Evaluation of the Effect of Transforaminal Epidural Steroid Injection on Neuropathic Pain Using the Neuropathic Pain Scale in Patients With Lumbosacral Radiculopathy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in Neuropathic Pain Severity Assessed by the Neuropathic Pain Scale (NPS)
研究概览
简要总结
Patients with lumbosacral radiculopathy frequently experience neuropathic pain due to nerve root compression. Transforaminal epidural steroid injection (TFESI) is commonly used for pain relief in these patients. This study aims to evaluate the effect of TFESI on neuropathic pain severity using the Neuropathic Pain Scale (NPS) in patients with lumbosacral radiculopathy. Clinical outcomes before and after the procedure will be compared.
详细描述
Lumbosacral radiculopathy is a common cause of chronic low back and leg pain and is frequently associated with neuropathic pain symptoms resulting from nerve root compression. Neuropathic pain may significantly impair quality of life and functional capacity. Transforaminal epidural steroid injection (TFESI) is a minimally invasive interventional procedure widely used in the management of radicular pain.
The aim of this prospective interventional study is to evaluate the effectiveness of TFESI on neuropathic pain severity in patients with lumbosacral radiculopathy. Neuropathic pain severity will be assessed using the Neuropathic Pain Scale (NPS). Secondary clinical evaluations may include pain intensity and functional status assessments.
Eligible patients diagnosed with lumbosacral radiculopathy and scheduled for TFESI treatment will be enrolled in the study. Clinical assessments will be performed before the procedure and during follow-up visits after the intervention. The study findings are expected to contribute to the understanding of the effects of TFESI on neuropathic pain components in patients with lumbosacral radiculopathy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
This is an open-label study without masking. All participants will receive the same intervention (TFESI).
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
- •Adults aged 18 years and older
- •Patients diagnosed with lumbosacral radiculopathy based on clinical evaluation and lumbar MRI findings
- •Presence of neuropathic pain symptoms associated with lumbosacral radiculopathy
- •Patients scheduled to undergo transforaminal epidural steroid injection (TFESI)
- •Patients able to understand and complete the study questionnaires and scales
- •Voluntary written informed consent provided
排除标准
- •Previous lumbar spinal surgery
- •Cauda equina syndrome or progressive neurological deficit
- •Spinal malignancy, infection, or acute vertebral fracture
- •Pregnancy or breastfeeding
- •Coagulation disorders or current anticoagulant therapy contraindicating injection procedures
- •Known allergy to contrast agents, local anesthetics, or corticosteroids
- •Severe uncontrolled systemic disease
- •Cognitive impairment preventing completion of assessment scales
- •Patients unwilling to participate or unable to attend follow-up visits
研究组 & 干预措施
TFESI Group
Participants with lumbosacral radiculopathy will receive transforaminal epidural steroid injection (TFESI) treatment. Neuropathic pain severity will be evaluated before and after the intervention using the Neuropathic Pain Scale (NPS).
干预措施: Transforaminal Epidural Steroid Injections (Procedure)
结局指标
主要结局
Change in Neuropathic Pain Severity Assessed by the Neuropathic Pain Scale (NPS)
时间窗: Baseline, 3 weeks after intervention, and 3 months after intervention
hange in Neuropathic Pain Severity Assessed by the Neuropathic Pain Scale (NPS) The primary outcome measure is the change in neuropathic pain severity assessed using the Neuropathic Pain Scale (NPS) before and after transforaminal epidural steroid injection (TFESI) in patients with lumbosacral radiculopathy. The NPS ranges from 0 to 100, with higher scores indicating greater neuropathic pain severity (worse outcomes). Changes in NPS scores will be assessed from baseline to 3 weeks and 3 months after the intervention.
次要结局
- Change in Pain Intensity Assessed by Numeric Rating Scale (NRS)(Baseline, 3 weeks after intervention, and 3 months after intervention)
- Change in Neuropathic Pain Symptoms Assessed by Douleur Neuropathique 4 (DN4)(Baseline, 3 weeks after intervention, and 3 months after intervention)
- Change in Functional Disability Assessed by Oswestry Disability Index (ODI)(Baseline, 3 weeks after intervention, and 3 months after intervention)
- Association Between Contrast Dispersion Pattern and Clinical Outcomes(Baseline, 3 weeks after intervention, and 3 months after intervention)
- Association Between Pfirrmann Grade and Clinical Outcomes(Baseline and throughout follow-up assessments up to 3 months)