NCT Number: NCT07725419
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Centre for Diabetes and Endocrinology (CDE), Houghton, Johannesburg, Gauteng, South Africa
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: Active PRF, tPRF
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.
Other names: Sham PRF
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.
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.
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.
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.
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.
Algiamed Technologies USA, Inc.
Industry
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
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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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