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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Pain alleviation by visual analogue scale (VAS)
研究概览
简要总结
Low back pain is very common problem, variable modalities have been introduced to control such problem. One of the emerging modalities is the ozone - oxygen (O2-O3 ) mixture that could reduce the herniation disk size and inflammation.
详细描述
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
- •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
- •Exclusion criteria
- •presence of bleeding disorder
- •local infection
- •uncontrolled or degenerative spine disease
- •pregnancy
- •multilevel disk involvement
- •patient refusal.
排除标准
- 未提供
研究组 & 干预措施
group A
percutaneous ozone intradiscal injection group A receive 10 ml of ozone oxygen mixture 40 ug O3/ ml O2
干预措施: ozone oxygen mixture (Drug)
group B
percutaneous ozone intradiscal injection group receive 10 ml of ozone oxygen mixture 30 ug O3/ ml O2.
干预措施: ozone oxygen mixture (Drug)
结局指标
主要结局
Pain alleviation by visual analogue scale (VAS)
时间窗: 12 months
assessing pain alleviation by visual analogue scale (VAS)
次要结局
- Reduction of disk herniation by MRI(6 months)
- Pain alleviation using Oswestry Low Back Pain Questionnaire(12 months)
研究者
Emad Zarief , MD
Lecturer of Anesthesia and ICU
Assiut University