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

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.