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临床试验/NCT01851044
NCT01851044已完成不适用

The Treatment of Lateral Epicondylitis: the Effect of Platelet Rich Plasma on Healing -- A Randomized Controlled Double-Blinded Trial

Tampere University2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2011年2月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
120
试验地点
2
主要终点
Pain (Visual Analog Scale)

研究概览

简要总结

The purpose of this study is to compare the effects of platelet rich plasma, whole blood and saline vehicle on the natural course of lateral epicondylitis.

详细描述

Lateral epicondylitis, also known as "tennis elbow", is the most common work-related disease of the upper extremity. Usually it has favorable natural healing-tendency, but sometimes it is responsible for long-lasting disability. The pathogenesis of this disease has remained unclear, however it has been speculated that the role of inflammation is smaller than previously believed. Instead, anatomical and vascular factors may play a much greater role. The evidence for the operative treatment is lacking, and the conservative treatment is therefore preferred. The conservative treatment used to rely largely on corticosteroid injections to the extensor muscle insertions. However, it has been shown that corticosteroids, in fact, tend to increase the subjective pain in the long run. Several studies -- most of them unfortunately underpowered -- have been carried out to find an efficient conservative treatment to this disease, but none of them has turned out to be significantly better than others. During the last couple of years, platelet rich plasma (PRP) has been used as a treatment in several musculoskeletal diseases (e.g. fracture healing, cartilage regeneration, wound healing). PRP is a substance centrifuged from patient own blood. There are a couple of studies regarding the use of PRP in lateral epicondylitis. The results are mostly positive; however it has not been thoroughly shown that it would be more effective than patient's whole blood. The hypothesis of this study is that PRP is more effective in the treatment of lateral epicondylitis than whole blood or saline vehicle injection. The primary outcome measures are pain (VAS) and the Disabilities of the Arm, Shoulder and Hand -score (DASH).

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)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • The duration of symptoms over 3 months
  • Primary conservative treatment (physiotherapy, NSAID, ...) has been tried

排除标准

  • Significant systemic diseases
  • Any surgical operation of the particular elbow

研究组 & 干预措施

Vehicle (Saline)

Placebo Comparator

2 ml of saline is injected to the proximal insertion of extensor carpi radialis brevis (ECRB) muscle.

干预措施: Platelet Rich Plasma (Procedure)

Whole Blood

Active Comparator

2 ml of patient own venous blood is injected to the proximal insertion of ECRB.

干预措施: Whole Blood Injection (Procedure)

Platelet Rich Plasma

Experimental

9 ml of patient own venous blood is centrifuged using The Arthrex ACP® Double Syringe System and 2 ml of platelet rich plasma is injected to the proximal insertion of ECRB.

干预措施: Saline Injection (Procedure)

结局指标

主要结局

Pain (Visual Analog Scale)

时间窗: 52 weeks

次要结局

  • Disabilities of the Arm, Shoulder and Hand -score(52 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Olli Leppänen

Researcher

Tampere University

研究点 (2)

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