Intraarticular Ozone Therapy for Pain Control in Osteoarthritis of the Knee
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 20
- 试验地点
- 2
- 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.
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
Howard Tandeter
POB 653 Beer Sheva
Ben-Gurion University of the Negev
