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To compare the effect of both low-level laser versus transcutaneous vagus nerve stimulation on vascular changes in patients with diabetic polyneuropathy
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low Level Laser | Experimental | 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 |
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| Transcutaneous auricular Vagus nerve stimulation | Active Comparator | Patients will receive 30 minutes Transcutaneous auricular Vagus nerve stimulation 3 sessions per week for 2 months. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low level laser | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| assessment of change of vascular blood flow | The study uses Duplex Doppler ultrasound to assess vascular changes in the posterior tibial and anterior tibial, assessing anteroposterior diameter, Tunica intima thickness, and resistive index and peak systolic velocity using a variable frequency range. | at baseline and after 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of change of Neuropathic Pain | The Douleur Neuropathique en 4 (DN4) is a screening questionnaire that consists of interview questions and physical tests to identify possible neuropathic pain. It has high test-retest and inter-rater reliability, with an ICC of 0.8 and a Cohen's kappa of 0.8. A total score is calculated as the sum of the 10 items. Scores _ 4 out 10 of indicate that neuropathic pain is likely. |
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Inclusion Criteria:
The patient selection will be according to the following criteria:
7 Neurological examination revealed abnormal sensation appeared at the ends of the extremities.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| out-patient clinic, faculty of physical therapy, Horus university | Damietta | Egypt |
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| Transcutaneous auricular Vagus nerve stimulation | 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. |
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| at baseline and after 8 weeks |
| Assessment of change of Quality of life | The 12-Item Short Form Health Survey is a validated instrument used to assess health-related quality of life in clinical and research settings. It evaluates both physical and mental health through 12 questions derived from the short form-36 questionnaire, covering domains such as physical functioning, pain, general health, vitality, social functioning, and emotional well-being. The questionnaire generates two summary scores: the Physical Component Summary and the Mental Component Summary. Scoring is based on weighted responses to each item, with scores transformed to a standardized scale ranging from 0 to 100, where higher scores indicate better health status and quality of life. Due to its brevity, reliability, and ease of administration, the short form-12 is widely used for rapid assessment of overall patient health outcomes. | at baseline and after 8 weeks |
| ID | Term |
|---|---|
| D028022 | Low-Level Light Therapy |
| ID | Term |
|---|---|
| D053685 | Laser Therapy |
| D013812 | Therapeutics |
| D010789 | Phototherapy |
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