New Castle

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.

This research evaluates anonymous, previously collected medical data to review the outcomes of different treatment methods for chronic pain. The study is a retrospective review involving multiple centers and independent patient groups to compare results across various subgroups. The study examines clinical outcomes related to the use of spinal cord stimulation, radiofrequency (RF), and other implantable device systems from Boston Scientific and other manufacturers. Multiple cohorts will be analyzed based on the type of treatment system used. Participants' medical charts will be reviewed to measure response rates through approximately two years of follow-up. The study focuses on clinical results documented in patient records without any new treatment or intervention administered during the study.