Shrewsbury

Researchers are evaluating the safety and effectiveness of VIA Disc NP, a non-surgical treatment designed to supplement damaged nucleus pulposus tissue in people with lumbar discogenic pain linked to degenerative disc disease (DDD). This randomized, sham-controlled, multi-center, double-blind clinical trial includes an open-label roll-in period with one participant per site. The study focuses on adults aged 22 to 85 years who have moderate to severe DDD and chronic low-back pain that has not improved with conservative care. Participants will receive one VIA Disc NP treatment per affected disc level, up to two levels. Those enrolled after the roll-in phase will be randomly assigned in a 2:1 ratio to either the VIA Disc NP intradiscal injection or a sham procedure that mimics the injection without penetrating the disc. Participants in the sham group who continue to experience symptoms after 12 months may cross over to receive VIA Disc NP and will follow an additional 12 months of study visits. During the study, participants will undergo assessments including pain severity and disability scores, physical tests, and imaging to monitor the treatment's effects and safety. Researchers will track the proportion of participants achieving meaningful pain improvement and report any treatment-related adverse events over 12 months. Those crossing over will be monitored for an additional year, ensuring close safety follow-up and evaluation of long-term outcomes.

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 exploring patient experiences with phrenic nerve reconstructive surgery as a treatment for diaphragmatic paralysis. This study uses a grounded theory approach to understand how this surgery affects patients, including their reported outcomes and the biopsychosocial aspects of surgical evaluation. Participants are individuals diagnosed with diaphragmatic paralysis who are scheduled to have phrenic nerve reconstructive surgery. The study focuses on gathering detailed patient feedback through interviews conducted before and after the surgery. Participants will be interviewed one week before and again 12 months after their surgery to share their experiences and outcomes. These semi-structured interviews help researchers learn about the surgery's impact on symptoms like chest pain and shortness of breath, as well as overall well-being.