Non-Invasive Pulsed Radiofrequency for the Treatment of Neuropathic Pain
ConditionPain, Nerve
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorStanford University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
-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
Disqualifiers
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)
Trial design
Design model
Single group
Treatments tested in this trial
Active Treatment
DeviceThe 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
Non-active Treatment
DeviceThe 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.
Treatment groups
95 Participants
are divided into 2 treatment groupsGroup A: Active TreatmentActive comparator 1 intervention
Group B: Non-Active TreatmentSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Treatment Response Rate
Time frame
After Three Weeks of Starting TreatmentSponsors and contacts
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Source ClinicalTrials.gov