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Found 3 Actively Recruiting clinical trials
Actively Recruiting
This research aims to evaluate the effects of integrating ear acupuncture with mindfulness therapy to reduce emotional distress and improve symptoms of post-traumatic stress disorder PTSD in military personnel and veterans. Emotional distress is a significant concern for service members due to the challenges faced during combat and peacetime. The study focuses on how these combined therapies might help alleviate emotional distress, sleep problems, pain, and alcohol use in this population. Participants will be randomly assigned to one of two groups one group will receive the National Acupuncture Detoxification Association NADA ear acupuncture protocol alongside weekly mindfulness therapy, while the other group will receive mindfulness therapy alone. The ear acupuncture involves inserting small, sterile semi-permanent needles into five specific points on both ears, which remain in place for 3 to 7 days. Mindfulness therapy sessions, lasting 30 minutes each, will be conducted weekly via the MS Teams platform. During the study, participants will be assessed using several measures including emotional distress, PTSD symptoms, insomnia severity, alcohol use, and pain levels at baseline, after 2 weeks, and after 4 weeks of intervention. The primary outcome is the change in emotional distress related to anger. Participants will engage in virtual mindfulness sessions and, if assigned, receive ear acupuncture treatment. The trial is expected to run until June 2028, with close monitoring of participant responses throughout the intervention period.
Actively Recruiting
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.
Actively Recruiting
Researchers are evaluating the effect and safety of using non-steroidal anti-inflammatory drugs NSAIDs alongside dextrose prolotherapy DPT injections in adults with knee osteoarthritis OA. This randomized, double-blinded, controlled trial involves men and women aged 45 to 75 with chronic knee OA, aiming to expand on earlier pilot study findings that suggested combining NSAIDs with DPT does not reduce treatment effectiveness and is safe. Participants will be randomly assigned to receive either ibuprofen or a placebo while undergoing three ultrasound-guided knee injections of 4 mL of 25% dextrose mixed with 1% lidocaine. These injections occur at baseline, week 4, and week 8, each accompanied by a 7-day supply of the assigned study drug. Participants are advised to avoid other pain medications and treatments during the study. During the 12-week study, participants will complete pain and function assessments using the Numeric Pain Rating Scale NPRS and Knee Injury and Osteoarthritis Outcome Score KOOS at weeks 0, 4, 8, and 12. Researchers will monitor changes in these scores to determine the impact of ibuprofen versus placebo combined with DPT. Safety and treatment adherence will be closely followed throughout the trial period.