Effects of injection of hyaluronic acid in managment of carpal tunnel syndrome
Design
Double blind, randomized clinical trial with a control group based on the hospital, two groups of 20 parallel interventions
Settings and conduct
A randomized, double blind clinical trial with control group of this clinical trial was conducted on 40 patients with mild to moderate mild carpal tunnel syndrome referred to the educational centers of Shohadaee Tajrish and Modarres Hospital in Tehran. Patients were randomly divided into two groups: Hyaluronic Acid Injection with Lidocaine and Normal Saline with Lidocaine with Ultrasound
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients aged 18-65 years with mild or moderate carpal tunnel syndrome; and had symptoms lasted for 3 months at least. The exclusion criteria: Pregnant women; severe carpal tunnel syndrome; underlying diseases like diabetes mellitus, thyroid dysfunction and rheumatoid arthritis; history of injection for carpal tunnel within last 6 months; presence of concurrent neuropathy or radiculopathy.
Intervention groups
The first group received an injection of half a cc of lidocaine 2% with one cc of normal saline under a single dose of 1 cc hyaluronic acid injection with 0/5 cc 2% lidocaine under ultrasound guidance in a carpal tunnel
Main outcome variables
Visual analog scale for pain; Nerve conduction of median; Grip strength;Cross section area of median nerve
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130523013442N27
Registration date:2019-05-29, 1398/03/08
Registration timing:registered_while_recruiting
Last update:2019-05-29, 1398/03/08
Update count:0
Registration date
2019-05-29, 1398/03/08
Registrant information
Name
Seyed Ahmad Raeissadat
Name of organization / entity
Modares Hospital
Country
Iran (Islamic Republic of)
Phone
+98 21 2273 1112
Email address
a_raeissadat@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-21, 1398/02/01
Expected recruitment end date
2019-09-23, 1398/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of ultrasound guided injection of hyaluronic acid in managment of carpal tunnel syndrome; A randomized clinical trial
Public title
Effects of ultrasound guided injection of hyaluronic acid in managment of carpal tunnel syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who suffer from mild or moderate carpal tunnel syndrome.
Participants aged between 18 to 65 years
Patients who had symptoms for at least 3 months
Exclusion criteria:
Women who were pregnant Participants who had severe carpal tunnel syndrome Patients who had past history of disorders like diabetes mellitus, thyroid dysfunction and rheumatoid arthritis Patients who had history of local injection of steroids within last 3 months Patients who had concomitant underlying neuropathy or radiculopathy
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
40
More than 1 sample in each individual
Number of samples in each individual:
2
Patients with bilateral carpal tunnel syndrome will gain from diffrent injection approaches
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, simple individual randomization method in the form of sealed envelopes, will be used
Blinding (investigator's opinion)
Double blinded
Blinding description
The participant and outcome assessor will be blinded about the patients` group
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
No. 1983969411, Shahid Beheshti University of Medical Sciences, Sahahid Arabi Street, Yaman Street, Shahid Chamran Highway, Velenjak
City
Tehran
Province
Tehran
Postal code
1983969411
Approval date
2019-03-12, 1397/12/21
Ethics committee reference number
IR.SBMU.MSP.REC.1397.797
Health conditions studied
1
Description of health condition studied
carpal tunnel syndrome
ICD-10 code
G56.00
ICD-10 code description
Carpal tunnel syndrome, unspecified upper limb
Primary outcomes
1
Description
pain
Timepoint
Before intervention and 10 weeks after injection
Method of measurement
Visual Analogue Scale
2
Description
function
Timepoint
Before intervention and 10 weeks after injection
Method of measurement
Boston questionnaire
3
Description
Sensory and motor nerve conduction
Timepoint
Before intervention and 10 weeks after injection
Method of measurement
Nerve electrophysiologic study
4
Description
Median nerve size in ultrasound
Timepoint
Before intervention and 10 weeks after injection
Method of measurement
Cross section area of median nerve in inlet of carpal tunnel by ultrasound
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Local ulnar in-plane injection of 1cc hyalouronic acid with 0/5 cc lidocaine 2% by ultrasound
Category
Treatment - Drugs
2
Description
Control group: Local ulnar in-plane injection of 1cc normal saline with 0/5 cc lidocaine 2% by ultrasound
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Modarres Hospital
Full name of responsible person
Marzieh Shakoori Arani
Street address
No. 1998734383, Shahid Modarres Hospital, Kaj square, Saadat Abad