Real-World Analysis

Abstract

Introduction: Spinal cord stimulation (SCS) is effective for patients with failed back surgery syndrome (FBSS). SCS improves their pain, as well as their functionality and health-related quality of life. Different waveforms for SCS have emerged that show improvement in small prospective studies. Analysis of real-world data shows the clinical implementation and the effect of different waveforms in SCS.

Methods: A real-world analysis was performed of 208 patients with FBSS who were treated over 3 years. Stimulators with tonic, burst, high-density, and 10-kHz high-frequency (HF10) waveforms were implanted in patients with FBSS who had predominant pain in the back, legs, or both back and legs. Pain as measured by the VAS, functional disability as measured by the Oswestry Disability Index (ODI), and health-related quality of life as measured by the 3-level EuroQol 5-Dimension (EQ5D-3L) questionnaire were determined at baseline and for outcome assessment.

Results: SCS is effective for patients with FBSS. This analysis showed a change in baseline VAS score from 8.0 to 4.7 (P < 0.0001) at 24 months. The EQ5D-3L score improved from 0.29 to 0.49 (P < 0.0001) at 24 months. The ODI score improved from 54% to 42% (P < 0.0001) at 24 months. The unanticipated explantation rate was only 1.6%.

Conclusion: This study of SCS showed significant long-term improvement in pain, disability, and quality of life in a large dataset of patients with FBSS. Strict selection procedures and a strong opioid policy contributed to the high success rate and low unanticipated explantation rate. There was no difference in pain reduction between tonic and HF10 stimulation. Further investigation is necessary to detect any difference between other waveforms of SCS.

Keywords: EuroQol 5-Dimension; Oswestry Disability Index; burst; failed back surgery syndrome; high density; high-frequency 10-kHz; spinal cord stimulation; tonic; visual analog scale.

© 2020 World Institute of Pain.