Introduction: Chronic mechanical low back pain (CMLBP) can be caused by impaired neuromuscular
control and degeneration of the multifidus muscles resulting in functional instability
of the lumbar spine. Available treatment options often lack long-term effectiveness
and prognosis is unfavourable. An implantable Restorative Neurostimulation system
(ReActiv8® by Mainstay Medical), that stimulates the L2 medial branches of the dorsal
rami to reactivate neuromuscular control, received FDA Premarket Approval based on
evidence from the ReActiv8-B pivotal trial (clinicaltrials.gov/show/NCT02577354).
Here we report the two-year results of the open-label phase of this trial.
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