Variable Approaches of Intradiscal O3-O2 Injection
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.
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?
研究概览
地位
条件
详细说明
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.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Assiut、埃及、71111
- Emad Zarief Kamel Said
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- radicular leg pain
- low back pain
- non-responsive to conservative treatment
Exclusion Criteria:
- patient refusal
- infection at injection site
- coagulopathy
- uncontrolled or degenerative spine disease
- pregnancy
- multilevel disk involvement
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
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其他：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). |
Receive 10 ml of ozone oxygen mixture 30 ug O3/ml O2 through the classic postrolateral extraarticular percutaneous approach
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有源比较器：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). |
Group B receive 10 ml of ozone oxygen mixture 30 ug O3/ml O2 through postrolateral transforaminal approach (Yess approach ).
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Quality of pain alleviation (visual analog scale)
大体时间：one year
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assessing visual analog scale (VAS)
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one year
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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Analgesia reduction (percent)
大体时间：one year
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the percent of analgesia reduction
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one year
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合作者和调查者
调查人员
- 研究主任：Abdelraheem Alawaamy, MD、Assiut university
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
在美国制造并从美国出口的产品
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Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University尚未招聘
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Daiichi Sankyo招聘中
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Université Victor Segalen Bordeaux 2Nanox International Laboratory (Belgique)完全的