Rockwall

Researchers are evaluating a treatment called cryoneurolysis to reduce pain and opioid use after reverse total shoulder arthroplasty (RTSA), a surgery for degenerative joint disease of the shoulder. This randomized pilot trial compares patients who receive cryoneurolysis of the suprascapular nerve before surgery to those who do not, aiming to assess if the treatment lowers opioid consumption and improves pain and shoulder function. Participants will be randomly assigned to either receive cryoneurolysis of the suprascapular nerve before their RTSA or to a control group that does not receive this intervention. Cryoneurolysis uses cold to temporarily block nerve signals and is performed pre-operatively. The study will monitor patients over a 90-day post-operative period to evaluate outcomes. During the study, participants will have their opioid use measured in morphine milligram equivalents to assess pain control. Researchers will also evaluate pain levels using a Pain Assessment Documentation Tool, shoulder range of motion, and patient-reported outcome scores with the American Shoulder and Elbow Surgeons shoulder score. Safety and feasibility of the treatment will be monitored throughout the 90-day follow-up period.

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 conducting a global, multi-center, prospective post-market study to observe the long-term effectiveness of Boston Scientific neurostimulation systems in managing pain. The study aims to gather real-world clinical outcomes, economic value, and technical performance data of these commercially approved neurostimulation devices when used in routine clinical practice. The treatment involves an initial trial period using a Boston Scientific neurostimulation device for pain relief. Participants who experience a positive response during the trial may proceed to receive a permanent implant of the neurostimulation system. The therapy is tailored individually based on the investigator's judgment and standard care practices at each study site, following specific inclusion and exclusion criteria. Participants will be monitored throughout the trial and permanent implant phases to assess pain relief and overall treatment effectiveness. Assessments may include patient evaluations of pain and ability to complete study requirements. The study focuses on capturing comprehensive data to evaluate both clinical outcomes and device performance during regular use. Total participation duration depends on individual treatment progression from trial to permanent implant.