Comparison of efficacy of ultrasound-guided midline and ulnar in-plane approach and blind midline approach triamcinolone acetonide injection in pain and fuction improvement among patients with carpal tunnel syndrome; A randomized clinical trial.
Comparison of efficacy of ultrasound-guided midline and ulnar in-plane approach and blind midline approach triamcinolone acetonide injection in pain and fuction improvement among patients with carpal tunnel syndrome
Design
Hospital based, double blind randomized trial with control group, three parallel arms with 15 patients in each group
Settings and conduct
Double blind Randomized controlled trial In this trial a total of 45 patients among those presenting to Shohadaye tajrish and Modarres hospitals with more than three months of symptoms will be enrolled and randomly assigned into three groups of 40 mg triamcinolone injection by ulnar in-plane,midline in-plane and blind approach.
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
In one group inject 40 mg triamcinolone ulnar in-plane,second group inject midline in-plane and in control group inject 40 mg triamcinolone blindly.
Main outcome variables
Visual analog scale for pain; Boston questionnaire; Nerve conduction of median; Grip strength;Cross section area of median nerve
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130523013442N25
Registration date:2018-09-16, 1397/06/25
Registration timing:registered_while_recruiting
Last update:2018-09-16, 1397/06/25
Update count:0
Registration date
2018-09-16, 1397/06/25
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
2018-09-01, 1397/06/10
Expected recruitment end date
2019-05-05, 1398/02/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of efficacy of ultrasound-guided midline and ulnar in-plane approach and blind midline approach triamcinolone acetonide injection in pain and fuction improvement among patients with carpal tunnel syndrome; A randomized clinical trial.
Public title
Comparison of efficacy of ultrasound-guided midline and ulnar in-plane approach and blind midline approach triamcinolone acetonide injection in pain and fuction improvement among patients with carpal tunnel syndrome; A randomized clinical trial.
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
Data analyser
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 the current study simple individualized block randomization method with three 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
2017-11-07, 1396/08/16
Ethics committee reference number
IR.SBMU.MSP.REC.1396.534
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 triamcinolon 40 mg by ultrasound
Category
Treatment - Drugs
2
Description
Intervention group: Local midline in-plane injection of triamcinolon 40 mg by ultrasound
Category
Treatment - Drugs
3
Description
Control group: Local blind injection of triamcinolon 40 mg by sham ultrasound