EPV020 - HIGH-DOSE SPINAL CORD STIMULATION FOR PATIENTS WITH FAILED BACK SURGERY SYNDROME: A MULTICENTER EFFECTIVENESS AND PREDICTION STUDY. (ID 470)
- Lisa Goudman, Belgium
- Lisa Goudman, Belgium
- Ann De Smedt, Belgium
- Sam Eldabe, United Kingdom
- Philippe Rigoard, France
- Bengt Linderoth, Sweden
- Mats De Jaeger, Belgium
- Discover Discover, Belgium
- Maarten Moens, Belgium
Abstract
Introduction
Since its first use in humans in 1967, Spinal Cord Stimulation (SCS) has been established as an effective therapy to treat refractory chronic pain conditions. More recently, new waveforms and frequencies have changed the paradigm of standard SCS to address SCS long-term failures and to optimize therapy outcomes. The use of High Dose SCS (HD-SCS) has drastically increased during the last years, with positive results. However, real-world data about the effectiveness of HD-SCS are currently still lacking. Therefore, the primary aim of this study was to evaluate the effectiveness of HD-SCS in patients with Failed Back Surgery Syndrome (FBSS). The second aim was to develop a prediction model for a holistic responder.
Methods/Materials
One hundred ninety-four patients with FBSS were recruited in this multicenter real-world registry. Self-reporting outcome variables were evaluated at baseline (before initiating SCS) and after 1, 3 and 12 months of HD-SCS. The primary The following outcome measurements were collected over time: mean pain intensity, sleep quality, disability, health-related quality of life and medication use. Besides the effectiveness, logistic regression and decision tree analysis were performed to define a holistic responder (pain intensity reduction, medication reduction, ODI reduction and EQ5D improvement) after 12 months of HD-SCS.
Results
Of the 185 FBSS patients who underwent a baseline visit (before receiving SCS), 75.13% had a successful HD trial. After 12 months, 92 patients were still receiving HD-SCS. Both low back and leg pain significantly decreased at 12 months. All secondary outcome measures revealed a significant time-dependant effect. Through a logistic regression model, holistic responders at 12 months of HD-SCS could be predicted with a sensitivity and specificity of 90%.
Discussion
Clinically significant and sustained pain relief over a period of 12 months was achieved with HD-SCS in patients with FBSS. Additionally, HD-SCS is also able to achieve more global benefits namely an improvement in sleep quality and functionality and a decrease in pain medication in this population.
Conclusions
Based on real-world data, this study demonstrated the effectiveness of HD-SCS to reduce back and leg pain after 12 months, in patients with FBSS, refractory to best medical treatment.
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