Comparison of the Therapeutic Effects of Intra-Articular Injection of Ozone and Corticosteroid in Knee Osteoarthritis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Visual Pain Score
研究概览
简要总结
This clinical trial aimed to involve patients aged 40-85 years who had been experiencing knee pain for at least 6 months and had received a clinical diagnosis of knee osteoarthritis through radiologic imaging. The patients were randomly assigned to two groups. One group received a 3-week intra-articular injection of 15 mg/ml ozone, while the second group received a 1 ml intra-articular injection of betamethasone. All patients were evaluated before treatment, as well as 4 and 12 weeks after the first dose of treatment. The study evaluated treatment efficacy using the Visual Pain Score (VAS) and the Western Ontario and McMaster Universities Arthritis Index (WOMAC).
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
- 40 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •40-85 years old,
- •have experienced knee pain and/or limited joint range of motion for at least 6 months,
- •have a diagnosis of KOA supported by radiographic imaging.
排除标准
- •patients had undergone knee joint surgery,
- •had a history of previous intra-articular injections,
- •had any rheumatological disease or malignancy,
- •being pregnant,
- •had pain radiating to the knee and leg.
研究组 & 干预措施
Study Group
The group received a 3-week intra-articular injection of 15 mg/ml ozone.
干预措施: Ozone - oxygen Therapy (Other)
Control Group
The group received a 1 ml intra-articular injection of betamethasone
干预措施: Corticosteroid (Other)
结局指标
主要结局
Visual Pain Score
时间窗: 4 weeks after the first dose of treatment
Pain status of the patients was questioned with a scale between 0-10
Western Ontario and McMaster Universities Arthritis Index
时间窗: 4 weeks after the first dose of treatment
The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is widely used in the evaluation of Hip and Knee Osteoarthritis. It is a self-administered questionnaire consisting of 24 items divided into 3 subscales:\[1\] Pain (5 items): during walking, using stairs, in bed, sitting or lying, and standing upright Stiffness (2 items): after first waking and later in the day Physical Function (17 items): using stairs, rising from sitting, standing, bending, walking, getting in / out of a car, shopping, putting on / taking off socks, rising from bed, lying in bed, getting in / out of bath, sitting, getting on / off toilet, heavy domestic duties, light domestic duties
次要结局
- Western Ontario and McMaster Universities Arthritis Index(12 weeks after the first dose of treatment)
- Visual Pain Score(12 weeks after the first dose of treatment)
研究者
Aylin Ayyıldız
Medical Doctor
Sisli Hamidiye Etfal Training and Research Hospital