Non-invasive pulsed radiofrequency for chronic nerve pain

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Stanford Pain Management Center
  Redwood City, California, United States Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.