[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"persistent-spinal-pain-syndrome-type-2-psps-t-lower-spine\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:persistent-spinal-pain-syndrome-type-2-psps-t-lower-spine":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,54],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":30,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":43,"startDateStruct":46,"completionDateStruct":48,"leadSponsor":50,"locationsCount":53},"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":21,"type":22},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.",[26,27,28,29],"Persistent Spinal Pain Syndrome Type 2 (PSPS-T) Lower Spine","Chronic Low Back Pain","Postoperative Pain","Lumbar Spine Surgery",[31,32,33,34,35,36,37,38,39,40],"predictive model","machine learning","random forest","LASSO regression","Modic changes","inflammatory biomarkers","pain catastrophizing","TRIPOD+AI","Venezuela","Latin America","NOT_YET_RECRUITING","2026-07-08",{"date":44,"type":45},"2026-07-10","ACTUAL",{"date":47,"type":22},"2026-09-04",{"date":49,"type":22},"2028-02-10",{"name":51,"class":52},"juan jose valero quintero,MD","OTHER",1,{"id":55,"slug":56,"hasResults":11,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":60,"eligibilityCriteria":61,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":62,"targetDuration":64,"studyType":23,"phases":4,"briefSummary":65,"conditions":66,"keywords":69,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":53},"100631586","evaluation-of-medication-tapering-on-the-sensitivity-of-the-spinal-cord-using-closed-loop-spinal-cord-stimulation-pilot-study-100631586","NCT07502612","Evaluation of Medication Tapering on the Sensitivity of the Spinal Cord Using Closed-Loop Spinal Cord Stimulation (Pilot Study)","Neurophysiological Effects of Pain Medication Reduction During Treatment With Closed-Loop Spinal Cord Stimulation: A Pilot Study","ECAP-MED Pilot","Inclusion Criteria:\n\n* Candidate for SCS and scheduled for trial with Evoke system.\n* Diagnosis of FBSS or FNSS (PSPS-T2).\n* Current use of ≥1 qualifying pain medication at or above minimum daily dose:\n* Gabapentin ≥150 mg\n* Pregabalin ≥75 mg\n* Morphine ≥40 mg\n* Hydromorphone ≥10 mg\n* Oxycodone ≥20 mg\n* Fentanyl ≥25 µg\n* Signed informed consent.\n* Age ≥18 years.\n\nExclusion Criteria:\n\n* Active disruptive psychiatric disorder or condition impacting pain perception or compliance.\n* Progressive neurological disease (MS, CIDP, progressive arachnoiditis, progressive diabetic neuropathy, brain\u002Fspinal tumor, severe spinal stenosis).\n* Coagulation disorder, platelet dysfunction, progressive vascular disease, or uncontrolled diabetes with procedural risk.\n* Active systemic or local infection.\n* Pregnancy.\n* Significant untreated addiction or substance abuse (within 6 months prior)",{"count":63,"type":22},20,"6 Months","This pilot study investigates the effects of reducing pain medication including opioids and anticonvulsants, on spinal cord sensitivity during closed-loop spinal cord stimulation (SCS). Patients with Persistent Spinal Pain Syndrome Type 2 (FBSS\u002FFNSS) will undergo a standard 21-day SCS trial with the Evoke closed-loop system, followed by permanent implantation if successful. Neurophysiological responses (activation plots, conduction velocity, chronaxie, rheobase) and patient-reported outcomes (VAS, activity, sleep, medication intake) will be collected during the trial and up to 6 months after implantation. The goal is to evaluate the relationship between medication tapering and spinal cord sensitivity",[67,26,68],"Failed Back Surgery Syndrome (FBSS)","Neurophysiological Sensitivity to Spinal Cord Stimulation",[70,71,72,73,74,75,76,77],"Spinal cord stimulation","Closed-loop stimulation","Evoked Compound Action Potentials (ECAPs)","Neurophysiology","Pain medication reduction","Neuromodulation","opioids","anticonvulsants","RECRUITING","2026-03-27",{"date":81,"type":45},"2026-03-31",{"date":83,"type":45},"2022-06-08",{"date":85,"type":22},"2026-08-28",{"name":87,"class":52},"Brai²n"]