Acute low back pain is a common condition characterized by sudden pain in the lower spine area, often prompting clinical assessment due to its impact on mobility and daily activities. Clinical trials explore various treatment approaches to manage pai...
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Found 206 Actively Recruiting clinical trials
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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.
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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.
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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.
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This research aims to evaluate whether phone calls or text messages improve adherence to a mobile health app compared to standard app notifications among adults living with chronic low back pain. The study focuses on individuals experiencing non-specific chronic low back pain who are currently consulting a general practitioner and have a minimum pain intensity score. It seeks to answer if these communication methods increase engagement with digital pain management interventions. Participants will receive pain education and clinical hypnosis through a mobile app designed for chronic low back pain management. They will be randomly assigned to one of three groups: one receiving only standard daily app notifications, another receiving notifications plus up to two phone calls if they miss app sessions for more than three days, and the last receiving notifications plus up to two text messages under the same conditions. The phone calls and texts are spaced one week apart and aim to motivate participants and check for difficulties using the app. Throughout the 8-week study period, researchers will monitor the number of app sessions completed, adherence rates, withdrawal rates, and missing follow-up rates. Participants' progress will be tracked through app usage data and communication records. The study also assesses cost-effectiveness and safety by monitoring participant engagement and any issues reported during calls or messages. The total participation duration aligns with the 8 weeks following randomization.
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Researchers are evaluating the safety and early effects of an investigational infusion made from umbilical cord blood-derived stem cells and exosomes in adults who have chronic mechanical lower back pain linked to degenerative spine conditions. This phase 1 clinical trial aims to determine if the infusion is safe and well tolerated, and whether it may reduce pain, improve physical function, and enhance quality of life. The study involves comparing this investigational treatment with a placebo to assess its potential benefits. Participants will receive one intravenous infusion of either the investigational stem cell and exosome product or a saline placebo during a study visit. The infusion is administered over about five minutes, followed by at least one hour of monitoring. After three months, those initially given the placebo may crossover to receive the investigational treatment. The study includes screening, baseline, and follow-up visits at 1, 3, and 6 months to assess outcomes and safety. During the study, participants will complete assessments measuring pain levels, disability, and quality of life, including Visual Analog Scale and Oswestry Disability Index scores, as well as MRI scans and lab tests for inflammatory markers. Safety is closely monitored through pre-infusion screening, structured adverse event tracking, and oversight by an independent board. The total participation time spans six months, with attention to any treatment-related effects and monitoring for potential risks such as infusion reactions or infections.
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Healthy Volunteer
Low back pain (LBP) is a widespread musculoskeletal issue affecting people of various ages and causing significant personal, social, and healthcare burdens. The study focuses on chronic low back pain (CLBP), which lasts more than 12 weeks and often leads to reduced daily activity due to fear of movement. Identifying risk factors and understanding those at risk of developing chronic LBP can help improve prevention and treatment strategies. This research aims to compare joint range of motion between individuals with low back pain and healthy people using artificial intelligence (AI) analysis methods. Participants in this observational study will have their joint range of motion (ROM) measured to assess specific movement limitations. The study includes two groups: patients experiencing low back pain and healthy control participants. AI-supported analysis will be used to detect differences in joint motion ranges between these groups, aiming to improve understanding of how LBP affects physical movement. During the study, participants will undergo pain evaluations lasting about 5 minutes and joint ROM assessments lasting about 20 minutes. The researchers will collect data to analyze and compare differences between the groups. The study is open to adults aged 18 to 65 who meet eligibility criteria, and it involves no treatment but diagnostic testing. Total participant involvement includes these assessments, with results helping to identify movement patterns related to LBP.
