Introduction: 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 evidence to support both efficacy and understanding of the mechanism is extensive.
Methods
A narrative review of the scientific basis and published and presented data supporting restorative neurostimulation from the ReActiv8 A, B, C and PMCF studies was conducted.
Results
While each trial has subtle variations in selection and outcome measures when viewed as a collective body of evidence, compelling long-term durability and efficacy has been demonstrated. The progressive improvement in outcome over time are consistent with a mechanism of action that is restorative in nature which. ReActiv8-A led to improvements in surgical technique and has subsequently demonstrated long term efficacy. ReActiv8-B has three year outcome data showing profound improvements over baseline. ReActiv8-C and ReActiv8-PMCF document long term real world follow up with 2 and 3 year prospective data.
Conclusion
The current evidence consists multiple studies with compelling improvements and durable outcomes. The phenotype of back pain and the proposed mechanism of action are consistent with decades of basic science and clinical research.