{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,14]],"date-time":"2026-10-14T11:58:09Z","timestamp":1791979089401,"version":"4.4.0"},"reference-count":30,"publisher":"American Medical Association (AMA)","issue":"6","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JAMA Netw Open"],"abstract":"<jats:sec id=\"ab-zoi240527-4\">\n                    <jats:title>Importance<\/jats:title>\n                    <jats:p>The modified Japanese Orthopaedic Association (mJOA) scale is the most common scale used to represent outcomes of degenerative cervical myelopathy (DCM); however, it lacks consideration for neck pain scores and neglects the multidimensional aspect of recovery after surgery.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"ab-zoi240527-5\">\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>To use a global statistical approach that incorporates assessments of multiple outcomes to reassess the efficacy of riluzole in patients undergoing spinal surgery for DCM.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"ab-zoi240527-6\">\n                    <jats:title>Design, Setting, and Participants<\/jats:title>\n                    <jats:p>This was a secondary analysis of prespecified secondary end points within the Efficacy of Riluzole in Surgical Treatment for Cervical Spondylotic Myelopathy (CSM-PROTECT) trial, a multicenter, double-blind, phase 3 randomized clinical trial conducted from January 2012 to May 2017. Adult surgical patients with DCM with moderate to severe myelopathy (mJOA scale score of 8-14) were randomized to receive either riluzole or placebo. The present study was conducted from July to December 2023.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"ab-zoi240527-7\">\n                    <jats:title>Intervention<\/jats:title>\n                    <jats:p>Riluzole (50 mg twice daily) or placebo for a total of 6 weeks, including 2 weeks prior to surgery and 4 weeks following surgery.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"ab-zoi240527-8\">\n                    <jats:title>Main Outcomes and Measures<\/jats:title>\n                    <jats:p>The primary outcome measure was a difference in clinical improvement from baseline to 1-year follow-up, assessed using a global statistical test (GST). The 36-Item Short Form Health Survey Physical Component Score (SF-36 PCS), arm and neck pain numeric rating scale (NRS) scores, American Spinal Injury Association (ASIA) motor score, and Nurick grade were combined into a single summary statistic known as the global treatment effect (GTE).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"ab-zoi240527-9\">\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      Overall, 290 patients (riluzole group, 141; placebo group, 149; mean [SD] age, 59 [10.1] years; 161 [56%] male) were included. Riluzole showed a significantly higher probability of global improvement compared with placebo at 1-year follow-up (GTE, 0.08; 95% CI, 0.00-0.16;\n                      <jats:italic>P<\/jats:italic>\n                      \u2009=\u2009.02). A similar favorable global response was seen at 35 days and 6 months (GTE for both, 0.07; 95% CI, \u22120.01 to 0.15;\n                      <jats:italic>P<\/jats:italic>\n                      \u2009=\u2009.04), although the results were not statistically significant. Riluzole-treated patients had at least a 54% likelihood of achieving better outcomes at 1 year compared with the placebo group. The ASIA motor score and neck and arm pain NRS combination at 1 year provided the best-fit parsimonious model for detecting a benefit of riluzole (GTE, 0.11; 95% CI, 0.02-0.16;\n                      <jats:italic>P<\/jats:italic>\n                      \u2009=\u2009.007).\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"ab-zoi240527-10\">\n                    <jats:title>Conclusions and Relevance<\/jats:title>\n                    <jats:p>In this secondary analysis of the CSM-PROTECT trial using a global outcome technique, riluzole was associated with improved clinical outcomes in patients with DCM. The GST offered probability-based results capable of representing diverse outcome scales and should be considered in future studies assessing spine surgery outcomes.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1001\/jamanetworkopen.2024.15643","type":"journal-article","created":{"date-parts":[[2024,6,21]],"date-time":"2024-06-21T11:33:37Z","timestamp":1718969617000},"page":"e2415643","source":"Crossref","is-referenced-by-count":20,"title":["Riluzole for Degenerative Cervical Myelopathy"],"prefix":"10.1001","volume":"7","author":[{"given":"Michael G.","family":"Fehlings","sequence":"first","affiliation":[{"name":"Division of Neurosurgery, Toronto Western Hospital, University of Toronto, Toronto, Ontario, Canada"},{"name":"Division of Neurosurgery and Spine Program, Department of Surgery, University of Toronto, Toronto, Ontario, Canada"},{"name":"Institute of Medical Science, University of Toronto, Toronto, Ontario, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Karlo M.","family":"Pedro","sequence":"additional","affiliation":[{"name":"Division of