346 Durable Responses at 24 Months With High-Frequency Spinal Cord Stimulation for Nonsurgical Refractory Back Pain

Abstract

INTRODUCTION: Chronic refractory back pain causes significant disability and is one of the most common reasons for patients seeking health care. Few treatment options exist for chronic back pain patients who have failed conventional medical management (CMM) and who have not had and are not candidates for spine surgery, a condition we refer to as non-surgical refractory back pain (NSRBP). METHODS: Patients with NSRBP were evaluated after 1:1 randomization to 10kHz SCS plus CMM or CMM alone. Primary endpoint and secondary endpoints were assessed, and optional crossover was allowed at 6 months, with observational follow-up over 12 months (Kapural, 2022). All patients treated with 10kHz SCS were eligible for follow-up through 24 months after implantation. Outcomes included pain, Oswestry Disability Index (ODI), quality-of-life (EQ-5D-5L), 3-item Pain Sleep Questionnaire (PSQ-3), opioid use, patient’s global impression of change (PGIC), and safety. RESULTS: Of the 125 patients who received a permanent implant, 121 completed 12-month follow-up, 101 reconsented for extended follow-up, and 98 completed 24-month follow-up. At 24 months after implantation 82% achieved =50% pain relief. All outcome measures improved by at least double the minimal clinically important difference. Ninety-percent of patients met at least one of the multidimensional outcomes. Of those who reported opioid use during the study, and 62% of decreased or stopped. Through 24 months, 3 of 125 (2.4%) devices were explanted due to patient dissatisfaction with SCS therapy. CONCLUSIONS: The addition of 10kHz SCS to CMM in patients with NSRBP offers profound improvements at 24 months in pain, function, quality-of-life, and reduced opioid use. This study provides much-needed evidence to inform current clinical practice for managing patients with NSRBP.