Non-Invasive Pulsed Radiofrequency for the Treatment of Neuropathic Pain

Inclusion criteria

• -Adults aged 18 or older with clinically diagnosed chronic neuropathic pain after peripheral injury defined as persistent or recurrent neuropathic pain caused by a peripheral nerve lesion, history of a plausible nerve trauma, pain onset in temporal relation to the trauma, and pain distribution within the innervation territory of a peripheral nerve (or nerves). Negative and positive sensory symptoms or signs must be compatible with the innervation territory of the affected nerve. Can be posttraumatic, post-surgical, nerve compression, nerve ischemia with or without loss of motor function
• Positive response (at least 50% pain relief) to diagnostic nerve block at the suspected site of CNP-PI.
• Continued pain despite conservative therapy for a minimum of 12 weeks
• Stable dosage of analgesic medications for at least 30 days, and willingness to refrain from trialing new analgesic medications for three weeks after randomization
• Worst pain intensity of ≥5/10 on the Numeric Rating Scale (NRS) of Pain (0-10) at the CNP-PI site at enrollment
• English-speaking
• Ability and willingness to complete online and phone assessments

Exclusion criteria

• Conditions causing inability to complete assessments (education, cognitive ability, mental status, medical status)
• Cancer diagnosis, active malignant neoplasm (metastatic or local) or evidence of paraneoplastic syndrome
• Painful polyneuropathy (e.g., metabolic, autoimmune, familial, infectious disease, environmental toxins, treatment with neurotoxic drug)
• Chronic central neuropathic pain (e.g., spinal cord injury, brain injury, multiple sclerosis)
• Peripheral vascular disease
• Diabetic neuropathy
• Other active implantable devices (e.g., implantable cardioverter defibrillator, spinal cord stimulator, dorsal root ganglion stimulator, sacral nerve stimulator, deep brain stimulator, intrathecal pump)
• Pregnancy, breastfeeding, or planning to conceive
• Systemic infection or local infection at the anticipated NIPRF treatment sites
• Interventional procedure and/or surgery to treat CNP-PI in the last 30 days (subjects should be enrolled 30 days after last procedure, for prior ablative treatment must be enrolled at least 3 months after last procedure)
• Epilepsy
• Metal implants within the target treatment area of the NIPRF.