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Transcutaneous Pulsed Radiofrequency for the Treatment of Diabetic Peripheral Neuropathy Pain

23. Juli 2026 aktualisiert von: Algiamed Technologies USA, Inc.

Can a Non-interventional Pulsed Radiofrequency Device Relieve Pain and Improve Function in Patients With Diabetic Neuropathy That Are Refractory to Medication? A Single Blind Randomized Placebo-controlled Trial

The purpose of this study is to determine if a non-invasive, electrical pulsed radio frequency (PRF) device can relieve pain and improve function in patients suffering from diabetic nerve pain in their feet, known as pedal diabetic peripheral neuropathy. Patients with this condition often experience severe pain, burning sensations, numbness, and tingling. Current medications for diabetic nerve pain often have unwanted side effects or do not provide sufficient relief.

In this single-blind, randomized trial, participants are assigned to receive either an active PRF treatment or a placebo (sham) treatment. Both treatments involve placing the device safely behind the knee (targeting the sciatic nerve) for 10 minutes, once a week for 3 weeks. The main question this study aims to answer is whether the active PRF treatment reduces nerve pain and symptoms significantly more than the placebo, measured by standard symptom questionnaires over a 6-month period.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

Diabetic peripheral neuropathy (DPN) is a common complication of diabetes, often presenting as a chronic, symmetrical, length-dependent sensorimotor polyneuropathy. Patients frequently experience neuropathic pain, hyperalgesia, allodynia, and paraesthesia in the lower extremities. Because pharmacological treatments for painful DPN are often ineffective and complicated by adverse side effects, there is a significant unmet clinical need for alternative, non-pharmacological therapies. This single-blind, randomized, placebo-controlled clinical trial evaluates the efficacy of a transcutaneous electrical pulsed radio frequency (PRF) device in alleviating the pain and sensory symptoms associated with pedal DPN.

Patients diagnosed with pedal DPN who scored 4 or higher on the DN4 neuropathic pain diagnostic test were randomized into two parallel groups: an active treatment group and a placebo group. To ensure successful patient blinding, participants were advised that they might not feel a physical sensation during the treatment, which aligns with the natural sensory loss (numbness/paraesthesia) commonly experienced by this patient population. Care providers and investigators administering the interventions were unblinded.

The treatment protocol involved mapping the sciatic nerve in the popliteal fossa posteriorly at the knee. The active or placebo device was then applied bilaterally at this site for 10 minutes. Interventions were administered once weekly for three consecutive weeks.

Clinical efficacy was assessed using validated patient-reported outcome measures. The primary outcome evaluated changes in neuropathic pain and symptoms using the DN4 test, while the secondary outcome measured pain severity and interference with daily life using the Brief Pain Inventory-Short Form (BPI-SF). Data was collected at baseline, immediately following the third treatment, and at subsequent follow-up visits at 1, 3, and 6 months to evaluate both immediate and sustained therapeutic effects.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

92

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Südafrika
    • Gauteng
      • Johannesburg, Gauteng, Südafrika
        • Centre for Diabetes and Endocrinology (CDE), Houghton
      • Johannesburg, Gauteng, Südafrika
        • Clinical Sites - West Johannesburg
      • Johannesburg, Gauteng, Südafrika
        • Diabetic Clinic at the Charlotte Maxeke Hospital
      • Krugersdorp, Gauteng, Südafrika
        • Clinical Sites - Krugersdorp
      • Pretoria, Gauteng, Südafrika
        • CDE / Clinical Sites - Pretoria

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

Inclusion Criteria:

  • Diagnosis of pedal Diabetic Peripheral Neuropathy.
  • A score of 4 or greater than 4/10 on the DN4 Test.
  • Naive to (no previous experience with) the electrical pulsed radio frequency current treatment.

