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

Autor: Gilligan C; Division of Pain Medicine, Brigham and Women's Hospital Harvard Medical School, Boston, MA, USA. Electronic address: cgilligan@bwh.harvard.edu., Volschenk W; Hunter Pain Specialists, Newcastle, Australia., Russo M; Hunter Pain Specialists, Newcastle, Australia., Green M; Pain Medicine of SA, Adelaide, Australia., Gilmore C; Center for Clinical Research, Carolinas Pain Institute, Winston-Salem, NC, USA., Mehta V; Barts Neuromodulation Center, St. Bartholomew's Hospital, London, UK., Deckers K; Department of Physical Medicine and Rehabilitation, GZA - Sint Augustinus Hospital, Wilrijk, Belgium., De Smedt K; Department of Neurosurgery, GZA - Sint Augustinus Hospital, Wilrijk, Belgium., Latif U; Department of Anesthesiology, University of Kansas School of Medicine, Kansas City, Kansas, USA., Sayed D; Department of Anesthesiology, University of Kansas School of Medicine, Kansas City, Kansas, USA., Georgius P; Sunshine Coast Clinical Research, Noosa Heads, Australia., Gentile J; Indiana Spine Group, Indianapolis, IN, USA., Mitchell B; Metro Pain Group, Melbourne, Australia., Langhorst M; OrthoIndy, Indianapolis, IN, USA., Huygen F; Department of Anaesthesiology Erasmus Medical Center, Rotterdam, The Netherlands., Baranidharan G; Leeds Pain and Neuromodulation Centre, Leeds Teaching Hospitals NHS Trust, Leeds, UK., Patel V; Department of Orthopedic Surgery, University of Colorado, Denver, CO, USA., Mironer E; Carolinas Center for the Advanced Management of Pain, Spartanburg, NC, USA., Ross E; Division of Pain Medicine, Brigham and Women's Hospital Harvard Medical School, Boston, MA, USA., Carayannopoulos A; Departments of Physical Medicine and Rehabilitation, Rhode Island Hospital, Brown University Medical School, Providence, RI, USA., Hayek S; Division of Pain Medicine, University Hospitals, Cleveland Medical Center, Cleveland, OH, USA., Gulve A; Department of Pain Medicine, The James Cook University Hospital, Middlesbrough, UK., Van Buyten JP; AZ Niklaas Multidisciplinary Pain Center, Sint Niklaas, Belgium., Tohmeh A; Multicare Neuroscience Institute, Spokane, WA, USA., Fischgrund J; Department of Orthopedic Surgery, Oakland University, Beaumont Hospital, Royal Oak, MI, USA., Lad S; Department of Neurosurgery, Duke University Medical Center, Durham, NC, USA., Ahadian F; Center for Pain Medicine, University of California, San Diego, CA, USA., Deer T; The Spine and Nerve Center of the Virginias, Charleston, WV, USA., Klemme W; Uniformed Services University of the Health Sciences, Bethesda, MD, USA., Rauck R; Carolinas Pain Institute, Wake Forest University, Winston-Salem, NC, USA., Rathmell J; Division of Pain Medicine, Brigham and Women's Hospital Harvard Medical School, Boston, MA, USA., Schwab F; Northwell Health Orthopaedic Institute, New York, NY, USA., Maislin G; Biomedical Statistical Consulting, Wynnewood, PA, USA., Heemels JP; Department of Scientific Affairs, Mainstay Medical, Dublin, Ireland., Eldabe S; Department of Pain Medicine, The James Cook University Hospital, Middlesbrough, UK.
Jazyk: angličtina
Zdroj: Neuromodulation : journal of the International Neuromodulation Society [Neuromodulation] 2023 Jan; Vol. 26 (1), pp. 98-108. Date of Electronic Publication: 2022 Sep 27.
DOI: 10.1016/j.neurom.2022.08.457
Abstrakt: 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.
(Copyright © 2022 The Authors. Published by Elsevier Inc. All rights reserved.)
Databáze: MEDLINE
Externí odkaz: