Platelet Rich Plasma vs. Corticosteroid Injection in the Treatment of Partial Thickness Rotator Cuff Tears. A Randomized, Prospective, Double Blinded Trial.
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Percent change in Disabilities of the Arm, Shoulder, and Hand score. (DASH)
研究概览
简要总结
The purpose of this study is to further define the optimal non-surgical treatment strategy for partial thickness rotator cuff tears. The specific aim of this study is to determine the outcomes of treatment of partial thickness rotator cuff tears with corticosteroid or platelet rich plasma (PRP). Subjects with partial thickness rotator cuff tears will be randomized to receive an injection of PRP or corticosteroid. Shoulder function and tendon healing will be evaluated using the patient surveys as well as ultrasound. Subjects will be followed for one year to determine the outcomes for each treatment. The hypothesis is that there is no difference in healing rate or functional outcomes in patients treated with corticosteroid injections vs. PRP injections for the treatment of partial thickness rotator cuff tears.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Shoulder pain for at least two weeks.
- •Partial thickness articular sided rotator cuff tear diagnosed by MRI and musculoskeletal ultrasound.
排除标准
- •Prior surgery to the injured shoulder
- •Full thickness rotator cuff tear
- •Pregnancy
- •Current treatment with anticoagulation medication
- •Steroid injection in the past 6 months in the injured shoulder
- •Prior PRP treatment to the injured shoulder
研究组 & 干预措施
platelet-rich plasma protein (PRP)
Subjects in this group will receive 2 injections with PRP. Each injection separated by two weeks.
干预措施: Platelet Rich Plasma (PRP) (Biological)
Corticosteroid
Subjects in this group will receive one injection with corticosteroids and then one injection with local anesthetic two weeks later.
干预措施: Corticosteroid (Drug)
结局指标
主要结局
Percent change in Disabilities of the Arm, Shoulder, and Hand score. (DASH)
时间窗: baseline and one year
Disabilities of the Arm, Shoulder, and Hand (DASH) is a 30-item self-reported questionnaire used assess shoulder function. The DASH is widely used in orthopaedic research and is considered valid and reliable.
次要结局
- Percent change in American Shoulder and Elbow Surgeons (ASES) scale(Baseline, six weeks, three months, six months, one year)
- Percent change in Disabilities of the Arm, Shoulder, and Hand score. (DASH)(baseline six weeks, 3 months, 6 months)
- Percent change in Visual Analog Pain scale (VAS)(Baseline, six weeks, three months, six months, one year)
- Size of rotator cuff tear size.(Baseline, six months and one year)