ID: 208698 Four-Year Durability of Restorative Neurostimulation Effectiveness in Patients With Refractory Chronic Low Back Pain

Abstract

Mechanical chronic low back pain (CLBP) can be caused by impaired neuromuscular control of the lumbar spine stability. An implantable Restorative Neurostimulation system (ReActiv8® by Mainstay Medical) bilaterally stimulates the medial branches of the L2 dorsal rami for up to 30 minutes twice daily to override underlying inhibition of the multifidus muscles to facilitate motor control restoration. The ReActiv8-B randomized sham-controlled pivotal trial provided evidence of safety, effectiveness, and durability of this therapy (clinicaltrials.gov/show/NCT02577354).[1,2] Few if any prospective neuromodulation trials have shared efficacy, safety, and participant accountability outcomes beyond two years. Here we report the four-year results.