The purpose of this study was to determine the effect of laser on lower extremity neuropathic pain in patients with diabetes. A total of 30 patients with peripheral polyneuropathy confirmed by using electro diagnostic tests and with diabetic neuropathy pain will be recruited and randomly assigned to receive an unreal laser as control group or actual laser (power 60 W), 6 times per week for 4 weeks. At the end of each week, pain intensity is measured by using VAS (Visual analogue scale) and compared between the groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201009203565N2
Registration date:2010-10-16, 1389/07/24
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-10-16, 1389/07/24
Registrant information
Name
Akbar Aliasgarzadeh
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1335 7850
Email address
asgharzadeha@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2009-07-23, 1388/05/01
Expected recruitment end date
2009-11-22, 1388/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of low-intensity laser on lower limb neuropathic pain in patients with diabetes mellitus.
Public title
Effect of laser on neuropathic pain control in patients with diabetes mellitus
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age more than 18 years, diabetic peripheral polyneuropathy confirmed by electrodiagnostic test, presence of pain with diabetic neuropathy
Exclusion criteria: receiving Peripheral analgesic therapies during the study period, unstable systemic illnesses (such as malignancy, uncontrolled thyroid disease, heart failure, disorders in brain circulatory, hematopoietic system disorders, fever with unknown origin, active pulmonary TB), presence of other neurological disorders, presence of pain in other parts of the body, Pregnancy, presence of metal prostheses, drug or alcohol abuse, history of excessive sensitivity to light
Age
From 18 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tabriz University of Medical Sciences
Street address
Glgsht street, Azadi Street, Tabriz
City
Tabriz
Postal code
Approval date
2010-09-29, 1389/07/07
Ethics committee reference number
5/4/4932
Health conditions studied
1
Description of health condition studied
Diabetes
ICD-10 code
E11
ICD-10 code description
Non-insulin-dependent diabetes mellitus
Primary outcomes
1
Description
Pain
Timepoint
Every week
Method of measurement
visual analogue scale (VAS)
Secondary outcomes
empty
Intervention groups
1
Description
The real low power laser: Ga.Al. Ars laser with wave length 630 nm
Category
Rehabilitation
2
Description
The unrealistic low power laser as placebo with a similar device but without the real laser
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Akbar Aliasgharzadeha
Street address
Glgsht street, Azadi Street, Tabriz,
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mohamad Jamshidi
Street address
Glgsht street, Azadi Street, Tabriz
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Akbar Aliasgharzadeha
Position
Associate Professor, Educational Assistant of Endocrinology department
Other areas of specialty/work
Street address
Glgsht street, Azadi Street, Tabriz
City
Tabriz
Postal code
Phone
+98 41 1336 4032
Fax
Email
asgharzadeha@tbzmed.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Akbar Aliasgharzadeha
Position
Associate Professor, Educational AssistantSection of Endocrinology
Other areas of specialty/work
Street address
Glgsht street, Azadi Street, Tabriz
City
Tabriz
Postal code
Phone
+98 41 1336 4032
Fax
Email
asgharzadeha@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)