Westcliffe

Researchers are investigating the effectiveness and safety of a single injection of rexlemestrocel-L combined with hyaluronic acid (HA) in adults with moderate to severe chronic low back pain due to degenerative disc disease. This Phase 3 study aims to compare this treatment to a control to see if it reduces low back pain at 12 months after treatment, while also monitoring safety outcomes up to 24 months. Participants will receive either an injection of a mixture of rexlemestrocel-L and HA directly into the lumbar intervertebral disc or a saline injection near the affected disc. The rexlemestrocel-L and HA are mixed in equal volumes and administered as an intradiscal injection. The study is randomized, double-blind, and controlled to ensure unbiased assessment of treatment effects. During the study, participants will be monitored for changes in their average daily low back pain using a visual analog scale from baseline to 12 months after treatment. Researchers will also record any adverse events or serious adverse events occurring up to 24 months post-treatment. Participants will undergo regular evaluations, including clinical assessments, to track pain levels and safety throughout the study period.

Researchers are evaluating the effectiveness of time variant pulse (TVP) spinal cord stimulation (SCS) in patients who suffer from chronic and intractable pain, including low back and leg pain. The study aims to gather real-world clinical outcomes using commercially approved Boston Scientific SCS systems following local instructions for use. It focuses on adults diagnosed with persistent spinal pain syndrome or failed back surgery syndrome who have experienced chronic trunk and/or limb pain for at least six months. The study uses the Boston Scientific WaveWriter Alpha194; SCS system with time varied pulse settings as the primary intervention. This device is designed to manage pain through optimized sequences by adjusting parameters with independent current control. Participants will have the device activated and monitored, though specific dosing or schedule details are not provided. Participants will be involved in assessments including questionnaires and other evaluations to track their pain response to the device. The primary outcome measured is the targeted pain responder rate three months after device activation. Safety and efficacy data will be collected to understand the impact of the treatment on chronic pain. The total study duration and additional follow-up details are not specified.

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.