Comparison of effectiveness of ultrasound guided versus blind injection of local corticosteroid on improvement of clinical and electrodiagnostic findings in patients with moderate carpal tunnel syndrome
(1) Objective: Our aim in this study is to compare injection of corticosteroid by palpation and via ultrasound in improving daily function and electro diagnostic indices in patients with moderate carpal tunnel syndrome. (2) Design: In this study fifty patients with carpal tunnel syndrome referred to Imam Reza physical medicine and rehabilitation clinic, Tabriz will be included in the study after qualifying the inclusion and exclusion criteria and obtaining the informed consent . (3) Setting and conduct: Patients will be randomly divided to two groups of twenty five. For randomization we will use computerized randomization with Excel software. Inclusion criteria are confirmed diagnosis of disease using EMG-NCV and unwillingness to have surgery . Exclusion criteria are contraindications for corticosteroid injection, tenar atrophy, surgery or local injection treatments in last six months, severe carpal tunnel syndrome in EMG-NCV and neoplastic or traumatic source of pain. (4) Interventions: Patients will be divided into two groups of local injection of forty mg of methyl prednisolone with and without ultrasound guidance. In intervention group, the trans carpal route will be determined and confirmed by an experienced physical medicine specialist using ultrasound and in-plane approach. In the other group, injection will be performed by approaching palmaris longus muscle without using any other devices. Routine treatments including non-steroid anti inflammatory drugs and wrist splint for 6 weeks will be performed for all patients. (5) Main outcome measures: EMG-NCV criteria and Boston questionnaire scores will be assessed before study and after injection.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201408013217N9
Registration date:2015-01-15, 1393/10/25
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-01-15, 1393/10/25
Registrant information
Name
Fariba Eslamian
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3337 3967
Email address
eslamiyanf@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research of Tabriz University of Medical Sciences
Expected recruitment start date
2014-09-23, 1393/07/01
Expected recruitment end date
2015-03-20, 1393/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of effectiveness of ultrasound guided versus blind injection of local corticosteroid on improvement of clinical and electrodiagnostic findings in patients with moderate carpal tunnel syndrome
Public title
Evaluating the effects of using an ancillary method for performing local injections in patients with moderate carpal tunnel syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria : Confirmed diagnosis of disease using EMG-NCV; Unwillingness to have surgery.
Exclusion criteria : Contraindications for corticosteroid injection; tenar atrophy; surgery or local injection treatments in last six months; severe carpal tunnel syndrome in EMG-NCV; neoplastic or traumatic source of pain.
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single 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 Tabriz University of Medical Sciences
Street address
Ethics committee, Tabriz University of Medical Sciences, Golgasht Street, Azadi Street, Tabriz
City
Tabriz
Postal code
Approval date
2014-09-01, 1393/06/10
Ethics committee reference number
9398
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
EMG-NCV criteria
Timepoint
Before study and after the injection
Method of measurement
By using EMG-NCV device
2
Description
Boston questionnare
Timepoint
Before study and after the injection
Method of measurement
By using Boston questionnare
Secondary outcomes
empty
Intervention groups
1
Description
In intervention group, the trans carpal route will be determined and confirmed by an experienced physical medicine specialist using ultrasound and in-plane approach.
Category
Treatment - Devices
2
Description
In the other group, injection will be performed by approaching palmaris longus muscle without using any other devices.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Dr. Fariba Eslamiyan
Street address
Department of Physical Medicine and Rehabilitation, Imam Reza Hospital, Daneshgah Square, Tabriz
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Tabriz University of Medical Sciences
Full name of responsible person
Dr. Seyyed Kazem Shakouri
Street address
Vice Chancellor for research, Tabriz University of Medical Sciences, Daneshgah square, Tabriz
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research of Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mojgan Zeynali
Position
Medicine student
Other areas of specialty/work
Street address
Department of Physical Medicine and Rehabilitation, Imam Reza Hospital, Daneshgah Square, Tabriz
City
Tabriz
Postal code
Phone
+98 41 3337 3967
Fax
Email
mojgan.zeynali@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Fariba Eslamiyan
Position
Associate professor of Physical Medicine & Rehabilitation
Other areas of specialty/work
Street address
Department of Physical Medicine and Rehabilitation, Imam Reza Hospital, Daneshgah Square, Tabriz
City
Tabriz
Postal code
Phone
+98 41 3337 3967
Fax
Email
eslamiyanf@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Fariba Eslamiyan
Position
Associate professor of Physical Medicine & Rehabilitation
Other areas of specialty/work
Street address
Department of Physical Medicine and rehabilitation, Imam Reza Hospital, Daneshgah Square, Tabriz
City
Tabriz
Postal code
Phone
+98 41 3337 3967
Fax
Email
eslamiyanf@tbzmed.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)