Transcutaneous Pulsed Radiofrequency in Diabetic Polyneuropathy

Study Overview
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Brief Summary
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Investigators want to investigate the efficacy of transcutaneous pulsed radiofrequency therapy in the treatment of diabetic peripheral neuropathy symptoms. For this purpose, investigators aimed to compare the results of two groups treated with sham electrode and active electrode.

Detailed Description
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Peripheral neuropathic pain is common in diabetes mellitus. Distal symmetrical polyneuropathy is the most common form. These patients have complaints such as burning, freezing, tingling and pain in their hands and feet. Peripheral nerve blocks or sympathetic blocks are applied to patients who cannot be treated with medical agents. Transcutaneous pulsed radiofrequency is a method used in the treatment of pain. The advantages of transcutaneous pulsed radiofrequency method are that it is not invasive, does not cause side effects, and does not interact with drugs. We want to investigate the efficacy of diabetic peripheral neuropathic pain treatment with this method. Sixty diabetic polyneuropathy patients will be included in the study. Transcutaneous pulsed radiofrequency therapy with active electrode will be applied to half of the patients. Sham electrode will be used for the other half. Patients will not know which group they belong to. Two treatments will be applied with 7 days intervals. The duration of treatment will be 8 minutes.Each patient will receive a Leeds Assessment of Neuropathic Symptoms and Signs questionnaire (LANSS). Before the treatment, in the first month and third month after the treatment, the patients will be filled with a visual analog scale. The results between both groups will be statistically compared.

Official Title
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Transcutaneous Pulsed Radiofrequency in Diabetic Neurophatic Pain

Conditions
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Neuropathy;Peripheral

Intervention / Treatment
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* Device: Transcutaneous pulsed radiofrequency current


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of Diabetes Mellitus Peripheric neuropathy with proved electroneuromyography Exclusion Criteria: Additional endocrinological disease, Pregnancy, malignancy, motor deficit in lower extremities

Ages Eligible for Study
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Minimum Age: 18 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Patients with bilateral neuropathic pain which treating active electrode<br>30 patients which treating with transcutaneous pulsed radiofrequency. All patients have diabetic polyneuropathy and confirmed with electroneuromyography. | Device: Transcutaneous pulsed radiofrequency current<br>* Active treating group: 80 volts, 2Hz, 20 ms pulsed radiofrequency current will be applied to the tibial nerve trace in the ankle with electrodes. Sham group: Elelctrodes will be attached but radiofrequency current will not be applied.<br>|
| Sham Comparator: Patients with bilateral neuropathic pain which applied sham electrode<br>Sham electrodes will be applied to 30 patients. All patients have diabetic polyneuropathy and confirmed with electroneuromyography. | Device: Transcutaneous pulsed radiofrequency current<br>* Active treating group: 80 volts, 2Hz, 20 ms pulsed radiofrequency current will be applied to the tibial nerve trace in the ankle with electrodes. Sham group: Elelctrodes will be attached but radiofrequency current will not be applied.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baselina in pain on the Visual Analog Scale (VAS) at week 4 and 12 | The visual analogue scale (VAS) is a scale that can be used measuring pain. Scores range from 0 (no pain) to 10 (the worst pain). | Bseline, week 4 and week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-Administered Leeds Assessment of Neuropathic Symptoms and Signs (S-LANSS) | it is a 7-item self-report scale developed to identify pain of predominantly neuropathic origin. Scores range 0 and 24. Scores of 12 and above are associated with neuropathic pain | baseline, week4 and week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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neuropathic pain, transcutaneous pulsed radiofrequency