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

NCT07367191 | Not Yet Recruiting

• 1 other identifier: MarmaraU-FTR-OK-3
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lumbar Radiculopathy; Radicular Low Back Pain; Sciatica; Lumbar Disc Herniation

Keywords

TFESI; Temporal Pain Response; Numeric Rating Scale; NRS; Transforaminal Epidural Steroid Injection; Treatment Success

Outcome Measures

Primary Outcomes (1)

• Role of Early Temporal Changes in Pain Response on Treatment Success

  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 Outcomes (4)

• Clinical Treatment Success at 3 Months

  3 months after transforaminal epidural steroid injection

• Clinical Treatment Success at 6 Months

  6 months after transforaminal epidural steroid injection

• Time to Maximum Pain Relief

  Up to 6 months after the procedure

• Association Between Radiological Findings and Pain Response

  Baseline to 6 months

Study Arms (1)

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

Interventions

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.

Patients Receiving Treatment for Lumbar Disc Herniation-Related Radiculopathy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Marmara Üniversitesi Tıp Fakültesi, Istanbul, Maltepe 34854

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Intervertebral Disc Displacement; Radiculopathy; Sciatica

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Sciatic Neuropathy; Mononeuropathies; Neuralgia; Pain; Neurologic Manifestations; Signs and Symptoms

Central Study Contacts

Oguzhan Kasimoglu

CONTACT

+90 5448911835; kasimogluoguzhan@gmail.com

Savas Sencan

CONTACT

savas-44@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2026
• First Posted: January 26, 2026
• Study Start: February 15, 2026
• Primary Completion (Estimated): August 16, 2026
• Study Completion (Estimated): October 15, 2026
• Last Updated: January 26, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)