Document Type
Article
Publication Date
6-3-2024
Abstract
IMPORTANCE: 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.
OBJECTIVE: 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.
DESIGN, SETTING, AND PARTICIPANTS: 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.
INTERVENTION: Riluzole (50 mg twice daily) or placebo for a total of 6 weeks, including 2 weeks prior to surgery and 4 weeks following surgery.
MAIN OUTCOMES AND MEASURES: 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).
RESULTS: 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; P = .02). A similar favorable global response was seen at 35 days and 6 months (GTE for both, 0.07; 95% CI, -0.01 to 0.15; P = .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; P = .007).
CONCLUSIONS AND RELEVANCE: 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.
Recommended Citation
Fehlings, Michael G.; Pedro, Karlo M.; Alvi, Mohammed Ali; Badhiwala, Jetan H.; Ahn, Henry; Farhadi, H. Francis; Shaffrey, Christopher I.; Nassr, Ahmad; Mummaneni, Praveen; Arnold, Paul M.; Jacobs, W. Bradley; Riew, K. Daniel; Kelly, Michael; Brodke, Darrel S.; Vaccaro, Alex; Hilibrand, Alan; Wilson, Jason; Harrop, James; Yoon, S. Tim; Kim, Kee D.; Fourney, Daryl R.; Santaguida, Carlo; Massicotte, Eric M.; and Huang, Peng, "Riluzole for Degenerative Cervical Myelopathy: A Secondary Analysis of the CSM-PROTECT Trial" (2024). Department of Orthopaedic Surgery Faculty Papers. Paper 224.
https://jdc.jefferson.edu/orthofp/224
Creative Commons License
This work is licensed under a Creative Commons Attribution 4.0 License.
PubMed ID
38904964
Language
English
Comments
This article is the author's final published version in JAMA network open, Volume 7, Issue 6, June 2024, Pages e2415643.
The published version is available at https://doi.org/10.1001/jamanetworkopen.2024.15643.
Copyright © Fehlings MG et al.