The comparison of electromyography results of nerve reconstruction by two ways of Perineurium and Epineurium on the patients having ulnar nerve injury hospitalized in Shahid- Rajaee Hospital of Qazvin
The objective of the study is to comparison of electromyography results of nerve reconstruction by two ways of Perineurium and Epineurium on the patients having ulnar nerve injury hospitalized in Shahid- Rajaee Hospital of Qazvin.
The main conditions to enter study is the patients having ulnar nerve injury in the distal of forearm surface
the main conditions to exit of study: The patients who have ulnar nerve injury in the other surface area.
Study design: Randomized, single blind, without placebo, Single center, Phase II, with Sample size of 28
Intervention: The patients who have surgery by Epineurium way, then their electromyography results and sensory and motor state of organ are examined four months later. The patients who have surgery by Perineurium way, then their electromyography results and sensory and motor state of organ are examined four months later.
The main outcomes of study are The rate of recovery by considering Electromyogram and sensory and motor examination performance in two groups .
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013122915971N1
Registration date:2014-01-27, 1392/11/07
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-01-27, 1392/11/07
Registrant information
Name
Ali Torkashvand
Name of organization / entity
Qazvin University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 982813335800
Email address
atorkashvand@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Department Of Research Of Qazvin University Of Medical Sciences
Expected recruitment start date
2013-04-04, 1392/01/15
Expected recruitment end date
2014-01-05, 1392/10/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of electromyography results of nerve reconstruction by two ways of Perineurium and Epineurium on the patients having ulnar nerve injury hospitalized in Shahid- Rajaee Hospital of Qazvin
Public title
The comparison of electromyography results of nerve reconstruction by two ways in the patients having nerve injury
Purpose
Treatment
Inclusion/Exclusion criteria
The main conditions to enter study:
the patients having ulnar nerve injury in the distal of forearm surface
the main conditions to exit of study:
The patients who have ulnar nerve injury in the other surface area.
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
28
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 Qazvin University Of Medical Sciences
Street address
Qazvin University Of Medical Sciences, Navab Street
City
Qazvin
Postal code
Approval date
2013-05-22, 1392/03/01
Ethics committee reference number
28.20.7411
Health conditions studied
1
Description of health condition studied
Ulnar Nerve Injury
ICD-10 code
G56.2
ICD-10 code description
Lesion Of Ulnar Nerve
Primary outcomes
1
Description
Electromyography results of nerve reconstruction by Perineurium
Timepoint
4 months after surgery
Method of measurement
Electromyography
2
Description
Electromyography results of nerve reconstruction by Epineurium
Timepoint
4 months after surgery
Method of measurement
Electromyography
Secondary outcomes
1
Description
Sensory state recovery by Epineurium way
Timepoint
4 months after surgery
Method of measurement
Examination of surface palpation sensation with cotton and pain sensation with needle
2
Description
Motor state recovery by Epineurium way
Timepoint
4 months after surgery
Method of measurement
Examination motor by qualitative measurement of muscular strength from one of fifth to fifth of fifth
3
Description
Sensory state recovery by Perineurium way
Timepoint
4 months after surgery
Method of measurement
Examination of surface palpation sensation with cotton and pain sensation with needle
4
Description
Motor state recovery by Perineurium way
Timepoint
4 months after surgery
Method of measurement
Examination motor by qualitative measurement of muscular strength from one of fifth to fifth of fifth
Intervention groups
1
Description
The patients who have surgery by Epineurium way, then their electromyography results and sensory and motor state of organ are examined four months later.
Category
Treatment - Surgery
2
Description
The patients who have surgery by Perineurium way, then their electromyography results and sensory and motor state of organ are examined four months later.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Rajaee Hospital
Full name of responsible person
Ali Torkashvand
Street address
Shahid Rajaee Hospital, Padegan Street
City
Qazvin
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Department Of Research Of Qazvin University Of Medical Sciences
Full name of responsible person
Mahnaz Abasi
Street address
Qazvin University Of Medical Surgery, Navab Street
City
Qazvin
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Department Of Research Of Qazvin 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
Qazvin University Of Medical Sciences
Full name of responsible person
Ali Torkashvand
Position
Surgery Resident
Other areas of specialty/work
Street address
Qazvin University Of Medical Sciences, Navab Street
City
Qazvin
Postal code
Phone
+98 28 1333 5800
Fax
Email
atorkashvand@qums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University Of Medical Sciences
Full name of responsible person
Ali Torkashvand
Position
Surgery Resident
Other areas of specialty/work
Street address
Qazvin University Of Medical Sciences, Navab Street
City
Qazvin
Postal code
Phone
+98 28 1333 5800
Fax
Email
atorkashvand@qums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University Of Medical Sciences
Full name of responsible person
Ali Torkashvand
Position
Surgery Resident
Other areas of specialty/work
Street address
Qazvin University Of Medical Sciences, Navab Street
City
Qazvin
Postal code
Phone
+98 28 1333 5800
Fax
Email
atorkashvand@qums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)