Mechanisms of Stimulation for Pain Alleviation

Recruiting Phase 3 Interventional Study
Peripheral Nerve Stimulation Chronic Neuropathic Pain Chronic Neuropathic Pain (Below the Shoulders)
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
148 (estimated)
Sponsor
Stanford University · Other
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About This Trial
This is a mechanistic randomized controlled trial of patients with chronic neuropathic pain (CNP) in the upper extremities, lower back, pelvis, and lower extremities, randomized to conventional medical management (CMM) or combined CMM and peripheral nerve stimulation therapy (PNS+CMM). Our goal is to compare treatment outcomes and trial response rate across the control and interventional device gr…
Trial Locations
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Eligibility Criteria
Inclusion criteria for study participants Adults aged 18 or older with clinically diagnosed unilateral CNP in the upper extremities, lower back, pelvis, or lower extremities, defined (per IASP classification) as persistent or recurrent neuropathic pain caused by a peripheral nerve lesion, history o…
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