Non-Surgical Treatment for Rotator-Cuff Tears Using Platelet-Rich-Plasma
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Diagnostic Ultrasound
研究概览
简要总结
The goal of this project is to identify an effective and conservative approach to treating partial thickness rotator cuff tears (PTRCT) that otherwise would end with a surgical correction needed.
详细描述
Based off literature and clinical practice, the majority of rotator cuff tears continue to progress to surgical correction despite conservative measures. These include physical therapy, medication management and minimally invasive procedures such as subacromial bursa injections and intra-articular injections with steroids. Recently a popular treatment of common musculoskeletal injuries (including tendinopathies) has emerged throughout the US and has been utilized worldwide for many years with good empiric evidence known as Platelet-Rich Plasma (PRP) injections. In partnership with UAB Orthopedics and Radiology, the UAB Department of Physical Medicine and Rehabilitation aims to compare PRP to corticosteroid injections for patients with partial rotator cuff tears or tendinopathy. Outcome measures are ultrasound imaging, pain and disability over the course of 6 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •subjects between ages 19 to 75, both male and female
- •radiologic imaging which can include either magnetic resonance imaging (MRI) or ultrasound (US) consistent with partial thickness rotator cuff tears of any degree except for full thickness tears
- •Failed a trial of physical therapy of at least 4 weeks
排除标准
- •Full thickness tears (well documented need for surgical correction)
- •sensory or neurologic complaint affecting the shoulder of interest
- •Coagulation disorder, platelet disorder
- •Pregnancy: Pregnancy test will be performed on women of childbearing age prior to their participation in the interventional portion of the study
- •Any major systemic illness such as ongoing infection or any condition that requires strict anti-platelet or anticoagulation therapy
- •Prior surgery to either cervical spine or shoulder
- •Active military
- •Injury part of worker compensation claim
研究组 & 干预措施
PRP injection into PTRCT
Treatment - PRP injection
干预措施: PRP injection into PTRCT (Procedure)
Subacromial steroid bursal injection
Current standard of care for treatment of resistant partial thickness rotator cuff tears
干预措施: Subacromial steroid bursal injection (Drug)
结局指标
主要结局
Diagnostic Ultrasound
时间窗: 6 months post procedure
Comparing baseline diagnostic ultrasound for structural changes. An initial diagnostic ultrasound image was obtained to demonstrate a tear of the supraspinatus tendon, a key tendon of the rotator cuff. Once a tear of this tendon was confirmed, patient were delegated to one of the study arms and proceeded to the injection phase of the study. Two subject's data (within the PRP group) is incomplete as these subjects were lost to follow up and do not have completed 6 month follow up ultrasound imaging to review.
次要结局
- Shoulder Pain and Disability Index(6 months post procedure SPADI scores for the treatment and control groups.)
研究者
Breanna Willeford
Resident Physician
University of Alabama at Birmingham