15 Clinical Trials for Various Conditions
Spinal surgeries are generally associated with intense pain in the postoperative period, especially for the initial few days. The aim of this study is to examine the effect of intraoperative intravenous acetaminophen in spine surgery on postoperative analgesic requirements, pain scores, patient satisfaction, and clinical recovery. Enrolled patients are randomized to receive either intravenous acetaminophen or placebo at the time of surgical closure. It is hypothesized that patients receiving intravenous acetaminophen will have improved pain scores, require less opiate medication, and have better patient satisfaction than those receiving placebo.
This project tests the feasibility a single session pain psychology class (TREK for Surgical Success) for patients undergoing spine surgery and compares outcomes in those who engage in the class to a historical group of similar patients undergoing usual care perioperatively. As of January 2020, the class option has been updated to include an online video module platform, to be used for patients unable to attend in person.
The goal of this clinical trial is to test in the effects of pain pressure threshold (PPT) looking out to 30 minutes in the lumbar spine. The main question\[s\] it aims to answer are: • Is there a difference between PPT from baseline, immediately after, or 30 minutes after compared to sham ultrasound control group? Participants will be exposed to sham ultrasound or sidelying lumbar manipulation with between groups and within group comparisons of PPT at the posterior superior iliac spine up to 30 minutes following the intervention.
A novel prehabilitation method has been implemented at our institution to decrease perioperative outcome complications for frail complex spine fusion surgery patients. The goal of this randomized trial is to evaluate whether this prehabilitation program improves preoperative functional status of frail spine disease patients and benefits patients in their postsurgical outcomes.
The purpose of this study is to determine whether administration of a non-centrally acting muscle relaxants will improve the Overall Benefit of Analgesia Score (OBAS), and Richmond Agitation Sedation Scale (RASS) scores in patients undergoing lumbar fusion.
The purpose of this study, entitled "Delivering Transcutaneous Auricular Neurostimulation as an Adjunct Non-Opioid Pain Management Therapy for Patients Undergoing Lumbar Fusion Surgery", is to demonstrate whether transcutaneous auricular neurostimulation (tAN) can non-invasively reduce the perception of pain in patients undergoing lumbar fusion surgery. tAN is placed on and around the ear to non-invasively stimulate branches of the vagus and trigeminal nerves and modulate specific brain regions associated with pain.
Unrecognized abdominal and pelvic injuries can result in catastrophic disability and death. Sporadic reports of "occult" injuries have generated concern, and physicians, fearing that they may miss such an injury, have adopted the practice of obtaining computed tomography on virtually all patients with significant blunt trauma. This practice exposes large numbers patients to dangerous radiation at considerable expense, while detecting injuries in a small minority of cases. Existing data suggest that a limited number of criteria can reliably identify blunt injury victims who have "no risk" of abdominal or pelvic injuries, and hence no need for computed tomography (CT), without misidentifying any injured patient. It is estimated that nationwide implementation of such criteria could result in an annual reduction in radiographic charges of $75 million, and a significant decrease in radiation exposure and radiation induced malignancies. This study seeks to determine whether "low risk" criteria can reliably identify patients who have sustained significant abdominal or pelvic injuries and safely decrease CT imaging of blunt trauma patients. This goal will be accomplished in the following manner: All blunt trauma victims undergoing computed tomography of the abdomen/pelvis in the emergency department will undergo routine clinical evaluations prior to radiographic imaging. Based on these examinations, the presence or absence of specific clinical findings (i.e. abdominal/pelvic/flank pain, abdominal/pelvic/flank tenderness, bruising abrasions, distention, hip pain, hematuria, hypotension, tachycardia, low or falling hematocrit, intoxication, altered sensorium, distracting injury, positive FAST imaging, dangerous mechanism, abnormal x-ray imaging) will be recorded for each patient, as will the presence or absence of abdominal or pelvic injuries. The clinical findings will serve as potential imaging criteria. At the completion of the derivation portion of the study the criteria will be examined to find a subset that predicts injury with high sensitivity, while simultaneously excluding injury, and hence the need for imaging, in the remaining patients. These criteria will then be confirmed in a separate validation phase of the study. The criteria will be considered to be reliable if the lower statistical confidence limit for the measured sensitivity exceeds 98.0%. Potential reductions in CT imaging will be estimated by determining the proportion of "low-risk" patients that do not have significant abdominal or pelvic injuries.
