• Neuromodulation · Jul 2023

    Comparison of Spinal Cord Stimulation Trial Reporting Protocols and Long-Term Pain Relief Outcomes Following Implantation.

    • Jonathan M Hagedorn, Markus A Bendel, Alexander Schmidt, Darrell R Schroeder, and W Michael Hooten.
    • Division of Pain Medicine, Department of Anesthesiology and Perioperative Medicine, Mayo Clinic, Rochester, MN, USA. Electronic address: jonhagedornmd@yahoo.com.
    • Neuromodulation. 2023 Jul 1; 26 (5): 104710501047-1050.

    ObjectivesAppropriate spinal cord stimulation (SCS) candidates are required to undergo an SCS trial before implant, typically with ≥50% pain relief deemed "successful." However, SCS trialing protocols can vary substantially. The primary aim of this retrospective study is to investigate the associations between SCS trial results and long-term SCS pain outcomes.Materials And MethodsThis study was a retrospective single-center review of successful SCS trials from January 1, 2017, to July 1, 2019. A total of 115 patients were included. Group differences in continuous variables were evaluated using t-tests, and group differences in categorical variables were evaluated using the χ2 test. The percentage improvement in long-term pain intensity was analyzed as a binary variable, where long-term success was defined as ≥50% improvement in numeric rating scale pain scores. The level of significance for all tests was set at p < 0.05.ResultsThe mean age was 64.9 years, and 52% of patients were men. The mean pain score at long-term follow-up was 4.7 ± 2.6, and the median time from implantation to follow-up was 13 months (25th-75th interquartile range; 4-22). In the logistic regression analysis adjusted for age, sex, and follow-up time, greater patient-reported percentage improvement in pain scale during the trial was significantly associated with greater odds of experiencing ≥50% improvement in pain scores (p = 0.048; 95% CI 1.00-1.70). All other assessed trial metrics were not significantly associated with greater odds of experiencing >50% improvement in pain scores at last follow-up.ConclusionsGiven the variability in current assessment techniques, we recommend the patient-reported percentage improvement in pain scale as the posttrial assessment method of choice instead of a calculated percentage improvement. However, our results indicate that current trial assessment methods are generally poor, and improved trial reporting protocols must be sought.Copyright © 2022 International Neuromodulation Society. Published by Elsevier Inc. All rights reserved.

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