AIRR - ANZCA Institutional Research Repository
Skip navigation
Please use this identifier to cite or link to this item: https://hdl.handle.net/11055/1260
Full metadata record
DC FieldValueLanguage
dc.contributor.authorGilligan Cen_US
dc.contributor.authorVolschenk Wen_US
dc.contributor.authorRusso Men_US
dc.contributor.authorGreen Men_US
dc.contributor.authorGilmore Cen_US
dc.contributor.authorMehta Ven_US
dc.contributor.authorDeckers Ken_US
dc.contributor.authorDe Smedt Ken_US
dc.contributor.authorLatif Uen_US
dc.contributor.authorSayed Den_US
dc.contributor.authorGeorgius Pen_US
dc.contributor.authorGentile Jen_US
dc.contributor.authorMitchell Ben_US
dc.contributor.authorLanghorst Men_US
dc.contributor.authorHuygen Fen_US
dc.contributor.authorBaranidharan Gen_US
dc.contributor.authorPatel Ven_US
dc.contributor.authorMironer Een_US
dc.contributor.authorRoss Een_US
dc.contributor.authorCarayannopoulos Aen_US
dc.contributor.authorHayek Sen_US
dc.contributor.authorGulve Aen_US
dc.contributor.authorVan Buyten JPen_US
dc.contributor.authorTohmeh Aen_US
dc.contributor.authorFischgrund Jen_US
dc.contributor.authorLad Sen_US
dc.contributor.authorAhadian Fen_US
dc.contributor.authorDeer Ten_US
dc.contributor.authorKlemme Wen_US
dc.contributor.authorRauck Ren_US
dc.contributor.authorRathmell Jen_US
dc.contributor.authorSchwab Fen_US
dc.contributor.authorMaislin Gen_US
dc.contributor.authorHeemels JPen_US
dc.contributor.authorEldabe Sen_US
dc.date2022-09-27-
dc.date.accessioned2025-01-10T03:37:26Z-
dc.date.available2025-01-10T03:37:26Z-
dc.date.issued2023-01-
dc.identifier.citation26(1):98-108.en_US
dc.identifier.issn1094-7159en_US
dc.identifier.urihttps://hdl.handle.net/11055/1260-
dc.description.abstractBackground: 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.en_US
dc.subject3-year durabilityen_US
dc.subjectChronic low back painen_US
dc.subjectFunctional segmental stabilityen_US
dc.subjectImputationen_US
dc.subjectMultifidus muscleen_US
dc.subjectNeuromuscular controlen_US
dc.subjectOpioid reductionen_US
dc.subjectPeripheral nerve stimulationen_US
dc.subjectRestorative neurostimulationen_US
dc.titleThree-Year Durability of Restorative Neurostimulation Effectiveness in Patients With Chronic Low Back Pain and Multifidus Muscle Dysfunctionen_US
dc.typeJournal Articleen_US
dc.type.contentTexten_US
dc.identifier.journaltitleNeuromodulation: Technology at the Neural Interfaceen_US
dc.identifier.doi10.1016/j.neurom.2022.08.457en_US
dc.description.affiliatesDivision of Pain Medicine, Brigham and Women's Hospital Harvard Medical School, Boston, MA, USA. Electronic address: cgilligan@bwh.harvard.edu.en_US
dc.description.affiliatesHunter Pain Specialists, Newcastle, Australia.en_US
dc.description.affiliatesPain Medicine of SA, Adelaide, Australia.en_US
dc.description.affiliatesCenter for Clinical Research, Carolinas Pain Institute, Winston-Salem, NC, USA.en_US
dc.description.affiliatesBarts Neuromodulation Center, St. Bartholomew's Hospital, London, UK.en_US
dc.description.affiliatesDepartment of Physical Medicine and Rehabilitation, GZA - Sint Augustinus Hospital, Wilrijk, Belgium.en_US
dc.description.affiliatesDepartment of Neurosurgery, GZA - Sint Augustinus Hospital, Wilrijk, Belgium.en_US
