A Prospective Comparison of Ultrasound-Guided Percutaneous Platelet-Rich Plasma Injection Versus Tenotomy for Treatment of Gluteus Minimus and Medius Tendinosis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Pain Level and Interference With Activity
研究概览
简要总结
The purpose of this study is to determine the effectiveness of various treatment soft tendinosis also known as tendinitis.
详细描述
Currently there are three treatments that are considered standard of care; rest, tenotomy and tenotomy with injections of platelet-rich plasma (PRP). Tenotomy is performed by passing a needle through the abnormal tendon repeatedly until the needle has passed through all areas of the abnormal tendon with softening of the tendon. Tenotomy with PRP injections is performed in the same manner but includes an injection of platelet-rich plasma (PRP) into the tendon. This study will evaluate the effectiveness of tenotomy versus PRP treatment.
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
- None
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
- •Adult subjects with a diagnosis of tendinosis of the hip.
- •Adult subjects who have been referred to Dr. Jacobson for the treatment of tendinosis by tenotomy.
排除标准
- •pregnancy
- •risk of bleeding due to anticoagulant medication
- •presence of malignancy
- •steroid injection less than 3 months before enrollment
研究组 & 干预措施
Tenotomy Group
Subject enrolled in this arm will receive treatment for tendinitis and pain evaluation of pain pre and post treatment.
干预措施: Tenotomy (no injection) (Procedure)
Plasma Injection Group
Treatment is Ultrasound guided platelet rich plasma injection.
干预措施: Ultrasound guided platelet rich plasma injection (Drug)
结局指标
主要结局
Pain Level and Interference With Activity
时间窗: Up to 23 days
Patient symptoms are measured on a 50 point scale where 0 is no pain or interference with activities and 50 is highest pain and interference. A verbal evaluation and assessment of subject's pain and symptoms will be completed prior to treatment. After receiving medication a second evaluation will be taken to determine how well the medication has relieved and controlled the subject's pain and inflammation associated with tendinitis. Subjects will be specifically asked to rate the level of pain and how the pain is affecting common activities of daily living. The outcomes will be assessed at 2 follow up periods, 1 and approximately 2 weeks after treatment (but no more than 23 days).
次要结局
- Number of Participants Showing Symptomatic Improvement as Assessed in Patient Chart(15 to 555 days post treatment)
研究者
Jon Jacobson
Principal Investigator
University of Michigan