Neurosurgery, Toronto Western Hospital, University of Toronto, Toronto, Ontario, Canada"},{"name":"Division of Neurosurgery and Spine Program, Department of Surgery, University of Toronto, Toronto, Ontario, Canada"},{"name":"Institute of Medical Science, University of Toronto, Toronto, Ontario, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mohammed Ali","family":"Alvi","sequence":"additional","affiliation":[{"name":"Division of Neurosurgery, Toronto Western Hospital, University of Toronto, Toronto, Ontario, Canada"},{"name":"Division of Neurosurgery and Spine Program, Department of Surgery, University of Toronto, Toronto, Ontario, Canada"},{"name":"Institute of Medical Science, University of Toronto, Toronto, Ontario, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jetan H.","family":"Badhiwala","sequence":"additional","affiliation":[{"name":"Division of Neurosurgery and Spine Program, Department of Surgery, University of Toronto, Toronto, Ontario, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Henry","family":"Ahn","sequence":"additional","affiliation":[{"name":"Division of Orthopaedic Surgery, St Michael\u2019s Hospital, University of Toronto, Toronto, Ontario, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"H. Francis","family":"Farhadi","sequence":"additional","affiliation":[{"name":"Department of Neurological Surgery, Ohio State University, Columbus"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christopher I.","family":"Shaffrey","sequence":"additional","affiliation":[{"name":"Department of Neurosurgery, University of Virginia, Charlottesville"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ahmad","family":"Nassr","sequence":"additional","affiliation":[{"name":"Department of Orthopedic Surgery, Mayo Clinic, Rochester, Minnesota"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Praveen","family":"Mummaneni","sequence":"additional","affiliation":[{"name":"Department of Neurosurgery, University of California, San Francisco"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Paul M.","family":"Arnold","sequence":"additional","affiliation":[{"name":"Department of Neurosurgery, Kansas University Medical Center, Kansas City"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"W. Bradley","family":"Jacobs","sequence":"additional","affiliation":[{"name":"Department of Clinical Neurosciences, University of Calgary, Calgary, Alberta, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"K. Daniel","family":"Riew","sequence":"additional","affiliation":[{"name":"Department of Orthopedic Surgery, Columbia University, New York, New York"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael","family":"Kelly","sequence":"additional","affiliation":[{"name":"Department of Orthopaedic Surgery, University of California, San Diego"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Darrel S.","family":"Brodke","sequence":"additional","affiliation":[{"name":"Department of Orthopaedics, University of Utah, Salt Lake City"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alexander R.","family":"Vaccaro","sequence":"additional","affiliation":[{"name":"Department of Orthopaedic Surgery, Rothman Orthopaedic Institute, Thomas Jefferson University, Philadelphia, Pennsylvania"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alan S.","family":"Hilibrand","sequence":"additional","affiliation":[{"name":"Department of Neurosurgery, Louisiana State University, New Orleans"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jason","family":"Wilson","sequence":"additional","affiliation":[{"name":"Department of Neurological Surgery, Thomas Jefferson University, Philadelphia, Pennsylvania"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"James S.","family":"Harrop","sequence":"additional","affiliation":[{"name":"Department of Orthopaedic Surgery, Rothman Orthopaedic Institute, Thomas Jefferson University, Philadelphia, Pennsylvania"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"S. Tim","family":"Yoon","sequence":"additional","affiliation":[{"name":"Department of Orthopaedics, Emory University, Atlanta, Georgia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kee D.","family":"Kim","sequence":"additional","affiliation":[{"name":"Department of Neurological Surgery, University of California, Davis, Sacramento"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daryl R.","family":"Fourney","sequence":"additional","affiliation":[{"name":"Division of Neurosurgery, University of Saskatchewan, Saskatoon, Saskatchewan, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Carlo","family":"Santaguida","sequence":"additional","affiliation":[{"name":"Department of Neurology and Neurosurgery, McGill University Health Centre, Montreal, Quebec, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eric M.","family":"Massicotte","sequence":"additional","affiliation":[{"name":"Division of Neurosurgery, Toronto 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P, Woolson? RF, Granholm? A. The use of a global statistical approach for the design and data analysis of clinical trials with multiple primary outcomes. 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