Clinical trial NCT05480527: Transcutaneous Pulsed Radiofrequency in Diabetic Polyneuropathy
Official title: Transcutaneous Pulsed Radiofrequency in Diabetic Neurophatic Pain
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Neuropathy;Peripheral
Keywords: neuropathic pain
transcutaneous pulsed radiofrequency
Lead sponsor: Diskapi Teaching and Research Hospital
Sponsor class: OTHER
First posted: 2022-07-29
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change from baselina in pain on the Visual Analog Scale (VAS) at week 4 and 12
timeFrame: Bseline, week 4 and week 12
Secondary outcomes:
measure: Self-Administered Leeds Assessment of Neuropathic Symptoms and Signs (S-LANSS)
timeFrame: baseline, week4 and week 12
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Dişkapi Reserch and Education Hospital
Study officials:
affiliation: Diskapi Yildirim Beyazit Education and Research Hospital
name: Mehlika Panpallı Ateş
role: STUDY_CHAIR
affiliation: Diskapi Yildirim Beyazit Education and Research Hospital
name: Damla Yürük
role: STUDY_CHAIR
affiliation: Diskapi Yildirim Beyazit Education and Research Hospital
name: Ömer Taylan Akkaya
role: STUDY_DIRECTOR
References: