Transcutaneous Pulsed Radiofrequency for the Treatment of Diabetic Peripheral Neuropathy Pain

NCT07725419 | Completed

• 1 other identifier: M161037
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Diabetic Peripheral Neuropathic Pain (DPN); Diabetic Peripheral Neuropathy; Diabetic Peripheral Neuropathic Pain

Keywords

PRF; Neuropathic Pain; Pedal Neuropathy; Transcutaneous Nerve Stimulation; Neuromodulation; Non-pharmacological treatment; Diabetic Foot; Pulsed Radiofrequency; Pulsed Radio Frequency

Outcome Measures

Primary Outcomes (1)

• Change in Neuropathic Pain and Symptoms as Measured by the DN4 Test

  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.

Secondary Outcomes (2)

• Change in Pain Severity as Measured by the Brief Pain Inventory-Short Form (BPI-SF)

  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)

  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.

Study Arms (2)

Group A: Active Transcutaneous Pulsed Radio Frequency

EXPERIMENTAL

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.

Device: NMS 460 Pulsed Radio Frequency Device

Group B: Placebo / Sham Device

SHAM COMPARATOR

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.

Device: Placebo Device

Interventions

Placebo Device 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.

Also known as: Sham PRF

Group B: Placebo / Sham Device

NMS 460 Pulsed Radio Frequency Device 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.

Also known as: Active PRF, tPRF

Group A: Active Transcutaneous Pulsed Radio Frequency

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Algiamed Technologies USA, Inc.: lead
• Xavant Technology (Pty) Ltd: collaborator

Study Sites (5)

Centre for Diabetes and Endocrinology (CDE), Houghton

Johannesburg, Gauteng, South Africa

Location

Clinical Sites - West Johannesburg

Johannesburg, Gauteng, South Africa

Location

Diabetic Clinic at the Charlotte Maxeke Hospital

Johannesburg, Gauteng, South Africa

Location

Clinical Sites - Krugersdorp

Krugersdorp, Gauteng, South Africa

Location

CDE / Clinical Sites - Pretoria

Pretoria, Gauteng, South Africa

Location

MeSH Terms

Conditions

Neuralgia; Diabetic Foot

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Study Officials

• Phyllis P Berger

  Faculty: University of the Witwatersrand

  PRINCIPAL INVESTIGATOR

• Stanley S Landau

  Centre for Diabetes and Endocrinology (CDE)

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patients were blinded to their group assignment. To maintain the blind, naive patients were informed prior to treatment that the current might not produce any physical sensation, which is plausible given the varied manifestation of sensory loss and numbness in this patient population. Investigators and care providers were unblinded and remained neutral during the procedures.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants were randomized into two parallel groups (Group A: Active treatment, Group B: Placebo) to evaluate the efficacy of the transcutaneous pulsed radio frequency device compared to a sham treatment.

Study Record Dates

• First Submitted: July 21, 2026
• First Posted: July 24, 2026
• Study Start: December 1, 2016
• Primary Completion: August 1, 2019
• Study Completion: August 1, 2019
• Last Updated: July 24, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

ZA (5)