[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"chronic-lower-back-pain\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:chronic-lower-back-pain":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,46,71,102,122,147],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100641865","phase-1-adia-med-of-winter-park-llc-lower-back-pain-research-study-100641865",false,"NCT07587047","Adia Med of Winter Park LLC Lower Back Pain Research Study","A Randomized, Placebo-Controlled, Single-Blind, Crossover Study to Evaluate the Safety and Preliminary Efficacy of a Single Intravenous AdiaVita (Umbilical Cord Blood - Stem Cells and Exosomes) Infusion in Adults With Chronic Mechanical Lower Back Pain","Inclusion Criteria:\n\n* Age 18-85 years\n* Chronic lower back pain ≥3 months\n* MRI within 12 months demonstrating one or more qualifying diagnoses:\n\nDegenerative disc disease Disc bulge or herniation Modic changes Facet joint osteoarthritis Mixed disc and facet pathology\n\n* Baseline VAS-Average ≥4\u002F10\n* Able to comply with study visits and procedures\n* Able to provide written informed consent\n* Able to meet study cost requirements ($5,000 study fee plus MRI costs, if applicable) as described in the informed consent\n\nExclusion Criteria:\n\n* Pregnancy or breastfeeding\n* Prisoners or decisionally impaired adults\n* Active malignancy (except non-melanoma skin cancer)\n* Immunodeficiency or active systemic infection\n* Prior lumbar surgery within 12 months\n* Epidural steroid or facet joint injection within 3 months\n* Participation in another interventional trial within 30 days\n* Known allergy to product components\n* Any medical condition posing unacceptable risk per investigator judgment.\n* Prior stem cell therapy: History of stem cell therapy (including umbilical cord blood-derived stem cells or exosomes) at any time prior to screening","ALL","18 Years","85 Years",{"count":20,"type":21},100,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","The goal of this clinical study is to evaluate the safety and preliminary efficacy of an investigational umbilical cord blood-derived stem cell and exosome infusion in adults with chronic lower back pain associated with degenerative spine disease. The primary questions this study aims to answer are whether the investigational infusion is safe and well tolerated and whether treatment may reduce pain and improve physical function and quality of life. Researchers will compare the investigational infusion to a placebo (saline solution) to evaluate potential treatment effects in participants with chronic mechanical lower back pain. Participants will receive either the investigational infusion or placebo intravenously during a study visit, complete pain, disability, and quality-of-life assessments, undergo magnetic resonance imaging (MRI) and laboratory testing, and attend follow-up evaluations over a 6-month period. Participants initially assigned to placebo may later receive the investigational treatment during an open-label crossover phase of the study.",[27,28,29],"Chronic Mechanical Lower Back Pain","Lower Back Pain","Chronic Lower Back Pain",[31,32,33],"stem cell","stem cell therapy","chronic lower back pain","RECRUITING","2026-06-16",{"date":37,"type":38},"2026-06-17","ACTUAL",{"date":35,"type":21},{"date":41,"type":21},"2028-01",{"name":43,"class":44},"Adia Med of Winter Park LLC","OTHER",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":22,"phases":54,"briefSummary":56,"conditions":57,"keywords":58,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":45},"100504100","tailored-pain-guide-tpg-study-100504100","NCT05843890","Tailored Pain Guide (TPG) Study","Inclusion Criteria:\n\n* Chronic Lower Back pain (cLBP) defined by the National Institutes of Health (NIH) Task Force Report on Research Standards for Chronic Low Back Pain, (i.e., low back pain present at least six months, and present more than half of those days.)\n* Individuals must have a score of greater or equal to (≥) 60 on PROMIS Pain Interference.\n* Non-Pharma Sub-study:\n\n  1. Must be referred and currently on the waitlist for the NPP at the Back \\& Pain Center (BPC)\n\nExclusion Criteria:\n\n* Current cancer related pain\n* Diagnosis of autoimmune disease\n* Unable to speak, write or read English\n* Visual or hearing difficulties\n* Pregnancy or breastfeeding\n* Any other diseases or conditions that would make a patient unsuitable for study participation as determined by the site principal investigators.",{"count":53,"type":21},550,[55],"NA","This research is studying whether changing an individual's behaviors may have an impact as a treatment or outcome for chronic low back pain. This research will try to understand how much an electronic, self-management website like PainGuide can help participants.