Study of 60-day Peripheral Nerve Stimulation PNS for Pain Relief and Function Improvement in Women with Recent Thoracolumbar Spine Compression Fractures

What this Trial Is About

Researchers are evaluating outcomes in female patients with acute thoracolumbar compression fractures, focusing on how pain is managed and how well patients can function after injury. This observational study tracks patients whose fractures occurred within the last 3 months or less. The study aims to measure pain levels using the Numeric Rating Scale NRS and Brief Pain Inventory BPI, and quality of life through the PROMIS questionnaire at multiple time points before and after intervention. Participants will receive treatment using the commercially available SPRINT Peripheral Nerve Stimulation PNS system for 60 days. Pain and quality of life will be assessed prior to the intervention, then again at 2 weeks, 3 months, and 6 months after PNS implantation. The primary focus is on pain reduction, while secondary outcomes include improvements in function and quality of life as reported by participants through digital data collection. During the study, participants will complete assessments of pain and function at specified intervals. These include questionnaires like the PROMIS and patient-reported outcome measures collected via CareSense, a digital system. Researchers will monitor changes in pain scores and quality of life over time. The total participation includes assessments up to 6 months following the nerve stimulation treatment, allowing for observation of both short- and longer-term effects.

Effect of 60-day Peripheral Nerve Stimulation (PNS) in Alleviating Pain and Improving Function After Acute Thoracolumbar Compression Fracture