Clinical and Radiological Comparison of the Efficacy of Hyaluronic Acid, PRP and Steroid Injections in Partial Rotator Cuff Tears: A Prospective Randomized Study
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- American Shoulder and Elbow Surgeons Shoulder Score (ASES)
研究概览
简要总结
There are many conservative treatment options available for partial rotator cuff tears. However, the superiority of a certain type of injection could not be demonstrated with the available data. Our aim is to compare the effectiveness of steroid, hyaluronic acid, prp and placebo (normal saline) injections in partial rotator cuff tears by applying the same physical therapy protocol after injection.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •persistent continous pain at least 3 months
- •partial thickness rotator cuff tear on MRI
排除标准
- •inflammatory disease
- •pregnancy
- •known malignancy
- •bleeding disorder ( or <10 g/dl Hb level, <150.000 ul platelet)
- •previous shoulder injection
- •history of shoulder surgery
- •full-thickness tear
- •other shoulder problem (osteoarthritis, bony lesions, etc)
研究组 & 干预措施
Hyaluronic Acid + Physical Therapy
4 ml hyaluronic acid (subacromial)
干预措施: Subacromial Injection (hyaluronic acid) + Physical Therapy. (Combination Product)
Platelet-Rich-Plasma (PRP) + Physical Therapy
4 ml platelet-rich-plasma (subacromial)
干预措施: Subacromial Injection (Platelet-Rich-Plasma) + Physical Therapy. (Combination Product)
Steroid + Physical Therapy
methylprednisolone acetate (1ml methylprednisolone acetate + 3 ml serum saline) (subacromial)
干预措施: Subacromial Injection (methylprednisolone acetate) + Physical Therapy. (Combination Product)
Placebo (serum saline) + Physical Therapy
4 ml serum saline (subacromial)
干预措施: Subacromial Injection (Serum Saline) + Physical Therapy. (Combination Product)
结局指标
主要结局
American Shoulder and Elbow Surgeons Shoulder Score (ASES)
时间窗: 12 months after injection
minimum score:0, maximum score:100, 100 is better function.
次要结局
- Constant-Murley Shoulder Outcome Score (CMS)(12 months after injection)
- Subjective Shoulder Value (SSV)(12 months after injection)
- Visual analogue scale (VAS)(12 months after injection)
- Range of Motion (ROM)(12 months after injection)
研究者
Muzaffer Ağır
MD
Bezmialem Vakif University