Exclusion Criteria:

  • Current pregnancy.
  • Presence of a pacemaker.
  • Presence of a peripheral or spinal cord stimulator.
  • Presence of metal implants in the knee and/or hip.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Single

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Group A: Active Transcutaneous Pulsed Radio Frequency
Patients in this group received the active electrical pulsed radiofrequency current treatment. The device was applied bilaterally at the sciatic nerve in the popliteal fossa. Each treatment session lasted for 10 minutes. The intervention was administered once weekly for three consecutive weeks.
Gerät: NMS 460 Pulsed Radio Frequency Device
Active transcutaneous electrical pulsed radio frequency stimulation. The device is applied bilaterally at the sciatic nerve in the popliteal fossa for 10 minutes, once weekly for 3 consecutive weeks.
Andere Namen:
  • Active PRF
  • tPRF
Schein-Komparator: Group B: Placebo / Sham Device
Patients in this group received a placebo (sham) treatment designed to mimic the active device. The placebo device was applied bilaterally at the sciatic nerve in the popliteal fossa. Each placebo session lasted for 10 minutes. The sham intervention was administered once weekly for three consecutive weeks.
Gerät: Placebo Device
A sham device designed to look and operate like the active device but delivering no therapeutic current. It is applied bilaterally at the sciatic nerve in the popliteal fossa for 10 minutes, once weekly for 3 consecutive weeks to mimic the active treatment.
Andere Namen:
  • Sham PRF

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in Neuropathic Pain and Symptoms as Measured by the DN4 Test
Zeitfenster: Baseline, prior to the third treatment (Week 3), and at 1, 3, and 6 months after the last treatment.
The DN4 (Douleur Neuropathique 4) questionnaire is a screening tool used to identify neuropathic pain and symptoms. It consists of 7 subjective questions regarding sensory symptoms (e.g., burning, painful cold, electric shocks, tingling, pins and needles, numbness) and 3 objective tests (hypoesthesia to touch, pinprick, and tactile allodynia). The maximum score is 10 points. A score of 4 or greater out of 10 represents a positive diagnosis of neuropathic pain. Higher scores indicate a greater severity of neuropathic pain and symptoms.
Baseline, prior to the third treatment (Week 3), and at 1, 3, and 6 months after the last treatment.

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in Pain Severity as Measured by the Brief Pain Inventory-Short Form (BPI-SF)
Zeitfenster: Baseline, after the first treatment (Week 1), second treatment (Week 2), third treatment (post-treatment at Week 3), and at 1, 3, and 6 months after the last treatment.
The BPI-SF is a validated patient-reported questionnaire that evaluates pain. This outcome focuses on the Pain Severity subscale, which assesses worst, least, average, and present pain using an 11-point numerical rating scale. Scores range from 0 to 10, where 0 equals "no pain" and 10 equals "pain as bad as you can imagine". Higher scores indicate greater pain severity.
Baseline, after the first treatment (Week 1), second treatment (Week 2), third treatment (post-treatment at Week 3), and at 1, 3, and 6 months after the last treatment.
Change in Pain Interference as Measured by the Brief Pain Inventory-Short Form (BPI-SF)
Zeitfenster: Baseline, after the first treatment (Week 1), second treatment (Week 2), third treatment (post-treatment at Week 3), and at 1, 3, and 6 months after the last treatment.
The BPI-SF also evaluates how much pain interferes with various aspects of the patient's daily life. This includes general activities, work, sleep, walking ability, mood, relations with other people, and overall quality of life. Interference is measured using an 11-point numerical rating scale ranging from 0 to 10, where 0 equals "does not interfere" and 10 equals "completely interferes". Higher scores indicate greater interference with daily functioning.
Baseline, after the first treatment (Week 1), second treatment (Week 2), third treatment (post-treatment at Week 3), and at 1, 3, and 6 months after the last treatment.

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Algiamed Technologies USA, Inc.

Mitarbeiter

Xavant Technology (Pty) Ltd

Ermittler

  • Hauptermittler: Phyllis P Berger, Faculty: University of the Witwatersrand
  • Studienleiter: Stanley S Landau, Centre for Diabetes and Endocrinology (CDE)

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

1. Dezember 2016

Primärer Abschluss (Tatsächlich)

1. August 2019

Studienabschluss (Tatsächlich)

1. August 2019

Studienanmeldedaten

Zuerst eingereicht

21. Juli 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

23. Juli 2026

Zuerst gepostet (Tatsächlich)

24. Juli 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

24. Juli 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

23. Juli 2026

Zuletzt verifiziert

1. Juli 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • M161037

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Beschreibung des IPD-Plans

Individual participant data will not be publicly shared in a secondary data repository. De-identified aggregate data and study findings are presented in the primary manuscript and supporting protocol documents.

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Produkt, das in den USA hergestellt und aus den USA exportiert wird

Nein

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