An observational study in Persistent Spinal Pain Syndrome Type 2 (PSPS-T) Lower Spine, Chronic Low Back Pain and Postoperative Pain, sponsored by juan jose valero quintero,MD. Not yet recruiting at 1 site in Venezuela. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-07-10.
Sponsored by juan jose valero quintero,MD · 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.
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.
Failed Back Surgery Syndrome (FBSS), formally reclassified as Persistent Spinal Pain Syndrome Type 2 (PSPS-T2) in ICD-11 (code MG30.51), affects 10-40% of patients undergoing lumbar spine surgery and constitutes one of the most complex therapeutic challenges in contemporary neurosurgery. Despite the identification of individual risk factors in the literature, no validated multimodal predictive model integrating laboratory biomarkers, lumbar magnetic resonance imaging (MRI) morphology, and psychosocial variables exist for Latin American surgical populations.
The best available predictive model to date achieved Area Under the Receiver Operating Characteristic Curve (AUC) of 0.715 for decompression and 0.701 for fusion using only electronic health record variables, without laboratory biomarkers or MRI-derived predictors, and without validation in any Latin American cohort. SPINE-RISK VE addresses this gap through a prospective multicenter cohort design enrolling 100-150 adults with Elective lumbar surgery indication at three Venezuelan referral centers.
PREDICTOR DOMAINS:
Domain 1 - Inflammatory biomarkers:
C-reactive protein (CRP greater than 3 mg/L), neutrophil-to-lymphocyte ratio (NLR greater than 3.0), serum albumin (less than 3.5 g/dL), glycated hemoglobin (HbA1c greater than 7%), and erythrocyte sedimentation rate (ESR). All obtainable from standard preoperative Laboratory panels.
Domain 2 - Lumbar MRI findings: Modic changes (Types I-III), disc degeneration grade (Pfirrmann scale I-V), foraminal stenosis, number of surgical levels, and Spondylolisthesis grade (Meyerding I-IV). All from already-requested preoperative imaging.
Domain 3 - Psychosocial factors: depression (Patient Health Questionnaire-9 [PHQ-9] cutoff of 10 or greater), pain catastrophizing (Pain Catastrophizing Scale [PCS] cutoff of 30 or greater, active smoking, preoperative benzodiazepine use, and prior lumbar surgery history.
PRIMARY OUTCOME: PSPS-T2/FBSS incidence at 12 months, defined as the Numeric Rating Scale (NRS) of 4 or greater AND Oswestry Disability Index (ODI) of 40% or greater at postoperative follow-up, consistent with International Association for the Study of Pain (IASP) criteria.
ANALYTICAL PLAN:
Phase 1: Multivariable logistic regression with Least Absolute Shrinkage and Selection Operator (LASSO) regularization to identify independent predictors and generate a Printable clinical nomogram. Software: R Version 4.x (glmnet, rms packages).
Phase 2: Random forest (500 trees, 10-fold cross-validation) compared against Extreme Gradient Boosting (XGBoost) and logistic regression. Performance metrics: AUC-ROC (target 0.80 or greater), sensitivity, specificity, calibration (Hosmer-Lemeshow test, Brier score). Model interpretability via SHapley Additive exPlanations (SHAP) values.
REPORTING: Transparent Reporting of a multivariable prediction model for an individual Prognosis Or Diagnosis plus Artificial Intelligence (TRIPOD+AI) 2024 and Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) guidelines.
EXPECTED OUTPUTS: (1) Printable preoperative nomogram applicable without additional technological infrastructure; (2) exportable machine learning (ML) model with AUC target of 0.80 or greater; (3) first structured lumbar surgery database with 12-month Follow-up generated in Venezuela.
5,640 studies on the registry are indexed under Pain, Postoperative; 1,230 are open to participants now.
This study's planned enrollment of 150 is above the median of 102 across 683 observational studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →This is the only study on the registry with juan jose valero quintero,MD as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Adult patients with degenerative lumbar spine disease undergoing elective lumbar surgery (discectomy, spinal fusion, or decompression) at three Venezuelan referral centers: Hospital Universitario de Caracas and two regional Neurosurgical referral centers in Venezuela. Consecutive recruitment during the study period. This population represents a low-middle income country (LMIC) Latin American surgical cohort not previously represented in published predictive models for PSPS-T2/FBSS
Inclusion Criteria:- Age 18 years or older
Exclusion Criteria:- Emergency lumbar spine surgery
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Other: 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
Predictive accuracy of SPINE-RISK VE model for PSPS-T2/FBSS at 12 months
Area Under the Receiver Operating Characteristic Curve (AUC-ROC) of the multimodal predictive model (Phase 1: LASSO logistic regression nomogram; Phase 2: random forest algorithm) for identifying patients who develop Persistent Spinal Pain Syndrome Type 2 (PSPS-T2/FBSS) at 12 months post-lumbar surgery, defined as NRS \>=4 AND ODI \>=40% at postoperative follow-up assessment. Target AUC \>=0.80 per Riley et al. (Stat Med 2020) Minimum criteria for clinical prediction models.
Time frame: 12 months post-lumbar surgery
Plan to share: No — Individual participant data (IPD) will not be shared. This study collects sensitive clinical and psychosocial data from Venezuelan patients In a low-resource setting. The research team does not have access to formal data repository infrastructure for anonymized IPD sharing that meets international data protection standards. Aggregate study results and the derived predictive model (nomogram and machine learning algorithm) will be made publicly available through peer-reviewed publication In an indexed journal.
Start is estimated for Sep 2026; primary completion for Nov 2027, 14 months later.
Of 391 non-industry observational studies under Pain, Postoperative, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 32. This study's planned 14 months is close to that.
Counting every sponsor, half of 395 studies reached it within 13 months; a quarter within 5 and three quarters within 33.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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