dc.description.affiliatesDepartment of Anesthesiology, University of Kansas School of Medicine, Kansas City, Kansas, USA.en_US
dc.description.affiliatesSunshine Coast Clinical Research, Noosa Heads, Australia.en_US
dc.description.affiliatesIndiana Spine Group, Indianapolis, IN, USA.en_US
dc.description.affiliatesMetro Pain Group, Melbourne, Australia.en_US
dc.description.affiliatesOrthoIndy, Indianapolis, IN, USA.en_US
dc.description.affiliatesDepartment of Anaesthesiology Erasmus Medical Center, Rotterdam, The Netherlands.en_US
dc.description.affiliatesLeeds Pain and Neuromodulation Centre, Leeds Teaching Hospitals NHS Trust, Leeds, UK.en_US
dc.description.affiliatesDepartment of Orthopedic Surgery, University of Colorado, Denver, CO, USA.en_US
dc.description.affiliatesCarolinas Center for the Advanced Management of Pain, Spartanburg, NC, USA.en_US
dc.description.affiliatesDivision of Pain Medicine, Brigham and Women's Hospital Harvard Medical School, Boston, MA, USA.en_US
dc.description.affiliatesDepartments of Physical Medicine and Rehabilitation, Rhode Island Hospital, Brown University Medical School, Providence, RI, USA.en_US
dc.description.affiliatesDivision of Pain Medicine, University Hospitals, Cleveland Medical Center, Cleveland, OH, USA.en_US
dc.description.affiliatesDepartment of Pain Medicine, The James Cook University Hospital, Middlesbrough, UK.en_US
dc.description.affiliatesAZ Niklaas Multidisciplinary Pain Center, Sint Niklaas, Belgium.en_US
dc.description.affiliatesMulticare Neuroscience Institute, Spokane, WA, USA.en_US
dc.description.affiliatesDepartment of Orthopedic Surgery, Oakland University, Beaumont Hospital, Royal Oak, MI, USA.en_US
dc.description.affiliatesDepartment of Neurosurgery, Duke University Medical Center, Durham, NC, USA.en_US
dc.description.affiliatesCenter for Pain Medicine, University of California, San Diego, CA, USA.en_US
dc.description.affiliatesThe Spine and Nerve Center of the Virginias, Charleston, WV, USA.en_US
dc.description.affiliatesUniformed Services University of the Health Sciences, Bethesda, MD, USA.en_US
dc.description.affiliatesCarolinas Pain Institute, Wake Forest University, Winston-Salem, NC, USA.en_US
dc.description.affiliatesNorthwell Health Orthopaedic Institute, New York, NY, USA.en_US
dc.description.affiliatesBiomedical Statistical Consulting, Wynnewood, PA, USA.en_US
dc.description.affiliatesDepartment of Scientific Affairs, Mainstay Medical, Dublin, Ireland.en_US
dc.description.pubmedurihttps://pubmed.ncbi.nlm.nih.gov/36175320/en_US
dc.type.studyortrialRandomized Controlled Clinical Trial/Controlled Clinical Trialen_US
dc.ispartof.anzcaresearchfoundationYesen_US
dc.type.specialtyAnaesthesiaen_US
dc.type.specialtyPain Medicineen_US
dc.identifier.fulltextlinkhttps://www.neuromodulationjournal.org/article/S1094-7159(22)01254-5/fulltexten_US
item.fulltextWith Fulltext-
item.openairetypeJournal Article-
item.grantfulltextrestricted-
item.openairecristypehttp://purl.org/coar/resource_type/c_18cf-
item.cerifentitytypePublications-
Appears in Collections:Scholarly and Clinical
Show simple item record

Page view(s)

110
checked on Mar 15, 2025

Download(s)

4
checked on Mar 15, 2025

Google ScholarTM

Check

Altmetric


Items in DSpace are protected by copyright, with all rights reserved, unless otherwise indicated.