Radicular upper limb pain (ULP) is a common chronic condition. Although conventional paresthesia-based spinal cord stimulation (SCS) could be a suitable treatment when conventional medical management of ULP fails, its clinical implementation has been limited due to the possible occurrence of uncomfortable paresthesia triggered by neck motion. Differential target multiplexed SCS (DTMTM SCS) has proven successful for the treatment of low back and lower limb pain. This study evaluated, during a 12-month follow up period, the safety and efficacy of DTM SCS in subjects with chronic ULP.

Design

Post-market, prospective, cohort, multicenter study. On-label subjects indicated for SCS: Upper Limb Pain (ULP)

Primary endpoint: Responder rate (>= 50% ULP relief) at 3-months

Other Outcomes: ULP VAS, extent of functional disability , PGIC, satisfaction, frequency of study-related AEs

Analysis populations

PP: subjects implanted who completed visits

DTM SCS provided sustained ULP responder rates above 86%. DTM SCS also provided pain relief above 78%. Pain outcomes corresponded to improvement in disability of 30 points (PDI), as well as >90% of patients feeling improved and satisfied with DTM SCS. Results imply that DTM SCS is a safe, feasible and sustainable treatment for chronic intractable ULP.