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NCT Number: NCT07367191

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

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.

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Key information

Conditions

Lumbar Disc Herniation Bone Diseases Hernia Intervertebral Disc Displacement Lumbar Radiculopathy Mononeuropathies Musculoskeletal Diseases Nervous System Diseases Neuralgia Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Radicular Low Back Pain Radiculopathy Sciatic Neuropathy Sciatica Signs and Symptoms Spinal Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Marmara Üniversitesi Tıp Fakültesi, Istanbul, Maltepe 34854

Istanbul, Turkey (Türkiye)

Location contact

Secretary General Secretary

CONTACT

[email protected]

+90 2166254545

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transforaminal Epidural Steroid Injection

Procedure

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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).

  2. 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.

  3. 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.

  4. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Oguzhan Kasimoglu

CONTACT

[email protected]

+90 5448911835

Savas Sencan

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Marmara University

Other

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 26, 2026
Registry last updated
Jan 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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