{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,30]],"date-time":"2026-10-30T09:47:02Z","timestamp":1793353622947,"version":"4.5.0"},"reference-count":33,"publisher":"Wiley","issue":"10","license":[{"start":{"date-parts":[[2024,6,28]],"date-time":"2024-06-28T00:00:00Z","timestamp":1719532800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["European Journal of Pain"],"published-print":{"date-parts":[[2024,11]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Differential target multiplexed spinal cord stimulation (DTM SCS) was shown to be superior to conventional SCS for treating chronic low back pain (CLBP) in subjects with persistent spinal pain syndrome with previous spinal surgery (PSPS\u2010T2) or ineligible for it (PSPS\u2010T1). This study reports 24\u2010month efficacy and safety of DTM SCS vs. conventional medical management (CMM) in PSPS\u2010T1 subjects across four European countries.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>This is a prospective, multicenter, open\u2010label, randomized, controlled trial with optional crossover. Subjects randomized 1:1 to DTM SCS or CMM. Primary endpoint was responder rate (% subjects reporting \u226550% CLBP relief) at 6 months. A superiority test compared responder rates between treatments. CLBP and leg pain levels, functional disability, quality of life (QoL), patient satisfaction and global impression of change were evaluated for 24 months. A Composite Responder Index (CRI) was obtained using CLBP relief, disability and QoL. Incidence of study\u2010related adverse events evaluated safety.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>A total of 55 and 57 subjects were randomized to DTM SCS and CMM respectively. DTM SCS was superior, with CLBP responder rates \u226580% and CLBP relief &gt;5.6\u2009cm (&gt;70% reduction) through the 24\u2010month follow\u2010up. Improvements with DTM SCS in other outcomes were sustained. The CRI was &gt;80% for DTM SCS through 24 months. Opioid medication intake decreased in subjects treated with DTM SCS. Most patients treated with DTM SCS felt satisfied and improved at the end of the study. Safety was congruent with other studies.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>DTM SCS is efficacious and safe during 24 months for the treatment of CLBP and leg pain in PSPS\u2010T1 patients ineligible for spine surgery.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Significance statement<\/jats:title>\n                    <jats:p>This randomized controlled trial shows that Differential Target Multiplexed SCS (DTM SCS) is an effective and safe long\u2010term treatment for PSPS type 1 patients suffering from axial low back pain with or without leg pain and who are ineligible for spinal surgery. Currently, CMM treatments are their only option and provide limited benefits. Besides superior pain relief, DTM SCS provides significant improvements in functional disability, quality of life, high levels of satisfaction and perceived impression of change.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1002\/ejp.2306","type":"journal-article","created":{"date-parts":[[2024,6,29]],"date-time":"2024-06-29T01:04:43Z","timestamp":1719623083000},"page":"1745-1761","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":32,"title":["European randomized controlled trial evaluating differential target multiplexed spinal cord stimulation and conventional medical management in subjects with persistent back pain ineligible for spine surgery: 24\u2010month results"],"prefix":"10.1002","volume":"28","author":[{"given":"Jan W.","family":"Kallewaard","sequence":"first","affiliation":[{"name":"Rijnstate  Elst The Netherlands"},{"name":"Amsterdam University Medical Centre  Amsterdam The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bart","family":"Billet","sequence":"additional","affiliation":[{"name":"AZ Delta  Roeselare Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Raf","family":"Van\u00a0Paesschen","sequence":"additional","affiliation":[{"name":"GZA Hospitals  Wilrijk Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Iris","family":"Smet","sequence":"additional","affiliation":[{"name":"Vitaz  St Niklaas Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Agustin","family":"Mendiola","sequence":"additional","affiliation":[{"name":"Hospital Universitario Puerta de Hierro  Madrid Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Isaac","family":"Pe\u00f1a","sequence":"additional","affiliation":[{"name":"Hospital Universitario Virgen del Roc\u00edo  Sevilla Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pablo","family":"L\u00f3pez","sequence":"additional","affiliation":[{"name":"Hospital Cl\u00ednico Universitario de Santiago  Santiago de Compostela Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Javier","family":"Carceller","sequence":"additional","affiliation":[{"name":"Hospital Cl\u00ednico Universitario de Santiago  Santiago de Compostela Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Carlos","family":"Tornero","sequence":"additional","affiliation":[{"name":"Hospital Cl\u00ednico Universitario de Valencia  Valencia Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xander","family":"Zuidema","sequence":"additional","affiliation":[{"name":"Diakonessenhuis  Zeist The Netherlands"},{"name":"Maastricht UMC+  Maastricht The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jan","family":"Vesper","sequence":"additional","affiliation":[{"name":"Uniklinik D\u00fcsseldorf  D\u00fcsseldorf Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jens","family":"Lehmberg","sequence":"additional","affiliation":[{"name":"M\u00fcnchen