Jasper

Researchers are evaluating the potential benefits and risks of active sub-threshold wireless neuromodulation stimulation for treating chronic knee pain caused by osteoarthritis. This trial aims to compare active stimulation versus no stimulation sham in reducing pain, with the primary goal of measuring the number of participants who experience at least a 50% decrease in pain on a visual analog scale after one month. Participants first undergo a diagnostic injection to confirm temporary pain relief before receiving a 7-day trial implant of the stimulation device near the target nerve. Those reporting more than 50% pain relief during this test proceed to receive a permanent implant under sedation. After a healing period of 10 days, participants are randomized to receive either active sub-threshold stimulation or sham stimulation for 30 days while both participants and staff remain unaware of group assignments. Stimulation programs include various high-frequency options. Throughout the study, participants attend in-person visits at 1 week, 1 month, 3 months, and 6 months post-randomization for physical exams, pain scales, knee function assessments, range of motion, work status, and medication use. Additional phone follow-ups are conducted at 12, 18, and 24 months to assess long-term pain relief and any adverse events. The study collects multiple outcome measures to evaluate the treatments impact on pain and physical function over time.

Researchers are evaluating the safety and effectiveness of the ReGelTec HYDRAFIL System for adults with axial chronic low back pain caused by degenerative disc disease DDD. This study focuses on participants who continue to experience severe back pain and dysfunction after at least six months of non-surgical conservative care. The trial is a multicenter, prospective, dual-arm, randomized controlled pivotal study designed to provide important data on this treatment device. Participants are divided into two groups one group receives continued conservative medical management plus a percutaneous hydrogel spinal implant delivered by the HYDRAFIL System, while the other group continues conservative care with a sham procedure involving needle insertion without implant delivery. After 24 months, participants in the control group may crossover to receive the hydrogel implant if they qualify. The study involves delivering an injectable hydrogel implant to the lumbar discs to address degeneration. During the study, participants will be monitored regularly and assessed for clinical success, including symptom improvement over a 12-month period. Evaluations will include imaging and clinical assessments to measure outcomes. Participants must comply with follow-up schedules and complete required forms. The total study duration extends through 2028, allowing long-term observation of safety and effectiveness.

Researchers are compiling real-world outcomes of the commercially approved Intracept2 Intraosseous Nerve Ablation Systems for treating patients diagnosed with vertebrogenic pain, including those with chronic low-back pain and vertebrogenic pain syndrome. This observational study aims to gather data on how this minimally invasive device performs in routine clinical use. Participants who are scheduled for treatment with the Intracept2 Intraosseous Nerve Ablation System will be observed following their procedure according to local instructions. The study focuses on patients receiving this commercially approved device without altering their treatment plan. Throughout the study, participants will have their disability levels assessed using the Oswestry Disability Index ODI from baseline up to 60 months after the procedure. Data collected will help understand the long-term effects of the device on pain and disability. The total duration of participation may extend up to five years post-treatment.

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.