Lyophilized Platelet-Rich Plasma Lysate vs Dextrose Prolotherapy for Partial Rotator Cuff Tears
Therapeutic Effect of PRP Lysate and Dextrose Prolotherapy Rotator Cuff Tear
The goal of this clinical trial is to learn whether lyophilized platelet-rich plasma (PRP) lysate can improve shoulder symptoms, shoulder muscle strength, and tendon tear size in adults with partial-thickness rotator cuff tears, compared with hypertonic dextrose prolotherapy.
The main questions this study aims to answer are:
- Does PRP lysate improve shoulder pain and function in people with partial-thickness rotator cuff tears?
- Does PRP lysate improve shoulder internal and external rotation strength?
- Does PRP lysate reduce the size of the rotator cuff tendon tear as measured by ultrasound?
Researchers will compare PRP lysate with hypertonic dextrose prolotherapy to determine whether the changes in shoulder symptoms, muscle strength, and tendon tear size differ between the two treatments.
Participants will be randomly assigned to receive either PRP lysate or hypertonic dextrose. Each participant will receive one ultrasound-guided injection into the partially torn rotator cuff tendon each month for 3 months, for a total of three injections. Participants will complete a questionnaire about shoulder symptoms and function, undergo ultrasound examination of the rotator cuff, and have their shoulder rotation strength measured before the first injection and 1 month after the final injection. Participants assigned to the PRP lysate group will also have blood collected for preparation of the PRP lysate used for their treatment.
研究概览
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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-
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Taichung、台湾
- Taichung Veterans General Hospital
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-
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- Age older than 20 years.
- Shoulder pain with a partial-thickness rotator cuff tear confirmed by physical examination and ultrasonography.
- Willing and able to provide written informed consent.
Exclusion Criteria:
- Adhesive capsulitis.
- Previous shoulder surgery.
- Neuromuscular disease affecting shoulder strength.
- Platelet dysfunction.
- Thrombocytopenia.
- Hypofibrinogenemia.
- Acute or chronic infectious disease.
- History of chronic liver disease.
- Current antiplatelet therapy.
- Depression or other psychological problems.
- Rheumatological disorders.
- Cognitive impairment that would prevent adherence to the study protocol.
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的:PRP lysate
Intralesional injection of PRP lysate
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Intralesional injection of PRP lysate
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有源比较器:Hypertonic dextrose
Intralesional injection of hypertonic dextrose
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Intralesional injection of hypertonic dextrose
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Sonographic Rotator Cuff Tear Size
大体时间:before the first injection and one month after the final injection.
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Use sono to detect the Rotator cuff tear size
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before the first injection and one month after the final injection.
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Oxford shoulder score
大体时间:Before the first intralesional injection and one month after the final intralesional injection.
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A 12-item patient-reported instrument that assesses shoulder pain and limitations in daily activities during the previous four weeks.
Each item is rated on a 5-point scale, producing a total score of 12-60; higher scores reflect more severe symptoms and greater impairment in shoulder function.
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Before the first intralesional injection and one month after the final intralesional injection.
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Shoulder internal and external rotation torque
大体时间:before the first injection and one month after the final injection.
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Utilizing isokinetic dynamometer (Biodex Multi-Joint System 3; Biodex Medical, New York, NY, USA) to measure Shoulder internal and external rotation torque at different angle.
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before the first injection and one month after the final injection.
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合作者和调查者
出版物和有用的链接
一般刊物
- Lazzarini SG, Buraschi R, Pollet J, Bettariga F, Pancera S, Pedersini P. Effectiveness of Additional or Standalone Corticosteroid Injections Compared to Physical Therapist Interventions in Rotator Cuff Tendinopathy: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Phys Ther. 2025 Mar 3;105(3):pzaf006. doi: 10.1093/ptj/pzaf006.
- Hopewell S, Keene DJ, Marian IR, Dritsaki M, Heine P, Cureton L, Dutton SJ, Dakin H, Carr A, Hamilton W, Hansen Z, Jaggi A, Littlewood C, Barker KL, Gray A, Lamb SE; GRASP Trial Group. Progressive exercise compared with best practice advice, with or without corticosteroid injection, for the treatment of patients with rotator cuff disorders (GRASP): a multicentre, pragmatic, 2 x 2 factorial, randomised controlled trial. Lancet. 2021 Jul 31;398(10298):416-428. doi: 10.1016/S0140-6736(21)00846-1. Epub 2021 Jul 12.
- Oh LS, Wolf BR, Hall MP, Levy BA, Marx RG. Indications for rotator cuff repair: a systematic review. Clin Orthop Relat Res. 2007 Feb;455:52-63. doi: 10.1097/BLO.0b013e31802fc175.
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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