The Role of Temporal Changes in Pain Response After Transforaminal Epidural Steroid Injection on Treatment Success
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorMarmara University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Transforaminal epidural steroid injection
Procedure/SurgeryFluoroscopy-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.
Treatment groups
120 Participants
are divided into 1 treatment groupGroup A: Patients Receiving Treatment for Lumbar Disc Herniation-Related Radiculopathy1 intervention
Trial outcomes
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.
Time frame
Baseline to 6 months after transforaminal epidural steroid injectionSecondary outcomes
1
Clinical Treatment Success at 3 Months
Proportion of participants achieving a ≥50% reduction in Numeric Rating Scale (NRS) pain score at 3 months compared with baseline (pre-procedure).
Time frame
3 months after transforaminal epidural steroid injection2
Clinical Treatment Success at 6 Months
Proportion of participants achieving a ≥50% reduction in Numeric Rating Scale (NRS) pain score at 6 months compared with baseline.
Time frame
6 months after transforaminal epidural steroid injection3
Time to Maximum Pain Relief
Time (in days) from transforaminal epidural steroid injection to the lowest recorded Numeric Rating Scale (NRS) pain score during follow-up.
Time frame
Up to 6 months after the procedure4
Association Between Radiological Findings and Pain Response
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.
Time frame
Baseline to 6 monthsSponsors and contacts
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Source ClinicalTrials.gov
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