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Comparison of the therapeutic effects of high-power laser therapy and routine physiotherapy on pain and quality of life in patients with diabetic polyneuropathy

Protocol summary

Study aim
Comparison of the Effectiveness of High-Power Laser Therapy and Routine Physiotherapy in Reducing Pain Intensity, Improving Sensory and Motor Nerve Conduction Velocity, and Enhancing Quality of Life in Patients With Diabetic Peripheral Neuropathy After Four Weeks of Intervention
Design
A randomized, non-blinded, controlled clinical trial with parallel groups will be conducted on 159 patients.
Settings and conduct
This single-blind randomized trial uses convenience sampling of diabetic patients from two Tehran hospitals and assigns them by block randomization to high-power laser therapy, physiotherapy, or pharmacological treatment, with outcomes evaluated by a blinded assessor.
Participants/Inclusion and exclusion criteria
Inclusion criteria:Diabetic patients with clinically confirmed diabetic neuropathy Exclusion criteria:Patients with type 1 diabetesPatients with fractures or joint injuriesPatients with vascular abnormalities other than diabetes mellitusPatients with radiculopathyPatients with neuropathy due to causes other than diabetesPatients with diabetic foot ulcersPatients with limb ischemiaPatients with limb venous thrombosisPatients with limb cellulitis or ulcersPatients with autoimmune diseases, vasculitis, or Raynaud’s phenomenon.
Intervention groups
Group 1 (HPLT): Class IV laser, 10W, 980nm, 6-8 J/cm², 10-15 min/limb, 12 sessions (3×week×4 weeks).Group 2 (Routine physiotherapy): 20 min heat + TENS + 1MHz US + hamstring/gastroc stretching (3×10×20s), 12 sessions.Group 3 (Control): Gabapentin 300mg nightly + B1 300mg daily, 4 weeks.
Main outcome variables
Pain intensity score based on Visual Analog Scale (VAS); Quality of life score based on Norfolk QOL-DN questionnaire; Peripheral neuropathy assessment score based on Michigan Neuropathy Screening Instrument (MNSI); Pin-prick sensory test results of the lower limbs.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20251008067547N1
Registration date: 2026-05-13, 1405/02/23
Registration timing: prospective

Last update: 2026-05-13, 1405/02/23
Update count: 0
Registration date
2026-05-13, 1405/02/23
Registrant information
Name
Mahdie Heidaryan
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 5429 8154
Email address
dyana21h@yahoo.com
Recruitment status
recruiting
Funding source
Expected recruitment start date
2026-05-22, 1405/03/01
Expected recruitment end date
2027-05-20, 1406/02/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the therapeutic effects of high-power laser therapy and routine physiotherapy on pain and quality of life in patients with diabetic polyneuropathy
Public title
Comparison of the therapeutic effects of high-power laser therapy and routine physiotherapy on pain and quality of life in patients with diabetic polyneuropathy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with type 2 diabetes and confirmed diabetic peripheral neuropathy based on clinical criteria (sensory-motor symptoms in the lower limbs), pin-prick test, and significant pain score on the VAS scale, whose diabetic medication (oral/insulin) has been stable without major dose changes for at least 3 months, have quality of life impairment related to Michigan Neuropathy Screening Instrument (MNSI) and Norfolk QOL-DN questionnaires, possess independent mobility capability and regular attendance at treatment sessions, and provide written informed consent, are eligible for study entry (no age restriction)
Exclusion criteria:
Type 2 diabetes mellitus Confirmed diabetic peripheral neuropathy based on clinical criteria Sensory-motor symptoms in the lower limbs.Positive pin-prick test result Significant pain score on VAS scale Impaired quality of life on Michigan Neuropathy Screening Instrument (MNSI).Impaired quality of life on Norfolk QOL-DN questionnaire Independent mobility capability (with/without simple assistive device).Ability to attend 12 treatment sessions regularly
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 159
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, sampling will be conducted using a non-probability convenience sampling method from the population of diabetic patients referred to Imam Hossein Hospital and Loghman Hakim Hospital in Tehran. After meeting the inclusion criteria, participants will be assigned to three intervention groups using the Simple Randomization method.In this method, each participant is randomly allocated to one of the groups using randomly 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
Research Ethics Committees of Vice-Chancellor in Research Affairs - Shahid Beheshti University of Me
Street address
Research Ethics Committees of Vice-Chancellor in Research Affairs - Shahid Beheshti University of Medical Sciences - koodakyar Ave. Daneshju Bolivar, Velenjak. Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2026-01-27, 1404/11/07
Ethics committee reference number
IR.SBMU.MSP.REC.1404.716

Health conditions studied

1

Description of health condition studied
diabetic polyneuropathy
ICD-10 code
E11.42
ICD-10 code description
Type 2 diabetes mellitus with diabetic polyneuropathy

Primary outcomes

1

Description
Pain intensity score measured by Visual Analog Scale (VAS)
Timepoint
At the begining of the study and four weeks after the interventions
Method of measurement
Clinical examination

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The high-power laser group will undergo treatment for 4 weeks, consisting of 12 sessions (3 sessions per week), using a Class IV high-power laser device with a power of 10 watts, a wavelength of 980 nanometers, and a dose of 6–8 joules per square centimeter. The laser will be applied along the course of the posterior tibial and common peroneal nerves, with each session lasting 10 to 15 minutes per limb.
Category
Other

2

Description
Intervention group: The routine physiotherapy group will undergo treatment for 4 weeks, consisting of 12 sessions (3 sessions per week). Each session will include 20 minutes of superficial heat using an infrared device or heating pad, conventional TENS (Transcutaneous Electrical Nerve Stimulation)applied to the affected nerve based, ultrasound therapy with a frequency of 1 MHz, and stretching exercises for the hamstring and gastrocnemius-soleus muscles performed in 3 sets of 10 repetitions, with each stretch held for 20 seconds.
Category
Other

3

Description
Control group: The control group will receive only pharmacological treatment, consisting of gabapentin capsules (300 mg) taken nightly and vitamin B1 tablets (300 mg) taken daily for a duration of 4 weeks.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Hossein Hospital
Full name of responsible person
Zahra Ebrahimabadi
Street address
Imam Hossein Hospital (AS), Shahid Madani St., Tehran
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 7343 0000
Email
z.ebrahima@gmail.com

2

Recruitment center
Name of recruitment center
Loghman Hakim Hospital
Full name of responsible person
Zahra Ebrahimabadi
Street address
South Kargar St., Lashgar Intersection, Makhsous St., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1665993111
Phone
+98 21 5541 9005
Email
z.ebrahima@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Afshin Zarqi
Street address
Shahid Beheshti University of Medical Sciences - koodakyar Ave. Daneshju Bolivar, Velenjak. Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2387 2502
Email
dean.medicalschool@sbmu.ac.ir
Web page address
https://www.sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mehdie Heidaryan
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Beginning of Shahid Madani Street, Imam Hossein Square, Tehran
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 7343 0000
Email
dyana21h@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mehdie Heidaryan
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Beginning of Shahid Madani Street, Imam Hossein Square, Tehran
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 7343 0000
Email
dyana21h@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mehdie Heidaryan
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Beginning of Shahid Madani Street, Imam Hossein Square, Tehran
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 7343 0000
Email
dyana21h@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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