Effectiveness of Intra- Articular Platelet Rich Plasma with Hyaluronic Acid in comparison with Intra- Articular Botulinum Toxin Type-A with Hyaluronic Acid in improving pain and functional limitation in Osteoarthritis of Knee: A Randomized Clinical Trial.
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- 1.To evaluate the efficacy of intra- articular Platelet rich plasma with Hyaluronic Acid (PRP with HA) in comparison with intra- articular Botulinum Toxin A with Hyaluronic Acid on knee pain.
研究概览
简要总结
Intra-articular injections like PRP, HA and Botox help in alleviating Knee pain, improving functionality of the joint and simultaneously improving quality of life of the patients with knee osteoarthritis, we intended to compare the efficacy of intra-articular PRP with HA (because of their synergistic effect) and Botox and HA in reducing the knee pain and functional limitation of the knee and also to assess the effect of patient factors post procedure like, weight reduction and regular physiotherapy on knee pain and functional limitation of the knee . Hence the need for the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 40.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Bilateral Knee Osteoarthritis Grade 3 and
- •2.Knee pain> 3 months.
- •3.Morning stiffness < 30 minutes.
排除标准
- •1.Patient’s unwillingness to participate.
- •2.History of other diseases affecting knee joint like Rheumatoid Arthritis, Gout, Neuromuscular diseases.
- •3.Previous intra-articular injections.
- •4.History of knee joint surgery.
- •5.Acute Trauma.
- •6.Contraindications to intra-articular injection e.g., sepsis, intra-articular infections, intra-articular fracture, or uncontrolled coagulopathy.
结局指标
主要结局
1.To evaluate the efficacy of intra- articular Platelet rich plasma with Hyaluronic Acid (PRP with HA) in comparison with intra- articular Botulinum Toxin A with Hyaluronic Acid on knee pain.
时间窗: Pre- Procedural, Immediate post procedure, 2weeks, 4 weeks, 12 weeks and 24 weeks.
2.To evaluate the effect of intra- articular PRP with HA in comparison with intra- articular Botulinum Toxin A with Hyaluronic Acid on functional limitation of Knee.
时间窗: Pre- Procedural, Immediate post procedure, 2weeks, 4 weeks, 12 weeks and 24 weeks.
3.To assess the effect of patient factors post procedure, on knee pain & functional limitation .
时间窗: Pre- Procedural, Immediate post procedure, 2weeks, 4 weeks, 12 weeks and 24 weeks.
次要结局
- To assess the effect of patient factors post procedure, on knee pain & functional limitation .(Baseline, At the end of 24 weeks.)