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Transcutaneous Pulsed Radiofrequency for the Treatment of Diabetic Peripheral Neuropathy Pain

23. juli 2026 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Faktiske)

92

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Enhet: 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.
Andre navn:
  • Active PRF
  • tPRF
Sham-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.
Enhet: 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.
Andre navn:
  • Sham PRF

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in Neuropathic Pain and Symptoms as Measured by the DN4 Test
Tidsramme: 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.

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in Pain Severity as Measured by the Brief Pain Inventory-Short Form (BPI-SF)
Tidsramme: 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)
Tidsramme: 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.

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Algiamed Technologies USA, Inc.

Samarbeidspartnere

Xavant Technology (Pty) Ltd

Etterforskere

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. desember 2016

Primær fullføring (Faktiske)

1. august 2019

Studiet fullført (Faktiske)

1. august 2019

Datoer for studieregistrering

Først innsendt

21. juli 2026

Først innsendt som oppfylte QC-kriteriene

23. juli 2026

Først lagt ut (Faktiske)

24. juli 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

24. juli 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

23. juli 2026

Sist bekreftet

1. juli 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • M161037

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

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.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

produkt produsert i og eksportert fra USA

Nei

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