Low Back Pain

Researchers are evaluating the PerQdisc Nucleus Replacement System in patients with degenerative disc disease (DDD) affecting one or more lumbar discs. This prospective, open-label, multi-center study aims to collect additional safety and effectiveness data for this minimally invasive device. The PerQdisc is designed to replace the nucleus pulposus in lumbar discs between L1 and S1, offering an alternative to spinal fusion surgery by aiming to preserve disc height and maintain spinal motion to reduce chronic low back pain. The study involves surgical implantation of the PerQdisc device using standard anterior, lateral, or minimally invasive posterolateral approaches. All patients who meet inclusion criteria and have no exclusions will be considered for nucleus replacement surgery following review by a Medical Advisory Board. The device replaces the disc nucleus at a single level of the lumbar spine, intending to preserve spinal movement and reduce pain. Participants will be monitored for safety and performance outcomes over time, including pain and disability scores at 6 and 12 months. Researchers will assess device expulsion, failure, revision surgeries, disc height, range of motion, neurological status, analgesic use, and serious adverse events up to 5 years after surgery. The study includes clinical evaluations, imaging, and questionnaires to track progress and safety, with total follow-up extending to 5 years post-implantation.

Researchers are evaluating the clinical effects and biomechanical impacts of different trigger modes of lever positioning manipulation (LPM) for treating lumbar disc herniation (LDH). This study aims to clarify the clinical efficacy of LPM, analyze the mechanical and spatial motion characteristics of its two trigger modes, and explore how these modes influence the stress-strain and flow-solid coupling effects on the lumbar intervertebral discs, particularly at the L4/5 segment. The investigation also uses 3D finite element technology combined with dynamic capture and mechanical sensing systems to better understand these effects. Participants include 64 LDH patients and 64 healthy volunteers divided into four groups: two patient groups receiving either unilateral or bilateral LPM or sham manipulation, and two healthy volunteer groups receiving unilateral or bilateral LPM. Treatments are administered every two days for a total of six sessions over two weeks. During manipulation, mechanical and kinematic data are collected using sensing gloves and motion capture systems. Additionally, a virtual simulation model is built from imaging data to analyze biomechanical loading and stress on the intervertebral discs under different LPM modes. Participants will complete clinical questionnaires such as the Visual Analog Scale (VAS) and Japanese Orthopaedic Association (JOA) scoring system to assess pain and function. Mechanical parameters and motion characteristics are recorded during manipulation sessions. Researchers will use these data alongside imaging and individual patient features to study correlations. The primary outcome is the overall clinical efficacy after two weeks. Secondary outcomes include pain and functional scores, as well as detailed mechanical and kinematic measurements during treatment.

Researchers are evaluating the effects of different exercise programs on pain and function in adults with chronic low back pain. This randomized controlled trial includes otherwise healthy participants aged 18 to 45 who experience pain or functional limitations due to low back pain lasting more than 3 months. The study aims to understand how various exercise types impact pain levels and physical ability. Participants are randomly assigned to one of three groups: a control group that continues their usual exercise routine, a running-based intervention group, or a swimming/cycling-based intervention group. The two intervention groups will follow an 8-week combined exercise program consisting of aerobic training (running or swimming/cycling), progressive resistance exercises, and flexibility exercises. The program gradually increases in intensity over the 8 weeks to encourage adherence and reduce injury risk. Throughout the study, participants will be assessed using validated measures of pain and disability at three points: before starting (baseline), after 8 weeks of exercise, and at 12 months to evaluate long-term effects. Researchers will collect self-reported pain scores and functional questionnaires to analyze changes over time. The total study duration allows for monitoring both immediate and lasting impacts of the exercise interventions on low back pain management.