\n\nThe study hypothesizes that tailored digital interventions (plus using PainGuide) will demonstrate greater improvement in pain interference.",[29],[59,60,61],"Online resources","Fitbit","Surveys","2026-03-05",{"date":64,"type":38},"2026-03-09",{"date":66,"type":38},"2023-08-18",{"date":68,"type":21},"2028-02",{"name":70,"class":44},"University of Michigan",{"id":72,"slug":73,"hasResults":11,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":4,"eligibilityCriteria":77,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":78,"enrollmentInfo":79,"targetDuration":4,"studyType":22,"phases":81,"briefSummary":82,"conditions":83,"keywords":85,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":101},"100537818","photobiomodulation-for-lower-back-pain-post-spinal-fusion-and-decompression-surgery-100537818","NCT06282770","Photobiomodulation for Lower Back Pain Post Spinal Fusion and Decompression Surgery","Utilizing Photobiomodulation Via Laser Diode Belts To Treat Chronic Lower Back Pain in Patients Who Have Undergone Spinal Fusion and Decompression Surgery","Inclusion Criteria:\n\n* Subject will have undergone minimally invasive spinal fusion surgery or spinal decompression surgery in their lower back L1-S1.\n* Have low back pain of \\>3 months and a pain threshold of \\> 4 (as described by the the subject), age \\> 18 years, and English speaking to eliminate possible miscommunication and consequent human error regarding belt use.\n* Subject must have had surgery at minimum to 1 year prior to start of study and no more than 5 years prior to start to study\n\nExclusion Criteria:\n\n* Patients with tumors\n* Current infection\n* Drug misuse history\n* Skin conditions preclude the use of laser belt\n* Severe spondylolisthesis, spondylolysis, spinal stenosis, ankylosing spondylitis\n* Previous low back surgery exceeding 5 years to initial start date.","75 Years",{"count":80,"type":21},80,[55],"After spinal fusion and decompression surgery there is a possible risk of developing chronic back pain. After surgery there is typically inflammation around the operation site and this inflammation can be painful and debilitating to patients.\n\nMany possible treatment plans have been incorporated to assist the patient with recovery - notably medications, physical therapy, and braces. However, few studies have looked at laser diodes that utilize high-power laser lights that are aimed at decreasing pain and inflammation. Investigators aim to look compare patients using a back brace with laser diodes within versus those who wear a normal brace used as a placebo. Investigators will also assess the patient's surgical wound to monitor the progression of wound healing while using the brace.",[84,29],"Spinal Fusion",[86,87,88,84,89,90,91],"Photobiomodulation","Laser Diode","Inflammation","Spinal Decompression","Lumbar","Back Pain","2026-01-11",{"date":94,"type":38},"2026-01-13",{"date":96,"type":38},"2023-07-01",{"date":98,"type":21},"2026-07-01",{"name":100,"class":44},"University of California, Los Angeles",2,{"id":103,"slug":104,"hasResults":11,"nctId":105,"briefTitle":106,"officialTitle":106,"acronym":4,"eligibilityCriteria":107,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":108,"targetDuration":4,"studyType":22,"phases":110,"briefSummary":111,"conditions":112,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":45},"100563688","assessment-of-usability-and-satisfaction-with-a-take-home-device-presenting-sound-and-body-stimulation-for-back-pain-100563688","NCT06619418","Assessment of Usability and Satisfaction With a Take-home Device Presenting Sound and Body Stimulation for Back Pain","Inclusion Criteria:\n\n* Must be 18 years of age or older\n* Must be within commuting distance to the University of Minnesota\n* Able to provide consent and follow study instructions\n* Must be able to understand English\n* Must have chronic LBP, which is defined as lower back pain for more than 3 months\n* A score of 4 or higher on the PEG\n* Must be willing to commit to full duration of the study\n* Not currently taking any benzodiazepines or sedative hypnotics\n\nExclusion Criteria:\n\n* Back Pain associated with:\n* Spondylolisthesis or spinal stenosis\n* Sciatica or radiculopathy\n* Rhematologic or inflammatory disease\n* Trauma, fracture, dislocation, or previous back surgery\n* A score of 10 on the PEG\n* Pregnant\n* Have an electrically implanted device, such as a pacemaker.\n* Heart Disease\n* Epilepsy\n* Cancer\n* Psychiatric conditions including psychosis, suicidal ideation, or substance abuse disorder\n* A pure tone average of more than 40 dB HL at 500 dB, 1000 dB, or 2000 dB HL.