[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100573424":3},{"organization":4,"armGroups":7,"interventions":8,"overallOfficials":7,"centralContacts":13,"locations":7,"responsibleParty":22,"collaborators":7,"id":24,"slug":25,"hasResults":26,"nctId":27,"briefTitle":28,"officialTitle":29,"acronym":30,"eligibilityCriteria":31,"healthyVolunteers":26,"sex":32,"minAge":33,"maxAge":7,"enrollmentInfo":34,"targetDuration":7,"studyType":37,"phases":7,"briefSummary":38,"conditions":39,"keywords":7,"overallStatus":41,"whyStopped":7,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":43,"startDateStruct":46,"completionDateStruct":48,"leadSponsor":50,"locationsCount":7},{"fullName":5,"class":6},"AO Foundation, AO Spine","OTHER",null,[9],{"type":10,"name":11,"description":12,"armGroupLabels":7,"otherNames":7},"PROCEDURE","Surgery","Surgery may be instrumented stabilization surgery alone, instrumented stabilization and decompression, or decompression surgery alone.",[14,19],{"name":15,"role":16,"phone":17,"phoneExt":7,"email":18},"Janneke Loomans","CONTACT","0798746348","janneke.loomans@aofoundation.org",{"name":20,"role":16,"phone":7,"phoneExt":7,"email":21},"Felix Thomas","felix.thomas@aofoundation.org",{"type":23,"investigatorFullName":7,"investigatorTitle":7,"investigatorAffiliation":7,"oldNameTitle":7,"oldOrganization":7},"SPONSOR","100573424","relieve-research-on-effectiveness-of-surgery-and-radiotherapy-on-relieving-spine-tumor-pain-in-patients-with-vertebral-metastases-100573424",false,"NCT06746103","RELIEVE: Research on Effectiveness of Surgery and Radiotherapy on Relieving Spine Tumor Pain in Patients with Vertebral Metastases","RELIEVE Research on Effectiveness of Surgery and Radiotherapy on Relieving Spine Tumor Pain in Patients with Vertebral Metastases","RELIEVE","Inclusion Criteria:\n\n* Age 18 years and older\n* Patients diagnosed with metastatic spinal tumors with one index metastatic site that, confirmed by the treating clinicians, is causing spine pain\n* Patients experience at least one type of pain that is of interest of this study, namely, axial non-triggered pain, axial triggered\u002Fmechanical pain, radicular non-triggered pain, and radicular triggered\u002Fmechanical pain\n* At least one type of the pain experienced has an NRS \\> 4 of 10\n* Patients undergoing surgery and\u002For radiotherapy\n\n  * Surgery may be instrumented stabilization surgery alone, instrumented stabilization and decompression, or decompression surgery alone.\n  * Percutaneous screw fixation counts as instrumented stabilization surgery.\n  * Any kind of radiotherapy is includable.\n* Ability to provide informed consent according to the IRB\u002FEC defined and approved procedures\n\nExclusion Criteria:\n\n* Estimated survival \\\u003C 3 months\n* Patients with more than one symptomatic spine metastasis site\n\n  o An example is a patient with two metastasis sites: a lumbar metastasis (causing vertebral fracture and epidural compression leading to mechanical lower back pain and static radicular pain to legs) and a cervical metastasis (causing tumor-related pain at the neck).\n* Patients with other sources of pain that may confound the measurement of the primary outcome\n\n  o An example is a patient with liver metastasis which causes visceral pain that can confound the thoracic spinal pain caused by the spinal metastasis.\n* Patients undergoing the following treatments alone without the surgeries listed in the inclusion criteria or radiotherapy\n\n  * Cement augmentation, vertebroplasty, kyphoplasty, and other emerging interventions such as local ablative technique\n  * Chemotherapy or systemic therapy alone","ALL","18 Years",{"count":35,"type":36},250,"ESTIMATED","OBSERVATIONAL","This is a prospective, multicenter, observational study focusing on assessing and managing pain in patients with metastatic spinal tumors. Pain from spinal metastases adversely impacts quality of life, function, and treatment outcomes. Advances in surgical techniques have shown significant benefits. However, previous studies either lacked nuanced differentiations or simply categorized pain as mechanical or non-mechanical; explaining the highly variable pain outcome measurements in these studies. This study employs the AO Spine Cancer-Related Pain Classification to better categorize neoplastic spinal pain by etiology.",[40],"Spinal Metastasis","NOT_YET_RECRUITING","2024-12-17",{"date":44,"type":45},"2024-12-24","ACTUAL",{"date":47,"type":36},"2025-03-31",{"date":49,"type":36},"2027-11-30",{"name":5,"class":6}]