33. Multidimensional outcomes of spinal cord simulation in patients with chronic pain: results from a European prospective multicenter observational study

Abstract

Background: Spinal cord stimulation (SCS) has been used since the late 1960s and is a safe and effective non-opioid therapeutic alternative to manage chronic pain patients. Over the past few years, SCS devices have been equipped to provide for an array of neuromodulation modalities thereby enabling the precise optimization of treatment on a personalized basis. Here we assessed real-world outcomes from a subset of patients as derived from a European multicentre prospective study and report the effects of SCS therapy in multiple dimensions. Method(s): RELIEF (clinicaltrials.gov identifier: NCT01719055) is a global multicentre prospective single-arm observational study designed to collect real-world data for neurostimulation systems utilized for chronic pain indications by patients within standard of care clinical practice. A sub-set of patients who have been treated in European centres were analysed. Study assessments include quality of life (EQ5D), disability (ODI/PDI), Global impression of change (P-GIC/C-GIC), percentage of pain relief (PPR), satisfaction with treatment (patient/clinician), and resource utilization inventory. Result(s): To date, over 200 enrolled patients have been implanted. In those patients who reached their 6- and 12-month follow-up visits, substantial improvements have been recorded for various patient-reported outcome measures (PROMs). At 6-month and 12-month evaluation visits, patients' function improved by over 30% per Oswestry Disability Index (ODI), and substantial improvement in quality of life measures have been reported (EQ5D). Patient Global impression of change evaluations at 6- and 12-month follow-up visits show that more than 85% patients reported improvement. The RELIEF study is ongoing and these preliminary results will be updated. Conclusion(s): This ongoing prospective evaluation of real-world outcomes shows that spinal cord stimulation using personalized therapies may provide substantial improvements in multiple domains such as quality of life, function, percent pain relief and global impression of change. Measuring the outcomes of SCS therapy via multidimensional assessments is valuable, so that the overall impact of the treatment on patients' daily life and global health is taken into account and measured. Copyright © 2025