Evaluation of Ultrasound Guided Platelet Rich Plasma Injection Versus Steroids Injection for Pain Relief in Cases of Partial Rotator Cuff Tears
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Shoulder pain assesment
研究概览
简要总结
Comparison between effects of ultrasound guided platelet rich plasma injection versus steroids injection for pain relief in cases of partial rotator cuff tears
详细描述
The effect of injection of platelet rich plasma will be compared with effects of steroids injection according to pain relief effects,, Side effects ,, healing ability ,, recurrence in both groups.
30 patient in each group will be included
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 (Participant)
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with positive tests for rotator cuff pain
- •Patients with positive radiological (US or MRI) findings of partial rotator cuff tear
排除标准
- •Patient refusal
- •Age less than 20 years.
- •Infection at injection site.
- •Prior surgery on the shoulder joint area.
- •Presence of other associated pathology in the shoulder joint
- •Patients using antiplatelet drugs (aspirin).
- •Contraindications to the use of platelet concentrate
- •Contraindications to the steroids injection
研究组 & 干预措施
Platelet rich plasma group
participants will receive Ultrasound guided subacromial injection of 3 ml platelet rich plasma+0.5 ml of PRP activator (10% calcium gluconate)+ 1ml 0.5%bupivacaine.
干预措施: Platelet rich plasma (Combination Product)
Methylprednisolone group
participants will receive Ultrasound guided subacromial injection of 1 ml methylprednisolone+ 1ml 0.5%bupivacaine + 2.5 ml normal saline.
干预措施: Methylprednisolone (Combination Product)
结局指标
主要结局
Shoulder pain assesment
时间窗: 4 months
The pain will be assessed using visual analogue scale( score range=0-10,less than 4,4-6 and more than 6 for mild, moderate and severe pain respectively)
次要结局
- Assesment of rotator cuff tendon healing(4 months)
- Assesment the rate of tear recurrence after shoulder joint injection(4 months)
- Assesment the failure rate after shoulder joint injection(4 months)
- The reinjection rate recording(4 months)
- Simple shoulder assessment test(4 months)
研究者
radwa saber
Radwa saber
Alexandria University