Westcliffe

Researchers are evaluating the effectiveness of the Time Varied Pulse TVP-SCS settings delivered through commercially approved Boston Scientific WaveWriter Alpha Spinal Cord Stimulation SCS Systems in patients experiencing chronic, intractable low back andor leg pain. This study aims to collect real-world clinical outcomes in individuals with persistent spinal pain syndrome or failed back surgery syndrome to better understand pain management using these devices. Participants will receive the TVP-SCS settings using the Boston Scientific WaveWriter Alpha SCS Systems according to local instructions for use. The study involves a single group of participants who will be treated with this device. The treatment is delivered through the device settings designed to adjust electrical stimulation parameters independently to manage chronic pain. Throughout the study, participants will be monitored up to three months post-activation to assess the primary outcome, which is the Targeted Pain Responder Rate. Participants will complete questionnaires and assessments in English to evaluate their pain levels and response to the treatment. Safety and effectiveness data will be collected during this period to understand the impact of the TVP-SCS settings on chronic pain management.

Researchers are comparing the rates of surgical and minimally invasive interventions, as well as any harms, in Medicare beneficiaries treated with the MILD procedure versus those treated with interspinous process decompression IPD for lumbar spinal stenosis with neurogenic claudication. This observational study uses Medicare claims data to follow patients for 24 months after their initial procedure starting from January 1, 2017. The purpose is to evaluate outcomes between these two types of procedures without requiring prior patient enrollment or consent. The study includes two groups patients who received MILD, which is a percutaneous image-guided lumbar decompression performed under fluoroscopic guidance through a dorsal approach to the spine, and patients who received IPD, a different device-based decompression procedure. Data on reoperations and complications will be collected for both groups over a 24-month follow-up period using Medicare claims. Enrollment continues until the sponsor decides to stop. Participants involvement is passive as the study uses existing Medicare claims data. Researchers will monitor rates of harms related to the initial procedure and subsequent surgical or minimally invasive interventions over two years. No direct patient visits or interventions are conducted, and the study is exempt from institutional review board oversight. The total study duration extends to December 2026, covering cases treated since early 2017.