Burst Spinal Cord Stimulation (Burst-SCS) Study

The study was terminated early following the identification of data quality concerns and protocol integrity issues, specifically related to inadequate sham stimulation parameters and compromised participant blinding. Results reporting was significantly delayed due to research-related pauses during the COVID-19 pandemic. Although there were initial plans to resume enrollment and study procedures once feasible, a comprehensive review of the study data identified the protocol integrity concerns, leading to the decision to terminate the study.