Status:
NOT_YET_RECRUITING
Non-Invasive Pulsed Radiofrequency for the Treatment of Neuropathic Pain
Lead Sponsor:
Stanford University
Conditions:
Pain, Nerve
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- -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
- 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.
Key Trial Info
Start Date :
January 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2029
Estimated Enrollment :
95 Patients enrolled
Trial Details
Trial ID
NCT06185816
Start Date
January 1 2024
End Date
January 1 2029
Last Update
December 29 2023
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