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

Horus University

Status: Not yet enrolling

Conditions: Transcutaneous Vagus Nerve Stimulation; Low Level Laser; Diabetic Peripheral Neuropathy

Treatments: Device: Low level laser; Device: Transcutaneous auricular Vagus nerve stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT07078058

Manar-005515

Details and patient eligibility

About

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

Full 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

Enrollment: 30 estimated patients

Sex: All

Ages: 45 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups

Low Level Laser

Experimental group

Description:

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

Treatment:

Device: Low level laser

Transcutaneous auricular Vagus nerve stimulation

Active Comparator group

Description:

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

Treatment:

Device: Transcutaneous auricular Vagus nerve stimulation