NCT01812564已完成2 期
Clinical Utilization of Growth Factors Preparations in the Management of Acute Hamstring Muscle Strain Injury
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Aspetar
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Time to Return to Play
研究概览
简要总结
The purpose of this study is to evaluate the therapeutic benefit of utilizing complex growth factor preparations (Platelet Rich Plasma (PRP) in the management of acute hamstring injuries.
The hypothesis is that the time to return to sport is shorter in the patient group treated with Complex Growth Factor Preparations (PRP) in combination with exercise therapy in comparison with 2 control groups:
- the patient group treated with Platelet Poor Plasma (PPP) injections in combination with exercise therapy (control injection AND usual care).
- the patient group treated with exercise therapy (usual care)
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 50 Years(Adult)
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Acute onset posterior thigh pain
- •MRI confirmed Grade I, II hamstring lesions
- •< 5 days from injury
- •Able to perform Physiotherapy at ASPETAR (5 sessions/week)
- •Available for follow-up
- •Age > 18 years
排除标准
- •Diabetes, immuno-compromised state
- •Overlying skin infection
- •Re-injury or Chronic ongoing hamstring injury
- •Unwilling to comply with follow up
- •Contraindication to MRI
- •Needle Phobia
- •Bleeding disorder or other medical contraindication to injection
- •Medication increasing bleeding risk (e.g. Plavix)
- •Concurrent other injury inhibiting rehabilitation
结局指标
主要结局
Time to Return to Play
时间窗: Patients will be followed for the duration of time to return to play with an expected average of 27 days and up to 1 year.
Time to return to full sports activity; either training or match play.
次要结局
- Recurrent hamstring lesions.(2 months after return to play, 1 year after return to play.)
研究者
研究点 (2)
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