Comparison of Interlaminar CT Guided Epidural Platelet Rich Plasma Versus Steroid Injection in Patients With Lumbar Radicular Pain : a Prospective Study With Long Term Follow up
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Functional ability
研究概览
简要总结
The treatment of persistent lumbar radicular pain (LRP) using CT-guided epidural steroid injection (ESI) is widely used and associated with rare but serious complications. Platelet-rich plasma (PRP), which has recently been shown to promote healing and the anti-inflammatory process by delivering growth factors and cytokines, could be an alternative and potentially safer option. A previous study showed that PRP was as effective as ESI in treating this condition, without major complications.
This study aims to compare these two treatments over the long term (2 years).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of unilateral resistant LRP associated with a herniated disc on MRI images. (Diagnosis of resistance after 6 weeks of appropriate medical treatment).
排除标准
- •Patients with infections,
- •Patients who have had previous percutaneous corticosteroid injections,
- •Patients undergoing systemic corticosteroid treatment,
- •Patients with immune deficiencies,
- •Patients who are allergic to the contrast medium used,
- •Pregnant or breastfeeding patients,
- •Patients with a history of allergies to anesthetics or corticosteroids,
- •Anticoagulant treatment or blood disorders, patients on antiplatelet therapy
- •Taking NSAIDs within two weeks prior to the procedure
研究组 & 干预措施
steroid treatment
干预措施: Epidural Steroid Injection (Procedure)
platelet-rich plasma treatment
干预措施: Epidural platelet-rich plasma injection (Procedure)
结局指标
主要结局
Functional ability
时间窗: 30 minutes before procedure ; 6 weeks after procedure ; 6 months, 1 year, 2 years after procedure
Oswestry Disability Questionnaire ranging from 0 to 100%
次要结局
- Pain evaluation(6 weeks, 6 months, 1 year and 2 years after procedure)