Implication of Two Doses of O2-O3 Upon the Pain Alleviation in Patients With Low Back Pain
Implication of Two Different Doses of Intradiscal O2-O3 Injection Upon the Pain Alleviation in Patients With Low Back Pain: A Randomized, Single-blind Study
研究概览
详细说明
Intervertebral disc herniation is the most common problem which induces low back pain LBP. The number of patients seek surgical and or alternative therapy increases. The rate of re-operation is between 7-9% at 2 years and increases up to 10-25% at ten years postoperative.
Epidural injections with local anesthetics and steroids are one of the most commonly used interventions in managing chronic low back pain and lower extremity pain of various causes. However, despite their extensive use, debate continues on this medications effectiveness due to the lack of well-designed, randomized, controlled studies to determine the effectiveness of epidural injections in general, and caudal epidural injections in particular.
Ozone in mixture with oxygen has been justified in multiple studies have been done, this study aims to evaluate variable doses of this mix upon patient satisfaction, pain alleviation over 12 month follow up period .
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:
- All patients Suffered radicular leg pain and some reported additional back pain.
- All patients are non-responsive to conservative treatment modalities with VAS more than 7.
Exclusion criteria
- presence of bleeding disorder
- local infection
- uncontrolled or degenerative spine disease
- pregnancy
- multilevel disk involvement
- patient refusal.
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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有源比较器：group A
percutaneous ozone intradiscal injection group A receive 10 ml of ozone oxygen mixture 40 ug O3/ ml O2
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receive 10 ml of ozone oxygen mixture under variable dosing
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有源比较器：group B
percutaneous ozone intradiscal injection group receive 10 ml of ozone oxygen mixture 30 ug O3/ ml O2.
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receive 10 ml of ozone oxygen mixture under variable dosing
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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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Pain alleviation by visual analogue scale (VAS)
大体时间：12 months
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assessing pain alleviation by visual analogue scale (VAS)
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12 months
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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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Reduction of disk herniation by MRI
大体时间：6 months
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evaluation of disk herniation by MRI 6 month after injection, in comparison to the pre-injection MRI
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6 months
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Pain alleviation using Oswestry Low Back Pain Questionnaire
大体时间：12 months
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using Oswestry Low Back Pain Questionnaire
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12 months
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合作者和调查者
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
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 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
ozone oxygen mixture的临床试验
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Negovsky Reanimatology Research InstituteGBWZ of Moscow city hospital n.a. S.P. Botkin招聘中
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Omaima Mossad Mahmoud AL-Sherbini完全的