| Eligibility |
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.
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