Diabetic Peripheral Neuropathic Pain (DPN)NCT07725419
Transcutaneous Pulsed Radiofrequency for the Treatment of Diabetic Peripheral Neuropathy Pain
A study testing NMS 460 Pulsed Radio Frequency Device in people with Diabetic Peripheral Neuropathic Pain (DPN) and Diabetic Peripheral Neuropathy, run by Algiamed Technologies USA, Inc. at 5 sites in South Africa.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Peripheral Neuropathic Pain (DPN), Diabetic Peripheral Neuropathy, Diabetic Peripheral Neuropathic Pain
- What is being tested?
- NMS 460 Pulsed Radio Frequency Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 92 participants
- Where
- 5 sitesSouth Africa
- Study dates
- Dec 2016to Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Current pregnancy.
- Presence of a pacemaker.
- Presence of a peripheral or spinal cord stimulator.
- Presence of metal implants in the knee and/or hip.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
South Africa5 sites
Centre for Diabetes and Endocrinology (CDE), Houghton
Johannesburg, Gauteng
Clinical Sites - West Johannesburg
Johannesburg, Gauteng
Diabetic Clinic at the Charlotte Maxeke Hospital
Johannesburg, Gauteng
Clinical Sites - Krugersdorp
Krugersdorp, Gauteng
CDE / Clinical Sites - Pretoria
Pretoria, Gauteng
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Diabetic Peripheral Neuropathic Pain (DPN), Diabetic Peripheral Neuropathy, Diabetic Peripheral Neuropathic Pain
- Being tested
- NMS 460 Pulsed Radio Frequency Device, Placebo Device
- Keywords
- PRF, Neuropathic Pain, Pedal Neuropathy, Transcutaneous Nerve Stimulation, Neuromodulation, Non-pharmacological treatment, Diabetic Foot, Pulsed Radiofrequency, Pulsed Radio Frequency
- Medical subject headings
- Neuralgia, Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NMS 460 Pulsed Radio Frequency DeviceDevice
Also called Active PRF, tPRF
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.
Placebo DeviceDevice
Also called Sham PRF
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Placebo Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2026
- Study startDec 2016
- Primary completionAug 2019
- Study completionAug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Peripheral Neuropathic Pain (DPN)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Algiamed Technologies USA, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Xavant Technology (Pty) Ltd
- Responsible party
- Sponsor
- Investigators
- Phyllis P Berger, Principal investigator, Faculty: University of the WitwatersrandStanley S Landau, Study director, Centre for Diabetes and Endocrinology (CDE)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07725419
- Sponsor's protocol ID
- M161037
- Status last verified
- Jul 2026
- First submitted
- 21 Jul 2026
- Last updated
- 24 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07725419
- Acronym / sponsor ID
- M161037
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Algiamed Technologies USA, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Xavant Technology (Pty) Ltd
- Study start
- Dec 2016 (actual)
- Primary completion
- Aug 2019 (actual)
- Study completion
- Aug 2019 (actual)
- First posted
- 24 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Group A: Active Transcutaneous Pulsed Radio Frequency | Experimental | Device: NMS 460 Pulsed Radio Frequency DevicePatients 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. |
| Group B: Placebo / Sham Device | Sham comparator | Device: Placebo DevicePatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- Current pregnancy.
- Presence of a pacemaker.
- Presence of a peripheral or spinal cord stimulator.
- Presence of metal implants in the knee and/or hip.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NMS 460 Pulsed Radio Frequency DeviceAlso: Active PRF, tPRFActive 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. | Device | Group A: Active Transcutaneous Pulsed Radio Frequency |
| Placebo DeviceAlso: Sham PRFA 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. | Device | Group B: Placebo / Sham Device |
Primary outcome
Change in Neuropathic Pain and Symptoms as Measured by the DN4 Test
Time frame: 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.
2 secondary outcomes
Change in Pain Severity as Measured by the Brief Pain Inventory-Short Form (BPI-SF)
Time frame: 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)
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2026.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Phyllis P Berger principal investigator
Faculty: University of the Witwatersrand
Stanley S Landau study director
Centre for Diabetes and Endocrinology (CDE)
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NMS 460 Pulsed Radio Frequency Device in people with Diabetic Peripheral Neuropathic Pain (DPN) and Diabetic Peripheral Neuropathy, run by Algiamed Technologies USA, Inc. at 5 sites in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Neuropathic Pain and Symptoms as Measured by the DN4 Test (time frame: Baseline, prior to the third treatment (Week 3), and at 1, 3, and 6 months after the last treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2026.