Intradiscal Injection of Gelified Ethanol for the Treatment of Discogenic Back Pain
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Visual Analog Scale (VAS)
研究概览
简要总结
Discogenic low back pain is the most common form of chronic low back pain. Its diagnosis is mainly based on MR imaging, showing MODIC I or II changes in patients with concordant symptomatology. The treatment of discogenic low back pain is nevertheless difficult: intradiscal therapies (corticosteroids, methylene blue, radiofrequency) have a limited efficacy, and surgical procedures (arthrodesis or disc replacement) are a final recourse with notable risk of side-effects.
In this study, the efficacy of intradiscal injection of gelified ethanol (DiscoGel) in patients with disabling discogenic pain is assessed.
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 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •MR imaging : MODIC 1or MODIC 2 changes limited to one single lumbar disc;
- •X rays: normal disc height, no instability;
- •Back pain for at least 3 months, without argument for another etiology;
- •Mean pain on 5 days VAS ≥ 5
排除标准
- •age <18 years or > 50 ; concomitant radicular pain ;
- •psychiatric pathology that may modify the perception or the evolution of pain;
- •MR imaging: multi-level discopathy, MODIC 3 changes;
- •X ray: loss of disc height > 50%, segmental instability;
- •previous history of lumbar surgery with or without instrumentation.
结局指标
主要结局
Visual Analog Scale (VAS)
时间窗: Six months after the procedure.
Mean pain intensity score on a Visual Analog Scale (VAS), six months after the procedure.
次要结局
- Oswestry Disability Index (ODI)(one month, three months, six months and 1 year after the procedure)
- Euroqol score(month, three months, six months and 1 year after the procedure)
- Visual Analog Scale (VAS),(one month, three months, six months and 1 year after the procedure)