The aim of our study was to compare effectiveness of local steroid injection versus CTR in relieving signs and symptoms of CTS and patient satisfaction. Population of study was all patients with CTS admitted at Shafa Hospital clinic from 19.2.2005 to 20.4.2008.Inclusion criteria were all patients with signs and symptoms of CTS documented by electrophysiological studies. Exclusion criteria were all patients with CTS having underlying disease. We had 94 cases for study. Patients were treated by local steroid injection into carpal tunnel or carpal tunnel release. Study was performed from 19.02.2005 to 20.04.2008. Effectiveness of these two treatment modalities in relieving CTS signs and symptoms and also patient satisfaction was compared with each other.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017011832046N1
Registration date:2017-07-06, 1396/04/15
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-07-06, 1396/04/15
Registrant information
Name
Reza Babaei
Name of organization / entity
ShafaYahyaiian hospital
Country
Iran (Islamic Republic of)
Phone
+98 913 310 2551
Email address
babaei.r@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
This study has done and completed previously
Expected recruitment start date
2005-02-19, 1383/12/01
Expected recruitment end date
2008-04-20, 1387/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing effectiveness of Local steroid injection versus CTR in the treatment of patients with mild to moderate CTS
Public title
Comparing effectiveness of local steroid injection into carpal tunnel with surgery in the treatment of patients with mild to moderate carpal tunnel syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Every patient with CTS. Exclusion criteria: Any patient with CTS having underlying diseases such as diabetes, thyroid diseases,previous wrist fx,ganglion cyst, etc.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
94
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Patients and their type of intervention were determined by one person of research team randomly .In fact surgeons were unaware of patients who were admitted and should obey recommended intervention and patients were unaware of type of intervention and type of intervention was recommended by giving odd or even numbers to patients in which odds were CTR and evens local steroid injection and contributor was unaware of this characteristic.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of university medical science Iran University Of Medical Science Tehran Iran
Street address
Iran University Of Medical Science, Aside to Milad Hospital, Hemmat Highway,Tehran, IRAN
City
Tehran
Postal code
1449614535
Approval date
2008-04-27, 1387/02/08
Ethics committee reference number
78/3198
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
Tingling, numbness, pain, atrophy.
Timepoint
Before treatment and 6 month afer treatment
Method of measurement
Boston questienare
2
Description
Severity of symptoms and patients satisfaction
Timepoint
Before and 6 month after treatment
Method of measurement
ElMG and NCV findings and patient satisfaction questionaire
3
Description
Physical signs such as Tinnel, compresion test, thenar atrophy and Phallen test
Timepoint
Before intervention and six month after it
Method of measurement
Physical examination tests were done according to rules in references
Secondary outcomes
1
Description
Pain and sudeck atrophy
Timepoint
Six month after intervention
Method of measurement
Physical examination
Intervention groups
1
Description
Injection of 40 mg triamcinolone with 20 gm lidocaine into the carpal tunnel in intervention group.
Category
Treatment - Drugs
2
Description
Carpal tunnel release in control group.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
ShafaYahyaiian Hospital
Full name of responsible person
Babaei Reza
Street address
Mojahedin Eslam St, Baharestan Sq.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research and Technology Iran University Of Medical Sciences
Full name of responsible person
moosavi Seyyed Ali Javad
Street address
Seventh floor, Department Of Internal Medicine, Hazrat-E-Rasoul Hospital, Iran University Of Medical Sciences, Niayesh St., Sattarkahn Ave., Tehran, Iran
City
Tehran
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 and Technology 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
Name of organization / entity
ShafaYahyaiian Hospital
Full name of responsible person
Babaei Reza
Position
Resident in orthopedic surgery
Other areas of specialty/work
Street address
Mojahedin Eslam St., Baharestan Sq.
City
Tehran
Postal code
11557638131
Phone
+98 21 3354 2011
Fax
+98 21 3354 2020
Email
Babaei.reza52@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
ShafaYahyaiian Hospital
Full name of responsible person
Jafari Davood
Position
Sub-specialist in hand surgery
Other areas of specialty/work
Street address
Mojahedin Eslam St., Baharestan Sq.
City
Tehran
Postal code
1157637131
Phone
+98 21 3354 2011
Fax
+98 21 3354 2020
Email
Jafaridiums@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
ShafaYahyaiian Hospital
Full name of responsible person
Babaei Reza
Position
Resident of orthopedic surgery
Other areas of specialty/work
Street address
Mojahedin Eslam St., Baharestan Sq.
City
Tehran
Postal code
1157637131
Phone
+98 21 3354 2011
Fax
+98 21 3354 2020
Email
Babaei.Reza52@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)