Low Back Pain

Researchers are evaluating the accuracy of the straight leg raise test in adults suspected of having lumbosacral radicular pain, which often results from lumbar disc herniation and causes pain radiating from the lower back or buttock to the leg. This observational study uses diagnostic transforaminal epidural steroid injection or selective nerve root block as reference standards to measure the tests sensitivity, specificity, and overall diagnostic performance. Participants will undergo clinical evaluation including the straight leg raise test followed by diagnostic injections targeting the L4, L5, or S1 nerve roots. Only selective injections performed without sedation and with a low volume of short-acting local anesthetic are included. The study will analyze the diagnostic value of the straight leg raise test compared to these injections, helping to determine when the test alone is sufficient or when further diagnostics are necessary. During the study, participants will be assessed before and one hour after the diagnostic injection using the straight leg raise test, pain intensity scales, and the Bragard test. Additional evaluations include questionnaires, lumbar MRI analysis for disc degeneration and nerve root compression, and monitoring of any changes in symptoms. The study aims to provide detailed diagnostic insights, with participation expected to cover assessments during the diagnostic procedure and related clinical evaluations.

Researchers are evaluating the safety and effectiveness of the PerQdisc Nucleus Replacement Device NRD for patients with degenerative disc disease DDD causing chronic low back pain. This prospective, open-label, multi-center study involves 72 patients who have DDD in one or more lumbar discs between L1 and S1. The study aims to collect additional data on this minimally invasive device, which is designed to maintain disc height and preserve spinal motion compared to the current standard spinal fusion surgery. Participants will undergo nucleus replacement surgery using the PerQdisc device via standard anterior, lateral, or minimally invasive posterolateral surgical approaches to replace the single nucleus pulposus in the affected lumbar disc. All surgeries require approval from a Medical Advisory Board. The study focuses on patients who have exhausted at least six months of conservative treatments for their back pain and meet specific criteria, including disc height and pain scores. During the study, participants will be monitored closely with evaluations at multiple time points up to five years. Researchers will assess performance outcomes such as disability Oswestry Disability Index, pain levels Visual Analog Scale, disc height, and range of motion, as well as safety outcomes including device expulsion, failure, neurological status, revision surgeries, and serious adverse events. Follow-up visits will include questionnaires, imaging, and clinical assessments to track the devices impact over time.

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 L45 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 swimmingcycling-based intervention group. The two intervention groups will follow an 8-week combined exercise program consisting of aerobic training running or swimmingcycling, 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 physioexercise 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 pain treatments for people experiencing chronic pain conditions such as osteoarthritis of the knee, diabetic neuropathic pain, and chronic low back pain. This study aims to compare different pain interventions by using a flexible design where specific intervention appendices ISAs can begin independently as new treatments become available. The study is sponsored by Eli Lilly and Company and is designed as a phase 2 randomized, placebo-controlled trial. Participants may receive one of several study drugs administered either intravenously or orally, including LY3016859 given through IV and LY3556050, LY3526318, and LY3857210 given orally. Each treatment group is compared to a matching placebo group. The study uses a parallel design where participants are assigned randomly to one of the intervention groups or placebo. The protocol includes disease-state addenda to define target populations and assessment scales for each pain condition. During the trial, participants undergo screening to confirm eligibility based on pain levels, history, and health status. They are monitored for outcomes such as the number of participants allocated to each intervention up to week 8. Researchers assess pain and other health measures while participants maintain consistent use of any ongoing non-drug pain therapies and discontinue other chronic pain medications except for rescue use. The study includes safety monitoring and will continue through April 2027, with results posted for each intervention.

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 programs 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.