Researchers are evaluating a combined lifestyle intervention integrated into standard care for patients with persistent low back pain (LBP) who are overweight or obese and referred back to primary care from the hospital. The study aims to improve physical functioning and physical activity over 36 months, while also reducing healthcare and societal costs. Lifestyle factors like physical inactivity, stress, sleep quality, excess weight, and diet are addressed because they contribute to LBP and related health risks such as diabetes and cardiovascular disease. The intervention is delivered by certified physio/exercise therapists following Dutch clinical guidelines. It includes a two-year program where the first six months focus on behavioral change, and the next 18 months focus on maintaining new healthy habits. The program uses group and individual sessions with techniques such as motivational interviewing and self-monitoring. Patients set their own goals and treatment is tailored to their lifestyle risks and LBP clinical factors. The comparison group receives usual care as prescribed by medical specialists, which may include education, exercise therapy, pain medication, or referral back to primary care. Participants will attend scheduled assessments at baseline and multiple follow-up points over 36 months. Researchers will measure physical activity using a device that tracks daily steps and assess physical functioning with a disability questionnaire. Additional evaluations include pain intensity, weight, sleep quality, diet, inflammation markers, quality of life, healthcare costs, and overall perceived effect. These measurements will help determine the effectiveness and cost-effectiveness of the combined lifestyle intervention compared to usual care in this patient group.

Researchers are comparing the effectiveness of two serotonin receptor blockers, palonosetron and granisetron, given with dexamethasone to prevent early and delayed postoperative nausea and vomiting (PONV) in adolescents and adults with idiopathic scoliosis undergoing posterior spinal fusion surgery using total intravenous anesthesia (TIVA). The study aims to find out which drug better prevents nausea and vomiting, the need for rescue medications, side effects, and patient satisfaction. Participants will be randomly assigned to one of two groups: one group receives palonosetron before anesthesia begins and saline placebo at wound closure, while the other group receives saline placebo before anesthesia and granisetron at wound closure. Both groups will also receive dexamethasone as part of their antiemetic treatment. Standard anesthesia with remifentanil and propofol will be used, and morphine will be given before surgery ends for pain. During the study, nausea, vomiting, and retching will be monitored at 1, 4, 12, 24, and 48 hours after surgery. Researchers will evaluate the need for additional antiemetic drugs, any side effects from the study drugs, and patient satisfaction at 48 hours. The trial is double-blinded and randomized, with a total planned enrollment of 92 participants aged 10 years and older with idiopathic scoliosis.

Researchers are conducting a master protocol study to evaluate multiple independent pain treatments for people with chronic pain conditions such as osteoarthritis of the knee, diabetic neuropathic pain, and chronic low back pain. This study aims to compare different interventions within a structured framework that includes specific criteria and unique assessments for each condition. The study is designed as a randomized, placebo-controlled Phase 2 clinical trial to better understand these treatments. Participants are randomly assigned to receive one of several investigational drugs or matching placebos. These drugs include LY3016859, administered intravenously, and LY3556050, LY3526318, and LY3857210, all given orally. The interventions are organized in separate appendices focusing on each pain condition, allowing some to begin independently as they become available for testing. During the study, participants will be monitored from baseline up to 8 weeks to track allocation to each intervention-specific appendix. Researchers will assess pain levels, functional status, and safety through various scales and tests. The study involves maintaining stable non-drug therapies and discontinuing current pain medications except rescue medications. Participants will undergo physical exams, lab tests, and screening for medical history to ensure safety throughout the trial, which is led by Eli Lilly and Company and is expected to continue until April 2027.

Researchers are evaluating a new way of providing physical therapy directly in the emergency department (ED) for adults with low back pain. This multi-site feasibility trial compares this embedded ED physical therapy model to usual care at two hospital EDs within the Northwestern Medicine and University of Utah Health systems. The study aims to test if this approach can be successfully implemented, including enrolling patients and collecting long-term outcome data, as a step toward a larger future trial focused on pain and opioid use outcomes. The trial randomly assigns two hospital EDs to either have a physical therapist available on-site to start timely care for low back pain patients or to continue with usual care, which may include imaging, education, and medications but no ED physical therapist involvement. The intervention period lasts 9 months, followed by 12 months of collecting patient-reported outcomes and electronic health record data. A third hospital ED will contribute baseline data without participating in the intervention or enrollment. Participants are adult patients visiting the ED with low back pain lasting up to 30 days during daytime hours. They will complete surveys over 12 months to measure pain interference and other health outcomes. Researchers will also review health records and survey clinicians to assess how well the intervention is adopted and delivered. The study monitors participant retention and data completeness to inform future research. Overall participation lasts 21 months, including intervention and follow-up phases.

