• Christopher Gilligan, Willem Volschenk, Marc Russo, Matthew Green, Christopher Gilmore, Vivek Mehta, Kristiaan Deckers, Kris De Smedt, Usman Latif, Peter Georgius, Jonathan Gentile, Bruce Mitchell, Meredith Langhorst, Frank Huygen, Ganesan Baranidharan, Vikas Patel, Eugene Mironer, Edgar Ross, Alexios Carayannopoulos, Salim Hayek, Ashish Gulve, Jean-Pierre Van Buyten, Antoine Tohmeh, Jeffrey Fischgrund, Shivanand Lad, Farshad Ahadian, Timothy Deer, William Klemme, Richard Rauck, James Rathmell, Greg Maislin, Jan Pieter Heemels, Sam Eldabe, and ReActiv8-B Investigators.
• Division of Pain Medicine, Department of Anesthesiology, Perioperative and Pain Medicine, Brigham and Women's Hospital Harvard Medical School, Boston, MA, USA. Electronic address: cgilligan@bwh.harvard.edu.
• Neuromodulation. 2023 Jan 1; 26 (1): 879787-97.

BackgroundImpaired neuromuscular control and degeneration of the multifidus muscle have been linked to the development of refractory chronic low back pain (CLBP). An implantable restorative-neurostimulator system can override the underlying multifidus inhibition by eliciting episodic, isolated contractions. The ReActiv8-B randomized, active-sham-controlled trial provided effectiveness and safety evidence for this system, and all participants received therapeutic stimulation from four months onward.ObjectiveThis study aimed to evaluate the two-year effectiveness of this restorative neurostimulator in patients with disabling CLBP secondary to multifidus muscle dysfunction and no indications for spine surgery.Materials And MethodsOpen-label follow-up of 204 participants implanted with a restorative neurostimulation system (ReActiv8, Mainstay Medical, Dublin, Ireland) was performed. Pain intensity (visual analog scale [VAS]), disability (Oswestry disability index [ODI]), quality-of-life (EQ-5D-5L), and opioid intake were assessed at baseline, six months, one year, and two years after activation.ResultsAt two years (n = 156), the proportion of participants with ≥50% CLBP relief was 71%, and 65% reported CLBP resolution (VAS ≤ 2.5 cm); 61% had a reduction in ODI of ≥20 points, 76% had improvements of ≥50% in VAS and/or ≥20 points in ODI, and 56% had these substantial improvements in both VAS and ODI. A total of 87% of participants had continued device use during the second year for a median of 43% of the maximum duration, and 60% (34 of 57) had voluntarily discontinued (39%) or reduced (21%) opioid intake.ConclusionsAt two years, 76% of participants experienced substantial, clinically meaningful improvements in pain, disability, or both. These results provide evidence of long-term effectiveness and durability of restorative neurostimulation in patients with disabling CLBP, secondary to multifidus muscle dysfunction.Clinical Trial RegistrationThe study is registered on clinicaltrials.gov with identifier NCT02577354.Copyright © 2021 The Authors. Published by Elsevier Inc. All rights reserved.

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