Non-Invasive Pulsed Radiofrequency for the Treatment of Neuropathic Pain

The purpose of this study is to examine non-invasive pulsed radiofrequency (NIPRF) and the effect it has on chronic neuropathic pain. Chronic neuropathic pain after peripheral nerve injury most often occurs in the context of post-traumatic or post-surgical pain. It is often treated with nerve blocks, prescription medication, physical therapy, neuromodulation, and surgery. The study team will be examining the efficacy of NIPRF and determining if it would be an appropriate treatment for chronic neuropathic pain after peripheral nerve injury.The Stimpod used in the present study is FDA approved and will be used for on label purposes.

Study Overview

• Status: Recruiting
• Conditions: Pain, Nerve
• Intervention / Treatment: Device: Active Treatment; Device: Non-active Treatment

• Study Type: Interventional
• Enrollment (Estimated): 95
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• United States
  • California
    • Redwood City, California, United States, 94063
      • Recruiting
      • Stanford Pain Management Center
      • Contact: Emma Raney; Phone Number: 650-721-7073

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Active Treatment; ACTIVE treatment will be conducted by the study PIs, who are licensed pain physicians, Participants will receive 3 treatments, once weekly, for three weeks. Treatments are about 20 minutes long. The Stimpod being used is FDA cleared and is commercially available. The treatment is a non-invasive pulsed radio frequency current that emits a high frequency magnetic field. It has a pulse width of 0.2ms, a pulse rate of 2Hz and an intensity between 0 - 30ma. There is a 'beep' sound as the pulses occur. There are 2 electrodes used - one is the indifferent electrode that is placed on the skin at a suitable distance away from the active electrode and the other, an active electrode - is a probe that is applied to the target nerve to treat the mononeuropathy	Device: Active Treatment; The treatment is a non-invasive pulsed radio frequency current that emits a high frequency magnetic field. It has a pulse width of 0.2ms, a pulse rate of 2Hz and an intensity between 0 - 30ma. There is a 'beep' sound as the pulses occur. There are 2 electrodes used - one is the indifferent electrode that is placed on the skin at a suitable distance away from the active electrode and the other, an active electrode - is a probe that is applied to the target nerve to treat the mononeuropathy
Sham Comparator: Non-Active Treatment; Participants enrolled in the non-active arm will receive 3 treatments, once weekly, for three weeks. After the trial is completed, participants will be offered three free treatments. The placebo device will be inert with nil current emitted however the device will look and be used in exactly the same way. There will also be a 'beep' sound emitted and only the investigator will know the difference. The placebo device will not deliver any electrical stimulation.	Device: Non-active Treatment; The placebo device will be inert with nil current emitted however the device will look and be used in exactly the same way. There will also be a 'beep' sound emitted and only the investigator will know the difference. The placebo device will not deliver any electrical stimulation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Treatment Response Rate	After Three Weeks of Starting Treatment

Collaborators and Investigators

• Sponsor: Stanford University

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2024
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2029

Study Registration Dates

• First Submitted: December 16, 2023
• First Submitted That Met QC Criteria: December 16, 2023
• First Posted (Actual): December 29, 2023

Study Record Updates

• Last Update Posted (Actual): April 24, 2026
• Last Update Submitted That Met QC Criteria: April 21, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neuralgia
• Other Study ID Numbers: 71629

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No