Fairfield

This research aims to evaluate how combining ear acupuncture with mindfulness therapy affects emotional distress and post-traumatic stress disorder (PTSD) symptoms in military personnel and veterans. Emotional distress significantly impacts well-being and is common among those in military settings due to their unique challenges. The study focuses on service members and veterans experiencing PTSD and emotional distress, exploring the potential benefits of these complementary therapies. Participants will receive a one-time bilateral ear acupuncture treatment following the National Acupuncture Detoxification Association (NADA) protocol, where sterile, semi-permanent needles are placed at five points on each ear and remain until they naturally fall out within 3 to 7 days. Alongside this, participants will take part in weekly 30-minute virtual mindfulness therapy sessions via the MS Teams platform, which include relaxation techniques like yoga and controlled breathing. During the study, emotional distress will be measured using the Patient-Reported Outcomes Measurement Information System Emotional Distress - Anger Short Form 8a at baseline, post 2-week intervention, and post 4-week intervention. Researchers will assess the effectiveness of these treatments in reducing emotional distress and improving related symptoms such as sleep problems, alcohol use, and pain. Participants must be active duty service members or veterans, and their involvement includes consenting to mindfulness therapy and completing questionnaires.

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.

Researchers are investigating the effect and safety of using non-steroidal anti-inflammatory drugs (NSAIDs), specifically ibuprofen, alongside dextrose prolotherapy (DPT) injections in adults with knee osteoarthritis (OA). This Phase 2, double-blinded, randomized controlled trial builds on a pilot study that suggested combining NSAIDs with DPT is safe and effective. The study includes men and women aged 45 to 75 years who have chronic, symptomatic knee OA and meet specific clinical and radiographic criteria. Participants are randomly assigned to receive either ibuprofen 400 mg or a placebo to take for 7 days starting on the day they get a DPT injection. The DPT treatment consists of three injections of 4 mL of 25% dextrose mixed with 1% lidocaine into the knee under ultrasound guidance, administered at 0, 4, and 8 weeks (plus or minus 1 week). Along with injections, participants take the assigned study drug at each treatment time point. They are advised to avoid other oral pain medications or knee treatments during the study. Participants complete assessments of pain and knee function using the Numeric Pain Rating Scale (NPRS) and the Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaires at baseline, 4, 8, and 12 weeks. The study will measure changes in these scores to evaluate the effects of ibuprofen versus placebo combined with DPT injections. Total study participation lasts 12 weeks, during which safety and treatment outcomes are closely monitored.