Improved Pain and Psychosocial Function with Burst SCS: 1-Year Outcomes
Burst stimulation is a spinal cord stimulation (SCS) mode tha provides pain relief with less paresthesia compared to tonic stimulationa,b. This study aimed to evaluate stimulation preferences and pain relief after 1 year of therapy for patients using an SCS device capable of delivering both burst and tonic stimulation.
The PRODIGY I post-market clinical follow-up was a condition of approval study designed to evaluate safety and efficacy of burst stimulation (BurstDRTM) using a device delivering both stimulation modes (ProdigyTM, Abbott). At 21 sites in Europe and Australia, ethics committee approval was obtained, and subjects were enrolled prior to the SCS trial evaluation period. After permanent implant, subjects used burst stimulation for 12 weeks. After which, subjects were followed for 1 year post-permanent implant and were allowed to use any combination of burst and tonic programming based upon patient preferences. Assessments were performed at 3, 6, and 12 months after implant. Pain intensity was recorded on a visual analog scale (VAS) for overall pain. Subjects also reported satisfaction with the device, answered questions about device usage, and completed the EQ-5D and the Pain Catastrophizing Scale (PCS). Programming information was collected at each study visit.