Variable Approaches of Intradiscal O3-O2 Injection for Management of Low Back Pain: Could it Make a Difference? a Prospective Double Blind Randomized Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Quality of pain alleviation (visual analog scale)
研究概览
简要总结
Cost Intradiscal injection of ozone-oxygen mixture (O3-O2) which offers a rapid onset amelioration of symptoms, with a sustained duration pain relief in low back pain.
Does change of injection approach make a difference?
详细描述
Low back pain (LBP) mostly is induced by disc herniation (DH), or degeneration and has a burden upon social and economic aspects of life. Medical and or surgical interventions have been used to resolve this problem, but one of the newly introduced is the minimally invasive low cost Intradiscal injection of ozone-oxygen mixture (O3-O2) which offers a rapid onset amelioration of symptoms, with a sustained duration pain relief.
A lot of injection approaches are available, but which offers the best results, is the question.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •radicular leg pain
- •low back pain
- •non-responsive to conservative treatment
排除标准
- •patient refusal
- •infection at injection site
- •coagulopathy
- •uncontrolled or degenerative spine disease
- •pregnancy
- •multilevel disk involvement
研究组 & 干预措施
A: Classic approach
Intradiscal O3 injection through classic postrolateral extraarticular percutaneous approach.
The participants will receive 10 ml of ozone oxygen mixture 30 ug O3/ml O2. The ozone-oxygen mixture was produced in real-time by a medical ozone generator (Ozonline E 80, Medica srl, Bologna Italy).
干预措施: Classic postrolateral extraarticular percutaneous approach for O3 injection (Procedure)
B: Transforaminal approach (Yess approach )
Participants will receive 10 ml of ozone oxygen mixture 30 ug O3/ml O2 through postrolateral transforaminal approach (Yess approach).
The ozone-oxygen mixture was produced in real-time by a medical ozone generator (Ozonline E 80, Medica srl, Bologna Italy).
干预措施: Postrolateral transforaminal approach (Yess approach ) for O3 injection (Procedure)
结局指标
主要结局
Quality of pain alleviation (visual analog scale)
时间窗: one year
assessing visual analog scale (VAS)
次要结局
- Analgesia reduction (percent)(one year)
研究者
Emad Zarief , MD
Lecturer of Anesthesia and ICU
Assiut University