[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"sacroiliitis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:sacroiliitis":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,48,76],{"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":29,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100641861","neurolyser-xr-for-the-treatment-of-sacroiliitis-100641861",false,"NCT07647757","Neurolyser XR for the Treatment of Sacroiliitis","Safety and Efficacy of Using the Neurolyser XR Device for the Treatment of Sacroiliac Joint Related Low Back Pain","Inclusion Criteria:\n\n* Adult males and females, legally able and willing to participate in the study and come for follow-up visits\n* Able and willing to fill the research questionnaires and to communicate with investigator and research team\n* Patient with bilateral or unilateral sacroiliac joint pain of \\> 6 months duration\n* Patients presenting with a) a positive (\\>70% pain relief) to a previous nerve ablation procedure of the sacroiliac joint and \u002F or b) with a positive (\\>70% pain relief) to a previous nerve block procedure of the sacroiliac joint within the last six months)\n* Average pain score of 4 or higher in the last month, (on 0-10 scale).\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding patient\n* Patients presenting with neurological deficits (including lumbosacral radiculopathy but not solitary radicular pain).\n* Patients with history of lumbar and \u002F or sacral spine surgery\n* Patients with the presence of metal hardware at the lumbosacral spine\n* Patients with history of pelvic pathology that may increase procedural risk and \u002F or influence symptoms and \u002F or generate unrelated adverse event (per the discretion of the study principal investigator)\n* Patients unable to understand and complete the research questionnaires in Italian.\n* Patients presenting with any severe medical condition preventing the patient from safely and effectively being treated in the study or reporting study outcome.\n* Patient with extensive scarring in the skin and tissue overlying the treatment area.\n* Patients enrolled in or planned to be enrolled in another clinical trial during the duration of this research project.","ALL","18 Years","80 Years",{"count":20,"type":21},30,"ESTIMATED","INTERVENTIONAL",[24],"NA","Our study aims to investigate the safety and efficacy of high intensity focused ultrasound in the management of low back pain due to sacroiliitis. Sacroiliitis is the inflammation of a joint in the lowest part of the spin and it is one of the cause of low back; the diagnosis is essentially based on clinical examination and the confirmation of this diagnosis relies on a significant pain relief following an infiltration of local anesthetic in the joint. One of the potential treatment is to ablate the nerves which carry the painful stimuli from the joint to the central nervous system through; these nerves enter the spinal canal through the sacral foramina which are two series of four pairs of openings located on the sacrum, the triangular bone at the base of the spine. Traditionally, these nerves are ablated by the heat produced by radiofrequency or the cold produced by cryoablation; both techniques require percutaneous needle insertion in close proximity to the targeted nerves, posing potential discomfort and risk of infection for the patient. High intensity focused ultrasound delivered by the device Neurolyser XR uses ultrasounds which are converged to the targeted point thanks to a gel pad positioned on the back of the patient; this mechanism of action does not require sterile conditions as the skin is not pierced and the discomfort of patient is dramatically reduced during the procedure for there is non need to insert and move any needle to properly position it. The correct orientation of the ultrasound beam is guaranteed by the alignment of the targeting system of the device and the X-ray image. The lesion is produced only if there is a bone right under the focus of the ultrasound beam and this is a safety system which assures that no direct injuries of other structures (e.g., vessels, spinal root) can be caused. To date, Neurolyser XR has been extensively used to treat facet joint syndrome through the ablation of the medial branches. However, its application in sacroiliitis has not yet been as deeply investigated.",[27,28],"Sacroiliitis","Low Back Pain",[30,31,32,33,34],"HIFU","High intensity focused ultrasound","sacroiliitis","low back pain","nerve ablation","NOT_YET_RECRUITING","2026-06-12",{"date":38,"type":39},"2026-06-16","ACTUAL",{"date":41,"type":21},"2026-07",{"date":43,"type":21},"2027-07",{"name":45,"class":46},"Federico II University","OTHER",1,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":22,"phases":57,"briefSummary":58,"conditions":59,"keywords":60,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":47},"100520183","use-of-the-neurolyser-xr-for-the-treatment-of-low-back-pain-related-to-sacroiliitis-100520183","NCT06053255","Use of the Neurolyser XR for the Treatment of Low Back Pain Related to Sacroiliitis","Safety and Efficacy of the Neurolyser XR for the Treatment of Low Back Pain Related to Sacroiliitis","Inclusion Criteria:\n\n1. Men and women aged 18 and older\n2. BPI \\\u003C 40\n3. Patients who are able and willing to give consent and able to attend all study visits.\n4. Patients who are able to communicate with the treating physician.\n5. Patients must have chronic lower back pain (LBP) attributed to degenerative sacroiliitis diagnosed by a pain physician using the following guidelines:\n6. At least 1 positive sacroiliac joint provocation test (Gaeslen's test, FABER (Patrick's test), and pelvic rock)\n7. Back pain predominantly below L5\n8. 50% relief following either sacroiliac joint (SI) joint injection and\u002For lateral branch blocks corresponding to the expected duration of the medication utilized. (i.e SI joint injection-expected pain relief duration of steroid, lateral branch blocks-expected pain relief duration of local anesthetic utilized).