Protocol summary

Summary
Nerve injuries due to trauma to extremities are among the most important injuries that need special consideration. Nerve disruption or Neurotemesis is the most severe form of nerve damage in which the axones and their supportive structures lose their integrity and fall apart. In some studies, low power laser has been shown as a reinforcement factor in the procedure of nerve repair. Studies also showed that laser therapy after damage to inferior alveolar nerve following jaw surgeries, would reduce nerve impairment and accelerate remission. The goal of this study is the comparison of treatment results of standard repair of traumatic injury of the distal half of the median nerve with applying laser therapy after repair. Forty patients with sharp rupture at volar side of distal end of forearm, who have been admitted in the plastic surgery ward of Hazrate Fateme Hospital within seventy two hours after injury and have paraesthesia in 1st, 2nd and 3rd fingers, have been divided into two groups. First group undergo standard nerve repair and end to end anastomosis while the second group take ten sessions of low power laser therapy subsequently. First session of laser therapy would be after twenty four hours of surgery and the rest would be done each forty eight hours. EMG,NCV and physical exams' results will be recorded at the end of 3rd week, 3rd month and 6th month and at the end.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201204109431N1
Registration date: 2012-05-31, 1391/03/11
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2012-05-31, 1391/03/11
Registrant information
Name
Siamak Farokh Forghani
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2220 2974
Email address
siamakfarokh@yahoo.com
Recruitment status
Recruitment complete
Funding source
Tehran university of medical sciences
Expected recruitment start date
2010-12-22, 1389/10/01
Expected recruitment end date
2012-06-21, 1391/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of treatment results of standard repair of traumatic injury of the distal half of the median nerve with applying laser therapy after repair
Public title
Effect of laser on hand's nerve repair
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: All the patients with sharp disruption on the distal end of forearm who have been admitted in the plastic surgery ward of Hazrate Fateme Hospital within seventy two hours after injury and have median nerve disruption. Exclusion criteria: Patients under 18 and over 60 years of age; concurrent Ulnar nerve injury; pregnant woman.
Age
From 18 years old to 60 years old
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)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
16 Azar street
City
Tehran
Postal code
Approval date
2011-09-11, 1390/06/20
Ethics committee reference number
٩١٠١٣٠١٣٩٤٧٥٠٦٨٨

Health conditions studied

1

Description of health condition studied
Forearm injury
ICD-10 code
S54.1
ICD-10 code description
Injury of median nerve at forearm level

Primary outcomes

1

Description
Fingers sensation
Timepoint
3 weeks, 3months and 6months after surgery
Method of measurement
Monofilament test, two points discremination test

2

Description
Fingers function
Timepoint
3 weeks, 3months and 6 months after surgery
Method of measurement
Thumb abdduction, opposition

Secondary outcomes

1

Description
tendon adhision
Timepoint
3rd week, 3rd month, 6th month
Method of measurement
fingers range of motions

2

Description
wound scar
Timepoint
3rd week, 3rd months, 6th month
Method of measurement
physical exam

Intervention groups

1

Description
10 sessions of low power laser therapy (DIOD LASER wavelenth 810 nm, power 50 mv, energy 4 j) with contact on anastomosis site. The first session during 24 hours after surgery and anothers with 48 hours interval.
Category
Treatment - Other

2

Description
Nothing
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Fateme hospital
Full name of responsible person
Siamak Farokh Forghani
Street address
Fateme hospital, Yusef abad ave, 21 street
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran university of medical sciences
Full name of responsible person
Dr Masood Younesian
Street address
Poorsina street, Keshavarz ave.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Siamak Farokh Forghani
Position
resident of plastic surgery
Other areas of specialty/work
Street address
Fateme hospital, Yusef abad ave, 21 street
City
Tehran
Postal code
Phone
+98 21 8871 0099
Fax
Email
siamakfarokh@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Siamak Farokh Forghani
Position
resident of plastic surgery
Other areas of specialty/work
Street address
Fateme hospital, Yusef abad ave, 21 street
City
Tehran
Postal code
Phone
+98 21 8871 0099
Fax
Email
siamakfarokh@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Siamak Farokh Forghani
Position
resident of plastic surgery
Other areas of specialty/work
Street address
Fateme hospital, Yusef abad ave, 21 street
City
Tehran
Postal code
Phone
+98 21 8871 0099
Fax
Email
siamakfarokh@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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