Persistent Spinal Pain Syndrome Type 2 (PSPS-T) Lower SpineSPINE-RISK VENCT07693517
SPINE-RISK VE: Multimodal Predictive Model for Failed Back Surgery Syndrome in Venezuelan Surgical Patients
An observational study of Persistent Spinal Pain Syndrome Type 2 (PSPS-T) Lower Spine and Chronic Low Back Pain, run by juan jose valero quintero,MD at 1 site in Venezuela.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Persistent Spinal Pain Syndrome Type 2 (PSPS-T) Lower Spine, Chronic Low Back Pain, Postoperative Pain
- What is being tested?
- SPINE-RISK VE multimodal preoperative assessment
- How many people
- 150 participants
- Where
- 1 siteVenezuela
- Study dates
- 4 Sep 2026to 10 Feb 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Venezuela1 site
Hopsital Universitario de Caracas
Caracas, Distrito Capitañ, 1050
juan j valero, Medical Doctor, 7868055589, juanjoseneuro@gmail.com
Edicson j Cardenas, Nursing, 00584241540328, edicsonjcardenas@gmail.com
About this study
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
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).
Read more
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.
Read the detailed description
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.
- Conditions
- Persistent Spinal Pain Syndrome Type 2 (PSPS-T) Lower Spine, Chronic Low Back Pain, Postoperative Pain, Lumbar Spine Surgery
- Being tested
- SPINE-RISK VE multimodal preoperative assessment
- Keywords
- predictive model, machine learning, random forest, LASSO regression, Modic changes, inflammatory biomarkers, pain catastrophizing, TRIPOD+AI, Venezuela, Latin America
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPINE-RISK VE multimodal preoperative assessmentOther
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: SPINE-RISK VE multimodal preoperative assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months post-lumbar surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2026
- Study start4 Sep 2026 (estimated)
- Primary completion4 Nov 2027 (estimated)
- Study completion10 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Persistent Spinal Pain Syndrome Type 2 (PSPS-T) Lower SpineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- juan jose valero quintero,MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, juan jose valero quintero,MD, Universidad Central de Venezuela
- Investigators
- juan j valero, Medical Doctor, Principal investigator, Universidad Central de Venezuela
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07693517
- Sponsor's protocol ID
- SPINE-RISK-VE-2026-001
- Acronym
- SPINE-RISK VE
- Status last verified
- Jul 2026
- First submitted
- 3 Jul 2026
- Last updated
- 10 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
von Elm E, Altman DG, Egger M, Pocock SJ, Gotzsche PC, Vandenbroucke JP; STROBE Initiative. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies. Prev Med. 2007 Oct;45(4):247-51. doi: 10.1016/j.ypmed.2007.08.012. Epub 2007 Sep 4.
PubMed 17950122Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
PubMed 11556941Riley RD, Snell KI, Ensor J, Burke DL, Harrell FE Jr, Moons KG, Collins GS. Minimum sample size for developing a multivariable prediction model: PART II - binary and time-to-event outcomes. Stat Med. 2019 Mar 30;38(7):1276-1296. doi: 10.1002/sim.7992. Epub 2018 Oct 24.
PubMed 30357870Collins GS, Moons KGM, Dhiman P, Riley RD, Beam AL, Van Calster B, Ghassemi M, Liu X, Reitsma JB, van Smeden M, Boulesteix AL, Camaradou JC, Celi LA, Denaxas S, Denniston AK, Glocker B, Golub RM, Harvey H, Heinze G, Hoffman MM, Kengne AP, Lam E, Lee N, Loder EW, Maier-Hein L, Mateen BA, McCradden MD, Oakden-Rayner L, Ordish J, Parnell R, Rose S, Singh K, Wynants L, Logullo P. TRIPOD+AI statement: updated guidance for reporting clinical prediction models that use regression or machine learning methods. BMJ. 2024 Apr 16;385:e078378. doi: 10.1136/bmj-2023-078378.
PubMed 38626948Xu W, Ran B, Zhao J, Luo W, Gu R. Risk factors for failed back surgery syndrome following open posterior lumbar surgery for degenerative lumbar disease. BMC Musculoskelet Disord. 2022 Dec 31;23(1):1141. doi: 10.1186/s12891-022-06066-2.
PubMed 36585650Hajilo P, Imani B, Zandi S, Mehrafshan A, Khazaei S. Risk factors analysis and risk prediction model for failed back surgery syndrome: A prospective cohort study. Heliyon. 2024 Nov 22;11(1):e40607. doi: 10.1016/j.heliyon.2024.e40607. eCollection 2025 Jan 15.
