Protocol summary

Study aim
Comparison of the effectiveness of topical injection of vitamin B6 and steroids under ultrasound guide in carpal tunnel syndrome (CTS) on clinical and electrodiagnostic symptoms of patients
Design
Clinical trial without control group, with parallel groups, No blinding, randomized, on 45 patients, for randomization, block method and random number table tool were used
Settings and conduct
Ultrasound guided injections are performed by onditudinalL method on the median nerve in the wrist area and injections are performed at the exit of the carpal canal from the distal to the proximal.The study site is in the physical medicine and rehabilitation clinic of Baqiyatallah Hospital.This study is without blinding.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with final diagnosis of moderate carpal tunnel syndrome, no history of steroid injection into the carpal tunnel and history of surgery, no underlying diseases Exclusion criteria: patients with severe carpal tunnel syndrome, patients with neuropathy, patients with drug allergies
Intervention groups
1) Combination of topical injection of triamcinolone and lidocaine in two doses two weeks apart, each time containing 2 cc of drug containing 1 cc of triamcinolone 40 mg and 1 cc of 2% lidocaine 2) Combination of topical injection of vitamin B6 and lidocaine in two doses two weeks apart, each time 2 cc of drug containing 1 cc of vitamin B6 100 mg and 1 cc of lidocaine 2% 3) In the first case, 2 cc of drug including 1 cc of triamcinolone 40 mg and 1 cc of lidocaine 2% and two weeks later 1 cc of vitamin B6 100 mg topically in the wrist
Main outcome variables
Patient symptoms include anesthesia, pain, and paresthesia based on the Visual analogue scale (VAS) ruler Electrophysiological findings based on Nerve Conduction Velocity (NCV)

General information

Reason for update
Acronym
‏CTS‏
IRCT registration information
IRCT registration number: IRCT20210219050413N1
Registration date: 2021-03-06, 1399/12/16
Registration timing: prospective

Last update: 2021-03-06, 1399/12/16
Update count: 0
Registration date
2021-03-06, 1399/12/16
Registrant information
Name
Meysam Ehsani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8804 0060
Email address
dr.meysamehsani@bmsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-03-21, 1400/01/01
Expected recruitment end date
2021-11-22, 1400/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of topical injection of vitamin B6 and steroids under ultrasound guide in carpal tunnel syndrome (CTS) on clinical and electrodiagnostic symptoms
Public title
Comparison of the effectiveness of topical injection of vitamin B6 and steroids in carpal tunnel syndrome(‏CTS‏)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with a final diagnosis of moderate carpal tunnel syndrome with pain or paresthesia No history of steroid injection into the carpal tunnel No history of carpal tunnel surgery Absence of underlying diseases
Exclusion criteria:
Patients with severe carpal tunnel syndrome Severe hand dysfunction that requires surgical release of the median nerve Patients with neuropathy Upper limb fractures Burns in the upper limbs Patients undergoing hand surgery Patients with allergies to steroids, vitamin B6 and lidocaine Patients who do not have the necessary cooperation to follow up after the injection
Age
From 30 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 45
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, the randomization method is block, the individual randomization unit and the randomization tool using a table of random numbers
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 Baqiyatallah University of Medical Sciences
Street address
South Sheikh Baha'i St, Mulla Sadra St, Vanak Square, Tehran
City
Tehran
Province
Tehran
Postal code
1435915371
Approval date
2021-02-08, 1399/11/20
Ethics committee reference number
IR.BMSU.BAQ.REC.1399.051

Health conditions studied

1

Description of health condition studied
Carpal Tunnel Syndrome(CTS)
ICD-10 code
G56.0
ICD-10 code description
Carpal tunnel syndrome

Primary outcomes

1

Description
Clinical symptoms of patients (anesthesia)
Timepoint
Before treatment, three weeks and three months after treatment
Method of measurement
Using the Visual Analogue Scale ruler

2

Description
Clinical symptoms of patients (paresthesia)
Timepoint
Before treatment, three weeks and three months after treatment
Method of measurement
Using the Visual Analogue Scale ruler

3

Description
Clinical symptoms of patients (pain)
Timepoint
Before treatment, three weeks and three months after treatment
Method of measurement
Using the Visual Analogue Scale ruler

4

Description
Electrodiagnostics
Timepoint
Before treatment, three weeks and three months after treatment
Method of measurement
Nerve Conduction Velocity

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: In the first group, the combination of topical injection of triamcinolone and lidocaine is injected twice in two weeks, each time 2 cc of drug including 1 cc of triamcinolone 40 mg and 1 cc of lidocaine 2% is injected
Category
Treatment - Drugs

2

Description
Intervention group: In the second group, the combination of topical injection of vitamin B6 and lidocaine is given twice in two weeks, each time 2 cc of medicine including 1 cc of 100 mg of vitamin B6 and 1 cc of 2% lidocaine
Category
Treatment - Drugs

3

Description
Intervention group: The third group first injects 2 cc of the drug, including 1 cc of triamcinolone 40 mg and 1 cc of lidocaine 2%, and two weeks later, 1 cc of vitamin B6 100 mg is injected topically into the wrist
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Physical Medicine and Rehabilitation Clinic of Baqiyatallah Hospital
Full name of responsible person
Meysam Ehsani
Street address
Baqiyatallah Hospital, South Sheikh Baha'i St, Mulla Sadra St, Vanak Square
City
Tehran
Province
Tehran
Postal code
1435915371
Phone
+98 21 8755 5531
Email
dr.meysamehsani@bmsu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Ghulam Hossein Alishiri
Street address
Baqiyatallah University of Medical Sciences, South Sheikh Baha'i St, Mulla Sadra St, Vanak Square
City
Tehran
Province
Tehran
Postal code
1435915371
Phone
+98 21 8755 5531
Email
ghalishiri@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bagheiat-allah 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
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Meysam Ehsani
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
South Sheikh Baha'i St, Mulla Sadra St, Vanak Square, Tehran
City
Tehran
Province
Tehran
Postal code
1435915371
Phone
+98 21 8804 0060
Fax
Email
dr.meysamehsani@bmsu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Meysam Ehsani
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
South Sheikh Baha'i St, Mulla Sadra St, Vanak Square, Tehran
City
Tehran
Province
Tehran
Postal code
1435915371
Phone
+98 21 8804 0060
Fax
Email
dr.meysamehsani@bmsu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Meysam Ehsani
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
South Sheikh Baha'i St, Mulla Sadra St, Vanak Square, Tehran
City
Tehran
Province
Tehran
Postal code
1435915371
Phone
+98 21 8804 0060
Fax
Email
dr.meysamehsani@bmsu.ac.ir

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
Undecided - It is not yet known if there will be 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
Loading...