Non-Invasive Pulsed Radiofrequency for the Treatment of Neuropathic Pain

Launched by STANFORD UNIVERSITY · Dec 16, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called non-invasive pulsed radiofrequency (NIPRF) for people suffering from chronic nerve pain, particularly after an injury or surgery. Chronic neuropathic pain can be persistent and is often difficult to manage with typical treatments like medications or physical therapy. The goal of this study is to see if NIPRF can effectively reduce this type of pain and determine if it could be a suitable option for patients experiencing it.

To participate in the trial, individuals must be at least 18 years old and have been diagnosed with chronic neuropathic pain linked to a nerve injury. They should have experienced significant pain relief (at least 50%) from a prior nerve block, have been in pain for at least 12 weeks despite other treatments, and need to have a certain level of pain intensity. Participants will be asked to complete assessments and will use a device approved by the FDA for this study. It's important to note that people with certain conditions, like cancer or other specific neuropathic pain disorders, will not be eligible to join. If you or a loved one is considering this trial, it could provide a new path for managing nerve pain effectively.

Gender

ALL

Eligibility criteria

• 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.