Loveland

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 investigating the long-term safety and effectiveness of Abbotts neurostimulation systems in people with chronic pain. This observational study includes a wide range of participants to reflect real-world use and aims to enroll up to 2,000 subjects across up to 100 centers. The study spans 13 years, covering enrollment, data collection, and study closure, with subjects followed for five years after implantation. Participants will receive one of Abbotts market-released neurostimulation devices, either spinal cord stimulation SCS or dorsal root ganglion stimulation DRG. Individuals scheduled for implantation within 60 days of baseline are eligible. The study is single-arm and open-label, meaning all participants receive the device without randomization or placebo control. During the study, researchers will monitor adverse events, deaths, and device issues at multiple time points from baseline through five years post-implant. Participants will undergo regular safety assessments and provide data on device performance and related outcomes. This comprehensive follow-up will help understand the long-term effects and real-world use of these neurostimulation systems.

Researchers are evaluating the effectiveness and safety of the Aurora Spine ZIP MIS Interspinous Fusion System combined with bone graft material in adults with chronic low back pain caused by degenerative disc disease and neurogenic claudication. This condition involves deterioration in the spine that can cause pain and difficulty walking. The study aims to provide insight into this device as a treatment option compared to existing therapies. The study uses the Aurora Spine ZIP device, a bilateral locking plate system that attaches to the spinous processes in the lower spine from T1 to S1 through a minimally invasive interlaminar approach. The device includes articulations and a central chamber for bone graft material to support fusion at a single spinal level. Participants have already tried at least three months of non-operative treatments before receiving this implant. During the study, participants will be monitored for improvements in pain and function at 3 and 12 months after the procedure. Researchers will collect data on pain relief using the Visual Analog Scale VAS, physical function scores, patient global impression of change, imaging outcomes, and complication rates. The study involves multiple centers and follows participants over time to assess real-world effectiveness and safety of this fusion device.