Compare the effectiveness of two different methods of ultrasound-guided local corticosteroid injection in the treatment of patient with carpal tunnel syndrome.
(1) Objective: our aim in this study is to compare the effectiveness of two different methods of ultrasound-guided local corticosteroid injection in the treatment of patient with carpal tunnel syndrome. (2) Design: in this study forty patients with carpal tunnel syndrome referred to Firuzgar physical medicine and rehabilitation clinic, Tehran, Iran 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. For randomization we will use randomized blocking method. (4) Interventions: ultrasound-guided local injection of forty mg of triamcinolone with the in-plane method; in the first group anterior to the median nerve and in the second group posterior to the median nerve will be done by a physical medicine and rehabilitation specialist. Routine treatments including wrist splint for 6 weeks will be performed for all patients. (5) Main outcome measures: electrodiagnostical and sonographic criteria, Boston questionnaire scores and VAS will be assessed in the 0, 6th week and 12th week.
General information
Acronym
CTS-Carpal Tunnel Syndrome
IRCT registration information
IRCT registration number:IRCT2015101724572N1
Registration date:2016-05-25, 1395/03/05
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-05-25, 1395/03/05
Registrant information
Name
Arash Babaei-Ghazani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6435 2683
Email address
babaei-ghazani.a@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research of Iran University of Medical Sciences
Expected recruitment start date
2016-04-03, 1395/01/15
Expected recruitment end date
2016-09-05, 1395/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Compare the effectiveness of two different methods of ultrasound-guided local corticosteroid injection in the treatment of patient with carpal tunnel syndrome.
Public title
Compare two different methods of ultrasound-guided corticosteroid injection in the treatment of carpal tunnel syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients with signs and symptoms of carpal tunnel syndrome (including pain and sensory disturbances in the territory of median nerve) which is confirmed through EMG-NCS and by electrodiagnostic criteria are mild to moderate carpal tunnel syndromes. Exclusion criteria: severe carpal tunnel syndrome in EMG-NCV; tenar atrophy; contraindications for corticosteroid injection (including sensitivity to corticosteroids and symptoms of skin infection at the injection site); diseases which mimic CTS symptoms such as polyneuropathy, cervical radiculopathy, thoracic outlet syndrome; surgery or local injection treatments in last six months; neoplastic or traumatic source of pain; wrist bones fracture.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double 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 Iran University of Medical Sciences
Street address
Ethics committee, Iran University of Medical Sciences, Hemmat Highway, Tehran
City
Tehran
Postal code
1449614535
Approval date
2015-07-26, 1394/05/04
Ethics committee reference number
IR.IUMS.REC.1394.9311524007
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
The severity of symptoms and functional limitations
Timepoint
Zero, six and twelve weeks after
Method of measurement
By using Boston questionnare
2
Description
The severity of symptoms
Timepoint
Zero, six and twelve weeks after
Method of measurement
Visual Analog Scale(VAS)
3
Description
Electrodiagnostic criteria
Timepoint
Zero, six and twelve weeks after
Method of measurement
By using EMG-NCV device
4
Description
Sonographic criteria
Timepoint
Zero, six and twelve weeks after
Method of measurement
By using Sonographic device
Secondary outcomes
1
Description
Side effects
Timepoint
Six and twelve weeks after
Method of measurement
questionnaire
Intervention groups
1
Description
In the first group,corticosteroid inject under the ultrasound-guid above the median nerve which will be done by an experienced physical medicine and rehabilitation specialist using in-plane approach.
Category
Treatment - Other
2
Description
In the other group, corticosteroid injection will be performed under the ultrasound-guid below the median nerve which will be done by an experienced physical medicine and rehabilitation specialist using in-plane approach.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Firuzgar hospital
Full name of responsible person
Dr Nadere Nikbakht
Street address
Department of Physical Medicine and Rehabilitation, Firuzgar Hospital, Valiasr Square, Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice President of Research Iran University of Medical Sciences
Full name of responsible person
Dr Motovalian
Street address
5th floor, Headquarters, Iran University of Medical Sciences, Hemmat Highway, Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice President of Research Iran 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
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Arash Babaei
Position
Associate Professor of Physical Medicine and Rehabilitation
Other areas of specialty/work
Street address
Department of Physical Medicine and Rehabilitation, Firuzgar Hospital, Valiasr Square, Tehran
City
Tehran
Postal code
1593747811
Phone
+98 21 8214 1229
Fax
Email
babaei-ghazani.a@iums.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)