\n* Individuals currently using other lower back pain treatments during the study in which they are unable to maintain a steady state while participating in our study for one month before beginning the multi-modal regimen.",{"count":109,"type":21},20,[55],"Pain symptoms can have a variety of ways to be treated, from medications to physical therapy, with several options being available to patients. However, no one treatment may work for all people who experience pain, especially cLBP. The purpose of this study is to measure the compliance, usability, and satisfaction of an at-home, multi-modal stimulation device in a diverse population of people with chronic lower back pain (cLBP). The multi-modal device will include a combination of electrical stimulation, auditory stimulation, and integrative-health techniques, including mindfulness breathing, health coaching, and reflective journaling. The multi-modal device creation is based on prior knowledge in lower back pain treatment, which includes electrical stimulation of the back (Transcutaneous Electrical Nerve Stimulator or TENS) and integrative health modalities. In isolation, these treatments are only somewhat effective in reducing symptoms.\n\nThis pilot study will involve participants who experience cLBP as we investigate a novel at-home, multi-modal device design. The main objective of the pilot usability study is to examine compliance to the intended use of the multi-modal device and approach, as well as protocol feasibility, and satisfaction with the settings and design.",[29],"2025-08-11",{"date":115,"type":38},"2025-08-13",{"date":117,"type":38},"2024-07-01",{"date":119,"type":21},"2026-08-11",{"name":121,"class":44},"University of Minnesota",{"id":123,"slug":124,"hasResults":11,"nctId":125,"briefTitle":126,"officialTitle":126,"acronym":4,"eligibilityCriteria":127,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":128,"enrollmentInfo":129,"targetDuration":4,"studyType":22,"phases":131,"briefSummary":132,"conditions":133,"keywords":134,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":138,"lastUpdatePostDateStruct":139,"startDateStruct":141,"completionDateStruct":143,"leadSponsor":145,"locationsCount":45},"100191284","efficacy-of-osteopathic-manipulative-medicine-omm-and-phototherapy-for-patients-with-chronic-lower-back-pain-100191284","NCT01765777","Efficacy of Osteopathic Manipulative Medicine (OMM) and Phototherapy for Patients With Chronic Lower Back Pain","Inclusion Criteria:\n\n* Age range: 18 - 65 years old\n* Subjects with constant or intermittent nonspecific lower back pain for a minimum of three (3) months duration.\n\nExclusion Criteria:\n\n* Prospective subjects with a diagnosis of the following potential underlying causes of lower back pain: ankylosing spondylitis, cancer or a history of a histologically demonstrated malignant carcinoma, cauda equine syndrome, herniated disc, spinal fracture, or spinal osteomyelitis.\n* Prospective subjects who have undergone surgery of the lower back in the preceding three (3) months.\n* Prospective subjects who have received worker's compensation in the preceding three (3) months, or are involved in litigation involving concerns of lower back.\n* Prospective subjects who are pregnant.\n* Prospective subjects who have been a patient receiving any osteopathic manipulative medicine (OMM) treatment at the clinical trial site in the previous three (3) months, or on greater than three (3) occasions in the preceding year.\n* Prospective subjects who have ever been an employee at the clinical trial site.\n* Prospective subjects who have received spinal manipulation in the previous three (3) months, or on greater than three (3) occasions in the preceding year.\n* Prospective subjects who are currently involved in a physical therapy rehabilitation program.\n* Prospective subjects who have photosensitivity.","65 Years",{"count":130,"type":21},48,[55],"The purpose of the research study entitled \"Efficacy of Osteopathic Manipulative Medicine (OMM) and Phototherapy for Patients with Chronic Lower Back Pain\" is to investigate the hypothesis that combined treatment with both osteopathic manipulative medicine (OMM) and phototherapy will provide greater pain relief for patients with chronic lower back pain, as compared with standard medical management or either treatment alone.",[29],[135,136,137],"Low back pain","Lower back pain","Chronic back pain","2024-08-05",{"date":140,"type":38},"2024-08-06",{"date":142,"type":38},"2011-06",{"date":144,"type":21},"2025-12-31",{"name":146,"class":44},"New York Institute of