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临床试验/NCT00832312
NCT00832312终止2 期

Intraarticular Ozone Therapy for Pain Control in Osteoarthritis of the Knee

Ben-Gurion University of the Negev1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2009年8月1日最近更新:
适应症
干预措施

试验速览

阶段
2 期
状态
终止
入组人数
20
试验地点
1
主要终点
Pain control

研究概览

简要总结

The purpose of this study is to determine whether an intraarticular injection of Ozone into the knee joint is an effective therapy for pain control in patients with osteoarthritis of the knee.

详细描述

Ozone, as a gas made of three atoms of oxygen with a cyclic structure, has been used as a medical therapy from the mid ninetieth century. Today, this therapy is a recognized modality in many European and Latin American nations for orthopedic problems, infections, ischemic diseases, and skin problems. However, despite of this wide use internationally, there is minimal mention of this treatment modality in the Anglo-American literature.

The present is the first of a series of studies planned to scientifically test the effectiveness of ozone as a main-stream therapy, introducing it to the Anglo-American literature. In this first study we will check whether intraarticular injections of Ozone into the knee joint are effective as a therapy for pain control in patients with osteoarthritis of the knee.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
50 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Osteoarthritis of knee

排除标准

  • •Positive rheumatologic serologic tests
  • •Cognitive impairment
  • •Adjacent osteomyelitis
  • •Bacteremia
  • •Hemarthrosis
  • •Impending (scheduled within days) joint replacement surgery
  • •Infectious arthritis
  • •Joint prosthesis
  • •Osteochondral fracture
  • •Periarticular cellulitis
  • •Poorly controlled diabetes mellitus
  • •Uncontrolled bleeding disorder or coagulopathy.

研究组 & 干预措施

ozone-oxygen mixture

Experimental

10 cc of an ozone-oxygen mixture with ozone concentration 10000 mcg/L (10 mcg/ml) injected into the knee joint

干预措施: ozone-oxygen mixture (Other)

Saline

Placebo Comparator

Injection of 1cc of saline into the knee joint

干预措施: placebo (saline) (Other)

结局指标

主要结局

Pain control

时间窗: 6 months

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Howard Tandeter

POB 653 Beer Sheva

Ben-Gurion University of the Negev

研究点 (1)

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