The Effect of Platelet Rich Plasma on Partial Thickness Rotator Cuff Tears: A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 104
- 主要终点
- Visual Analog Scale (VAS)
研究概览
简要总结
Randomized controlled trial examining platelet rich plasma versus corticosteroid injection in partial thickness rotator cuff tears or tendinopathy.
详细描述
We performed a randomized controlled trial on patients with imaging-shown rotator cuff tendinopathy or partial thickness tearing. Patients were randomized to receive either platelet rich plasma or corticosteroid. Follow-up was done at 6 weeks, 3 months and 12 months following 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, Investigator, Outcomes Assessor)
盲法说明
Subjects, assessors, and the PI were blinded to the assigned treatment allocation.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •>18 years
- •MRI or US evidence of supraspinatus tendinopathy or partial thickness tearing
- •symptomatic for minimum of 3 months
- •patient has exhausted a course of adequate conservative treatment (including but not limited to home/out patient physical therapy, oral analgesics, and/or shoulder injections)
排除标准
- •prior surgical intervention on affected shoulder
- •full thickness rotator cuff tear
- •concomitant ipsilateral shoulder pathology (i.e. osteoarthritis, inflammatory arthritis)
- •confounding cervical neck pain or radiculopathy
- •more than 3 previous CS injections
- •a CS injection within 6 months of study intervention
- •elite level athlete
- •worker's compensation case
- •litigation or secondary gain issues
- •unwilling or unable to provide informed consent or complete study outcomes
研究组 & 干预措施
Platelet Rich Plasma (PRP)
Patients had 10ml venous blood drawn. Injection was performed under ultrasound guidance by one of two musculoskeletal radiologists. Injection was 3-5ml at the site of tendon pathology with the remainder of the PRP preparation infiltrated into the subacromial space. A leukocyte-poor preparation was used from a pre-packaged kit (RegenLab, Lausanne, Switzerland). The samples were centrifuged at 1500g for 5 mins to yield approx 5.5ml of 80% platelets at 1.6x concentration. The supernatant was then resuspended by inverting the tube several times and was drawn into a separate 5-ml syringe for subacromial injection.
干预措施: Platelet Rich Plasma (PRP) (Biological)
Corticosteroid (CS)
Patients had 10ml venous blood drawn. Injection was performed under ultrasound guidance by one of two musculoskeletal radiologists. The blood sample was kept for a similar time delay for centrifugation prior to injection, and was then discarded. 1ml of 40-mg/ml triamcinolone was suspended in 2ml of 0.5% bupivicaine. Injection was performed through a lateral subacromial approach after needle fenestration of the supraspinatus tendon under ultrasound visualization. CS was infiltrated into the subacromial bursa and not the tendon itself.
干预措施: Corticosteroid (CS) (Drug)
结局指标
主要结局
Visual Analog Scale (VAS)
时间窗: change from baseline at 6 weeks, 3 months, 12 months
visual analog scale for pain
次要结局
- "Failure"(anytime from injection out to 12 months)
- Anatomic changes(3 months and 12 months post injection)
- American Shoulder and Elbow Surgeons shoulder score (ASES)(change from baseline at 6 weeks, 3 months, 12 months)
- Western Ontario Rotator Cuff Index (WORC)(change from baseline at 6 weeks, 3 months, 12 months)
研究者
Ian King Yeung Lo
MD, FRCSC, Clinical Assistant Professor
University of Calgary