1Department of Neurosurgery, Poitiers University Hospital, Poitiers, France; PRISMATICS Lab, Faculty of Medicine, University of Poitiers, Poitiers, France and UMR 3346, CNRS, P’ Institute, Futuroscope, Poitiers, France2Department of Neurosurgery, Nottingham University Hospital, Nottingham, UK3International Spine, Pain & Performance Center, Washington, DC, USA; George Washington University Medical Center, Washington, DC, USA4Institute of Health Research, University of Exeter Medical School, Exeter, UK5Interuniversity Centre for Health Economics Research, Ghent University, Brussels University, Ghent and Brussels, Belgium6Department of Clinical Research, Medtronic, Minneapolis, MN, USA7Department of Clinical Research, Medtronic International Trading Sàrl, Tolochenaz, Switzerland8The Neuromodulation Foundation, Inc., Baltimore, Maryland, USA; Department of Neurosurgery, Johns Hopkins University (retired) Baltimore, Maryland, USA
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Despite optimal medical management (OMM), low back pain (LBP) can be disabling, particularly after spinal surgery. Spinal cord stimulation (SCS) is effective in reducing neuropathic leg pain; however, evidence is limited for LBP.This prospective, open-label, parallel-group trial randomized (1:1) failed back surgery syndrome (FBSS) patients with predominant LBP to SCS plus OMM (SCS group) or OMM alone (OMM group) in 28 sites in Europe and the Americas. If trial stimulation was successful, a SCS system was implanted. Outcomes were assessed at baseline (pre-randomization) and 1, 3, 6, and 12 months post-randomization. Patients could change treatment groups at 6 months. The primary outcome was the proportion of patients with ≥50% reduction in LBP (responder) at 6 months. Secondary outcomes included change in pain intensity, functional disability and health-related quality of life (HRQoL). Results are posted at ClinicalTrials.gov registration number NCT01697358.In the intent-to-treat analysis, there were more responders in the SCS group than the OMM group (13.6%,15/110 versus 4.6%, 5/108, difference 9% with 95% CI 0.6-17.5%, P=0.036) at 6 months. The SCS group improved in all secondary outcomes compared to the OMM group. The OMM group only improved in HRQoL. In the SCS group, 17.6% (18/102) experienced SCS-related AEs through 6 months, with 11.8% (12/102) requiring surgical re-intervention.Adding multicolumn SCS to OMM improved pain relief, HRQoL and function in a traditionally difficult to treat population of FBSS patients with predominant LBP. Improvements were sustained at 12 months.This is an open-access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND) , where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal.