Actively Recruiting
Non-Invasive Pulsed Radiofrequency for the Treatment of Neuropathic Pain
Led by Stanford University · Updated on 2026-04-24
95
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of non-invasive pulsed radiofrequency (NIPRF) therapy for treating chronic neuropathic pain that occurs after peripheral nerve injury. This type of pain often follows trauma or surgery and is commonly managed with nerve blocks, medications, physical therapy, neuromodulation, or surgery. The study aims to determine if NIPRF, delivered by an FDA-cleared device called the Stimpod, is an effective treatment option for this condition. Participants will be randomly assigned to receive either active NIPRF treatment or a non-active (placebo) device treatment. Those receiving active treatment will undergo three weekly sessions lasting about 20 minutes each. The device emits a high-frequency magnetic field via two electrodes, one placed on the skin and the other applied to the target nerve. The placebo device looks and sounds the same but does not deliver electrical stimulation. After the trial, participants in the placebo group will be offered three free active treatments. During the study, participants will be assessed for treatment response after three weeks of starting treatment. They will complete online and phone assessments to monitor pain levels and other outcomes. The study will track how well participants respond to the treatment and will monitor safety throughout the trial, which is sponsored by Stanford University and planned to continue until January 2029.
CONDITIONS
Brief Title
Non-Invasive Pulsed Radiofrequency for the Treatment of Neuropathic Pain
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 or older with clinically diagnosed chronic neuropathic pain after peripheral nerve injury
- Pain caused by peripheral nerve lesion with symptoms matching the affected nerve area
- Positive response (at least 50% pain relief) to diagnostic nerve block at the suspected pain site
- Persistent pain despite conservative therapy for at least 12 weeks
- Stable analgesic medication dosage for at least 30 days, willing to avoid new pain medications for 3 weeks after randomization
- Worst pain intensity of 5 or higher on a 0-10 Numeric Rating Scale at enrollment
- English-speaking
- Ability and willingness to complete online and phone assessments
You will not qualify if you...
- Inability to complete assessments due to education, cognitive, mental, or medical status
- Cancer diagnosis or active malignant neoplasm
- Painful polyneuropathy from metabolic, autoimmune, infectious, or toxic causes
- Chronic central neuropathic pain (e.g., spinal cord injury, brain injury, multiple sclerosis)
- Peripheral vascular disease
- Diabetic neuropathy
- Presence of other active implantable devices (e.g., defibrillator, spinal cord stimulator)
- Pregnancy, breastfeeding, or planning to conceive
- Systemic or local infection at treatment sites
- Interventional procedure or surgery to treat neuropathic pain in last 30 days (3 months for ablative treatment)
- Epilepsy
- Metal implants within the target treatment area of NIPRF
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 3 weeks
Participants receive non-invasive pulsed radiofrequency treatments or a placebo device once weekly for three weeks to treat neuropathic pain.
3 weekly visits (in-person)
Trial Site Locations
Total: 1 location
1
Stanford Pain Management Center
Redwood City, California, United States, 94063
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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