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

NCT ID: NCT07078058

Last Updated: 2025-07-22

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-01
• Study Completion Date: 2025-12-01

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Low Level Laser

Patients will receive Low Level Laser irradiated with two wavelengths of visible 630 nm and near infra-red 810 nm for 15 min on entire surface of each foot three times a week for 2 months

Group Type: EXPERIMENTAL

Low level laser

Intervention Type: DEVICE

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.

Transcutaneous auricular Vagus nerve stimulation

Patients will receive 30 minutes Transcutaneous auricular Vagus nerve stimulation 5 sessions per week for 2 months.

Group Type: ACTIVE_COMPARATOR

Transcutaneous auricular Vagus nerve stimulation

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

The patient selection will be according to the following criteria:

1. 30 patients diagnosed with diabetic neuropathy from both genders their ages will be ranged from 45-60 years old.

2. All patients are ambulant independently.

3. All patients are under full medical control

4. Glycated hemoglobin is ranged from 6.5: 7 %.

5. Patients have had diabetes for more than 5 or 10 years.

6. patients experiencing painful peripheral neuropathic symptoms for more than 6 months involving both lower extremities and complained of burning pain with paresthesia in both legs.

7 Neurological examination revealed abnormal sensation appeared at the ends of the extremities.

Exclusion Criteria

1. Patients had unstable glycemic control and/or medical conditions that would confound assessment of neuropathy such as malignancy, active/untreated thyroid disease, peripheral vascular diseases, vascular insufficiency (claudication, skin discoloration, ulceration).

2. Following the implantation of cardiac pacemakers or other electrical stimulation devices.

3. Patient had sinus bradycardia, long QT syndrome, or other arrhythmias or mental disorders.

4. Patients whose heart rate dropped below 50 beats/min after vagus nerve stimulation.

5. Nerve damage as a result of prior reconstructive or replacement knee surgery, back surgery, spinal stenosis, spinal compression or radiculopathy

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Horus University

OTHER

Sponsor Role: lead

Responsible Party

Manar Elbaz

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

out-patient clinic, faculty of physical therapy, Horus university

Damietta, , Egypt

Countries

Egypt

Central Contacts

Manar Elbaz Mohamed nasr, Assistant lecturer

Role: CONTACT

melbaz@horus.edu.eg

01008805149

Facility Contacts

Manar Elbaz Mohamed Nasr, Assistant lecturer

Role: primary

melbaz@horus.edu.eg

01008805149

Other Identifiers

Manar-005515

Identifier Type: -

Identifier Source: org_study_id