Age
From 18 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
60
More than 1 sample in each individual
Number of samples in each individual:
2
In some patients both hands are involved
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization with help of www.sealedenvelope.com website.
According to treatment groups, block sizes and list length, the website generates a list of random codes consisting of an English letter and digits.
These codes are printing the codes on a card, and placing the cards in a sealed envelope (SNOSE method).
After generating the list, each code will be printed on one card that, after shuffling, are placed in envelopes. Each patient will be given an envelope to assign to one of the groups. Also, in a separate list, the person is assigned to the code taken out of the envelope.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study participants and outcomes assessor are masked.
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, Sina hospital
Street address
Room 605، Secretariat of the Ethics Committee in University Biomedical Research، Vice Chancellor for Research and Technology, 6th Floor, Central University Organization, Corner of Ghods St., Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2021-02-28, 1399/12/10
Ethics committee reference number
IR.TUMS.SINAHOSPITAL.REC.1399.121
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
Boston carpal tunnel syndrome questionnaire (BCTQ)
Timepoint
Pre-treatment, 1st, 3rd and 6th months after injection
Method of measurement
five-point rating scale questionnaire
Secondary outcomes
1
Description
Visual Analog Scale (VAS) for Pain
Timepoint
Pre injection, 2 weeks, 1, 3 and 6 months intervals
Method of measurement
Visual and numeric scale
2
Description
Cross-sectional area of the Median nerve
Timepoint
Pre injection, 1, 3 and 6 months intervals
Method of measurement
Ultrasound device
3
Description
Conduction Velocity, Distal Latency and Amplitude of Median nerve SNAP & CMAP
Timepoint
Pre injection, 1, 3 and 6 months intervals
Method of measurement
EMG- NCV
4
Description
Hand grip strength
Timepoint
Pre injection, 1, 3 and 6 months intervals
Method of measurement
Dynamometer
Intervention groups
1
Description
Intervention group: Patients in this group will undergo a Ultrasound-guided Median nerve hydrodissection with corticosteroid injection. Total of 5cc solution consisting of 1cc of Triamcinolone acetonide (40mg), 1cc of lidocaine, and 3cc of saline is used. Using ultrasound guidance and aseptic technique, the needle will be inserted from an ulnar approach, then be angled deep to inject 2 ml of mixture for separating nerve from Flexor tendons beneath. The needle will then be angled superficial to the median nerve and 3ml of mixture will be injected to to peel the median nerve off the overlying flexor retinaculum.
Category
Treatment - Other
2
Description
Intervention group: Patients in this group will undergo a Ultrasound-guided Median nerve hydrodissection without corticosteroid injection. Total of 5cc solution consisting of 1cc of lidocaine, and 4cc of saline is used. Using ultrasound guidance and aseptic technique, the needle will be inserted from an ulnar approach, then be angled deep to inject 2 ml of mixture for separating nerve from Flexor tendons beneath. The needle will then be angled superficial to the median nerve and 3ml of mixture will be injected to to peel the median nerve off the overlying flexor retinaculum.
Category
Treatment - Other
3
Description
Control group: Patients in this group will undergo a routine and standard Corticosteroid injection for CTS treatment. Using ultrasound guidance and aseptic technique, the needle will be inserted from an ulnar approach, and 1ml of Triamcinolone acetonide (40mg) will be injected into the area above Median nerve without separating the nerve from surrounding structures.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam khomeini hospital
Full name of responsible person
Sahar Ghorbanpour
Street address
Keshavarz blvd
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119 0000
Email
sahar.ghorbanpour@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohadese Azadvari
Street address
Keshavarz Blvd, Qods street, TUMS
City
Tehran
Province
Tehran
Postal code
1416753955
Phone
+98 21 8889 6692
Email
drazadvari@yahoo.com
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
Sahar Ghorbanpour
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
No.1. Aghili St. Aazodi Ave. Karimkhan St. Tehran
City
Tehran
Province
Tehran
Postal code
1598684813
Phone
+98 21 8870 1551
Fax
Email
sahar.ghorbanpour@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohadese Azadvari
Position
assistant professor
Latest degree
Specialist
Other areas of specialty/work
Physical Medicine
Street address
Physical medicine and rehabilitation department, Sina hospital, Hassan Abad square
City
Tehran
Province
Tehran
Postal code
1418733141
Phone
+98 21 61190
Email
drazadvari@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Sahar Ghorbanpour
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
No. 1, Aghili st, Azodi st, Karimkhan Blvd
City
Tehran
Province
Tehran
Postal code
1598684813
Phone
+98 21 8870 1551
Email
sahar.ghorbanpour@gmail.com
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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The data of the study participants will be evaluated for statistical analysis, and their results will be published in the form of an article.
When the data will become available and for how long
Immediately after the publication of the results in the form of a scientific article, the results of data analysis will be available to researchers at the request of the data.
To whom data/document is available
Researchers of this project and individuals who have the right to access the project data based on the written permission of the corresponding researcher can access the project data.
Under which criteria data/document could be used
If the permission of the main researcher of the project is obtained with an acceptable justification and explanation, the data obtained from this project can be used.
From where data/document is obtainable
Imam Khomeini Hospital Complex, Physical Medicine and Rehabilitation department, Dr Mohadese Azadvari
What processes are involved for a request to access data/document
A written request will be sent to the researcher in charge of the study with appropriate evidence and justification; Once approved by him, access to data and documents will be possible.