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Transcutaneous Pulsed Radiofrequency in Diabetic Polyneuropathy

Primary Purpose

Neuropathy;Peripheral

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Transcutaneous pulsed radiofrequency current
Sponsored by
Diskapi Teaching and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neuropathy;Peripheral focused on measuring neuropathic pain, transcutaneous pulsed radiofrequency

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Dişkapi Reserch and Education HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Patients with bilateral neuropathic pain which treating active electrode

Patients with bilateral neuropathic pain which applied sham electrode

Arm Description

30 patients which treating with transcutaneous pulsed radiofrequency. All patients have diabetic polyneuropathy and confirmed with electroneuromyography.

Sham electrodes will be applied to 30 patients. All patients have diabetic polyneuropathy and confirmed with electroneuromyography.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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

Full Information

First Posted
July 27, 2022
Last Updated
May 15, 2023
Sponsor
Diskapi Teaching and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05480527
Brief Title
Transcutaneous Pulsed Radiofrequency in Diabetic Polyneuropathy
Official Title
Transcutaneous Pulsed Radiofrequency in Diabetic Neurophatic Pain
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2021 (Actual)
Primary Completion Date
November 1, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Diskapi Teaching and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuropathy;Peripheral
Keywords
neuropathic pain, transcutaneous pulsed radiofrequency

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patients with bilateral neuropathic pain which treating active electrode
Arm Type
Active Comparator
Arm Description
30 patients which treating with transcutaneous pulsed radiofrequency. All patients have diabetic polyneuropathy and confirmed with electroneuromyography.
Arm Title
Patients with bilateral neuropathic pain which applied sham electrode
Arm Type
Sham Comparator
Arm Description
Sham electrodes will be applied to 30 patients. All patients have diabetic polyneuropathy and confirmed with electroneuromyography.
Intervention Type
Device
Intervention Name(s)
Transcutaneous pulsed radiofrequency current
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from baselina in pain on the Visual Analog Scale (VAS) at week 4 and 12
Description
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).
Time Frame
Bseline, week 4 and week 12
Secondary Outcome Measure Information:
Title
Self-Administered Leeds Assessment of Neuropathic Symptoms and Signs (S-LANSS)
Description
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
Time Frame
baseline, week4 and week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Clinical diagnosis of Diabetes Mellitus Peripheric neuropathy with proved electroneuromyography Exclusion Criteria: Additional endocrinological disease, Pregnancy, malignancy, motor deficit in lower extremities
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gevher Rabia Genc Perdecioglu
Phone
05332009184
Email
gevhergenc@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Mehlika Panpallı Ateş
Phone
5337122286
Email
muefhulkika@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mehlika Panpallı Ateş
Organizational Affiliation
Diskapi Yildirim Beyazit Education and Research Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Damla Yürük
Organizational Affiliation
Diskapi Yildirim Beyazit Education and Research Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Ömer Taylan Akkaya
Organizational Affiliation
Diskapi Yildirim Beyazit Education and Research Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Dişkapi Reserch and Education Hospital
City
Ankara
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
damla S YURUK
Phone
5319932378
Ext
5319932378
Email
damlayuruk@hotmail.com
First Name & Middle Initial & Last Name & Degree
Ömer Taylan S Akkaya
Phone
5067152323
Ext
5319932378
Email
dr.taylanakkaya@gmail.com

12. IPD Sharing Statement

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Transcutaneous Pulsed Radiofrequency in Diabetic Polyneuropathy

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