Radiculopathy LumbarNCT07870720
Clinical and MRI Factors Associated With Procedural Difficulty in Lumbar TFESI
An observational study of Radiculopathy Lumbar, run by Selcuk University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Radiculopathy Lumbar
- How many people
- 190 participants
- Where
- No sites listed yet
- Study dates
- 9 Oct 2026to 30 Apr 2027
- How long will I take part?
- 1 Day
- Phase
- Observational
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: Evaluation of the Association Between Clinical and Magnetic Resonance Imaging Characteristics and Procedure Duration, Fluoroscopy Time, and Technical Difficulty in Lumbar Transforaminal Epidural Steroid Injection (TFESI): A Single-Center, Prospective Observational Cohort Study
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
Read more
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.
- Conditions
- Radiculopathy Lumbar
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: rom the predefined start to completion of the TFESI procedure, on the day of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2026
- Study start9 Oct 2026 (estimated)
- Primary completion8 Apr 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiculopathy LumbarStudies 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
- 190 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Selcuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmet Hilmi Gunuc, Selcuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07870720
- Sponsor's protocol ID
- 2026/644
- Status last verified
- Oct 2026
- First submitted
- 6 Oct 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No