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.