Coatesville

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.

Researchers are studying veterans who have both posttraumatic stress disorder PTSD and substance use disorders SUDs, as these combined conditions increase the risk of hypertension and cardiovascular diseases, often leading to premature death. The trial aims to compare the effects of Trauma Informed Heart Rate Variability Biofeedback T-HRVB with Present Centered Therapy PCT to see how each impacts symptoms and physiological outcomes in this high-risk group. This study addresses a gap by comparing these two active interventions among veterans engaged in residential PTSD programs at the Coatesville VA Medical Center. Participants will be randomly assigned to one of two groups the T-HRVB group, which receives six sessions of biofeedback combined with trauma-informed psychotherapy to improve autonomic nervous system regulation and coping skills or the PCT group, which receives six supportive psychotherapy sessions focused on stress reduction and psychoeducation. Both treatments involve active sessions designed to reduce PTSD and SUD symptoms, with T-HRVB emphasizing breathing techniques to increase heart rate variability while PCT serves as an active control. Veterans will attend visits before and after the treatment period for diagnostic interviews, questionnaires related to PTSD and SUD symptoms, and physiological assessments including heart rate, respiratory sinus arrhythmia, skin conductance, and PTSD symptom scales. The primary outcomes include changes in the Clinician Administered PTSD Scale for DSM-5 Revised and baseline physiological measures. The study monitors participants through the first and last week of treatment, with safety and symptom screening conducted throughout the process.