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临床试验/NCT07509580
NCT07509580进行中(未招募)不适用

Comparison of Treatment Response to Transforaminal Epidural Steroid Injection and Dorsal Root Ganglion Pulsed Radiofrequency in Patients With Lumbar Spinal Stenosis and Lumbar Disc Herniation

Marmara University1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2024年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
200
试验地点
1
主要终点
Comparison of change in pain intensity (Numeric Rating Scale, NRS) between lumbar disc herniation and lumbar spinal stenosis

研究概览

简要总结

Lumbar radiculopathy caused by conditions such as lumbar disc herniation (LDH) and lumbar spinal stenosis (LSS) can lead to chronic pain and reduced quality of life. In patients who do not respond to conservative treatments, minimally invasive procedures such as transforaminal epidural steroid injection (TFESI) and pulsed radiofrequency (pRF) applied to the dorsal root ganglion (DRG) are commonly used.

This study aims to compare treatment responses between patients with lumbar disc herniation and those with lumbar spinal stenosis who have undergone TFESI combined with dorsal root ganglion pulsed radiofrequency. Pain levels and clinical outcomes will be evaluated to determine whether the underlying condition affects treatment effectiveness.

The results of this study may help guide clinicians in selecting the most appropriate treatment approach for patients with lumbar radiculopathy.

详细描述

Lumbar radiculopathy is a common clinical condition associated with degenerative spine disorders such as lumbar disc herniation (LDH) and lumbar spinal stenosis (LSS), often resulting in chronic pain and functional limitation. In patients who do not respond adequately to conservative management, minimally invasive interventional procedures are frequently employed. Among these, transforaminal epidural steroid injection (TFESI) and pulsed radiofrequency (pRF) applied to the dorsal root ganglion (DRG) are widely used for pain control.

Pulsed radiofrequency (pRF) is thought to exert its analgesic effect through neuromodulatory mechanisms rather than neurodestruction, including modulation of nociceptive transmission and reduction of neuroinflammatory processes. When combined with transforaminal epidural steroid injection (TFESI), these interventions may provide enhanced clinical benefit.

Despite the increasing use of combined TFESI and dorsal root ganglion (DRG) pulsed radiofrequency (pRF), there is limited evidence comparing treatment responses across different etiological subgroups. The pathophysiological mechanisms underlying lumbar disc herniation (LDH) and lumbar spinal stenosis (LSS) differ, with LDH typically involving focal nerve root irritation and LSS characterized by chronic compression and ischemic changes. These differences may influence the effectiveness of interventional treatments.

This retrospective study aims to evaluate treatment outcomes in patients who underwent transforaminal epidural steroid injection (TFESI) combined with dorsal root ganglion (DRG) pulsed radiofrequency (pRF), by categorizing them into two groups based on underlying etiology: lumbar disc herniation and lumbar spinal stenosis. Changes in pain intensity and clinical outcomes will be compared between these groups. The findings are expected to contribute to a better understanding of patient selection and optimization of interventional pain management strategies.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age between 18 and 75 years
  • Presence of symptoms associated with lumbar spinal stenosis or lumbar disc herniation
  • Symptom duration of at least 3 months
  • Having undergone lumbar transforaminal epidural corticosteroid injection and dorsal root ganglion pulsed radiofrequency

排除标准

  • Absence of sufficient records in the hospital system
  • Inaccessibility of radiological imaging

研究组 & 干预措施

Lumbar Disc Herniation

Patients diagnosed with lumbar disc herniation (LDH) who underwent transforaminal epidural steroid injection (TFESI) and dorsal root ganglion (DRG) pulsed radiofrequency (pRF).

Lumbar Spinal Stenosis

Patients diagnosed with lumbar spinal stenosis (LSS) who underwent transforaminal epidural steroid injection (TFESI) and dorsal root ganglion (DRG) pulsed radiofrequency (pRF).

结局指标

主要结局

Comparison of change in pain intensity (Numeric Rating Scale, NRS) between lumbar disc herniation and lumbar spinal stenosis

时间窗: Baseline, 1 hour, and 3 weeks post-procedure

Pain intensity will be assessed using the Numeric Rating Scale (0-10), and changes from baseline at 1 hour and 3 weeks post-procedure will be compared between patients with lumbar disc herniation and lumbar spinal stenosis.

次要结局

  • Radiological severity grading(Baseline (based on pre-procedural MRI))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Haner Direskeneli

Professor, MD

Marmara University

研究点 (1)

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