350 Surgical Treatment of Refractory Low Back Pain Using BurstDR Capable Spinal Cord Stimulation (SCS) in Patients Without Options for Corrective Surgery; 12-month Results From a Paddle Lead Cohort

Abstract

INTRODUCTION: DISTINCT is a randomized controlled trial evaluating passive recharge burst SCS compared to CMM in improving pain and pain-related physical function in patients suffering from chronic back pain without prior lumbar surgery, and for whom corrective surgery is not an option. Sub analysis of outcome measures are presented for subjects implanted with paddle leads at both 6 and 12 months. METHODS: An independent board-certified spine surgeon reviewed each case confirming a lack of corrective surgical options. Out of 29 sites and 115 implants, 10 sites implanted 50 subjects with paddle leads. Primary and secondary endpoints assessed improvements in low back pain intensity (NRS), low back pain-related disability (ODI), pain catastrophizing (PCS), and patient global impression of change (PGIC). RESULTS: Data are available for 47 and 44 subjects at 6 and 12 months respectively. Subjects reported significant reductions in pain relief at 6 and 12 months, decreasing from 7.8 ± 1.2 at baseline to 2.0 ± 1.6 and 2.2 ± 2.2 respectively (p < 0.0001). Disability was substantially (< 20 points) reduced from severe to mild at 6 and 12 months; ODI reduced from 54.4 ± 15.0 at baseline to 19.9 ± 14.1 and 22.1 ± 13.6 respectively (p < 0.0001). Pain catastrophizing improved to reflect the average of a non-chronic pain population; decreased from 27.6 ± 13.1 at baseline to 8.1 ± 8.2 and 7.8 ± 9.9 (p < 0.0001). 76% report definite and meaningful improvements on PGIC. One lead related event was reported and resolved by repositioning CONCLUSIONS: Passive recharge bursts using paddle leads provide substantial relief to patients suffering from severe, debilitating, NSLBP. Patients report dramatic improvements in pain, function, and pain-related emotional distress. In addition, the rate of adverse events is low supporting a favorable safety profile.