Non-invasive pulsed radiofrequency for chronic nerve pain
Non-Invasive Pulsed Radiofrequency for the Treatment of Neuropathic Pain
PHASE2; PHASE3 · Stanford University · NCT06185816
This trial tests whether a non-invasive pulsed radiofrequency device can reduce chronic neuropathic pain in adults after peripheral nerve injury.
Quick facts
| Phase | PHASE2; PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 95 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Stanford University (other) |
| Locations | 1 site (Redwood City, California) |
| Trial ID | NCT06185816 on ClinicalTrials.gov |
What this trial studies
The study delivers non-invasive pulsed radiofrequency (NIPRF) treatment using the FDA-approved Stimpod device and compares active NIPRF to a non-active control treatment. Eligible adults have chronic neuropathic pain from a peripheral nerve lesion, persistent symptoms despite conservative therapy, and a positive diagnostic nerve block response. Participants must have stable analgesic medications and a worst pain score of at least 5/10 before enrollment. Outcomes will measure changes in pain intensity and functional status to determine whether NIPRF is an appropriate treatment option.
Who should consider this trial
Good fit: Adults with chronic neuropathic pain after peripheral nerve injury who had at least 50% relief from a diagnostic nerve block, have pain ≥5/10, and have had stable analgesic medication for at least 30 days.
Not a fit: Patients without a peripheral nerve lesion, those who did not respond to a diagnostic nerve block, or those unable to attend follow-up visits or keep medications stable are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this approach could offer a non-surgical, low-risk way to reduce neuropathic pain and lower reliance on medications.
How similar studies have performed: Invasive pulsed radiofrequency techniques have shown mixed but sometimes promising results for neuropathic pain, while non-invasive pulsed radiofrequency approaches remain less well studied and are more novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Redwood City, California
- Stanford Pain Management Center — Redwood City, California, United States (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Pain, Nerve