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临床试验/NCT06503835
NCT06503835已完成不适用

Efficacy of Fluoroscopy Guided Transforaminal Epidural Steroid and Steroid Plus Ozone Injection in Patients With Lumbar Radiculopathy

Ibn Sina Hospital1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2020年6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
120
试验地点
1
主要终点
Visual Analog Scale (VAS)

研究概览

简要总结

This retrospective study aimed to assess the clinical effectiveness and safety of transforaminal epidural injections of steroid and ozone mixture versus steroid alone in low back and radicular leg pain related to disk herniation.

详细描述

Low back and radicular leg pain due to radiculopathy are the common presenting symptoms in the field of pain medicine.For patients with chronic low back and radicular leg pain, pain relief can be achieved through minimally invasive interventional procedures under fluoroscopic guidance. Since some patients may experience persistent pain and the potential development risk of failed back surgery syndrome, minimally invasive procedures are preferred as a pre-surgical intervention.

Interlaminar or transforaminal epidural steroid injections are the most commonly used nonsurgical interventions for disc herniation. Ozone therapy has also started to be used as frequently as steroids. Previous studies have shown that ozone can be given through intradiscally, epidural space, and paravertebral muscles. Ozone gase is thought to modulate levels of cytokines and prostaglandins, minimize reactive oxidant species levels, and improve local periganglionic circulation.

The objective of this study was to assess the short- and long-term clinical efficacy of transforaminal epidural steroid and steroid plus ozone injection in patients presenting with low back and radicular leg pain and to analyze which treatment method is most beneficial in reducing pain relief.

This was a retrospective study of 120 patients who underwent transforaminal epidural steroid or combination of steroid and ozone injection between June and December 2020 in the Ankara University Faculty of Medicine, Department of Pain Medicine.

Demographic information, pain intensity, localization, pattern (neuropathic/nonneuropathic/mix), and patients' quality of life and the treated level (the innervation territories of L2 (Lomber), L3, L4, L5, or S1 (Sacral)) were analyzed. Pain intensity was assessed with the Visual Analog Scale (VAS), and patient disability was evaluated with the Oswestry Disability Questionnaire (ODI).

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

  • Files of patients underwent transforaminal epidural steroid or combination of steroid and ozone injection
  • Age between 18-75 years
  • Body mass index (BMI) <35,
  • VAS score ≥ 4
  • Radicular pain not responding to conservative therapy related to lumbar disk herniation on magnetic resonance imaging
  • Duration of pain of >3 months

排除标准

  • Pregnancy
  • Major progressive neurologic deficits
  • Infective or inflammatory diseases
  • Uncontrolled diabetes or other severe internal comorbidities
  • Malignancy
  • international normalized ratio (INR) > 1.2
  • Glucose-6-phosphate dehydrogenase deficiency

结局指标

主要结局

Visual Analog Scale (VAS)

时间窗: 24th hours, 1st, 3rd, 6th, and 12th months

The VAS score for pain assessment ranges between 0-10 ( (0=no pain, 5=moderate pain, 10=extremely severe pain).

次要结局

  • Oswestry Disability Questionnaire (ODI)(1st, 3rd, 6th, and 12th months)
  • MacNab Scale Scores(1st and 12th months)

研究者

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

Derya Bayram

Medical Doctor, Pain Specialist

Ibn Sina Hospital

研究点 (1)

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