Milwaukie

Researchers are evaluating surgical and minimally invasive treatments for lumbar spinal stenosis (LSS) by comparing Medicare patients who received the MILD procedure against those who had interspinous process decompression (IPD). The study focuses on outcomes such as the rate of harms related to the initial procedure and the frequency of additional surgical or minimally invasive interventions within 24 months after treatment. Enrollment includes patients treated from January 1, 2017, onward, with continuation until the sponsor decides to stop. The MILD procedure involves percutaneous image-guided lumbar decompression, performed under fluoroscopy through a dorsal approach to partially remove tissue and bone at the affected spinal level. The control group receives the IPD procedure for LSS. Both groups are monitored for a 24-month period post-index procedure using Medicare claims data to track reoperations and any harms. Participants contribute data through Medicare claims without needing prior enrollment or consent, as the study is exempt from IRB oversight. Researchers collect and analyze information on procedure-related harms and subsequent interventions over two years. This approach allows evaluation of long-term safety and effectiveness outcomes for patients treated with either MILD or IPD.

Researchers are evaluating the real-world experience of Nevro's Spinal Cord Stimulation (SCS) therapy in patients with chronic, hard-to-treat leg pain caused by painful diabetic neuropathy (PDN). This multicenter, prospective, observational global study involves collaboration between diabetes management teams and pain physicians to offer an interdisciplinary treatment plan for PDN patients. The study aims to assess outcomes using standardized measures to better understand the therapy's effects in everyday clinical practice. The treatment being studied is the Spinal Cord Stimulation system, an approved device designed to manage chronic pain in the limbs or legs. It delivers electrical stimulation through implantable leads connected to a rechargeable pulse generator placed under the skin. Patients receive this SCS therapy, which includes a 10 kHz stimulation component, as part of their pain management regimen. Participants will be involved in scheduled visits where their pain levels and quality of life will be assessed using various tools, including patient-reported pain relief and health status measures. Researchers will monitor leg pain, overall pain relief, quality of life, and global impressions of health changes over a 12-month period. Trial success and responder rates will also be evaluated after 2 weeks to understand short-term treatment effects.