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Efficacy of Noninvasive Radiofrequency in Attenuating Diabetic Neuropathic Pain

Sponsor
Cairo University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05917249
Collaborator
(none)
20
Enrollment
1
Location
1
Arm
4.3
Anticipated Duration (Months)
4.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Capacitive-Resistive Noninvasive Radiofrequency
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Efficacy of Capacitive-Resistive Noninvasive Radiofrequency in Improving Perfusion Index and Attenuating Diabetic Neuropathic Pain; A Pre-post Study
Actual Study Start Date :
Jun 7, 2023
Anticipated Primary Completion Date :
Oct 1, 2023
Anticipated Study Completion Date :
Oct 15, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: interventional

Device: Capacitive-Resistive Noninvasive Radiofrequency
The two passive plates were under the back of the patient. The active capacitive plates of the machine (CAPENGERY, C200, Spain) will be applied initially for 20 minutes over the sole of both feet, with the machine adjusted on the A-thermal mode (37 oC). During the remaining 20 minutes, active capacitive plates are relocated over femoral vessels at the femoral triangle with the machine adjusted on the frank thermal mode (41 oC).
Other Names:
  • TECAR

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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.

    2. 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.

    3. 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).

    4. The total remission rate [2 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Medicine Cairo Egypt 1772

    Sponsors and Collaborators

    • Cairo University

    Investigators

    • Principal Investigator: Mohamed Abdelrauof, MD, Cairo University
    • Principal Investigator: Waleed Al-Hamimy, MD, Cairo University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Bassant M. Abdelhamid, Professor, Cairo University
    ClinicalTrials.gov Identifier:
    NCT05917249
    Other Study ID Numbers:
    • Ms-399-2022
    First Posted:
    Jun 23, 2023
    Last Update Posted:
    Jun 23, 2023
    Last Verified:
    Jun 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Neuralgia
    Diabetic Neuropathies

    Study Results

    No Results Posted as of Jun 23, 2023