The comparative effectiveness of intraarticular steroid, ozone and prolotherapy in improving functionality, quality of life, pain and articular cartilage thickness in patients suffering from moderate knee osteoarthritis: A prospective observational study
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 63
- 试验地点
- 1
- 主要终点
- Visual analog scale
研究概览
简要总结
Knee osteoarthritis is a chronic degenerative condition characterised by articular cartilage degeneration, subchondral sclerosis in middle-aged and elderly people. It causes functional limitations to the patient and hampers their day-to-day activities immensely. The worldwide prevalence of OA knee is around 3.8% , affecting more than 25% of people above 45 years.
The treatment approach is divided into surgical and conservative treatment. Because of the cost and post-surgical complications, and limitations, many of the people suffering from OA of the knee accept conservative management. Along with the pharmacological management, intra-articular injection therapy is one of the most common procedures for alleviating the symptoms of OA knee. Among the recommended intra-articular injections,corticosteroids, dextrose, hyaluronic acid (HA), platelet-rich plasma and ozone are used.Inrecent years, some studies have also documented the effectiveness of intraarticular mesenchymal stem cells, bone marrow aspirate and stromal vascular fraction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 45.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Clinically diagnosed as an OA knee according to the American College of Rheumatology (ACR) criteria
- •Radiographic Kellgren-Lawrence grades2 and 3
- •Knee pain with pain intensity of more or equal to 4 of 10 on a visual analoguescale,most days for at least 3 months, refractory to conservative treatments.
排除标准
- •Severe neurological or psychiatric diseases
- •History of any steroid injection within 3 months
- •Previous knee surgeries (unicompartmental or total arthroplasty, debridement arthroscopy, osteotomies)
- •Persons using anticoagulants or with bleeding disorders
- •Persons with uncontrolled diabetes and hypertension
- •Any history of allergy or superficial skin infection.
结局指标
主要结局
Visual analog scale
时间窗: At baseline, after 1month, after 4 month and after 6 month
次要结局
- Western Ontario and McMaster Universities Osteoarthritis Index(1 months, 4 months and 6 months)
- Oxford knee score(1 months, 4 months, 6 months)
研究者
Lt Col Dr Mohit Kataruka
AIIMS Kalyani