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IRCT20251008067547N1 IRCT 2026-05-13 Shahid Beheshti University of Medical Sciences Comparison of the therapeutic effects of high-power laser therapy and routine physiotherapy on pain and quality of life in patients with diabetic polyneuropathy Comparison of the therapeutic effects of high-power laser therapy and routine physiotherapy on pain and quality of life in patients with diabetic polyneuropathy 2026-05-22 anticipated 159 Recruiting https://irct.ir/trial/86719 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, 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. N/A diabetic polyneuropathy. Intervention 1: 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. Intervention 2: 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. Intervention 3: 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. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is The final statistical analyses and data quality assessments are being completed.until they are completed, fully publishing the results could be misleading.
public Mehdie Heidaryan
Beginning of Shahid Madani Street, Imam Hossein Square, Tehran
Tehran Iran (Islamic Republic of) 1617763141 +98 21 7343 0000 dyana21h@yahoo.com Shahid Beheshti University of Medical Sciences scientific Mehdie Heidaryan
Beginning of Shahid Madani Street, Imam Hossein Square, Tehran
Tehran Iran (Islamic Republic of) 1617763141 +98 21 7343 0000 dyana21h@yahoo.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) 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) no limit no limit Both 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 E11.42 Type 2 diabetes mellitus with diabetic polyneuropathy Other Other Other 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. 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. 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. 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. Shahid Beheshti University of Medical Sciences Approved 2026-01-27 Research Ethics Committees of Vice-Chancellor in Research Affairs - Shahid Beheshti University of Me Research Ethics Committees of Vice-Chancellor in Research Affairs - Shahid Beheshti University of Medical Sciences - koodakyar Ave. Daneshju Bolivar, Velenjak. Tehran, Iran Tehran Tehran Iran (Islamic Republic of)