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Transcutaneous Pulsed Radiofrequency in Diabetic Polyneuropathy

D

Diskapi Teaching and Research Hospital

Status

Enrolling

Conditions

Neuropathy;Peripheral

Treatments

Device: Transcutaneous pulsed radiofrequency current

Study type

Interventional

Funder types

Other

Identifiers

NCT05480527
Diabetic PNP

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

60 participants in 2 patient groups

Patients with bilateral neuropathic pain which treating active electrode
Active Comparator group
Description:
30 patients which treating with transcutaneous pulsed radiofrequency. All patients have diabetic polyneuropathy and confirmed with electroneuromyography.
Treatment:
Device: Transcutaneous pulsed radiofrequency current
Patients with bilateral neuropathic pain which applied sham electrode
Sham Comparator group
Description:
Sham electrodes will be applied to 30 patients. All patients have diabetic polyneuropathy and confirmed with electroneuromyography.
Treatment:
Device: Transcutaneous pulsed radiofrequency current

Trial contacts and locations

1

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Central trial contact

Gevher Rabia Genc Perdecioglu; Mehlika Panpallı Ateş

Data sourced from clinicaltrials.gov

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