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临床试验/NCT03986372
NCT03986372Unknown2 期

The Effect of Multiple Injection of Platlet-rich Plasma in Chronic Patellar Tendinopathy

Chang Gung Memorial Hospital2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2019年8月20日最近更新:
适应症

试验速览

阶段
2 期
发起方
入组人数
60
试验地点
2
主要终点
Change from baseline Victorian Institute of Sport Assessment (VISA-P) score to 36 weeks

研究概览

简要总结

According to previous studies, the effect of PRP to patellar tendinopathy could last longer. However, the type, concentration, time and frequent of injection are still debated。 This study is to understand the effect of multiple injection of platlet-rich plasma in chronic patellar tendinopathy and to analyze the relation between efficacy of PRP and the growth factor in PRP.

详细描述

Patellar tendinopathy, also known as jumper's knee,is clinically common characterised by anterior knee pain, activity-related pain、local tenderness over inferior pole of patella. The discomfort can result in decreasing athletic performance and be one of the most challenge for sports medicine doctor.

The patellar tendon suffer from repetitive microtrauma,result in reactive patellar tendinopathy. The overload tendon combining with risk factors of patellar tendinopathy will not recover timely and progress to chronic patellar tendinopathy. Hence, to reverse the progression is our aim.

According to previous studies, several nonsurgical treatment options have been proposed such as medication, eccentric exercise, corticosteroid injection, shockwave and platelet-rich plasma (PRP). Among all the options, the effect of PRP could last longer. However, the type, concentration, time and frequent of injection are still debated。Moreover, there is no study about the relationship between efficacy and the ratio and concentration of growth factor in the PRP.

The aim of this study is to understand (1) The effect of multiple injection of platlet-rich plasma in chronic patellar tendinopathy. (2) The effect of leukocyte-rich PRP in chronic patellar tendinopathy (3) Analyze the relation between efficacy of PRP and the growth factor in PRP.

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
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Chronic patellar tendinopathy

排除标准

  • Corticosteroid injections within 12 months
  • Previous knee surgery
  • Any confounding diagnosis to the knee joint
  • Rheumatoid arthritis
  • Infections of knee joint
  • NSAIDs in the 10 days before the procedure

结局指标

主要结局

Change from baseline Victorian Institute of Sport Assessment (VISA-P) score to 36 weeks

时间窗: 36 weeks

Clinical evaluation for patellar tendinopathy minimum score: 0(worse outcome) maximum score: 100(better outcome)

Change from baseline modified Blazina Scale to 36 weeks

时间窗: 36 weeks

Clinical evaluation for patellar tendinopathy Stage 0 - No pain Stage 1 - Pain only after intense sports activity; no undue functional impairment Stage 2 - Pain at the beginning and after sports activity; still able to perform at a satisfactory level Stage 3 - Pain during sports activity; increasing difficulty in performing at a satisfactory level Stage 4 - Pain during sports activity; unable to participate in sport at a satisfactory level Stage 5 - Pain during daily activity; unable to participate in sport at any level

Change from baseline thickness of patellar tendon to 36 weeks

时间窗: 36 weeks

Sonographic evaluation for patellar tendinopathy to measure the thickness of proximal patellar tendon.

Change from baseline Visual analogue score(VAS) to 36 weeks

时间窗: 36 weeks

evaluation for pain(minimal score:0, maximal score:10)

次要结局

  • Correlation between Platlet derived growth factor (PDGF) and VISA-P score(36 weeks)
  • Correlation between Epithelial growth factor (EGF) and VISA-P score(36 weeks)
  • Change from baseline Victorian Institute of Sport Assessment (VISA) score to 104 weeks(104 weeks)
  • Correlation between Transforming growth factor beta 1 (TGF beta 1) and VISA-P score(36 weeks)

研究者

发起方
Chang Gung Memorial Hospital
申办方类型
Other
责任方
Sponsor

研究点 (2)

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