[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"msk-conditions\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:msk-conditions":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,49],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"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":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100575377","phase-3-efficacy-of-antibiotic-treatment-for-patients-with-chronic-low-back-pain-and-modic-type-i-changes---randomized-placebo-controlled-trial-100575377",false,"NCT06771492","Efficacy of Antibiotic Treatment for Patients With Chronic Low Back Pain and Modic Type I Changes - Randomized Placebo-controlled Trial","ABBA","Inclusion Criteria:\n\n* Aged 18-65 years.\n* Chronic low back pain (i.e. duration \\>6 months) after a previous (MRI confirmed) disc herniation within the past 6 months to 2 years.\n* At least 2 of the following questions should be answered with \"Yes\":\n\n  * Does training and\u002For exercise increase your pain?\n  * Is your sleep during the night disturbed due to your back pain?\n  * Is it painful to turn over in bed at night?\n  * Do you suffer from morning pain?\n* The mean pain intensity should be at least 5 points on a 0-10 NRS-scale, calculated as the mean pain intensity of 3 indices: current pain, worst pain within the preceding two weeks, and the usual mean pain within the preceding two weeks.\n* Modic Type I changes visible on the MRI-scan in the vertebrae adjacent to the previous herniated disc.\n\nExclusion Criteria:\n\n* Received antibiotic treatment in the past month.\n* Current pregnancy, lactation or pregnancy-wish.\n* Severe physical or psychiatric co-morbidities.\n* LBP resulting from a specific cause such as a tumor or fracture.\n* Surgery or epidural injection in the past 6 months.\n* Previous antibiotic course of 100 days.\n* Contra-indication for amoxicillin use: allergy to penicillins\u002Famoxicillin, cephalosporin or carbapenem; mononucleosis; leukemia; phenylketonuria (PKU)\n* Contra-indication for MRI.\n* Current use of any of the following medications: allopurinol, methotrexate, phenylbutazone or probenecid.\n* Hepatic or renal (eGFR≤30) impairment.\n* Inability to swallow capsules.","ALL","18 Years","65 Years",{"count":20,"type":21},204,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","The goal of this clinical trial is to learn if antibiotics (amoxicillin) work to treat chronic low back pain in adults. In some patients, this type of back pain may be caused by bacteria in the vertebrae, resulting in a condition known as \"Modic type I change.\"\n\nThe main questions the trial aims to answer are:\n\n* What is the efficacy (primary objective) of antibiotic treatment for patients with chronic low back pain and Modic type I changes?\n* What is the cost-effectiveness (secondary objective) of antibiotic treatment for patients with chronic low back pain and Modic type I changes?\n\nResearchers will compare amoxicillin to a placebo (a look-alike substance that contains no active drug) to see if amoxicillin works to treat chronic low back pain.\n\nParticipants in the trial will:\n\n* Be invited for an MRI scan to determine if they have a Modic type I change; those who do will be included in the study.\n* Take either amoxicillin or a placebo daily for 100 days.\n* Take probiotics daily for 100 days to reduce the occurrence and impact of any side effects from the antibiotics.\n* Attend clinic visits at baseline (the start), 4 weeks, 3 months, and 12 months for checkups and tests.\n* Complete questionnaires at baseline, 3 months, 6 months, and 12 months.",[27,28,29],"MSK Conditions","Chronic Low Back Pain (CLBP)","Modic Changes",[31,32,33,34,35],"Antibiotics","Amoxicillin","Low back pain (LBP)","Modic changes","Randomized controlled trial","RECRUITING","2025-08-05",{"date":39,"type":40},"2025-08-06","ACTUAL",{"date":42,"type":40},"2025-04-02",{"date":44,"type":21},"2027-08",{"name":46,"class":47},"Bart Koes","OTHER",1,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":16,"minAge":55,"maxAge":18,"enrollmentInfo":56,"targetDuration":4,"studyType":22,"phases":58,"briefSummary":60,"conditions":61,"keywords":62,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":48},"100598531","feasibility-and-acceptability-of-an-evidence-informed-virtual-intervention-to-reduce-perceptions-of-injustice-following-work-injury-100598531","NCT07072702","Feasibility and Acceptability of an Evidence-Informed Virtual Intervention to Reduce Perceptions of Injustice Following Work Injury","Inclusion Criteria:\n\n1. working knowledge of English,\n2. work absence of less than 8 weeks duration following a musculoskeletal injury to the back or neck,\n3. a score above clinical threshold on a self-report measure of perceived injustice,\n4. between 25 and 65 years of age,\n5. referred for primary care physiotherapy, and\n6. currently receiving wage indemnity benefits from the WSIB.\n\nExclusion Criteria:\n\n1. currently receiving psychological services for a mental health problem,\n2. clinical evidence of vertebral fracture, disk herniation, infectious disease, or rheumatoid arthritis (determined from referral information),\n3. illiteracy or severe cognitive impairment (determined informally through the intake interview).","25 Years",{"count":57,"type":21},75,[59],"NA","Many individuals who have sustained disabling injuries in the workplace react to their situation with a sense of 'injustice'. Research over the past 20 years has revealed that, interpreting one's post-injury life situation as 'unjust', actually interferes with recovery from the disabling injury. Post-injury perceptions of injustice contribute to more severe pain, more severe symptoms of depression and PTSD, and more prolonged absence from work. Several clinical researchers have highlighted the need to develop approaches to treatment that can reduce post-injury perceptions of injustice.\n\nA brief intervention was developed to reduce post-injury perceptions of injustice. The intervention consists of 4 30-minute sessions with a psychologist. The intervention is called 'Managing Post-Injury Challenges' (MPIC). The MPIC sessions are delivered virtually (online). As a first step toward determining whether MPIC has added value for promoting more successful recovery following work injury, the proposed research will assess the feasibility of MPIC. Some of the feasibility questions that will be addressed include: Are injured workers interested in participating in MPIC? Do injured individuals remain sufficiently engaged to complete all 4 sessions of MPIC? Does participation in MPIC contribute to meaningful reductions in perceived injustice? And are injured individuals satisfied with the benefits of MPIC?\n\nMPIC differs from many other rehabilitation interventions in that it focuses on a 'risk-factor' for problematic recovery as opposed to treating a specific health or mental health problem. At this time, there is little information about whether injured workers are interested in interventions focusing on 'risk factors' for problematic recovery. As a first step in evaluating the effectiveness of MPIC, it is necessary to demonstrate that MPIC is acceptable to injured workers. We would consider the study to be successful if 1) at least 75% of eligible injured workers agree to enrol in MPIC, 2) if at least 75% of participants attend all 4 sessions of MPIC, and if at least 75% of participants are satisfied with the benefits they derived from their involvement in MPIC. If MPIC is ultimately shown to be effective in reducing post-injury perceptions of injustice, offering MPIC to injured workers with elevated scores on a measure of perceived injustice could contribute to more successful recovery.",[27],[63,64,65,66],"Pain","Disability","Psychosocial","Perceived Injustice","2025-07-17",{"date":69,"type":40},"2025-07-18",{"date":71,"type":40},"2024-09-30",{"date":73,"type":21},"2026-06-30",{"name":75,"class":47},"McGill University"]