ReActiv8 Stimulation Therapy vs. Optimal Medical Management: A Randomized Controlled Trial for the Treatment of Intractable Mechanical Chronic Low Back Pain (RESTORE Trial Protocol)

Abstract

Plain Language Summary Restorative neurostimulation is a treatment for intractable CLBP associated with dysfunction of the multifidus muscle, which normally provides functional stability to the lumbar spine. To date, ReActiv8® (Mainstay Medical) is the only neurostimulator specifically developed and approved for this indication. Electrical stimulation of the muscle’s nerve overrides the dysfunction and reactivates it. Several prior studies demonstrated that the most of participants experienced clinically substantial and durable symptom relief compared to baseline. This protocol describes a second RCT in which all participants are on individualized optimal medical management and half of them are randomly selected to be implanted with a ReActiv8 system to receive restorative neurostimulation. The purpose of this design is to measure if there is any clinical benefit of restorative neurostimulation over individualized optimal medical management alone over the course of a full year.

Keywords

• Restorative neurostimulation
• Chronic low back pain
• Multifidus
• Stimulation
• Protocol