Three-Year Durability of Restorative Neurostimulation Effectiveness in Patients With Chronic Low Back Pain and Multifidus Muscle Dysfunction

Christopher Gilligan*, Willem Volschenk, Marc Russo, Matthew Green, Christopher Gilmore, Vivek Mehta, Kristiaan Deckers, Kris De Smedt, Usman Latif, Dawood Sayed, Peter Georgius, Jonathan Gentile, Bruce Mitchell, Meredith Langhorst, Frank Huygen, Ganesan Baranidharan, Vikas Patel, Eugene Mironer, Edgar Ross, Alexios CarayannopoulosSalim Hayek, Ashish Gulve, Jean Pierre Van Buyten, Antoine Tohmeh, Jeffrey Fischgrund, Shivanand Lad, Farshad Ahadian, Timothy Deer, William Klemme, Richard Rauck, James Rathmell, Frank Schwab, Greg Maislin, Jan Pieter Heemels, Sam Eldabe

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

14 Citations (Scopus)
46 Downloads (Pure)

Abstract

Background: Restorative neurostimulation is a rehabilitative treatment for patients with refractory chronic low back pain (CLBP) associated with dysfunction of the lumbar multifidus muscle resulting in impaired neuromuscular control. The ReActiv8-B randomized, sham-controlled trial provided evidence of the effectiveness and safety of an implanted, restorative neurostimulator. The two-year analysis previously published in this journal demonstrated accrual of clinical benefits and long-term durability. Objective: Evaluation of three-year effectiveness and safety in patients with refractory, disabling CLBP secondary to multifidus muscle dysfunction and no indications for spine surgery. Materials and Methods: Prospective, observational follow-up of the 204 implanted trial participants. Low back pain visual analog scale (VAS), Oswestry Disability Index (ODI), EuroQol quality of life survey, and opioid intake were assessed at baseline, six months, and one, two, and three years after activation. The mixed-effects model repeated measures approach was used to provide implicit imputations of missing data for continuous outcomes and multiple imputation for proportion estimates. Results: Data were collected from 133 participants, and 16 patients missed their three-year follow-up because of coronavirus disease restrictions but remain available for future follow-up. A total of 62% of participants had a ≥ 70% VAS reduction, and 67% reported CLBP resolution (VAS ≤ 2.5cm); 63% had a reduction in ODI of ≥ 20 points; 83% 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 71% (36/51) participants on opioids at baseline had voluntarily discontinued (49%) or reduced (22%) opioid intake. The attenuation of effectiveness in the imputed (N = 204) analyses was relatively small and did not affect the statistical significance and clinical relevance of these results. The safety profile remains favorable, and no lead migrations have been observed to date. Conclusion: At three years, 83% of participants experienced clinically substantial improvements in pain, disability, or both. The results confirm the long-term effectiveness, durability, and safety of restorative neurostimulation in patients with disabling CLBP associated with multifidus muscle dysfunction. Clinical Trial Registration: The Clinicaltrials.gov registration number for the study is NCT02577354.

Original languageEnglish
Pages (from-to)98-108
Number of pages11
JournalNeuromodulation
Volume26
Issue number1
Early online date27 Sept 2022
DOIs
Publication statusPublished - Jan 2023

Bibliographical note

Publisher Copyright: © 2022 The Authors

Fingerprint

Dive into the research topics of 'Three-Year Durability of Restorative Neurostimulation Effectiveness in Patients With Chronic Low Back Pain and Multifidus Muscle Dysfunction'. Together they form a unique fingerprint.

Cite this