Transcutaneous Pulsed Radiofrequency in Diabetic Polyneuropathy
NCT ID: NCT05480527
Last Updated: 2023-05-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
60 participants
INTERVENTIONAL
2021-12-01
2023-12-01
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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.
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.
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Peripheric neuropathy with proved electroneuromyography
Exclusion Criteria
* Pregnancy, malignancy, motor deficit in lower extremities
18 Years
70 Years
ALL
No
Sponsors
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Diskapi Teaching and Research Hospital
OTHER
Responsible Party
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Damla Yürük
Director, medical doctor
Principal Investigators
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Mehlika Panpallı Ateş
Role: STUDY_CHAIR
Diskapi Yildirim Beyazit Education and Research Hospital
Damla Yürük
Role: STUDY_CHAIR
Diskapi Yildirim Beyazit Education and Research Hospital
Ömer Taylan Akkaya
Role: STUDY_DIRECTOR
Diskapi Yildirim Beyazit Education and Research Hospital
Locations
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Dişkapi Reserch and Education Hospital
Ankara, , Turkey (Türkiye)
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Diabetic PNP
Identifier Type: -
Identifier Source: org_study_id
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