\n9. All other possible sources of low back pain have been ruled out as the primary pain generator, including but not limited to: the intervertebral discs, bone fracture, the zygapophyseal joints, the hip joint, symptomatic spondylolisthesis, tumor, and other regional soft tissue structures (this is done by physical exam, medical history, and MRI\u002FCT\u002FX-ray as required)\n10. Patients with NRS (0-10 scale) LBP average score ≥ 4\n11. Patients with chronic LBP for at least 12 months.\n12. Patients with Oswestry Disability Questionnaire (ODQ) for LBP score \\> 40%\n\nExclusion Criteria:\n\n1. Patients on dialysis\n2. Patients with evidence of lumbosacral radiculopathy on MRI, CT or physical exam findings, including radicular leg pain (symptomatic moderate or severe foraminal or central canal stenosis).\n3. Spinal pathology that may impede recovery such as spina bifida occulta, grade II or higher.\n4. Spondylolisthesis at L5\u002FS1, or scoliosis\n5. Patients with radiofrequency ablation (RF\u002FRFA) treatment for sacroiliitis LBP\n6. Patients with bilateral sacroiliitis LBP\n7. Patients with previous low back surgery\n8. Patients who are pregnant\n9. Patients with existing malignancy\n10. Patients with allergies to relevant anesthetics\n11. Patients with motor deficit or any other indication for surgical intervention\n12. Patients with contraindications for MRI\n13. Patients with an acute medical condition (e.g., pneumonia, sepsis, systemic infection, uncontrolled immunosuppression-AIDS, cancer, DM) that is expected to hinder them from completing this study.\n14. Patients with unstable cardiac status including:\n15. Unstable angina pectoris on medication\n16. Patients with documented myocardial infarction less than 40 days prior to protocol enrolment\n17. Patients with Severe Congestive Heart Failure, New York Heart Association (NYHA) class 4.\n18. Patients on anti-arrhythmic drugs or with uncontrolled and\u002For untreated arrhythmia status\n19. Patients with severe cerebrovascular disease (CVA within last 6 months)\n20. Patients with severe hypertension (diastolic BP \\> 100 on medication)\n21. Patient Body Mass Index \\> 45 or \\\u003C20\n22. Patients with known intolerance or allergies to the MRI contrast agent (e.g. Gadolinium or Magnevist) including advanced kidney disease\n23. Patients with an active infection or severe hematological, neurological, or other uncontrolled disease.\n24. The patient is unable to communicate with the investigator and staff.\n25. Patients who are not able or willing to tolerate the required prolonged stationary position during treatment (approximately 2 hours)\n26. Patient with acute pelvic inflammatory conditions\n27. Ongoing\u002F unresolved Worker's compensation, injury litigation, military medical board, or disability remuneration claims\n28. Morphine Milligram Equivalents (MME) \\> 60 per 24 hrs.\n29. Patients with platelets \\\u003C 100.",{"count":56,"type":21},10,[24],"The Neurolyser XR is a device used to deliver high-intensity focused ultrasound for the ablation of the lateral sacral branch nerve in patients with Sacroiliitis.",[27],[61,62,34,63,64],"neurolysis","high-intensity focused ultrasound","neurotomy","sacral joint pain","RECRUITING","2025-05-19",{"date":68,"type":39},"2025-05-22",{"date":70,"type":39},"2024-09-13",{"date":72,"type":21},"2026-12-15",{"name":74,"class":75},"FUSMobile Inc.","INDUSTRY",{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":80,"acronym":4,"eligibilityCriteria":81,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":82,"targetDuration":4,"studyType":84,"phases":4,"briefSummary":85,"conditions":86,"keywords":90,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":105},"100460469","evaluation-of-the-ifuse-bedrock-technique-in-association-with-posterior-lumbosacral-fusion-with-iliac-fixation-100460469","NCT05276024","Evaluation of the IFuse Bedrock Technique in Association with Posterior Lumbosacral Fusion with Iliac Fixation.","Inclusion Criteria:\n\n* Subject scheduled for open posterior lumbosacral arthrodesis (including at least the following three vertebrae: L4, L5 and S1) associated with a sacroiliac fusion procedure and iliac fixation (thoracolumbar fusion procedures extended to sacrum are eligible in the study);\n* Insertion of at least 1 iFuse-3D implant according to the iFuse Bedrock technique (uni- and bilateral insertion are eligible);\n* Subject who preoperatively responded positively to pain provocation tests for SIJ dysfunction with or without a positive SIJ infiltration test;\n* Patient with a degenerative sacroiliac joint disease requested a fusion procedure;\n\nExclusion Criteria:\n\n* Major osteoporosis (DEXA scan \\> 3);\n* Any previous history of sacroiliac joint fusion or any surgical procedure involving a S2-iliac fusion;\n* Subjects requested a SIJ fusion without the iFuse-3D device or iFuse-3D not inserted according to the manufacturer instruction (Bedrock technique);\n* Subjects with a medical or surgical contraindication preventing the intervention from being performed or potentially interfering in the interpretation of the data collected (neurologic condition, local or systemic infection, any known allergy to surgical implants, psychiatric diseases, ...);\n* Currently pregnant or planning pregnancy;\n* Prisoner or a ward of the state;\n* Subject no willing to participate in the study;\n* Subject not affiliated to a social security insurance.",{"count":83,"type":21},50,"OBSERVATIONAL","The purpose of this study is to describe the impact of the iFuse Bedrock technique to decrease post-operative pains in patients who underwent multilevel posterior lumbosacral fusion.",[27,87,88,89],"Sacroiliac; Fusion","Lumbosacral; Fusion","Spine Deformity",[91,92,93,94,95],"Sacroiliac joint pain","Sacroiliac joint fusion","Bedrock technique","Open posterior lumbosacral fusion","Spine deformties","2024-11-06",{"date":98,"type":39},"2024-11-08",{"date":100,"type":39},"2022-06-10",{"date":102,"type":21},"2026-04-01",{"name":104,"class":46},"Polyclinique Bordeaux Nord Aquitaine",2]