ClinicalTrials.gg
Sign In
Not yet recruitingNCT07870720Updated Oct 13, 2026

Clinical and MRI Factors Associated With Procedural Difficulty in Lumbar TFESI

An observational study in Radiculopathy Lumbar, sponsored by Selcuk University. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-13.

Sponsored by Selcuk University · Observational

Updated Oct 13, 2026Newly registeredGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
190
Ages
18 Years and older
Sex
All
01

Study summary

The technical difficulty of transforaminal epidural steroid injection (TFESI) may be influenced by patient-related characteristics, the target spinal level, a history of lumbar surgery, the presence of spinal instrumentation, and degenerative or anatomical changes at the target level. The inability to predict procedural difficulty before the intervention may result in inefficient use of procedure-room time, fluoroscopy, and personnel resources. This prospective study will evaluate the associations between preprocedurally available clinical and magnetic resonance imaging (MRI) variables and objective measures of procedural difficulty.

Objectives

Primary Objective

To determine the associations between preprocedural clinical and magnetic resonance imaging (MRI) characteristics and standardized TFESI procedural time, and to identify independent predictors of procedural duration.

Secondary Objectives

  • To identify preprocedural factors associated with fluoroscopy time.
  • To identify factors associated with the number of fluoroscopic images acquired.
  • To identify factors associated with dose-area product/kerma-area product (DAP/KAP).
  • To identify factors associated with the number of major needle repositioning maneuvers and the need for additional skin puncture.
  • To evaluate differences in technical procedural outcomes among the L3-4, L4-5, and L5-S1 target levels.
  • If an adequate sample size and number of outcome events are available, to develop an exploratory TFESI Technical Difficulty Score.

Hypotheses

  • Higher body mass index (BMI) and greater skin-to-target distance are associated with longer procedural and fluoroscopy times.
  • More severe foraminal stenosis, reduced intervertebral disc height, advanced disc degeneration, and spondylolisthesis are associated with greater technical difficulty.
  • A history of lumbar spine surgery and instrumentation at the target level are associated with less favorable technical procedural outcomes.
  • The target spinal level is independently associated with procedural difficulty after adjustment for other clinical and imaging variables.
02

Conditions studied

  • Radiculopathy Lumbar
03

In context

Lead sponsor

Selcuk University is the lead sponsor of 255 studies on the registry; 66 are open to participants now.

Browse Selcuk University studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Consecutive adult patients scheduled to undergo clinically indicated unilateral, single-level lumbar transforaminal epidural steroid injection (TFESI) at the L3-4, L4-5, or L5-S1 neural foramen at the study center will be screened for eligibility. Participants must have an adequate preprocedural lumbar MRI available for analysis and provide written informed consent.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age 18 years or older.
  • A clinical indication for unilateral, single-level lumbar transforaminal epidural steroid injection (TFESI) based on routine clinical assessment.
  • Planned TFESI at the L3-4 neural foramen for the L3 nerve root, the L4-5 neural foramen for the L4 nerve root, or the L5-S1 neural foramen for the L5 nerve root.
  • Availability of a clinically adequate lumbar magnetic resonance imaging (MRI) study obtained before the procedure.
  • Provision of written informed consent.

Exclusion criteria

Exclusion Criteria:

  • Lumbar MRI of insufficient quality for the required measurements or classifications.
  • Inability to complete the procedure for reasons unrelated to technical difficulty, such as equipment malfunction or an acute clinical event.
  • Known or suspected pregnancy.
  • Withdrawal of consent or withdrawal from the study.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
190 participants (estimated)
Target follow-up
1 Day
Patient registry
Yes
06

What researchers measure

Primary outcomes

  1. Standardized TFESI Procedural Time

    he standardized technical procedural time for unilateral, single-level lumbar transforaminal epidural steroid injection (TFESI), measured in seconds from the predefined start of the procedure to the predefined completion point. The association of preprocedural clinical and MRI variables with procedural time will be evaluated, and independent predictors of longer procedural duration will be identified.

    Time frame: rom the predefined start to completion of the TFESI procedure, on the day of intervention

07

Study locations

No study locations are listed for this record.

08

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 13, 2026
Show all 1 update
  1. Oct 13, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07870720
Lead sponsor
Selcuk University
Responsible party
Ahmet Hilmi Gunuc (lecturer and pain medicine specialist, Selcuk University) — Principal investigator
First posted
Oct 13, 2026
Start date
Oct 9, 2026 (estimated)
Primary completion
Apr 8, 2027 (estimated)
Completion
Apr 30, 2027 (estimated)
Last update
Oct 13, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

Selcuk University →

Start the discussion