Postoperative drain placement is often used following spine surgery. These drains are placed with the intention to decrease the incidence of postoperative hematoma and its associated complications including wound complications, infections and neurologic compression. The use of drains, however, are not without its disadvantages including the risk of retrograde infection, increased postoperative blood loss, increased length of stay and increased hospital costs. The purpose of this study is to evaluate the postoperative outcomes and complications in patients undergoing primary lumbar fusion with and without a postoperative drain
The goal of this phase 1 randomized controlled safety and feasibility clinical trial are to determine the safety of external lumbar drainage (ELD) in select patients with severe Traumatic Brain Injury (TBI). The main questions it aims to answer are (i) if ELD is feasible and (ii) safe to perform in severe TBI patients who have radiological evidence of patent basal cisterns and midline shift \<5mm without increasing the risk of neurological worsening or cerebral herniation. All participants will receive routine usual care. The study group will additionally have ELD for cerebrospinal fluid (CSF) drainage. A comparison will be made between the usual treatment plus ELD (interventional) groups, and the usual treatment (control) groups on incidence rate of neurological worsening or cerebral herniation events, and whether total hours with raised intracranial pressure (ICP) are different.
To compare post-operative wound complications in patients randomized to normal saline versus Irrisept solution and any other adverse reactions from the solution.
To evaluate the efficacy of full thickness placental allograft use in Microdiscectomy application. To evaluate post-microdiscectomy reherniation rate in patients treated with full-thickness placental allografts.
The Viper Prime/Expedium spine systems are intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracolumbar and sacral spine. The Fibergraft Bioactive Glass (BG) is engineered to mimic the body's natural bone healing process. While previous studies have compared the use of Viper prime/Expedium spine system in minimally invasive and open surgeries, these studies did not specifically study the clinical and radiographic outcomes of patients who have received these implants in addition to Fibergraft. We aim to recruit patients with degenerative disc disease, spondylolisthesis, trauma, and/or pseudarthrosis who require spine surgery under standard of care and use these implants. We will then follow these patients for a duration of two years to report their clinical and radiographic outcomes to determine fusion, complication rate, and revision surgeries if any.
Determine the effect of Vancomycin Powder added to the surgical wound at closure on surgical infection rates.
This project will determine the clinical utility of non-surgical spine decompression for chronic low back pain (LBP). LBP is one of the highest incidence medical conditions that contributes to disability, decreased activities of daily living, decreased quality of life, and inability to work. LBP affects ≈70-85% of people during their lifetime, with ≈20% becoming chronic by age 20-59 years. Many current LBP therapeutics have detrimental long-term effects, undesired side effects, are invasive procedures with low success rates, and do not fare better than conservative care. Further, many chronic musculoskeletal pain patients do not respond to surgery, and many develop dependence on opioids. This project will implement a small-scale double-blinded, randomized proof-of-concept clinical trial to gather biomechanical and MRI data that will objectively determine the effectiveness of non-surgical spinal decompression (NSSD) over a 12-week longitudinal timeframe. The potential to provide a non-invasive alternative to chronic LBP via NSSD is innovative and addresses the pressing need for safer, more effective pain management options with fewer negative sequelae. NSSD has the potential to greatly improve lives, offering a new paradigm for chronic pain management.
Patient Power is a patient research network and database (registry) to collect prospective information about demographics, self-reported diagnoses and medications, and willingness to participate in research from participants with rheumatoid arthritis (RA), spondyloarthritis (SpA), other musculoskeletal conditions, chronic neurological conditions like migraine, chronic pulmonary conditions like Chronic Obstructive Pulmonary Disease (COPD), asthma, autoimmune dermatological conditions such as psoriasis, and other chronic inflammatory or immune-mediated conditions. In addition, since patients with chronic conditions often have other co-morbidities like cardiovascular health and obesity-related metabolic disorders, these conditions will also be included. Participants will provide information from their smartphones or personal computers. The information will be used by researchers and clinicians to help patients and their providers make better, more informed decisions about treatment of chronic conditions.