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New tool aims to predict failed back surgery before it happens

NCT ID NCT07693517

Knowledge-focused Sponsor: juan jose valero quintero,MD Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 09, 2026 · Last updated Jul 10, 2026 · Updated 1 time

Summary

This study aims to create a tool that predicts which patients are likely to have persistent pain after lumbar spine surgery, a condition known as failed back surgery syndrome. Researchers will combine routine blood tests, MRI scans, and psychological questionnaires from 150 adults in Venezuela who are scheduled for elective back surgery. The goal is to develop a risk score that surgeons can use to better counsel patients and plan treatment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could give surgeons a simple, low-cost way to identify patients at high risk for failed back surgery before they go under the knife.
What could go wrong
This is an early-stage model development study in a single country (Venezuela). The tool may not work as well in other populations or settings, and it does not test any treatment.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 150 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Feb 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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

Ages

18 to 100 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

complex regional pain syndrome type 2 lumbar disk degenerative disorder Pain, Postoperative

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic low back pain Lumbar spine surgery Persistent spinal pain syndrome type 2 (PSPS-T) lower spine Postoperative pain

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Hopsital Universitario de Caracas

    Caracas, Distrito Capitañ, 1050, Venezuela

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