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

Обзор

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.

Подробное описание

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.

Вмешательства

• Процедура 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.

Первичные конечные точки

• Role of Early Temporal Changes in Pain Response on Treatment Success [Срок оценки: Baseline to 6 months after transforaminal epidural steroid injection]

Вторичные конечные точки (4)

• Clinical Treatment Success at 3 Months [Срок оценки: 3 months after transforaminal epidural steroid injection]
• Clinical Treatment Success at 6 Months [Срок оценки: 6 months after transforaminal epidural steroid injection]
• Time to Maximum Pain Relief [Срок оценки: Up to 6 months after the procedure]
• Association Between Radiological Findings and Pain Response [Срок оценки: Baseline to 6 months]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Turkey (Türkiye) · 1 центр

• Marmara Üniversitesi Tıp Fakültesi, Istanbul, Maltepe 34854 — Istanbul

Идентификаторы

NCT: NCT07367191 · MarmaraU-FTR-OK-3

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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