Shrewsbury

This research investigates the safety and effectiveness of VIA Disc NP, a non-surgical treatment designed to supplement nucleus pulposus tissue in people experiencing lumbar discogenic pain due to degenerative disc disease DDD. The study is a randomized, sham-controlled, double-blind trial conducted across multiple centers, including an initial open-label roll-in phase for one participant per site. It focuses on adults aged 22 to 85 years with moderate to severe disc degeneration confirmed by MRI and persistent low-back pain unresponsive to conservative care. Participants receive a single intradiscal injection of VIA Disc NP, which is made from processed cadaveric disc tissue, at up to two affected lumbar levels L1-S1. Participants who enroll after the roll-in phase are randomly assigned in a 21 ratio to receive either the VIA Disc NP injection or a sham procedure where a needle is inserted but no injection is given. Those initially assigned to the sham group who continue to have symptoms after 12 months may cross over to receive VIA Disc NP and undergo an additional 12 months of follow-up. During the study, participants will be monitored through assessments including pain severity using the Visual Analog Scale VAS and safety evaluations for any treatment-related adverse events over a 12-month period. The primary outcomes measure the proportion of participants achieving meaningful improvement in pain scores and the incidence of treatment-related side effects. The study duration includes screening, treatment, and follow-up visits, with careful tracking of participants symptoms and safety throughout the trial.

Researchers are evaluating the intravenous drug neridronate AMBTX-01 for treating adults with the warm subtype of Complex Regional Pain Syndrome Type 1 CRPS-1. This phase 3, multicenter, randomized, triple-blind, placebo-controlled trial aims to assess the efficacy, safety, and tolerability of neridronate 400 mg in participants who have a positive triple phase bone scan. The study is sponsored by Ambros Therapeutics, Inc. and focuses on improving pain and related symptoms in affected limbs. Participants will receive either 400 mg of neridronate or a placebo through intravenous infusion on Days 1, 4, 7, and 10. The trial includes a screening period lasting 2 to 6 weeks to confirm eligibility, followed by the four treatment infusions, and then a post-treatment follow-up period lasting through Week 12. The treatment and follow-up phases will monitor changes in pain and CRPS symptoms over time. During the study, participants will undergo various assessments including pain intensity measurements, CRPS severity scoring, physical functioning surveys, and global impressions of change. These evaluations occur at multiple timepoints including baseline, Days 4, 7, 10, and Weeks 3, 6, 9, and 12. Researchers will track medication use, limb temperature, edema, and sleep interference among other outcomes. The total participation duration is approximately up to 18 weeks, ensuring thorough monitoring of treatment effects and safety.

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 exploring patient experiences with phrenic nerve reconstructive surgery as a treatment for diaphragmatic paralysis. This study uses a grounded theory approach to understand the biopsychosocial aspects of surgical evaluation and outcomes. It focuses on how patients perceive and report their outcomes following this specific surgery. Participants in this observational study undergo phrenic nerve reconstructive surgery to treat diaphragmatic paralysis. The study does not involve additional treatments or interventions beyond the scheduled surgery. The evaluation centers on the surgerys impact from the patients perspectives before and after the procedure. Participants will be interviewed one week before and again 12 months after surgery using semi-structured interviews. These interviews aim to collect detailed information about their experiences and outcomes related to the surgery. The study follows participants for a full year after surgery to understand long-term effects and patient-reported outcomes.