The Role of Temporal Changes in Pain Response After Transforaminal Epidural Steroid Injection on Treatment Success
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Role of Early Temporal Changes in Pain Response on Treatment Success
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Transforaminal epidural steroid injection (Procedure)
结局指标
主要结局
Role of Early Temporal Changes in Pain Response on Treatment Success
时间窗: 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.
次要结局
- 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)