SPINE-RISK VE: Multimodal Predictive Model for Failed Back Surgery Syndrome in Venezuelan Surgical Patients

Sponsor
juan jose valero quintero,MD
Study ID
NCT07693517
Status
Not Yet Recruiting

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Conditions

  • Chronic Low Back Pain
  • Lumbar Spine Surgery
  • Persistent Spinal Pain Syndrome Type 2 (PSPS-T) Lower Spine
  • Postoperative Pain

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • SPINE-RISK VE multimodal preoperative assessment — OTHER
    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

Study Details

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.

Key Dates

First listed
Jul 9, 2026
Start date
Sep 4, 2026
Status verified
Jul 2026
Primary completion
Nov 4, 2027
Completion
Feb 10, 2028

Study Design

Enrollment
150 participants (estimated)

Arms

  • Arm: Lumbar surgery candidates
    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.

Primary Outcome Measure

Predictive accuracy of SPINE-RISK VE model for PSPS-T2/FBSS at 12 months [ Time Frame: 12 months post-lumbar surgery ]

Central Contacts

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