E-Poster Orals

EPV024 - BURST SPINAL CORD STIMULATION PROVIDES SUSTAINED, LONG-TERM IMPROVEMENTS IN PAIN, QUALITY OF LIFE, AND EMOTIONAL WELL-BEING: 2-YEAR RESULTS FROM THE TRIUMPH STUDY (ID 506)

Session Name
E-Poster Orals
Presenter
  • Isaac Peña, Spain
Authors
  • Isaac Peña, Spain
  • Edward Tavel, United States of America
  • Gregory Moore, United States of America
  • Kelby Hutcheson, United States of America
  • Giuliano De Carolis, Italy
  • Mikael Von und zu Fraunberg, Finland
  • Bram A. Blomme, Belgium
  • Robyn Capobianco, United States of America
Presentation Number
EPV024
Presentation Topic
05a. Pain

Abstract

Introduction

We have previously presented one-year outcomes after burst spinal cord stimulation (SCS) in the prospective, multi-center, international TRIUMPH study (NCT03082261).1 These data showed improvements across all evaluated psychological measures with the largest impact observed on catastrophizing and depression (the affective component of pain processing). Herein we present data for the entire follow-up period, up to 24 months after permanent implant.

Methods/Materials

Eligible patients with chronic, intractable pain of the trunk and/or lower limbs were enrolled. After a successful trial period using burst stimulation, subjects received a permanent SCS implant and returned for regular follow-up at 6, 12, 18, and 24 months. Pain, psychometric, and global health measures were collected at baseline and all follow-up timepoints. Responder analyses were performed based on published clinical impact scores.

Results

24-month data were available for 128 subjects enrolled at 17 centers. A composite responder analysis2 showed 72% (92/128) of subjects improved across quality of life, pain intensity, physical function, and emotional well-being at 24 months. Individually, quality of life (EQ-5D index) increased from 0.46 to 0.66, in line with previous timepoints. Catastrophizing on PCS (12.4) remained below the population norm (13.9). 79% who were clinically catastrophizing (PCS ≥30) and 61% who were clinically depressed (PHQ9 ≥10) at baseline, were not at 24 months; within the range of previous timepoints. Patient reported pain relief was consistent across timepoints at 60-63%. The results obtained for patient satisfaction (range 80%-87%), proportion who reported at least a considerable change on PGIC (range 73%-79%), and proportion who were active (from 32% at baseline to 48%-63% at follow-up) were also maintained out to 2 years. Finally, 62% who were taking opioids at baseline decreased their intake at 24 months, including 27% who were completely off opioids; a further improvement compared with 6 and 12 months. The data collected for other pain medication followed a similar pattern with 38% (for antidepressants and muscle relaxants) and 46% (for analgesics, anticonvulsants, and NSAIDs) decreasing their intake at 24 months.

Discussion

24-month data were in line with all previous timepoints; subjects improve baseline to 6 months and consecutively remained at a similar level in terms of pain, quality-of-life, and psychological profile up to 2 years post-permanent implant. After 2 years of burst SCS, subjects were satisfied with the therapy, feeling better, getting more active, while taking less pain medication.

Conclusions

Burst SCS provides consistent long-term effective results on pain, quality-of-life, and emotional well-being.

References

1. Falowski SM, Moore GA, Cornidez EG et al. Improved Psychosocial and Functional Outcomes and Reduced Opioid Usage Following Burst Spinal Cord Stimulation. Neuromodulation 2021;24(3):581-590

2. Pilitsis JG, Marie Fahey M, Custozzo A et al. Composite Score Is a Better Reflection of Patient Response to Chronic Pain Therapy Compared with Pain Intensity Alone. Neuromodulation 2021;24(1):68-75

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