Document Type
Article
Publication Date
11-17-2023
Abstract
OBJECTIVE: The objective of this study was to evaluate the 24-month durability of pain relief, function, quality of life, and safety outcomes for patients with nonsurgical refractory back pain (NSRBP) treated with high-frequency spinal cord stimulation (SCS) within a large, national, multicenter randomized controlled trial (RCT).
METHODS: Following the completion of an RCT comparing high-frequency SCS plus CMM with CMM alone for the treatment of NSRBP, patients gave additional consent for a follow-up extension to 24 months. Presented is the cohort analysis of all patients treated with high-frequency SCS following the optional crossover at 6 months. The outcomes assessed to 24 months included responder rate of ≥ 50% pain relief measured according to the visual analog scale [VAS]), disability (Oswestry Disability Index [ODI]), quality of life (EQ-5D 5-level [EQ-5D-5L]), opioid reduction.
RESULTS: Of the 125 patients who received a permanent implant, 121 completed the 12-month follow-up, 101 gave additional consent for extended follow-up, and 98 completed the 24-month follow-up. At 24 months after implantation, the mean back pain VAS score was reduced by 73% and the responder rate was 82%. ODI and EQ-5D-5L both improved by at least double the minimal clinically important difference for each measure. No unexpected adverse events were observed, and the rates of serious adverse events (3.4%) and device explantations (4.8%) were low.
CONCLUSIONS: The addition of high-frequency SCS to CMM in patients with NSRBP offers profound improvements at 24 months in pain, function, quality of life, and reduced opioid use. This study provides much-needed evidence to inform current clinical practice for managing patients with NSRBP.
Recommended Citation
Patel, Naresh P.; Jameson, Jessica; Johnson, Curtis; Kloster, Daniel; Calodney, Aaron; Kosek, Peter; Pilitsis, Julie; Bendel, Markus; Petersen, Erika; Wu, Chengyuan; Cherry, Taissa; Lad, Shivanand; Yu, Cong; Sayed, Dawood; Goree, Johnathan; Lyons, Mark K.; Sack, Andrew; Bruce, Diana; Bharara, Manish; Province-Azalde, Rose; Caraway, David; and Kapural, Leonardo, "Durable Responses at 24 Months With High-Frequency Spinal Cord Stimulation for Nonsurgical Refractory Back Pain" (2023). Department of Neurosurgery Faculty Papers. Paper 223.
https://jdc.jefferson.edu/neurosurgeryfp/223
Creative Commons License
This work is licensed under a Creative Commons Attribution-Noncommercial-No Derivative Works 4.0 License.
PubMed ID
37976509
Language
English
Comments
This article is the author's final published version in the Journal of Neurosurgery: Spine, Volume 40, February 2024, Pg. 229 - 239.
The published version is available at https://doi.org/10.3171/2023.9.spine23504. Copyright © 2024 The authors.