The Effect of Platelet Rich Plasma Injection Combined With Exercise Rehabilitation in Patients With Rotator Cuff Tear
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Constant-Murley shoulder score
研究概览
简要总结
This study aims to evaluate the effect of platelet rich plasma combined with exercise therapy for patients with partial thickness rotator cuff tears.
详细描述
The purpose of this study is to exam the outcome of rotator cuff tear patients who received platelet rich plasma injection followed by rehabilitative exercise. The specific aim of this study is to determine the outcomes of treatment of partial thickness rotator cuff tears with platelet rich plasma (PRP) and rehabilitative exercise. Subjects with partial thickness rotator cuff tears will be designated to receive an injection of PRP or hyaluronic acid, followed by rehabilitative exercise. Shoulder function and tendon healing will be evaluated using the patient surveys as well as ultrasound. Subjects will be followed for 3 months to determine the outcomes of the treatment.
The hypothesis is that there is no difference in healing rate or functional outcomes in patients treated with PRP injections plus rehabilitative exercise compared with hyaluronic acid injection plus rehabilitative exercise for the treatment of partial thickness rotator cuff tears.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 40 and 85 years old, without significant cognition impairment (MMSE>20)
- •Shoulder pain score(NRS)> 5
- •Partial tear of supraspinatus tendon, proved by ultrasonography or MRI
- •Patients who signed informed consent
- •Patients who agreed to stop using analgesics during the experimental period
排除标准
- •Thrombocytopenia (platelets less than 15000 per microliter)
- •Patient who is using anticoagulant or has history of coagulation dysfunction
- •Uncontrolled infection
- •End stage malignant disease
- •Infection or other skin condition over injection site
- •History of shoulder or humeral fracture, dislocation or operation
- •Psychiatric problems that precludes informed consent or inability to read or write
- •Other serious problems that preclude participation of the study
研究组 & 干预措施
Platelet-Rich Plasma Protein (PRP) Group
Subjects in this group will receive PRP injection into tear site, followed by rehabilitative exercise
干预措施: Platelet-Rich Plasma (Biological)
Platelet-Rich Plasma Protein (PRP) Group
Subjects in this group will receive PRP injection into tear site, followed by rehabilitative exercise
干预措施: Exercise (Other)
Hyaluronic Acid Group
Subjects in this group will receive one injection with hyaluronic acid followed by rehabilitative exercise
干预措施: Hyaluronic Acid (Drug)
Hyaluronic Acid Group
Subjects in this group will receive one injection with hyaluronic acid followed by rehabilitative exercise
干预措施: Exercise (Other)
结局指标
主要结局
Constant-Murley shoulder score
时间窗: Change is measured from baseline to 1.5 and 3 months
The Constant score assesses pain, function, ROM, and strength. Pain is allotted a maximum of 15 points, activities of daily living (function)20 points, ROM 40 points, and strength 25 points. The component scores are summated to achieve a maximum possible total score of 100.
次要结局
- Size of rotator cuff tear(Change is measured from baseline to 1.5 and 3 months)
- Numeric Pain Rating Scale(Change is measured from baseline to 1.5 and 3 months)
- Shoulder Pain and Disability Index (SPADI)(Change is measured from baseline to 1.5 and 3 months)
- Shoulder range of motion(Change is measured from baseline to 1.5 and 3 months)