22nd Annual Pain Medicine Meeting 2023

DTM SCS has been shown to be superior for the treatment of neuropathic chronic low back pain (CLBP) in patients with persistent spinal pain syndrome type 2 (PSPS-T2). In contrast, options for the treatment of CLBP in PSPS-T1 not eligible for spine surgery, with degenerative disc disease, herniated disc, or radiculopathy are limited. A European RCT (ISRCTN10663814) studying the effect of DTM SCS vs conventional medical management (CMM) in the treatment of CLBP in these patients reported primary endpoint results that were consistent with those reported in the RCT for PSPS-T2 patients. The current work presents a RCT that evaluated, for the first time, the efficacy of DTM SCS versus Conventional SCS (Conv-SCS) on PSPS-T1 patients with chronic LBP who are not candidates for spine surgery across the USA.

Design

Prospective Post-Market, Multi Center, Randomized Controlled

•On-label subjects indicated for SCS: CLBP and Leg Pain

•Randomized (1:1) across 20 US Sites

•DTM™ SCS vs Conv-SCS

•Option to crossover at 6-month

Primary endpoint

•Responder rate (≥ 50% CLBP relief) at 3-months

Analysis population

•mITT: subjects completing Trial Phase

•PP: subjects implanted completing visits

This RCT demonstrated the long-term superior efficacy of DTM SCS relative to Conv-SCS for treating neuropathic CLBP in PSPS-T1 patients who were not eligible for spine surgery. Significant clinical improvements in functional disability and quality of life provided by DTM SCS were sustained over the study period. The results of this RCT indicate that DTM SCS provides significant benefits on the management of PSPS-T1 patients who are not eligible for spine surgery, including those who were not treated satisfactorily by Conv-SCS.

22nd Annual Pain Medicine Meeting 2023

DTM™ SCS FOR INDICATED CHRONIC BACK PAIN PATIENTS REFRACTORY TO SPINE SURGERY: US RCT OUTCOMES

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