NCT00566007终止2 期
Trial on the Effect of Ozone Therapy for Lumbar Herniated Disc With Criteria for Surgery
Kovacs Foundation1 个研究点 分布在 1 个国家目标入组 156 人开始时间: 2008年12月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 156
- 试验地点
- 1
- 主要终点
- To evaluate the efficacy of infiltration with corticoids+anesthetics+ozone in comparison with corticoids+anesthetics+oxygen (considered placebo for ozone)
研究概览
简要总结
The purpose of this study is to assess the efficacy (vs. placebo) of ozone infiltration and its effectiveness in comparison with micro discectomy in the treatment of lumbar herniated disc with criteria for surgery.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of herniated disc by surgeons from participating hospitals
- •Sciatic pain of 5 or more on Visual Analogue Scale
- •Pain radiated to appropriate area according to herniated disc
- •On waiting list for disc surgery at one of participating hospitals
排除标准
- •Inability to fill out questionnaires (VAS, Roland Morris, SF12)
- •Calcified or migrated herniated disc
- •Herniated disc with indications for laminectomy or arthrodesis
- •Clinically relevant partial paralysis
- •Simultaneous cervical and dorsal symptomatic herniated discs
- •Previous lumbar spine surgery
- •Presence of other spinal pathology
- •Significant glucose-6-phosphate-dehydrogenase deficit
- •Allergy to ozone
- •Treatment with oral anticoagulants
研究组 & 干预措施
1
Active Comparator
Discectomy/micro discectomy
干预措施: Discectomy/ micro discectomy (Procedure)
1
Active Comparator
Discectomy/micro discectomy
干预措施: Ozone therapy (Drug)
1
Active Comparator
Discectomy/micro discectomy
干预措施: Oxygen therapy (Drug)
2
Active Comparator
Intradiscal ozone infiltration
干预措施: Ozone therapy (Drug)
2
Active Comparator
Intradiscal ozone infiltration
干预措施: Oxygen therapy (Drug)
3
Active Comparator
Intradiscal oxygen infiltration (control arm)
干预措施: Oxygen therapy (Drug)
结局指标
主要结局
To evaluate the efficacy of infiltration with corticoids+anesthetics+ozone in comparison with corticoids+anesthetics+oxygen (considered placebo for ozone)
时间窗: 12 months
次要结局
- To evaluate the effectiveness of both types of infiltration (used in primary outcome) in comparison with discectomy/micro discectomy(12 months)
研究者
研究点 (1)
Loading locations...
相似试验
Unknown
不适用
Clinical Effects of Ozone Therapy in Cervical Disc HerniaPain, NeckNCT03056911Sakarya University43
已完成
不适用
Effects of Ozone Therapy as an Adjunct to Periodontal TreatmentPeriodontitisNCT03652558TC Erciyes University20
已完成
2 期
The Effect of Epiduroscopy and Ozone Therapy in Patients With Failed Back Surgery SyndromeLow Back PainFailed Back Surgery SyndromeNCT01172457University of Sao Paulo40
尚未招募
2 期
Comparative study on the effect of ozone therapy, honey dressing and combination of ozone and honey dressing on healing of diabetic foot ulcerDiabetic foot ulcer.E10-E14Diabetes mellitusIRCT20181105041563N3Vice chancellor for research, Kermanshah University of Medical Sciences140
招募中
早期 1 期
Evaluate the effectiveness of ozone therapy on recuperation of patient suffering from Medication-related osteonecrosis of the jawOsteonecrosis.Osteonecrosis due to drugsM87.1IRCT20201201049555N1Mashhad University of Medical Sciences28