[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100646096":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":23,"locations":34,"responsibleParty":60,"collaborators":10,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":70,"eligibilityCriteria":71,"healthyVolunteers":66,"sex":72,"minAge":73,"maxAge":74,"enrollmentInfo":75,"targetDuration":10,"studyType":78,"phases":10,"briefSummary":79,"conditions":80,"keywords":85,"overallStatus":95,"whyStopped":10,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":105},{"fullName":5,"class":6},"Universidad Central de Venezuela","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Lumbar surgery candidates",null,"Adult patients (18 years or older) with an indication for elective lumbar spine surgery (discectomy, spinal fusion, or decompression) for degenerative lumbar disease at three Venezuelan referrals centers. All participants undergo standardized preoperative assessment, including inflammatory laboratory biomarkers, lumbar MRI morphological evaluation, and validated psychosocial instruments (PHQ-9, PCS). The primary outcome assessed at 12-month postoperative follow-up.",[13],"Other: SPINE-RISK VE multimodal preoperative assessment",[15],{"type":6,"name":16,"description":17,"armGroupLabels":18,"otherNames":10},"SPINE-RISK VE multimodal preoperative assessment","Adult patients (18 years or older) with an indication for elective lumbar spine surgery (discectomy, spinal fusion, or decompression) for degenerative lumbar disease at three Venezuelan referral centers. All participants undergo standardized preoperative assessment, including inflammatory laboratory biomarkers, lumbar MRI morphological evaluation, and validated psychosocial instruments (PHQ-9, PCS). Primary outcome assessed at 12-month postoperative follow-up",[9],[20],{"name":21,"affiliation":5,"role":22},"juan j valero, Medical Doctor","PRINCIPAL_INVESTIGATOR",[24,30],{"name":25,"role":26,"phone":27,"phoneExt":28,"email":29},"juan j Valero, Medical Doctor","CONTACT","7868055589","00584224263876","juanjoseneuro@gmail.com",{"name":31,"role":26,"phone":32,"phoneExt":10,"email":33},"Fredy Contreras, PHD","00584149109021","sicontreras2009@gmail.com",[35],{"facility":36,"status":10,"city":37,"state":38,"zip":39,"country":40,"countryCode":10,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"Hopsital Universitario de Caracas","Caracas","Distrito Capitañ","1050","Venezuela",{"type":42,"coordinates":43},"Point",[44,45],-66.87919,10.48801,{"lat":45,"lon":44},[48,49,53,54,56,58],{"name":21,"role":26,"phone":27,"phoneExt":10,"email":29},{"name":50,"role":26,"phone":51,"phoneExt":10,"email":52},"Edicson j Cardenas, Nursing","00584241540328","edicsonjcardenas@gmail.com",{"name":21,"role":22,"phone":10,"phoneExt":10,"email":10},{"name":31,"role":55,"phone":10,"phoneExt":10,"email":10},"SUB_INVESTIGATOR",{"name":57,"role":55,"phone":10,"phoneExt":10,"email":10},"Hector r Aceituno, Medical doctor",{"name":59,"role":55,"phone":10,"phoneExt":10,"email":10},"Edicson j cardenas, Nursing",{"type":61,"investigatorFullName":62,"investigatorTitle":63,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"SPONSOR_INVESTIGATOR","juan jose valero quintero,MD","Principal Investigator, Neurosurgeon and Pain Medicine Specialist","100646096","spine-risk-ve-multimodal-predictive-model-for-failed-back-surgery-syndrome-in-venezuelan-surgical-patients-100646096",false,"NCT07693517","SPINE-RISK VE: Multimodal Predictive Model for Failed Back Surgery Syndrome in Venezuelan Surgical Patients","SPINE-RISK VE: Development and Internal Validation of a Multimodal Preoperative Predictive Model for Failed Back Surgery Syndrome Using Inflammatory Biomarkers, Lumbar MRI Findings, and Psychosocial Factors