Efficacy of Noninvasive Radiofrequency in Attenuating Diabetic Neuropathic Pain

Study Overview
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Brief Summary
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Peripheral neuropathy increases the prevalence of diabetic foot ulcers following a decrease in foot sensation. Therefore, the treatment of this disorder is very important.

Detailed Description
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The current study aimed to investigate the efficacy of TECAR therapy on lower limb perfusion index (PI) and to evaluate the efficacy of TECAR therapy in improving the peripheral vascularity, reducing foot pain, and improving the tactile sensation of the soles in diabetic peripheral neuropathy (DPN) patients. twenty three diabetic neuropathy patients were included in the study and underwent 12 sessions of Capacitive TECAR therapy over one month. Pain, tactile sensation of the sole and PI were evaluated at the start and after each session till the end of the study.

Official Title
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Efficacy of Capacitive-Resistive Noninvasive Radiofrequency in Improving Perfusion Index and Attenuating Diabetic Neuropathic Pain; A Pre-post Study

Conditions
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Diabetic Neuropathy, Painful

Intervention / Treatment
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* Device: Capacitive-Resistive Noninvasive Radiofrequency


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 40-70 years Type II DM with DPN (grade I-II) in lower limbs Duration of DM>5 years Visual Analog Scale (VAS) ≥3 in the feet Sensory impairments in the lower extremities Exclusion Criteria: Patient with previous stenting or surgical intervention of lower limb arterial system. Patients with previous history of DVT. Pregnancy Diabetic infectious wound Cardiac pacemaker presence Severe liver and kidney dysfunction or history of heart and lung disease.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: interventional<br> | Device: Capacitive-Resistive Noninvasive Radiofrequency<br>* The two passive plates were under the back of the patient. The active capacitive plates of the machine (CAPENGERY, C200, Spain) will be applied initially for 20 minutes over the sole of both feet, with the machine adjusted on the A-thermal mode (37 oC). During the remaining 20 minutes, active capacitive plates are relocated over femoral vessels at the femoral triangle with the machine adjusted on the frank thermal mode (41 oC).<br>* Other names: TECAR;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of the perfusion index at the end of the first session compared to baseline readings. | the perfusion index readings will be taken before the first session and set as baseline reading and after the first session and the change will be calculated.The Masimo SET Mighty-Sat Fingertip Pulse Oximetry (Masimo Corporation, Irvine, CA, USA model 9900) was attached to the big toe of each patient. the reading will be the the mean of three measurements of perfusion index (PI) taken at one-minute intervals. | 40 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analogue Scale | Patient defines the degree of pain on a visual scale without numeric values, while the values are visible on the back side for the registrar where 0 indicates no pain and 10 indicates the most unbearable pain. The test was performed before intervention, after each session and one month after the end of all twelve sessions. | 2 months | 
| Tactile sensation of the sole | Tactile sensation of the sole using Semmes-Weinstein monofilament 5.07/10 g. the test will be performed after each session. | 2 months | 
| Analgesic effect | Analgesic effect after each session; will be evaluated using the four grades of WHO evaluation criteria for pain relief: Complete remission (CR) Partial remission (PR) Mild remission (MR) No response (NR). | 2 months | 
| The total remission rate |  | 2 months |