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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 201 Actively Recruiting clinical trials

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Actively Recruiting

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.

Age: 18Years +All GendersPhase Not Applicable
1 location
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Actively Recruiting

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.

Age: 18Years +All GendersPhase Not Applicable
2 locations
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Actively Recruiting

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.

Age: 18Years +All GendersPhase Not Applicable
2 locations
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Actively Recruiting

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.

Age: 18Years +All GendersPhase Not Applicable
1 location
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Actively Recruiting

This research aims to evaluate the safety and early effects of an investigational intravenous infusion made from umbilical cord blood-derived stem cells and exosomes in adults with chronic mechanical lower back pain linked to degenerative spine disease. The study is designed as a randomized, placebo-controlled, single-blind crossover trial involving about 100 participants aged 18 to 85 years. Researchers want to find out if the infusion is safe, well tolerated, and whether it can reduce pain, improve physical function, and enhance quality of life compared to a placebo. Participants receive a single intravenous infusion of either the investigational stem cell and exosome product or a saline placebo administered over about five minutes, followed by at least one hour of monitoring. After three months, those initially given placebo may receive the investigational treatment during an open-label crossover phase. The study includes screening, baseline, and follow-up visits at months 1, 3, and 6, with assessments including MRI scans and laboratory tests. The trial excludes pregnant or breastfeeding individuals, prisoners, those with recent lumbar surgery or spinal injections, active infections, malignancies, or prior stem cell therapy. During the study, participants complete pain, disability, and quality-of-life questionnaires. Researchers monitor safety through adverse event tracking and laboratory evaluations. The main outcomes measured are changes in average low back pain intensity and functional disability from baseline to three months. Secondary outcomes include any treatment-emergent adverse events over six months. The study lasts about six months per participant and includes safeguards such as pre-infusion screening and independent safety oversight. Participants pay a 5,000 study fee plus possible MRI costs, and the trial aims to provide preliminary data to guide future research rather than confirm treatment effectiveness.

Age: 18Years - 85YearsAll GendersPhase 1
1 location
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Actively Recruiting

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.

Age: 18Years - 65YearsAll Genders
1 location
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Actively Recruiting

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.

Age: 30Years - 60YearsAll Genders
1 location
A

Actively Recruiting

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 GLAD 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.

Age: 18Years +All GendersPhase 2
1 location
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Actively Recruiting

This research investigates pain relief methods after total hip arthroplasty, a common surgery in older adults to relieve hip pain and improve joint function. It compares two types of nerve blocks, Quadro-iliac Plane Block and Erector Spinae Plane Block, to assess their effectiveness for postoperative pain management and reduce opioid-related side effects. Participants will receive either the Quadro-iliac plane block or the erector spinae plane block on the same side as the surgery. Both blocks use 20ml of bupivacaine 0.25%. The study randomly assigns patients to one of these two groups to compare their analgesic effects following the hip replacement surgery. During the 24 hours after surgery, researchers will monitor how long it takes before patients need additional pain medication, their total morphine use, pain levels, recovery quality, and any adverse events. Participants will be carefully observed for these outcomes to better understand which nerve block may provide better pain relief. The study is expected to complete by November 2026.

Age: 18Years +All GendersPhase Not Applicable
1 location
S

Actively Recruiting

Researchers are studying the treatment of recent lumbago acute lower back pain by evaluating the effectiveness of an anesthetic block of the erector spinae muscles using a combination of ropivacaine and dexamethasone. This approach is commonly used in some French institutions but has not yet been tested in a randomized placebo-controlled study to confirm its pain relief effect within the first four days of treatment. The study is designed as a randomized, double-blind trial to compare this anesthetic block to placebo during recent lumbago. Participants will receive either a single interlaminal injection of ropivacaine combined with dexamethasone or a placebo injection of sodium chloride 0.9%. The injection is administered bilaterally over specific lumbar vertebrae L4-L5 and L5-S1. Both groups will continue with usual treatment. This pilot study focuses on the first four days after injection to observe differences in pain relief and functional impact. During the study, participants will be assessed for lumbar pain during activity at multiple time points from injection up to four days. Additional measures include pain at rest, use of other lumbago treatments, functional indexes, and duration of work or activity interruption over 28 days. Researchers will also monitor for any complications. The total participation involves close monitoring of pain and function to evaluate the treatments effect over the short term.

Age: 18Years +All GendersPhase 3
1 location

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