NCT05480527

Transcutaneous Pulsed Radiofrequency in Diabetic Polyneuropathy

Transcutaneous Pulsed Radiofrequency in Diabetic Neurophatic Pain

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Diskapi Teaching and Research Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Neuropathy;Peripheral

Interventions

Type	Name	Description
DEVICE	Transcutaneous pulsed radiofrequency current	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.

Timeline

• Start date: 2021-12-01
• Primary completion: 2023-11-01
• Completion: 2023-12-01
• First posted: 2022-07-29
• Last updated: 2023-05-16

Locations

1 site across 1 country: Turkey (Türkiye)