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临床试验/NCT05088954
NCT05088954已完成不适用

Effect of Metabolic Syndrome on Outcomes of Transforaminal Epidural Steroid Injection Treatment in Patients With Chronic Lumbar Radiculopathy

Marmara University2 个研究点 分布在 1 个国家目标入组 51 人开始时间: 2024年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
51
试验地点
2
主要终点
Rate of Successful Response

研究概览

简要总结

Transforaminal epidural steroid injection (TFESI) has been increasingly preferred in patients who can not benefit from conservative approach in the treatment of lumbosacral radiculopathic pain due to lumbar disc herniation. The aim of our study is to evaluate the effect of metabolic syndrome on the treatment results of transforaminal epidural steroid injection in patients with chronic radicular low back pain due to lumbar disc herniation.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

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

入选标准

  • lumbar radiculopathy due to lumbar disc herniation, unresponsive to conservative treatments, duration of pain is at least 3 months, Patients aged 18 and above

排除标准

  • the cases when fluoroscopy or epidural injection is contraindicated (coagulation disorders, pregnancy etc...), to have a history of lumbar spinal surgery, inflammatory diseases (rheumatoid arthritis, spondyloarthropathy), spinal infection or malignancy, systemic infection, Spondylolisthesis or spinal stenoz at the involved or adjacent segments, allergies to local anesthetics, contrast dyes or steroids, Refusal of a patient, History of prior lumbar spine surgery, presence of hip pathology (avascular necrosis, congenital hip dislocation etc...

结局指标

主要结局

Rate of Successful Response

时间窗: 6 months

The primary outcome measure of our study is successful response (\>50% reduction in NRS)

次要结局

  • Numerical Rating Scale(6 months)
  • Istanbul Low Back Pain Disability Index (ILBPDI)(6 months)
  • Short Form 12 (SF-12)(6 months)
  • Numerical Rating Scale(6 months)
  • Istanbul Low Back Pain Disability Index (ILBPDI)(6 months)
  • Short Form 12 (SF-12)(6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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