PubMed 39866404Khazanchi R, Kumar D, Oris RJ, Bajaj A, Herrera DE, Chen AR, Shah RM, Asthana S, Reyes SG, Bajaj P, Hsu WK, Patel AA, Divi SN. Identifying Predictors of Failed Back Surgery Syndrome Following Lumbar Spine Surgery: A Machine Learning Approach. Spine (Phila Pa 1976). 2026 May 15;51(10):736-742. doi: 10.1097/BRS.0000000000005411. Epub 2025 May 29.
PubMed 40443211
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07693517
- Acronym / sponsor ID
- SPINE-RISK VE / SPINE-RISK-VE-2026-001
- Conditions
- Persistent Spinal Pain Syndrome Type 2 (PSPS-T) Lower Spine, Chronic Low Back Pain, Postoperative Pain, Lumbar Spine Surgery
- Keywords
- predictive model, machine learning, random forest, LASSO regression, Modic changes, inflammatory biomarkers, pain catastrophizing, TRIPOD+AI
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- juan jose valero quintero,MDUniversity, hospital or other
- Study start
- 4 Sep 2026 (estimated)
- Primary completion
- 4 Nov 2027 (estimated)
- Study completion
- 10 Feb 2028 (estimated)
- First posted
- 9 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lumbar surgery candidates | – | Other: SPINE-RISK VE multimodal preoperative assessmentAdult 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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SPINE-RISK VE multimodal preoperative assessmentAdult 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 | Other | Lumbar surgery candidates |
Primary outcome
Predictive accuracy of SPINE-RISK VE model for PSPS-T2/FBSS at 12 months
Time frame: 12 months post-lumbar surgery
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2026.
- Results publication: PubMed 17950122von Elm E, Altman DG, Egger M, Pocock SJ, Gotzsche PC, Vandenbroucke JP; STROBE Initiative. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies. Prev Med. 2007 Oct;45(4):247-51. doi: 10.1016/j.ypmed.2007.08.012. Epub 2007 Sep 4.
- Results publication: PubMed 11556941Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
- Results publication: PubMed 30357870Riley RD, Snell KI, Ensor J, Burke DL, Harrell FE Jr, Moons KG, Collins GS. Minimum sample size for developing a multivariable prediction model: PART II - binary and time-to-event outcomes. Stat Med. 2019 Mar 30;38(7):1276-1296. doi: 10.1002/sim.7992. Epub 2018 Oct 24.
- Results publication: PubMed 38626948Collins GS, Moons KGM, Dhiman P, Riley RD, Beam AL, Van Calster B, Ghassemi M, Liu X, Reitsma JB, van Smeden M, Boulesteix AL, Camaradou JC, Celi LA, Denaxas S, Denniston AK, Glocker B, Golub RM, Harvey H, Heinze G, Hoffman MM, Kengne AP, Lam E, Lee N, Loder EW, Maier-Hein L, Mateen BA, McCradden MD, Oakden-Rayner L, Ordish J, Parnell R, Rose S, Singh K, Wynants L, Logullo P. TRIPOD+AI statement: updated guidance for reporting clinical prediction models that use regression or machine learning methods. BMJ. 2024 Apr 16;385:e078378. doi: 10.1136/bmj-2023-078378.
- Results publication: PubMed 36585650Xu W, Ran B, Zhao J, Luo W, Gu R. Risk factors for failed back surgery syndrome following open posterior lumbar surgery for degenerative lumbar disease. BMC Musculoskelet Disord. 2022 Dec 31;23(1):1141. doi: 10.1186/s12891-022-06066-2.
- Results publication: PubMed 39866404Hajilo P, Imani B, Zandi S, Mehrafshan A, Khazaei S. Risk factors analysis and risk prediction model for failed back surgery syndrome: A prospective cohort study. Heliyon. 2024 Nov 22;11(1):e40607. doi: 10.1016/j.heliyon.2024.e40607. eCollection 2025 Jan 15.
- Results publication: PubMed 40443211Khazanchi R, Kumar D, Oris RJ, Bajaj A, Herrera DE, Chen AR, Shah RM, Asthana S, Reyes SG, Bajaj P, Hsu WK, Patel AA, Divi SN. Identifying Predictors of Failed Back Surgery Syndrome Following Lumbar Spine Surgery: A Machine Learning Approach. Spine (Phila Pa 1976). 2026 May 15;51(10):736-742. doi: 10.1097/BRS.0000000000005411. Epub 2025 May 29.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
juan j valero, Medical Doctor principal investigator
Universidad Central de Venezuela
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Persistent Spinal Pain Syndrome Type 2 (PSPS-T) Lower Spine and Chronic Low Back Pain, run by juan jose valero quintero,MD at 1 site in Venezuela.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Venezuela. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact juan j Valero, Medical Doctor (7868055589 ext. 00584224263876, juanjoseneuro@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Predictive accuracy of SPINE-RISK VE model for PSPS-T2/FBSS at 12 months (time frame: 12 months post-lumbar surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07693517, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2026; AzTrials last refreshed its copy on 26 Oct 2026.