Transcutaneous Pulsed Radiofrequency in Diabetic Polyneuropathy

Neuropathy;Peripheral Clinical Trial

Official title:

Transcutaneous Pulsed Radiofrequency in Diabetic Neurophatic Pain

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05480527
• Other study ID #: Diabetic PNP
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2021
• Est. completion date: December 1, 2023

Study information

• Verified date: February 2023
• Source: Diskapi Teaching and Research Hospital
• Contact: Gevher Rabia Genc Perdecioglu
• Phone: 05332009184
• Email: gevhergenc[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 1, 2023
• Est. primary completion date: November 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Clinical diagnosis of Diabetes Mellitus

• Peripheric neuropathy with proved electroneuromyography

Exclusion Criteria:

• Additional endocrinological disease,

• Pregnancy, malignancy, motor deficit in lower extremities

Related Conditions & MeSH terms

• Neuropathy;Peripheral
• Peripheral Nervous System Diseases

Intervention

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.

Locations

Country	Name	City	State
Turkey	Diskapi Reserch and Education Hospital	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Diskapi Teaching and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Bseline, week 4 and week 12
Secondary	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	baseline, week4 and week 12