Objective: The aim of the study is comparison of the results of endoscopic carpal tunnel release as a newly introduced method with open carpal tunnel surgery. Design: This is a parallel controlled trial without no randomization and blinding. Setting and conducting: All patients who will meet the inclusion criteria will be enrolled in the study for the endoscopic carpal tunnel surgery (they will be called group A or treatment group). Total sample size of treatment group is 81. For selecting control group (who will be called group B), we will apply the retrospective method among all records of patients who had the open carpal tunnel surgery in hospital data bank from 5-year ago (2007). Total sample size of control group is 95. Inclusion criteria are all patients with the history of recurrent or persistent parethesia in the median nerve territory, worsening of symptoms with hand activity, nocturnal paresthesia and presence of positive Tinnel's and/or Phalen's signs on physical examination and also positive electro-myography. Intervention for treatment group is one-portal endoscopic method for carpal tunnel release with Microaire instrument per standard technique will be implemented. Main outcome of study is complete hand functional recovery. The variables of study are the pain, paresthesia and grip strength measurement. For measuring of pain we will be used the thermometer visual tool. A standard check list will be used for paresthesia and for grip strength, Jamar dynamometer will be applied.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013040612914N1
Registration date:2013-05-18, 1392/02/28
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-05-18, 1392/02/28
Registrant information
Name
Shahram Nazerani
Name of organization / entity
Iran University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2254 1429
Email address
sh-nazerani@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor of research, Iran University of Medical Sciences
Expected recruitment start date
2007-01-01, 1385/10/11
Expected recruitment end date
2012-08-01, 1391/05/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical Trial study for comparison of endoscopic carpal tunnel release in patients with median nerve compressive neuropathy with open method
Public title
Effect of endoscopic surgery in comparison with open method in carpal tunnel syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: all patients with the history of recurrent or persistent parethesia in the median nerve territory, worsening of symptoms with hand activity, nocturnal paresthesia and presence of positive Tinnel's and/or Phalen's signs on physical examination and also positive electro-myography;
Exclusion criteria: previous carpal tunnel surgery, incomplete records, trauma, patients' refusal to participate in the study.
Age
From 41 years old to 64 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
176
Randomization (investigator's opinion)
Not 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
Ethics Committee of Iran University of Medical Sciences
Patients with Carpal Tunnl Syndrome (with positive signs in physical exam and also electro-myography)
ICD-10 code
G56.0
ICD-10 code description
Carpal Tunnel Syndrome
Primary outcomes
1
Description
Pain
Timepoint
0ne, three, six months and one year after operation
Method of measurement
Thermometer visual tool
2
Description
Paresthesia
Timepoint
0ne, three, six months and one year after operation
Method of measurement
Standard check list
Secondary outcomes
1
Description
Grip strength measurement
Timepoint
One, three and six months and one year after operation
Method of measurement
Jamar dynamometer
Intervention groups
1
Description
Intervention for treatment group is one-portal endoscopic method for carpal tunnel release with Microaire instrument per standard technique will be implemented. According to the type of intervention (Surgery), it is not any dosage or type of consumption and etc.
Category
Treatment - Surgery
2
Description
For control group the open surgery method will be applied.