Efficacy of Noninvasive Radiofrequency in Attenuating Diabetic Neuropathic Pain

Not Applicable

Completed

• Conditions: Diabetic Neuropathy, Painful
• Interventions: Device: Capacitive-Resistive Noninvasive Radiofrequency

• Registration Number: NCT05917249
• Lead Sponsor: Cairo University

Brief Summary

Peripheral neuropathy increases the prevalence of diabetic foot ulcers following a decrease in foot sensation. Therefore, the treatment of this disorder is very important.

Detailed Description

The current study aimed to investigate the efficacy of TECAR therapy on lower limb perfusion index (PI) and to evaluate the efficacy of TECAR therapy in improving the peripheral vascularity, reducing foot pain, and improving the tactile sensation of the soles in diabetic peripheral neuropathy (DPN) patients. twenty three diabetic neuropathy patients were included in the study and underwent 12 sessions of Capacitive TECAR therapy over one month. Pain, tactile sensation of the sole and PI were evaluated at the start and after each session till the end of the study.

Study Timeline

• Study First Submitted: 2023-06-05
• Study Start: 2023-06-07
• Study First Submitted QC: 2023-06-22
• Study First Posted: 2023-06-23
• Primary Completion: 2024-01-01
• Study Completion: 2024-01-30
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-10
• Last Update Posted: 2024-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

Inclusion Criteria

• Age 40-70 years
• Type II DM with DPN (grade I-II) in lower limbs
• Duration of DM>5 years
• Visual Analog Scale (VAS) ≥3 in the feet
• Sensory impairments in the lower extremities

Exclusion Criteria

• Patient with previous stenting or surgical intervention of lower limb arterial system.
• Patients with previous history of DVT.
• Pregnancy
• Diabetic infectious wound
• Cardiac pacemaker presence
• Severe liver and kidney dysfunction or history of heart and lung disease.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
interventional	Capacitive-Resistive Noninvasive Radiofrequency	-

Primary Outcome Measures

Name	Time	Method
Change of the perfusion index at the end of the first session compared to baseline readings.	40 minutes	the perfusion index readings will be taken before the first session and set as baseline reading and after the first session and the change will be calculated.The Masimo SET "Mighty-Sat Fingertip Pulse Oximetry" (Masimo Corporation, Irvine, CA, USA model 9900) was attached to the big toe of each patient. the reading will be the the mean of three measurements of perfusion index (PI) taken at one-minute intervals.

Secondary Outcome Measures

Name	Time	Method
Visual Analogue Scale	2 months	Patient defines the degree of pain on a visual scale without numeric values, while the values are visible on the back side for the registrar where 0 indicates no pain and 10 indicates the most unbearable pain. The test was performed before intervention, after each session and one month after the end of all twelve sessions.
Tactile sensation of the sole	2 months	Tactile sensation of the sole using Semmes-Weinstein monofilament 5.07/10 g. the test will be performed after each session.
The total remission rate	2 months
Analgesic effect	2 months	* Analgesic effect after each session; will be evaluated using the four grades of WHO evaluation criteria for pain relief: * Complete remission (CR); * Partial remission (PR); * Mild remission (MR); * No response (NR).

Trial Locations

Locations (1)

Medicine; 🇪🇬 Cairo, Egypt