• Timothy Deer, Christopher Gilligan, Steven Falowski, Mehul Desai, Julie Pilitsis, Jessica Jameson, Susan Moeschler, Robert Heros, Edward Tavel, Anne Christopher, Denis Patterson, Sayed Wahezi, Jacqueline Weisbein, Ajay Antony, Robert Funk, Mohab Ibrahim, Chi Lim, Derron Wilson, Michael Fishell, Keith Scarfo, David Dickerson, Edward Braun, Patrick Buchanan, Robert M Levy, Nathan Miller, Jonathan Duncan, Jijun Xu, Kenneth Candido, Scott Kreiner, Marie E Fahey, and James Yue.
• The Spine and Nerve Center of the Virginias, Charleston, WV, USA.
• Neuromodulation. 2023 Oct 1; 26 (7): 138713991387-1399.

ObjectiveSpinal cord stimulation (SCS) is effective for relieving chronic intractable pain conditions. The Dorsal spInal cord STImulatioN vs mediCal management for the Treatment of low back pain study evaluates the effectiveness of SCS compared with conventional medical management (CMM) in the treatment of chronic low back pain in patients who had not undergone and were not candidates for lumbar spine surgery.Methods And MaterialsPatients were randomized to passive recharge burst therapy (n = 162) or CMM (n = 107). They reported severe pain and disability for more than a decade and had failed a multitude of therapies. Common diagnoses included degenerative disc disease, spondylosis, stenosis, and scoliosis-yet not to a degree amenable to surgery. The six-month primary end point compared responder rates, defined by a 50% reduction in pain. Hierarchical analyses of seven secondary end points were performed in the following order: composite responder rate (numerical rating scale [NRS] or Oswestry Disability Index [ODI]), NRS, ODI, Pain Catastrophizing Scale responder rate, Patient Global Impression of Change (PGIC) responder rate, and Patient-Reported Outcome Measure Information System-29 in pain interference and physical function.ResultsIntention-to-treat analysis showed a significant difference in pain responders on NRS between SCS (72.6%) and CMM (7.1%) arms (p < 0.0001). Of note, 85.2% of those who received six months of therapy responded on NRS compared with 6.2% of those with CMM (p < 0.0001). All secondary end points indicated the superiority of burst therapy over CMM. A composite measure on function or pain relief showed 91% of subjects with SCS improved, compared with 16% of subjects with CMM. A substantial improvement of 30 points was observed on ODI compared with a ConclusionsThis study found substantial improvement at six months in back pain, back pain-related disability, pain-related emotional suffering, PGIC, pain interference, and physical function in a population with severe, debilitating back pain for more than a decade. These improvements were reported in conjunction with reduced opioid use, injection, and ablation therapy.Clinical Trial RegistrationThe Clinicaltrials.gov registration number for the study is NCT04479787.Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.

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