Pasadena

Researchers are evaluating a home-based treatment called Computerized Chemosensory-Based Orbitofrontal Networks Training for Pain (CBOT-P) for adults with chronic low back pain. This Phase II randomized clinical trial compares the effects of CBOT-P, which includes beta-caryophyllene, to a sham version without the active ingredient. The study aims to assess the short- and long-term impact on pain severity, negative mood, cognitive function, and brain structure, particularly focusing on preventing shrinkage in brain regions related to pain and emotion regulation. Participants will be randomly assigned to use either the active CBOT-P device or a sham device daily for six months. The treatment involves controlled olfactory stimuli designed to modulate brain areas involved in pain and mood. Magnetic resonance imaging (MRI) scans will be done at the start and after six months to observe brain changes. Assessments of pain, mood, cognition, and physical function will take place at baseline, and at 1, 3, and 6 months during the treatment period. Throughout the study, participants will be encouraged to regularly report their pain, mood, sleep, and functional status via mobile health prompts. The primary outcomes measured include changes in pain intensity and negative affect using standardized rating scales, along with brain volume measurements from MRI. Safety and user experience will also be monitored to support future product development and potential regulatory approval.

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.