Comparing Active and Passive Recharge Burst Spinal Cord Stimulation for Pain Relief in Persistent Spinal Pain Syndrome Type 2 A Multicenter Randomized Study

What this Trial Is About

Researchers are evaluating the effects of two types of burst spinal cord stimulation SCS on pain relief and emotional aspects of pain in patients with Persistent Spinal Pain Syndrome Type 2 PSPS Type 2, also known as Failed Back Surgery Syndrome. The trial compares active recharge burst SCS versus passive recharge burst SCS, as no prior clinical studies have directly compared these two waveform methods. This randomized clinical trial aims to improve understanding of how different burst waveforms influence pain experience. The trial enrolls 96 patients across six Dutch hospitals who are randomly assigned to receive either active recharge or passive recharge burst SCS. After a successful trial period, patients will be permanently implanted with the assigned device. Active recharge burst uses negative pulses to directly compensate for charge differences, while passive recharge burst passively compensates for charge differences. Treatments are assessed over 12 months following implantation. Participants will complete various assessments including the Pain Catastrophizing Scale PCS at 6 months as the primary outcome. Secondary measures include pain ratings, patient vigilance, anxiety and depression scales, quality of life, disability index, patient global impression of change, and painDETECT questionnaires at baseline, after trial, and at 1, 3, 6, and 12 months post-implantation. The study monitors device usage and collects patient-reported outcomes to evaluate differences in pain relief and emotional response.

Effects of Active Versus Passive Recharge Burst Spinal Cord Stimulation on Pain Experience in Persistent Spinal Pain Syndrome Type 2: a Multicenter Randomized Trial (BURST-RAP Study)