A Single Blind, Randomized Controlled Trial Evaluating Platelet Poor Plasma Versus Corticosteroid Injections as A Control for Thigh Muscle Injuries
试验速览
- 阶段
- 4 期
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Return to Play
研究概览
简要总结
The purpose of this study is to compare the number of days it takes for a sport participant to return to play between ultrasound guided intramuscular corticosteroid injections and platelet-poor plasma (PPP) injections for thigh muscle injuries.
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
- Single (Participant)
入排标准
- 年龄范围
- 15 Years 至 30 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •15-30 years of age (and)
- •Participant in a sport (and)
- •Confirmed thigh muscle injury
排除标准
- •Patient is incapable or unwilling to provide informed consent.
- •Patient is not within the age range
- •Patient does not have a thigh injury
- •Patient's thigh injury occurred more than 4 weeks prior to treatment
- •Patient's thigh injury requires surgical intervention
- •Patient has had an injection for their thigh injury within the past 30 days
- •Patient has thrombocytosis or other platelet abnormality in whole blood
研究组 & 干预措施
Platelet Poor Plasma
干预措施: Platelet Poor Plasma (Biological)
Corticosteroid Injection
干预措施: Corticosteroid (Drug)
结局指标
主要结局
Return to Play
时间窗: Up to 1 year
Number of days required for a patient to resume full, unrestricted, and asymptomatic participation in sports following the injection.
VAS Pain Scale
时间窗: Up to 1 year
Visual Analog Scale (VAS) scores will be collected and analyzed at the following time points: immediately post-procedure, 24 hours, 2 weeks, 6 weeks, 12 weeks, and 1 year after the procedure. The Visual Analog Scale is a pain measurement to be obtained from the patient that ranges from 0 (no pain at all) to 10 (worst pain you can ever imagine).
次要结局
- Modified BAMIC(Pre-Injection)
- Peak Strength(Up to 1 year post-injection)