Transcutaneous Pulsed Radiofrequency in Diabetic Polyneuropathy

Not Applicable

Recruiting

• Conditions: Neuropathy;Peripheral

• Registration Number: NCT05480527
• Lead Sponsor: Diskapi Teaching and Research Hospital

Brief 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.

Study Timeline

• Study Start: 2021-12-01
• Study First Submitted: 2022-07-27
• Study First Submitted QC: 2022-07-27
• Study First Posted: 2022-07-29
• Status Verified: 2023-02
• Last Update Submitted: 2023-05-15
• Last Update Posted: 2023-05-16
• Primary Completion: 2023-11-01
• Study Completion: 2023-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Clinical diagnosis of Diabetes Mellitus
• Peripheric neuropathy with proved electroneuromyography

Exclusion Criteria

• Additional endocrinological disease,
• Pregnancy, malignancy, motor deficit in lower extremities

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change from baselina in pain on the Visual Analog Scale (VAS) at week 4 and 12	Bseline, week 4 and week 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).

Secondary Outcome Measures

Name	Time	Method
Self-Administered Leeds Assessment of Neuropathic Symptoms and Signs (S-LANSS)	baseline, week4 and week 12	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

Trial Locations

Locations (1)

Dişkapi Reserch and Education Hospital; 🇹🇷 Ankara, Turkey