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New treatment option for Pain, Nerve
Official title Non-Invasive Pulsed Radiofrequency for the Treatment of Neuropathic Pain
ClinicalTrials.gov ID: NCT06185816
What this study is testing
- What it's testing
- 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.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- -Adults aged 18 or older with clinically diagnosed chronic neuropathic pain after peripheral injury defined as persistent or recurrent neuropathic...
- 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...
- Worst pain intensity of ≥5/10 on the Numeric Rating Scale (NRS) of Pain (0-10) at the CNP-PI site at enrollment
You likely can't join if
- 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
See the full eligibility 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...
- 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
- 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
- treatment procedure and/or surgery to treat CNP-PI in the last 30 days (people 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.
The study team makes the final eligibility decision.
Where it's taking place
- Redwood City, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Redwood City, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.