Comparison of the efficacy of low-power laser therapy and transcutaneous electrical nerve stimulation in the treatment of diabetic peripheral neuropathy
Design
An open-label randomized clinical trial study with parallel groups and phases 3 on 60 diabetic patients with diabetic neuropathy. Randomization will be done with the block randomization method using Random allocation software.
Settings and conduct
This study will be conducted on patients with diabetic neuropathy hospitalized in Urmia Imam Khomeini Hospital. Patients will be divided into three groups: routine treatment, routine treatment combined with low-level laser therapy, and routine treatment combined with transcutaneous electrical nerve stimulation. The study will be conducted as open-label clinical trial.
Participants/Inclusion and exclusion criteria
In this study, 60 type 1 or types 2 diabetic patients with diabetic neuropathy who have been treated with conventional pharmacotherapy for at least three months will be enrolled. Major exclusion criteria for patients include other lower limb problems and diseases, history of any lower limb amputation, lower limb trauma, and history of stroke.
Intervention groups
Patients will be randomly divided into three groups: 1- Group one: the conventional treatment method will continue (without receiving any new intervention); Group two: the conventional treatment method combined with low-power laser therapy; and Group three: the conventional treatment method combined with transcutaneous electrical nerve stimulation.
Main outcome variables
Clinical signs of neuropathy; nerve conduction velocity; neuropathic motor potential latency.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230910059395N2
Registration date:2025-02-03, 1403/11/15
Registration timing:prospective
Last update:2025-02-03, 1403/11/15
Update count:0
Registration date
2025-02-03, 1403/11/15
Registrant information
Name
Ebrahim Mohammadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 3345 7286
Email address
mohammadi.e@umsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-02-19, 1403/12/01
Expected recruitment end date
2025-08-22, 1404/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Low-level laser therapy and Transcutaneous Electrical Nerve Stimulation for Treating Diabetic peripheral Neuropathy
Public title
Comparison of Low-level laser therapy and Transcutaneous Electrical Nerve Stimulation for Treating Diabetic peripheral Neuropathy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Type 2 or type 1 diabetes with at least 5 years of diabetes history
Having diabetic neuropathy of the lower extremities with a confirmed diagnosis by a neurologist
Patients treated with conventional pharmacotherapy methods (including gabapentin, pregabalin, duloxetine, TCAs, and other drugs) for at least three months
Exclusion criteria:
Other lower limb problems and diseases
History of any lower limb amputation
Lower limb trauma
Stroke history
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be divided into intervention and control groups using block randomization based on generated numbers by Random allocation software. Thus, in this software, first the number of groups and the total number of the sample size )60 patients) will be entered, and then in the block section, the Block randomization method will be selected. Patients will be allocated in intervention or control groups based on generated numbers.
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 Urmia University of Medical Sciences
Other specified diabetes mellitus with neurological complications
Primary outcomes
1
Description
Clinical symptoms (pain and heat, pressure sensation (monofilament), position, superficial and deep touch, paraesthesia, anesthesia, lower limb pulse)
Timepoint
Before and 6 weeks after the intervention
Method of measurement
Clinical examination based on expert opinion
2
Description
Motor nerve conduction velocity
Timepoint
Before and 6 weeks after the intervention
Method of measurement
Nerve and leg muscle stripe test
3
Description
Neuropathic motor potential
Timepoint
Before and 6 weeks after the intervention
Method of measurement
Nerve and leg muscle stripe test
Secondary outcomes
1
Description
Neuropathic sensory potential amplitude
Timepoint
Before and 6 weeks after the intervention
Method of measurement
Nerve and leg muscle strip test
Intervention groups
1
Description
Control group: The conventional treatment method will continue (without receiving any new intervention)
Category
Treatment - Drugs
2
Description
Intervention group: Second group: The conventional treatment method combined with low-power laser therapy, which duration of the laser therapy will be 6 weeks (12 sessions), with 2 sessions of 30-minute per week. The laser therapy device is Icoone Laser Med Italy (2022).
Category
Treatment - Other
3
Description
Intervention group: Third group: Conventional treatment method combined with transcutaneous electrical nerve stimulation, the duration of treatment will be 6 weeks (12 sessions), with 2 sessions of 15-minute per week based on modulated type.