Klinik Bogenhausen  Bogenhausen Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wim","family":"Laloo","sequence":"additional","affiliation":[{"name":"SGX Medical LLC  Bloomington Illinois USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David L.","family":"Cede\u00f1o","sequence":"additional","affiliation":[{"name":"SGX Medical LLC  Bloomington Illinois USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ricardo","family":"Vallejo","sequence":"additional","affiliation":[{"name":"SGX Medical LLC  Bloomington Illinois USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2024,6,28]]},"reference":[{"key":"e_1_2_11_2_1","doi-asserted-by":"publisher","DOI":"10.1136\/bmjopen\u20102021\u2010049676"},{"key":"e_1_2_11_3_1","doi-asserted-by":"publisher","DOI":"10.1093\/pm\/pnab015"},{"key":"e_1_2_11_4_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.neurom.2023.07.009"},{"key":"e_1_2_11_5_1","doi-asserted-by":"publisher","DOI":"10.1111\/ner.12208"},{"key":"e_1_2_11_6_1","doi-asserted-by":"publisher","DOI":"10.1097\/BRS.0000000000002298"},{"key":"e_1_2_11_7_1","doi-asserted-by":"crossref","unstructured":"Dowell D. Ragan K. R. Jones C. M. Baldwin G. T. &Chou R.(2022).CDC clinical practice guideline for prescribing opioids for pain\u2014United States. MMWR Recomm Rep 2022; 71 (No. RR\u20103):1\u201395.https:\/\/doi.org\/10.15585\/mmwr.rr7103a1","DOI":"10.15585\/mmwr.rr7103a1"},{"key":"e_1_2_11_8_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jpain.2007.09.005"},{"key":"e_1_2_11_9_1","doi-asserted-by":"publisher","DOI":"10.1111\/papr.13186"},{"key":"e_1_2_11_10_1","doi-asserted-by":"publisher","DOI":"10.1111\/papr.13066"},{"key":"e_1_2_11_11_1","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2022.24748"},{"key":"e_1_2_11_12_1","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2022.18231"},{"key":"e_1_2_11_13_1","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2022.24751"},{"key":"e_1_2_11_14_1","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2022.24739"},{"key":"e_1_2_11_15_1","unstructured":"Intellis. (2017).Intellis\u2122 with AdaptiveStim\u2122 Technology 97715 Intellis\u2122 97716. Rechargeable neurostimulators. Implant Manual. Manual Document Number: M946871A007 REV A. Medtronic Inc."},{"key":"e_1_2_11_16_1","doi-asserted-by":"publisher","DOI":"10.1227\/NEU.0000000000001418"},{"key":"e_1_2_11_17_1","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2022.24745"},{"key":"e_1_2_11_18_1","doi-asserted-by":"publisher","DOI":"10.1177\/2192568220970163"},{"key":"e_1_2_11_19_1","doi-asserted-by":"publisher","DOI":"10.1136\/rapm\u20102023\u2010104751"},{"key":"e_1_2_11_20_1","doi-asserted-by":"publisher","DOI":"10.1111\/ner.13141"},{"key":"e_1_2_11_21_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.berh.2005.03.003"},{"key":"e_1_2_11_22_1","doi-asserted-by":"publisher","DOI":"10.3171\/2023.9.SPINE23504"},{"key":"e_1_2_11_23_1","doi-asserted-by":"publisher","DOI":"10.2147\/JPR.S320923"},{"key":"e_1_2_11_24_1","doi-asserted-by":"publisher","DOI":"10.1111\/ner.13212"},{"key":"e_1_2_11_25_1","doi-asserted-by":"publisher","DOI":"10.2147\/JEP.S124391"},{"key":"e_1_2_11_26_1","doi-asserted-by":"publisher","DOI":"10.3390\/jcm10163533"},{"key":"e_1_2_11_27_1","doi-asserted-by":"publisher","DOI":"10.1111\/anae.15801"},{"key":"e_1_2_11_28_1","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2022.24742"},{"key":"e_1_2_11_29_1","doi-asserted-by":"publisher","DOI":"10.1007\/s11916\u2010020\u201000907\u20102"},{"key":"e_1_2_11_30_1","unstructured":"Vectris. (2017).Vectris\u2122 SureScan\u00ae MRI 1\u00d78 Compact Implant Manual. Manual document number: M939859A0048 REV A. Medtronic Inc. Minneapolis MN USA."},{"key":"e_1_2_11_31_1","doi-asserted-by":"publisher","DOI":"10.1007\/s11136\u2010004\u20107713\u20100"},{"key":"e_1_2_11_32_1","volume-title":"SF\u201012: How to score the SF\u201012 physical and mental health summary scales","author":"Ware J.","year":"1998"},{"key":"e_1_2_11_33_1","doi-asserted-by":"crossref","unstructured":"White T. Justiz R. Almonte W. Micovic V. Shah B. Anderson E. \u2026Vallejo R.(2024).12\u2010Month results from a randomized controlled trial comparing Differential Target Multiplexed Spinal Cord Stimulation and Conventional Spinal Cord Stimulation in subjects with chronic refractory axial low back pain not eligible for spine surgery. Submitted toNASS Journal(10\u2010May\u20102024).","DOI":"10.1016\/j.xnsj.2024.100528"},{"key":"e_1_2_11_34_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jpain.2021.02.011"}],"container-title":["European Journal of Pain"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/ejp.2306","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,10,22]],"date-time":"2024-10-22T05:17:32Z","timestamp":1729574252000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1002\/ejp.2306"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,6,28]]},"references-count":33,"journal-issue":{"issue":"10","published-print":{"date-parts":[[2024,11]]}},"alternative-id":["10.1002\/ejp.2306"],"URL":"https:\/\/doi.org\/10.1002\/ejp.2306","archive":["Portico"],"relation":{},"ISSN":["1090-3801","1532-2149"],"issn-type":[{"value":"1090-3801","type":"print"},{"value":"1532-2149","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,6,28]]},"assertion":[{"value":"2024-01-22","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2024-06-13","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2024-06-28","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}