Transcutaneous Pulsed Radiofrequency in Diabetic Polyneuropathy

May 15, 2023 updated by: Damla Yürük, Diskapi Teaching and Research Hospital

Transcutaneous Pulsed Radiofrequency in Diabetic Neurophatic Pain

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Patients with bilateral neuropathic pain which treating active electrode
30 patients which treating with transcutaneous pulsed radiofrequency. All patients have diabetic polyneuropathy and confirmed with electroneuromyography.
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.
Sham Comparator: Patients with bilateral neuropathic pain which applied sham electrode
Sham electrodes will be applied to 30 patients. All patients have diabetic polyneuropathy and confirmed with electroneuromyography.
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.

What is the study measuring?

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
Time Frame: 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).
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)
Time Frame: 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
baseline, week4 and week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Diskapi Teaching and Research Hospital

Investigators

  • Study Chair: Mehlika Panpallı Ateş, Diskapi Yildirim Beyazit Education and Research Hospital
  • Study Chair: Damla Yürük, Diskapi Yildirim Beyazit Education and Research Hospital
  • Study Director: Ömer Taylan Akkaya, Diskapi Yildirim Beyazit Education and Research Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2021

Primary Completion (Anticipated)

November 1, 2023

Study Completion (Anticipated)

December 1, 2023

Study Registration Dates

First Submitted

July 27, 2022

First Submitted That Met QC Criteria

July 27, 2022

First Posted (Actual)

July 29, 2022

Study Record Updates

Last Update Posted (Actual)

May 16, 2023

Last Update Submitted That Met QC Criteria

May 15, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Diabetic PNP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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