Technology",{"id":148,"slug":149,"hasResults":11,"nctId":150,"briefTitle":151,"officialTitle":151,"acronym":4,"eligibilityCriteria":152,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":153,"enrollmentInfo":154,"targetDuration":156,"studyType":157,"phases":4,"briefSummary":158,"conditions":159,"keywords":160,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":163,"lastUpdatePostDateStruct":164,"startDateStruct":166,"completionDateStruct":168,"leadSponsor":170,"locationsCount":45},"100552541","assessing-the-functional-movement-screen-as-a-reliable-physical-therapy-discharge-criteria-for-chronic-lower-back-pain-patients-100552541","NCT06474429","Assessing the Functional Movement Screen as a Reliable Physical Therapy Discharge Criteria for Chronic Lower Back Pain Patients","* Non-surgical patients who have had lower back pain for \\>3 months\n* Patients who include and are between the ages of 18 and 49\n* Patients with a BMI of \\<30\n* Not pregnant with no plans of becoming pregnant during the duration of the study\n* Be able and willing to understand and sign consent for study participation\n* Be physically able to comply with study protocol requirements\n* Not have had recent surgeries or have confounding factors that would keep them from being able to perform any portion of the FMS assessment","49 Years",{"count":155,"type":21},50,"6 Months","OBSERVATIONAL","Overview of Research Design and Objectives\n\nThis study is a prospective, concurrent cohort study aimed at evaluating the reliability of the Functional Movement Screen (FMS) as a discharge criterion for patients with chronic lower back pain (LBP) undergoing physical therapy. The primary objective is to identify a benchmark FMS score that correlates with a low risk of recurrence and high levels of functional performance post-discharge.\n\nSpecific Aims and Hypotheses\n\nThe study specifically aims to:\n\nAssess the effectiveness of FMS in determining discharge readiness for chronic LBP patients.\n\nThe hypothesis is that a specific threshold score on the FMS can reliably indicate a patient\\'s readiness for discharge, reducing the risk of recurrence and ensuring better long-term functional outcomes.\n\nRationale for the Study\n\nChronic LBP is a prevalent condition requiring multidisciplinary management. The FMS, widely used in athletic and military settings, has potential utility in clinical management of chronic LBP, particularly in establishing discharge criteria. This study seeks to explore this potential, addressing a gap in evidence regarding discharge benchmarks for chronic LBP patients.\n\nProcedures\n\nThe study involves 50 chronic LBP patients from the Texas Back Institute. Participants will undergo their standard physical therapy regimen, supplemented by regular FMS assessments to evaluate discharge readiness. Assessments include a series of functional tasks, with scores ranging from 0 to 3 for each task, culminating in a total possible score of 21.\n\nRisks and Anticipated Benefits\n\nRisks are minimal, akin to those in low-intensity exercises. Benefits include improved discharge criteria for chronic LBP patients, potentially enhancing long-term outcomes. All procedures adhere to Good Clinical Practice and Health Insurance Portability and Accountability Act guidelines. This study\\'s risks include potential loss of confidentiality, psychological, and physical risks. Physical risks are minimal, similar to those in low-intensity exercises like squatting and lunging. To protect confidentiality, data will be managed in compliance with Good Clinical Practice and HIPAA guidelines, with encryption and secure storage. Psychological and physical risks are mitigated through thorough instruction, practice trials, and breaks for participants. Additionally, trained study personnel can terminate a participant\\'s involvement at any point for safety reasons.\n\nOutcomes\n\nThe study will report on the average FMS score correlating with discharge readiness and the variance in scores across different functional assessments.\n\nStatistical Analysis\n\nData will be analyzed using descriptive statistics, correlation analysis, and repeated measures ANOVA or Friedman Test, with a significance level set at α=0.05.\n\nCompletion Time\n\nThe study is expected to complete enrollment within two years.\n\nAbbreviations and Terms\n\nLBP: Lower Back Pain FMS: Functional Movement Screen PROM: Patient-Reported Outcome Measures VAS: Visual Analog Scale ODI: Oswestry Disability Index ANOVA: Analysis of Variance PROMIS: Patient-Reported Outcomes Measurement Information System®",[29],[29,161,162],"Physical Therapy","Discharge","2024-06-19",{"date":165,"type":38},"2024-06-25",{"date":167,"type":38},"2024-04-26",{"date":169,"type":21},"2026-09-08",{"name":171,"class":44},"Texas Back Institute"]