The Role of Temporal Changes in Pain Response After Transforaminal Epidural Steroid Injection on Treatment Success

January 16, 2026 updated by: Marmara University

Transforaminal epidural steroid injection (TFESI) is a commonly used minimally invasive procedure for the treatment of lumbar radicular pain secondary to disc herniation. Although TFESI has been shown to provide significant pain relief in a substantial proportion of patients, the onset, duration, and temporal pattern of pain relief after the procedure vary considerably among individuals. The relationship between early pain response patterns and long-term treatment success remains poorly understood.

This prospective observational study aims to evaluate whether temporal changes in pain intensity following TFESI, particularly during the early post-procedural period, are associated with clinical treatment success at mid- and long-term follow-up. Pain intensity will be assessed using the Numeric Rating Scale (NRS) at predefined time points following the procedure, and treatment success will be defined as a ≥50% reduction in NRS score compared with baseline.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Transforaminal epidural steroid injection (TFESI) is widely utilized in patients with lumbar disc herniation-related radiculopathy who do not respond adequately to conservative treatment and are not immediate candidates for surgery. While previous studies have demonstrated the overall effectiveness of TFESI, there is limited evidence regarding the temporal characteristics of pain relief following the procedure and how these patterns influence long-term outcomes.

In routine clinical practice, patients may exhibit heterogeneous pain trajectories after TFESI, including early responders, delayed responders, transient responders, or those with minimal or no response. Identifying early pain response patterns that predict treatment success may help clinicians optimize patient counseling, follow-up strategies, and decisions regarding repeat interventions.

In this prospective observational cohort study, adult patients undergoing fluoroscopy-guided TFESI as part of routine clinical care will be followed longitudinally. Pain intensity will be assessed using the Numeric Rating Scale (NRS) before the procedure; at 1 hour post-procedure; every 72 hours during the first 21 days; and at 1, 3, and 6 months. Demographic data, clinical characteristics, and radiological findings from lumbar magnetic resonance imaging will be recorded.

The primary objective is to determine whether early temporal changes in pain intensity following TFESI are associated with treatment success at 3 months. Secondary objectives include evaluating treatment success at 6 months and identifying early pain response thresholds that predict favorable outcomes.

Study Type

Observational

Enrollment (Estimated)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study population consists of adult patients aged 18 to 65 years with lumbar disc herniation-related radiculopathy who are undergoing fluoroscopy-guided transforaminal epidural steroid injection as part of routine clinical care. All participants have clinically significant radicular pain with a pre-procedural Numeric Rating Scale (NRS) score of 4 or higher and lumbar disc herniation confirmed by magnetic resonance imaging (MRI) at a segmental level consistent with clinical findings.

Patients included in the study are those who have not achieved adequate symptom relief with conservative treatment modalities and are therefore referred for transforaminal epidural steroid injection by the algology clinic. Participants are prospectively followed after the procedure to evaluate temporal changes in pain intensity and their association with clinical treatment success.

Description

Inclusion Criteria:

  • Age between 18 and 65 years
  • Pre-procedural Numeric Rating Scale (NRS) pain score of 4 or higher
  • Presence of segmental lumbar disc herniation demonstrated on magnetic resonance imaging (MRI) consistent with clinical findings
  • Undergoing fluoroscopy-guided transforaminal epidural steroid injection due to insufficient response to conservative treatments, as determined by the algology clinic

Exclusion Criteria:

  • Presence of spondylolisthesis, scoliosis, or lumbar spinal stenosis accompanying lumbar disc herniation
  • Presence of malignancy
  • History of lumbar spine surgery for disc herniation
  • Transforaminal epidural steroid injection within the previous 6 months
  • Requirement for repeat epidural steroid injection during the data collection or follow-up period
  • Inability to be contacted for follow-up assessments by telephone

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients Receiving Treatment for Lumbar Disc Herniation-Related Radiculopathy
Adult patients with lumbar disc herniation-related radiculopathy undergoing routine fluoroscopy-guided transforaminal epidural steroid injection as part of standard clinical care, followed prospectively for pain outcomes.
Procedure: Transforaminal epidural steroid injection
Fluoroscopy-guided transforaminal epidural steroid injection performed as part of routine clinical care. After confirmation of correct needle placement with contrast medium and exclusion of intravascular uptake, a mixture of betamethasone, bupivacaine, and normal saline is injected slowly into the epidural space. This procedure is not assigned by the study and is performed according to standard clinical practice.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Role of Early Temporal Changes in Pain Response on Treatment Success
Time Frame: Baseline to 6 months after transforaminal epidural steroid injection

Association between temporal changes in pain response following transforaminal epidural steroid injection and clinical treatment success.

Pain intensity will be assessed using the Numeric Rating Scale (NRS) at baseline (pre-procedure), at 1 hour post-procedure via face-to-face assessment, every 72 hours during the first 21 days, and at 1, 3, and 6 months via telephone follow-up. Temporal patterns of pain response over these time points will be analyzed in relation to clinical treatment success, defined as a ≥50% reduction in NRS score at 3 months compared with baseline.Clinical treatment success is defined as a ≥50% reduction in NRS score at 3 months compared with baseline.
Baseline to 6 months after transforaminal epidural steroid injection

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Treatment Success at 3 Months
Time Frame: 3 months after transforaminal epidural steroid injection
Proportion of participants achieving a ≥50% reduction in Numeric Rating Scale (NRS) pain score at 3 months compared with baseline (pre-procedure).
3 months after transforaminal epidural steroid injection
Clinical Treatment Success at 6 Months
Time Frame: 6 months after transforaminal epidural steroid injection
Proportion of participants achieving a ≥50% reduction in Numeric Rating Scale (NRS) pain score at 6 months compared with baseline.
6 months after transforaminal epidural steroid injection
Time to Maximum Pain Relief
Time Frame: Up to 6 months after the procedure
Time (in days) from transforaminal epidural steroid injection to the lowest recorded Numeric Rating Scale (NRS) pain score during follow-up.
Up to 6 months after the procedure
Association Between Radiological Findings and Pain Response
Time Frame: Baseline to 6 months
Relationship between lumbar magnetic resonance imaging characteristics (disc herniation level, location, size, and nerve root compression) and temporal pain response patterns following transforaminal epidural steroid injection.
Baseline to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Marmara University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 15, 2026

Primary Completion (Estimated)

August 16, 2026

Study Completion (Estimated)

October 15, 2026

Study Registration Dates

First Submitted

January 16, 2026

First Submitted That Met QC Criteria

January 16, 2026

First Posted (Actual)

January 26, 2026

Study Record Updates

Last Update Posted (Actual)

January 26, 2026

Last Update Submitted That Met QC Criteria

January 16, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MarmaraU-FTR-OK-3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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