Efficacy of Fluoroscopy Guided Transforaminal Epidural Steroid and Steroid Plus Ozone Injection in Patients With Lumbar Radiculopathy
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
- 否
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
Derya Bayram
Medical Doctor, Pain Specialist
Ibn Sina Hospital
