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临床试验/NCT06795542
NCT06795542Enrolling By Invitation2 期

Predictive Factors for the Success of Transforaminal Epidural Injection in Lumbosacral Radiculopathy

Amr Mohamed Sedik1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年2月1日最近更新:
适应症
干预措施

试验速览

阶段
2 期
状态
Enrolling By Invitation
发起方
入组人数
30
试验地点
1
主要终点
Transformainal Epidural Injection

研究概览

简要总结

the aim of the study is to identify predictive factors for the success of transforaminal epidural injection in the treatment of patients with lumbosacral radiculopathy

详细描述

Lumbar radicular pain (known as sciatica) represents a prevalent medical and socioeconomic problem.

More than half of the patients with sciatica report a decline in their activities of daily living and ability to work.

Mixed Pathologies as foraminal stenosis, spondylolisthesis, and space-occupying lesions in the lumbar spine can cause Sciatica but the most common cause is lumbar disc herniation. (1) Overall, the vast majority of patients with lumbosacral radiculopathy recover with conservative care as trial of bed rest, oral medications, lumbar corsets and physiotherapy. (2) The involvement of inflammation has attracted the use of steroids (corticosteroids) to reduce the inflammation and, thereby, relieve the pain. Injections of steroids, by various routes, have been used as an alternative to surgery, and as an alternative or complement to conservative therapy, for the treatment of lumbar radicular pain. (3) Steroids are believed to have a therapeutic effect due to their anti inflammatory properties.

This belief is supported by evidence from in vitro studies that show that steroids have a role in decreasing inflammatory mediators such as cytokines and chemokines another study suggests that steroids may provide a stabilizing effect on nociceptive signaling in C-fibers and suppression of ectopic neural discharges. (4) The most widely used injection therapy is epidural injection of steroids, by either the interlaminar route or the caudal route. More contentious are transforaminal injections of steroids. These involve the injection of steroids directly and accurately onto the affected spinal nerve, under radiologic guidance. Meanwhile, transforaminal injection of steroids has been shown to be more effective than interlaminar injection of steroids (5) Transforaminal epidural injection may be by autologous Platelet Rich Plasma (PRP) as a novel pharmaceutical agent that has strongly emerged in recent years to treat patients of lumbar disc herniation.(6)

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

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •1.Patients who underwent lumbosacral transforaminal epidural injection at the level of L4-5, L5-S1, or S1 neural foramina 2.Patients age 18 to 60 years 3.Patients had been symptomatic longer than 6 Weeks with Leg pain more than back pain with failure conservative treatment.
  • •4.Patients had undergone an MRI Lumbosacral imaging scan documenting disc prolapse

排除标准

  • •1- Patients had previous lumbar surgery 2- Patients had a large herniated disc with severe central or foraminal stenosis on magnetic resonance imaging 3- Patients had Scoliosis , spondylolisthesis or malignancy 4- patients with neurological deficit. 5-Patients had a blood coagulation disorder, or had experienced an allergic reaction to local anesthetics or corticosteroids.

研究组 & 干预措施

lumbosacral transforaminal epidural injection

Experimental

Transforaminal Epidural Injections using C-arm imaging with or without Fluoroscopic Guidance

干预措施: lumbosacral transforaminal epidural injection at the level of L4-5, L5-S1, or S1 neural foramina (Procedure)

结局指标

主要结局

Transformainal Epidural Injection

时间窗: 3 months

All patients will be followed up in outpatient clinic every 2 weeks for 3months by assessing Visual Analogue Pain Scale (VAS)

次要结局

未报告次要终点

研究者

发起方
Amr Mohamed Sedik
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Amr Mohamed Sedik

Amr Mohamed Sedek Ahmed

Sohag University

研究点 (1)

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