Intra-articular Platelet Rich Plasma vs Corticosteroid in Treatment of Knee Osteoarthritis
试验速览
- 阶段
- 早期 1 期
- 状态
- 尚未招募
- 入组人数
- 100
- 主要终点
- Assessment of knee pain, stiffness and physical function 6 weeks after injection
研究概览
简要总结
Knee osteoarthritis is the most common type of osteoarthritis in the lower extremity and constitutes 23% of all arthritis cases, about 13% of females and 10% of males aged above 60 years have symptomatic knee OA. Intra-articular corticosteroids (IACs) are a frequently-used treatment regimen for pain relief from symptomatic knee OA as it inhibits inflammation and reduces prostaglandin synthesis. Platelet-rich plasma (PRP) is an autologous blood product containing a high percentage of various growth factors (GFs), such as fibroblast growth factor, epidermal growth factor, vascular endothelial growth factor, transforming growth factor-β and platelet-derived growth factor. The aim of this study is to compare effect of intra-articular injection of platelet rich plasma versus corticosteroid in treatment of primary knee osteoarthritis.
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
- None
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients 40-70 years of age suffering from knee OA with Kellgren Lawrence grade II or III on standing antero-posterior and lateral knee radiographs.
- •Patients diagnosed according to ACR classification criteria.
排除标准
- •Systemic diseases as Patients having diabetes mellitus,Cardiovascular diseases or coagulopathies.
- •Those receiving treatment with anticoagulant , anti_platelet medications or systemic corticosteroid 10 days before injection or recent use of NSAIDs.
- •Pregnant and breast feeding females.
- •Patients have hemoglobin values <10 g/dl or platelet values<150,000/ml.
研究组 & 干预措施
OA group injected by corticosteroid
Group l include 50 patients who will be injected with one intra_articular injection of 2 ml of methylprednisolone acetate 40 mg/ml mixed with 2ml of lidocaine
干预措施: Corticosteroid (Drug)
OA group injected by Platelet Rich Plasma
Group lI include 50 patients who will be injected with a single 5 ml intra_articular injection of PRP prepared in our hospital
干预措施: Platelet Rich Plasma (Other)
结局指标
主要结局
Assessment of knee pain, stiffness and physical function 6 weeks after injection
时间窗: 6 weeks after injection
Assessment through WOMAC score
Assessment of knee pain, stiffness and physical function 12 weeks after injection
时间窗: 12 weeks after injection
Assessment through WOMAC score
Assessment of knee pain, stiffness and physical function prior knee injection
时间窗: Assessment will be done just before injection
Assessment through the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score. The final score for the WOMAC was determined by adding the aggregate scores for pain, stiffness, and function. Scores range from 0 to 96 for the total WOMAC where 0 represents the best health status and 96 the worst possible status.
Assessment of knee pain, stiffness and physical function 2 weeks after injection
时间窗: 2 weeks after injection
Assessment through WOMAC score
次要结局
未报告次要终点
研究者
Arwa El Sayed Abdel Rahman
Lecturer of Rheumatology, Rehabilitation and Physical Medicine
Benha University