ABSTRACT
INTRODUCTION: Chronic low back pain (CLBP) is the leading cause of years lived with disability globally. The role of restorative neurostimulation in the treatment of patients with refractory mechanical CLBP and multifidus muscle dysfunction has been established in one randomized controlled trial (RCT) and several clinical studies that demonstrated both safety and clinical benefit. This post-market trial provides a direct comparison to optimized medical management to test the hypothesis that the addition of restorative neurostimulation to current care paradigms results in significant improvements in back pain-related disability. METHODS AND ANALYSIS: This trial will include people who have reported significant levels of back pain and back pain-related disability with symptoms that have persisted for longer than 6 months prior to enrollment and resulted in pain on most days in the 12 months prior to enrollment. Eligible patients will be randomized to either optimal medical management or optimal medical management plus ReActiv8® restorative neurostimulation therapy. Patient-reported outcomes will be collected at regular intervals out to the 1-year primary endpoint, at which time the patients in the control arm will be offered implantation with the ReActiv8 system. Assessment of each group will continue for an additional year. ETHICS AND DISSEMINATION: The RESTORE trial follows the principles of the Declaration of Helsinki. The WCG IRB acts as the Central Institutional Review Board (IRB) for most sites and some sites will receive local IRB approval prior to enrollment of patients. Each IRB assessed the protocol and related documentation. The protocol complies with Good Clinical Practice (GCP). All patients provide written informed consent to participate in the trial. PROTOCOL VERSION: Version C, 07 Sep 2022. CLINICALTRIALS: gov registration number. NCT04803214 registered March 17, 2021.
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.
