Comparison the results of surgical treatment for carpal tunnel syndrome in both the classical and minimal invasive Smillie knife in patients with carpal tunnel syndrome
This study has been aimed to compare the results of open surgery with minimal invasive surgery by Smillie knife.Inclusion criteria such as failure to respond to non-surgical treatment in patients with carpal tunnel syndrome and exclusion criteria such as neuropathy and radiculopathy were determined .72 patients (98 procedures) with carpal tunnel syndrome were enrolled and were randomized into two groups: open surgery (46 cases) and minimal invasive surgery (52 cases) using Smillie knife and Clinical improvement were compared between the two group by the Boston questionnaire, pain, paresthesia, return to daily activities and scar surgery .
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015053110492N1
Registration date:2015-07-12, 1394/04/21
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-07-12, 1394/04/21
Registrant information
Name
Afshin Ahmadzadeh Heshmati
Name of organization / entity
Kerman university of medical science
Country
Iran (Islamic Republic of)
Phone
+98 34 1247 1551
Email address
dr.heshmati@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Kerman University of Medical Sciences
Expected recruitment start date
2013-03-20, 1391/12/30
Expected recruitment end date
2014-12-22, 1393/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the results of surgical treatment for carpal tunnel syndrome in both the classical and minimal invasive Smillie knife in patients with carpal tunnel syndrome
Public title
Comparison the results of surgical treatment for carpal tunnel syndrome in both the classical and minimal invasive Smillie knife
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: non-surgical treatment failure in patients with carpal tunnel syndrome; moderate and severe disease based on nerve-muscle strip .
Exclusion criteria: cervical radiculopathy; peripheral nerve lesions; old fractures of the forearm and wrist; congenital bone deformity of the upper limb; rheumatic diseases such as rheumatoid arthritis; minor clashes in the nerve strip ; neuropathy
Age
From 25 years old to 78 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
98
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Kerman University of Medical Sciences Ethics Committee
Street address
In front of Beast clinic- Somaye intersection -Kerman
City
kerman
Postal code
Approval date
2013-01-20, 1391/11/01
Ethics committee reference number
k/93/157
Health conditions studied
1
Description of health condition studied
Carpal Tunnel Syndrom
ICD-10 code
G56.0
ICD-10 code description
Carpal tunnel syndrome
Primary outcomes
1
Description
pain
Timepoint
Before surgery, after five day,two week , six weeks, three and six month of surgery
Method of measurement
Based on patient response
2
Description
Paresthesia
Timepoint
Before surgery, after five day,two week , six weeks, three and six month of surgery
Method of measurement
Based on patient response
3
Description
Return to daily activities
Timepoint
Before surgery, after five day,two week , six weeks, three and six month of surgery
Method of measurement
Based on boston form
4
Description
Scar-site surgery
Timepoint
Five day,two week , six weeks, three and six month of surgery
Method of measurement
Based on surgeon observation
Secondary outcomes
1
Description
Wound infection
Timepoint
Five day,two week , six weeks, three and six month of surgery
Method of measurement
Surgeon observation
2
Description
Nerve injury
Timepoint
Six week after surgery
Method of measurement
Electrodiagnostic finding
Intervention groups
1
Description
Intervention group :Minimal invasive surgery by Smillie knife
Category
Treatment - Surgery
2
Description
Control group: Open surgery
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Besat clinic
Full name of responsible person
Dr Ahmadzadeh Heshmati Afshin
Street address
Research Assistant- Intersection Somayeh-Kerman
City
kerman
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
kerman University of Medical Sciences
Full name of responsible person
Dr Pardakhti
Street address
In fron of Besat clinic- Somayeh intersection- kerman
City
kerman
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
kerman 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
kerman University of Medical Sciences
Full name of responsible person
Dr Ahmadzadeh Heshmati Afshin
Position
Assistant Professor of Orthopedic Group
Other areas of specialty/work
Street address
Orthopedy group- Shahid Bahonar Hospital- kerman
City
kerman
Postal code
Phone
00
Fax
Email
aahorthoped@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Dr Ahmadzadeh Heshmati Afshin
Position
Assistan professor of orthopedy group
Other areas of specialty/work
Street address
Orthopedic group- Shahid Bahonar hospital- kerman
City
kerman
Postal code
Phone
+98 913 341 9527
Fax
Email
aahorthoped@gmail.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)