Evaluation of LASER therapy in the treatment of peripheral neuropathy of diabetic patients
Design
A control trial with a control group, with parallel groups, without blinding, randomized, on 60 patients, will use the online random number generation site for randomization.
Settings and conduct
The subjects will be referred to Imam Hossein Hospital in Tehran and will undergo laser therapy in 12 sessions of15 minutes for each foot at intervals of one day. People undergoing laser treatment are unaware of the existence of the control group.
Participants/Inclusion and exclusion criteria
Inclusion criteria: peripheral neuropathy; satisfied with participating in this research. Exclusion criteria: other neurological diseases; people who underwent laser sessions for the purpose of recent cosmetic surgery.
Intervention groups
In the control group, patients with diabetic neuropathy do not receive laser therapy. Patients in the intervention group، receive laser therapy.
Main outcome variables
Reducing diabetic neuropathy in patients; reducing the complication of diabetic neuropathy such as amputation, improving the quality of life of diabetic patients with peripheral neuropathy.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201009048972N1
Registration date:2021-11-07, 1400/08/16
Registration timing:prospective
Last update:2021-11-07, 1400/08/16
Update count:0
Registration date
2021-11-07, 1400/08/16
Registrant information
Name
sahar tavakkoli
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 3310 1479
Email address
sahartavakoli44@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-11-11, 1400/08/20
Expected recruitment end date
2021-12-11, 1400/09/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of LASER therapy in treatment of peripheral neuropathy of diabetic patients referred to Imam Hossein Hospital
Public title
Laser therapy in diabetic patient with neuropathy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diabetic patients
Peripheral neuropathy
Exclusion criteria:
No willingness to participate in the study;
Other neurological diseases;
People who underwent laser sessions for the purpose of recent cosmetic surgery.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
I will number the names of patients referred to the Imam Hossein hospital who have diabetes and are willing to participate in the research, and using an online random number generation site, I will select two groups of numbers as the control group and the patient.
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 Shahid Beheshti University of Medical Science
Street address
No 193، Esmaiili Alley ، North Nabard Ave، Piroozi Ave
City
Tehran
Province
Tehran
Postal code
1765847145
Approval date
2019-06-24, 1398/04/03
Ethics committee reference number
IR.SBMU.MSP.REC.1398.277
Health conditions studied
1
Description of health condition studied
Peripheral neuropathy in diabetic patients
ICD-10 code
E11.40
ICD-10 code description
Type 2 diabetes mellitus with diabetic neuropathy, unspecified
Primary outcomes
1
Description
Peripheral neuropathy in diabetic patients
Timepoint
Before and after laser therapy
Method of measurement
Michigan neuropathy screening test and monofilament test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Diabetic patients with peripheral neuropathy who undergo laser therapy with a wavelength between 650 to 810 nm three times a week for twelve sessions and each session for fifteen minutes per foot. The Noura instrument NIL IR105 laser device is made by Noura Layehnegar Company.
Category
Treatment - Other
2
Description
Control group: Diabetic patients with peripheral neuropathy who are being treated with common neuropathic drugs including gabapentin or B1 300 but will not receive laser treatment.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Hossein Hospital in Tehran
Full name of responsible person
Sahar Tavakoli
Street address
No 193، Esmaiili Alley ، Nabard Ave، Piroozi Ave
City
Tehran
Province
Tehran
Postal code
1765847145
Phone
+98 21 3310 1479
Email
sahartavakoli44@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mostafa Rezaii Tavirani
Street address
sixth floor . University Headquarters Building No 2.Shahid Beheshti University of Medical Sciences and Health Services. - Next to Taleghani Hospital -- Parvaneh St. -Yemen St.Shahid Chamran Highway
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2243 9788
Email
info@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?