SPINE-RISK VE: Multimodal Predictive Model for Failed Back Surgery Syndrome in Venezuelan Surgical Patients
Not yet recruitingNCT07693517
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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. The 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). Analysis 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. SPINE-RISK VE aims to produce the first validated multimodal predictive model for PSPS-T2/FBSS was developed in a Latin American surgical cohort, providing neurosurgeons with an evidence-based preoperative risk stratification tool applicable without Additional technological infrastructure.
Study details
- Official title
- 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
- Conditions
- Persistent Spinal Pain Syndrome Type 2 (PSPS-T) Lower Spine
- Chronic Low Back Pain
- Postoperative Pain
- Lumbar Spine Surgery
- Interventions
- Other: SPINE-RISK VE multimodal preoperative assessment
- Sponsor
- juan jose valero quintero,MD
- Organization
- Universidad Central de Venezuela
- Start date
- 2026-09-04
- Primary completion
- 2027-11-04
- Sex
- All
- Age range
- from 18 Years to 100 Years
- Results posted
- No results posted in this snapshot
- Countries
- Venezuela
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria:- Age 18 years or older * Confirmed indication for elective lumbar spine surgery (discectomy, spinal fusion, or decompression) for degenerative lumbar disease * Availability of preoperative lumbar MRI (with and without gadolinium contrast) within 6 months before surgery * Availability of standard preoperative laboratory panel (CRP, CBC with differential, albumin, HbA1c, ESR) within 30 days before surgery * Ability to complete validated psychosocial instruments (PHQ-9, PCS) in Spanish * Provision of written informed consent prior to any study procedure * Attending one of the three participating Venezuelan referral centers during the recruitment period Exclusion Criteria:- Emergency lumbar spine surgery * Active spinal infection or spinal tumor requiring oncological surgery * Traumatic spinal fracture as primary indication * Cognitive impairment preventing completion of self-report psychosocial instruments * Active psychiatric emergency at time of preoperative assessment * Prior participation in another clinical trial that could influence surgical or pain outcomes * Inability to complete 12-month postoperative follow-up (geographic inaccessibility, planned relocation, or terminal illness) * Age under 18 years
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT07693517