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Completed

NCT Number: NCT05917249

Efficacy of Noninvasive Radiofrequency in Attenuating Diabetic Neuropathic Pain

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

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Key information

Conditions

Diabetic Neuropathy, Painful Diabetes Complications Diabetes Mellitus Diabetic Neuropathies Endocrine System Diseases Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medicine

Cairo, 1772, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Capacitive-Resistive Noninvasive Radiofrequency

Device

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

Primary outcomes

  1. Change of the perfusion index at the end of the first session compared to baseline readings.

    Time frame: 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 outcomes

  1. Visual Analogue Scale

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 2 months

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Efficacy of Capacitive-Resistive Noninvasive Radiofrequency in Improving Perfusion Index and Attenuating Diabetic Neuropathic Pain; A Pre-post Study

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jun 23, 2023
Registry last updated
Feb 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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