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Healthy Volunteer
Researchers are developing and testing an artificial intelligence (AI) model to predict the risk of developing five major diseases or conditions: cardiovascular disease, type 2 diabetes, breast cancer, low back pain, and osteoarthritis. The study focuses on adults aged 30 to 60 years and combines past health data with new biological and lifestyle information to improve how these risks are estimated. This observational study collects both retrospective and prospective data. Retrospective data include medical records, health screening results, lab tests, and imaging, covering up to 10 years after a defined baseline date. Prospective data collection involves blood samples for proteomic and genomic testing, lifestyle and behavioral questionnaires, and digital health assessments completed mostly at home over about one week, with up to two extra weeks if needed. Participants will provide information through questionnaires and digital tools, and have blood samples taken for detailed analysis. Researchers will review electronic medical records to identify new disease diagnoses occurring up to 10 years after the baseline date. The study aims to combine these various data to improve prediction accuracy and understand factors linked to disease onset. About 1,000 adults, both with and without these diseases, will take part, with study activities lasting around one to two weeks for prospective data collection.
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Healthy Volunteer
Low back pain (LBP) causes increasing pain, disability, addiction, and healthcare costs, especially in Alberta where family physicians face barriers in providing effective, guideline-based care. These barriers include lack of training, limited low-cost access to treatments, and insufficient time and reimbursement. The Alberta Back Care Pathway (ABCp) was developed with input from patients, providers, and scientists to offer family physicians a common, guideline-based approach to assess and manage LBP patients effectively in daily practice. The ABCp trains physicians to categorize patients into five groups, each with evidence-based interventions that can be offered at no or low cost to patients and minimal cost to the healthcare system. The study compares the ABCp intervention to usual care in a multi-clinic, controlled, non-randomized stepped-wedge design. The intervention includes patient education, structured exercise programs, and decision-making tools to reduce low-value care. Enrollment lasts one year, followed by a one-year follow-up, with training provided for clinicians and possible telehealth delivery of the GLA:D Back program. Participants will be assessed using ABCp categories and followed for healthcare resource use, quality of life, and opioid use. Data collected include the number of visits to family physicians, specialist referrals, and imaging requests over about 30 months. Quality of life is measured with patient-reported outcomes, and opioid prescription data are tracked. The study aims to reduce healthcare costs and improve outcomes through guideline-based care, with a total project duration of about 2.5 years including pre-implementation activities, enrollment, and follow-up.
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The trial investigates pain management techniques after total hip arthroplasty (THA), a common surgery for older adults to relieve hip pain and improve joint function. Researchers are comparing two nerve block methods, the Quadro-Iliac Plane Block (QIPB) and the Erector Spinae Plane Block (ESPB), to assess their effectiveness in reducing postoperative pain and opioid use. The study addresses concerns about opioid side effects such as nausea and dependence. Participants receive either the QIPB or ESPB, each involving an injection of 20ml of 0.25% bupivacaine on the side of surgery. These blocks aim to numb nerves to control pain after surgery. The study is randomized and double-blind, meaning participants are assigned randomly to one of the two groups and neither participants nor researchers know the assignment during the trial. During the first 24 hours after surgery, participants are monitored for how long it takes before they need extra pain relief, the total amount of morphine used, their pain levels, quality of recovery, and any side effects. Various assessments track these outcomes to compare the two treatments. This comprehensive monitoring helps evaluate which block may better manage pain with fewer complications.
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Researchers are evaluating the effectiveness of the Anterior Quadratus Lumborum Block at the lateral supra-arcuate ligament under laparoscopic direct vision compared to local infiltration anesthesia for pain relief after laparoscopic renal surgery. This randomized controlled trial involves 66 patients undergoing laparoscopic nephrectomy or partial nephrectomy, with the goal of assessing postoperative analgesia and recovery. The study measures include opioid use, pain scores, comfort, recovery quality, and side effects related to anesthesia. Participants are randomly assigned to one of two groups: the experimental group receives the Anterior Quadratus Lumborum Block using 20 ml of 0.375% ropivacaine hydrochloride administered under laparoscopic direct vision, while the control group receives local infiltration anesthesia with the same dose of ropivacaine. Randomization is done by a clinical researcher using sealed envelopes before surgery. During the study, data collection includes opioid consumption at various postoperative time points up to 48 hours, pain ratings at rest and during activity, comfort and recovery questionnaires, and monitoring for adverse reactions and anesthesia-related complications for up to 72 hours. Length of hospital stay is also recorded for up to 10 days after surgery. Data is carefully recorded in case report forms and maintained in an electronic database, with follow-up assessments to evaluate patient outcomes.
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