At a glance
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PROLONG Prospective, Multi-center, Open-label, Post-market Study
In Brief
A clinical study evaluating Burst-capable SCS system and DRG Stimulator for Chronic Pain. Completed, enrolled 118 participants across 21 sites.
Detailed Summary
Spinal cord stimulation (SCS) has been shown to be effective for relieving intractable chronic pain. However, a portion of patients who initially succeed with SCS will eventually lose their therapeutic benefit. Reliable methods have not been identified for restoring neuromodulation benefit to this underserved population, so additional research is required. This study will prospectively observe subjects who utilize Abbott neurostimulation devices after failing to sustain pain relief with their previous SCS system. The effectiveness of Abbott systems in restoring neuromodulation benefit will be evaluated over the course of a two-year follow-up.
Study Details
Timeline
Interventions
Subjects will be given Burst stimulation using a market-released Abbott SCS system. Burst stimulation may be achieved through surgical or non-surgical means.
Subjects will be implanted with a market-released Abbott DRG stimulation system.