in Venezuelan Surgical Patients","SPINE-RISK VE","Inclusion Criteria:- Age 18 years or older\n\n* Confirmed indication for elective lumbar spine surgery (discectomy, spinal fusion, or decompression) for degenerative lumbar disease\n* Availability of preoperative lumbar MRI (with and without gadolinium contrast) within 6 months before surgery\n* Availability of standard preoperative laboratory panel (CRP, CBC with differential, albumin, HbA1c, ESR) within 30 days before surgery\n* Ability to complete validated psychosocial instruments (PHQ-9, PCS) in Spanish\n* Provision of written informed consent prior to any study procedure\n* Attending one of the three participating Venezuelan referral centers during the recruitment period\n\nExclusion Criteria:- Emergency lumbar spine surgery\n\n* Active spinal infection or spinal tumor requiring oncological surgery\n* Traumatic spinal fracture as primary indication\n* Cognitive impairment preventing completion of self-report psychosocial instruments\n* Active psychiatric emergency at time of preoperative assessment\n* Prior participation in another clinical trial that could influence surgical or pain outcomes\n* Inability to complete 12-month postoperative follow-up (geographic inaccessibility, planned relocation, or terminal illness)\n* Age under 18 years","ALL","18 Years","100 Years",{"count":76,"type":77},150,"ESTIMATED","OBSERVATIONAL","SPINE-RISK VE is a prospective multicenter cohort study designed to develop and internally validate a multimodal preoperative predictive model for Failed Back Surgery Syndrome (FBSS), now classified as Persistent Spinal Pain Syndrome Type 2 (PSPS-T2) per ICD-11 (code MG30.51), in Venezuelan adults patients undergoing elective lumbar spine surgery.\n\nThe model integrates three variable domains obtainable from routine preoperative evaluation at zero additional cost to the patient: (1) inflammatory laboratory biomarkers (C-reactive protein \\[CRP\\], neutrophil-to-lymphocyte ratio \\[NLR\\], albumin, glycated hemoglobin \\[HbA1c\\], erythrocyte sedimentation rate \\[ESR\\]); (2) preoperative lumbar magnetic resonance imaging (MRI) findings (Modic changes, Pfirrmann disc degeneration grade, foraminal stenosis, number of surgical levels, spondylolisthesis); and (3) validated psychosocial instruments (Patient Health Questionnaire-9 \\[PHQ-9\\], Pain Catastrophizing Scale \\[PCS\\], smoking status, benzodiazepine use, prior lumbar surgery).\n\nAnalysis proceeds in two phases: Phase 1 applies multivariable logistic regression with Least Absolute Shrinkage and Selection Operator (LASSO) variable selection to generate a printable clinical nomogram; Phase 2 applies a random forest machine learning algorithm with 10-fold cross-validation. Model reporting follows Transparent Reporting of a multivariable prediction model for Individual Prognosis Or Diagnosis plus Artificial Intelligence (TRIPOD+AI) guidelines.\n\nSPINE-RISK VE aims to produce the first validated multimodal predictive model for PSPS-T2\u002FFBSS was developed in a Latin American surgical cohort, providing neurosurgeons with an evidence-based preoperative risk stratification tool applicable without Additional technological infrastructure.",[81,82,83,84],"Persistent Spinal Pain Syndrome Type 2 (PSPS-T) Lower Spine","Chronic Low Back Pain","Postoperative Pain","Lumbar Spine Surgery",[86,87,88,89,90,91,92,93,40,94],"predictive model","machine learning","random forest","LASSO regression","Modic changes","inflammatory biomarkers","pain catastrophizing","TRIPOD+AI","Latin America","NOT_YET_RECRUITING","2026-07-08",{"date":98,"type":99},"2026-07-10","ACTUAL",{"date":101,"type":77},"2026-09-04",{"date":103,"type":77},"2028-02-10",{"name":62,"class":6},1]