跳至主要内容
临床试验/NCT05719792
NCT05719792进行中(未招募)不适用

Comparison of the Effectiveness of Erector Spina Plane Block and Transforaminal Anterior Epidural Steroid Injections in Lumbar Radicular Pain

Marmara University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2022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
50
试验地点
1
主要终点
Change in NRS (Numeric Rating Scale)

研究概览

简要总结

Low back pain is one of the leading causes of disability and its social burden and economic cost are quite high. The lifetime prevalence in the population is frequently reported between 40% and 70%. Although there are many reasons that can lead to low back pain, radicular pain, which develops mostly secondary to lumbar disc hernia, is one of the most common pathologies.

Epidural corticosteroid and local anesthetic injections are an important treatment option in the treatment of lumbar radicular pain that does not respond to conservative methods. epidural injections; includes transforaminal, interlaminar and caudal approaches. The advantage of the transforaminal approach is that it allows access to the anterior epidural area, which is the region of pathology, and that it can spread to the target specifically around the inflamed nerve roots. The standard imaging technology used for steroid injections with this approach is fluoroscopy.

However, the aforementioned approaches carry the risk of dural puncture, epidural hematoma, epidural abscess, nerve damage, paralysis and many complications. In addition, radiation exposure is another problem. It may be possible to avoid a significant part of these risks by applying interfacial blocks used in regional anesthesia and postoperative pain control in the lumbar region. Recently, Erector Spina Plan Block (ESPB), an interfascial block technique, has been frequently applied under ultrasound (US) guidance as an alternative method to conventional paravertebral block. Investigators also frequently refer to this procedure in the clinic for patients with lumbar radicular pain.

In the literature, there are case reports of lumbar ESPB applied to patients with radicular pain due to disc herniation. Beyond case-level reports, there is no clinical study investigating the efficacy of this procedure technique for applications in the lumbar region. Starting from here, the aim of this study is; Investigators determined to compare the efficacy of erector spina plane block and transforaminal anterior epidural steroid injections in patients with radicular pain due to lumbar disc herniation.

研究设计

研究类型
Observational
观察模型
Case Control
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

入选标准

  • Being between the ages of 18-65
  • Radicular low back pain
  • Failure to respond to conservative treatments
  • Single level lumbar nerve root compression due to disc herniation
  • Agree to participate in the research

排除标准

  • Patients younger than 18 years and older than 65 years
  • Those with non-radicular low back pain
  • Those with nerve root compression due to reasons other than disc herniation
  • Those with Modic type-1 changes in lumbar MRI
  • Those with spinal stenosis or spondylolisthesis
  • Those diagnosed with spondylodiscitis
  • Those with inflammatory rheumatic disease
  • Patients whose use of non-steroidal anti-inflammatory drugs is contraindicated (renal failure, bleeding disorders, etc.)

结局指标

主要结局

Change in NRS (Numeric Rating Scale)

时间窗: at first hour, at three weeks, at 3 months, at 6 months

≥50% reduction in the NRS scores at month 6 relative to the initial NRS scores.

Change in ODI (Oswestry Disability Index)

时间窗: at first hour, at three weeks, at 3 months, at 6 months

≥40% reduction in ODI scores at month 6 relative to the initial ODI scores. (ODI is a deficiency/competence index that includes assessments grouped according to the types of daily activities in patients with low back pain.)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验