NCT07078058

Low Level Laser VS Transcutaneous Vagus Nerve Stimulation on Vascular Changes in Patients With Diabetic Polyneuropathy

Low Level Laser Versus Transcutaneous Vagus Nerve Stimulation on Vascular Changes in Patients With Diabetic Polyneuropathy

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Horus University · Academic / Other
• Sex: All
• Age: 45 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

To compare the effect of both low-level laser versus transcutaneous vagus nerve stimulation on vascular changes in patients with diabetic polyneuropathy

Detailed description

Diabetic polyneuropathy is a prevalent and severe diabetes-related complication linked to cardiovascular mortality and disease events, even after accounting for risk factors and diabetes status. Diabetic polyneuropathy affects the peripheral nervous system, leading to dysfunctions in sensory, motor, and autonomic nervous systems. It predisposes diabetics to refractory neuropathic pain, foot ulcers, and amputation, lowering quality of life, increasing mortality, and prompting patients with diabetes to seek medical attention. Over half of diabetes patients experienced painful diabetic polyneuropathy over the past few decades Painful diabetic polyneuropathy therapy uses various drugs for symptom relief, but they often have systemic side effects and do not slow neuropathy progression. Therefore, investigating non-pharmacological interventions like low-level laser and transcutaneous auricular vagus nerve stimulation is crucial for developing more effective and potentially safer pain management options. low-level laser therapy and transcutaneous auricular vagus nerve stimulation are emerging non-invasive interventions that have shown potential in alleviating pain associated with diabetic polyneuropathy, a common diabetes complication affecting quality of life. The effectiveness of conservative treatment options for painful diabetic polyneuropathy needs further investigation. If one method proves superior in reducing pain, improving macrovascular health, and quality of life, it could guide clinical decisions

Conditions

• Low Level Laser
• Transcutaneous Vagus Nerve Stimulation
• Diabetic Peripheral Neuropathy

Interventions

Type	Name	Description
DEVICE	Low level laser	Patients in the low level laser group will be irradiated with visible and near-infra-red lasers at a pulsed mode with a frequency of 35 Hz, peak power of 100 mW, and a spot diameter of 5 mm. The 15-minute sessions were performed three times a week for two months, with each laser having a power density of 0.35 mW/cm2 and an energy density of 32.08 J/cm2.
DEVICE	Transcutaneous auricular Vagus nerve stimulation	Patients will receive 30 minutes of transcutaneous vagus nerve stimulation for 2 months, with 5 sessions per week. The antihelix and cymba concha will be sterilized with 75% alcohol, and the electrode will be attached. The device parameters include a wave width of 0.2 ms ± 30%, pulse frequency of 20 Hz, gradually increasing intensity to a tolerable intensity (4-6 mA), and duration of 30 minutes.

Timeline

• Start date: 2025-08-01
• Primary completion: 2025-10-01
• Completion: 2025-12-01
• First posted: 2025-07-22
• Last updated: 2025-07-22

Locations

1 site across 1 country: Egypt