Researchers are evaluating a multicomponent mindfulness and movement program called Move-MORE designed for patients with lumbosacral radiculopathy, a condition causing pain, weakness, and numbness in the lower limbs often known as sciatica. The study aims to develop this non-invasive, non-drug treatment by combining mindfulness training, gentle physical activity, and motivational interviewing to help manage pain and improve function. The study will assess the program's feasibility, acceptability, and preliminary effects on pain, disability, and psychological factors. Participants will engage in the Move-MORE program remotely, attending weekly virtual classes for eight weeks. The program includes mindfulness practice, physical activity, and motivational interviewing based on self-determination theory. Between sessions, participants will track their home practice, pain levels, and any adverse events through daily surveys. The intervention is specifically tailored for those with lumbosacral radiculopathy, using feedback from patients and physicians to guide program design. During the study, participants will complete online surveys at baseline, midpoint, post-intervention, and three-month follow-up, including daily pain ratings via ecological momentary assessment. They will wear an activity monitor continuously to measure movement and undergo quantitative sensory testing to assess pain sensitivity. At the end, participants will share their experiences in interviews to help refine the program. The primary outcome measured is disability related to back pain, with additional assessments of pain characteristics and satisfaction.

Low back pain is a leading cause of disability worldwide and a common reason for primary care visits. This research aims to improve how low back pain is managed in primary care by testing a multilevel intervention developed with general practitioners, physiotherapists, and occupational therapists. The study evaluates the effectiveness of this new care approach compared to usual care, focusing on cost-effectiveness, imaging rates, and patient disability over time. The intervention includes training general practitioners, sending reminders, providing patient education, and using a clinical pathway based on risk of chronicity. Patients may receive education and self-management support, individual physiotherapy sessions after a specialized two-day workshop, and multidisciplinary group management if needed. Care pathways involve screening, follow-up questionnaires assessing risk and work ability, and tailored treatment steps over several weeks, with coordination among healthcare providers encouraged. Participants will be monitored for 12 months through questionnaires at multiple time points and administrative data. Outcomes measured include back-related disability, imaging referrals, opioid and sick leave prescriptions, pain intensity, quality of life, work participation, and beliefs about back pain. Healthcare professionals' confidence and beliefs will also be assessed. Implementation outcomes such as acceptability and feasibility will be explored via interviews and focus groups with patients and practitioners to understand integration into routine care.

The trial investigates the real-world use of INFUSE174 Bone Graft for patients in Korea who require lumbar fusion surgery due to degenerative disc disease. It is a prospective, observational, multi-center post-market surveillance study designed to collect data on the safety and effectiveness of this commercially available device used as intended. The study aims to follow over 600 cases during a four-year period after approval in Korea. Participants in this study are patients treated with INFUSE174 Bone Graft via anterior (ALIF) or oblique (OLIF) lumbar interbody fusion techniques. The device is approved for use as a substitute for autogenous bone graft in patients with degenerative disc disease who have undergone at least six months of nonoperative treatment. The study observes patients who have received this device according to standard care without altering their treatment. During the study, patients will be monitored for at least 12 months after surgery. Researchers will collect information about any adverse device effects and assess fusion status within this period. Clinical outcomes such as disability index (ODI), pain levels (VAS), and neurological success will be recorded at multiple timepoints including 6 weeks, 3 months, 6 months, and 12 months after surgery. This comprehensive follow-up aims to provide important real-world data on patient recovery and device performance.