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dc.contributor.authorDeckers Ken_US
dc.contributor.authorDe Smedt Ken_US
dc.contributor.authorMitchell Ben_US
dc.contributor.authorVivian Den_US
dc.contributor.authorRusso Men_US
dc.contributor.authorGeorgius Pen_US
dc.contributor.authorGreen Men_US
dc.contributor.authorVieceli Jen_US
dc.contributor.authorEldabe Sen_US
dc.contributor.authorGulve Aen_US
dc.contributor.authorVan Buyten JPen_US
dc.contributor.authorSmet Ien_US
dc.contributor.authorMehta Ven_US
dc.contributor.authorRamaswamy Sen_US
dc.contributor.authorBaranidharan Gen_US
dc.contributor.authorSullivan Ren_US
dc.contributor.authorGassin Ren_US
dc.contributor.authorRathmell Jen_US
dc.contributor.authorGilligan Cen_US
dc.description.abstractOBJECTIVES: The purpose of the international multicenter prospective single arm clinical trial was to evaluate restorative neurostimulation eliciting episodic contraction of the lumbar multifidus for treatment of chronic mechanical low back pain (CMLBP) in patients who have failed conventional therapy and are not candidates for surgery or spinal cord stimulation (SCS). MATERIALS AND METHODS: Fifty-three subjects were implanted with a neurostimulator (ReActiv8, Mainstay Medical Limited, Dublin, Ireland). Leads were positioned bilaterally with electrodes close to the medial branch of the L2 dorsal ramus nerve. The primary outcome measure was low back pain evaluated on a 10-Point Numerical Rating Scale (NRS). Responders were defined as subjects with an improvement of at least the Minimal Clinically Important Difference (MCID) of ≥2-point in low back pain NRS without a clinically meaningful increase in LBP medications at 90 days. Secondary outcome measures included Oswestry Disability Index (ODI) and Quality of Life (QoL; EQ-5D). RESULTS: For 53 subjects with an average duration of CLBP of 14 years and average NRS of 7 and for whom no other therapies had provided satisfactory pain relief, the responder rate was 58%. The percentage of subjects at 90 days, six months, and one year with ≥MCID improvement in single day NRS was 63%, 61%, and 57%, respectively. Percentage of subjects with ≥MCID improvement in ODI was 52%, 57%, and 60% while those with ≥MCID improvement in EQ-5D was 88%, 82%, and 81%. There were no unanticipated adverse events (AEs) or serious AEs related to the device, procedure, or therapy. The initial surgical approach led to a risk of lead fracture, which was mitigated by a modification to the surgical approach. CONCLUSIONS: Electrical stimulation to elicit episodic lumbar multifidus contraction is a new treatment option for CMLBP. Results demonstrate clinically important, statistically significant, and lasting improvement in pain, disability, and QoL.en_US
dc.subjectArthrogenic muscle inhibitionen_US
dc.subjectchronic nonspecific low back painen_US
dc.subjectelectrical stimulationen_US
dc.subjectlumbar multifidusen_US
dc.subjectmotor controlen_US
dc.titleNew Therapy for Refractory Chronic Mechanical Low Back Pain-Restorative Neurostimulation to Activate the Lumbar Multifidus: One Year Results of a Prospective Multicenter Clinical Trialen_US
dc.typeJournal Articleen_US
dc.description.affiliatesGZA Hospitals, Wilrijk, Belgiumen_US
dc.description.affiliatesMonash Clinical Research Pty Ltd, Clayton, VIC, Australiaen_US
dc.description.affiliatesHunter Pain Clinic, Broadmeadow, NSW, Australiaen_US
dc.description.affiliatesSunshine Coast Clinical Research, Noosa Heads, QLD, Australiaen_US
dc.description.affiliatesPain Medicine of South Australia, Welland, SA, Australiaen_US
dc.description.affiliatesThe James Cook University Hospital, Middlesbrough, UKen_US
dc.description.affiliatesAlgemeen Ziekenhuis Nikolaas, Sint-Niklaas, Belgiumen_US
dc.description.affiliatesSt. Bartholomew's Hospital, London, UKen_US
dc.description.affiliatesLeeds Teaching Hospitals NHS Trust, Leeds, UKen_US
dc.description.affiliatesPrecision Neurosurgery, Kew, VIC, Australiaen_US
dc.description.affiliatesBrigham and Women's Healthcare, Harvard Medical School, Boston, MA, USAen_US
dc.type.studyortrialProspective Cohort Studyen_US
dc.identifier.studynameNCT01985230: ReActiv8-Aen_US
item.openairetypeJournal Article-
item.fulltextWith Fulltext-
Appears in Collections:Scholarly and Clinical
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