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.
Inclusion Criteria:
Exclusion Criteria:
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.
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.
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.
Johannesburg, Gauteng, South Africa
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