Randomized Clinical Trial About the Therapeutic Use of Platelet-Rich Plasma (PRP) for the Treatment of Acute Muscular Injuries in Football Players.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 41
- 试验地点
- 2
- 主要终点
- Pain intensity
研究概览
简要总结
OBJECTIVE: To evaluate the effect of Platelet Rich Plasma (PRP) injection in muscle injuries. The investigators check football players in the acute phase of hamstrings or quadriceps injuries.
Efficacy and safety are evaluated. There are two intramuscular infiltration of PRP (Ortho pras ® system) or a homeopathic product (Traumeel ®) in each of the football players. The number of days between the date of injury and the return to play, the pain, the recurrence and the adverse reactions are registered.
详细描述
STUDY DESIGN: Randomized Clinical Trial.
METHODS:
41 football players are included in the study. It is used randomly PRP injection or a homeopathic product in muscle injuries (hamstring), in the early stage (first 48-72 hours).
One week later, the investigators do a second infiltration with the same product, always ultrasound guided. 3-4 weeks after the injury, different variables are evaluated: the injurie with ultrasounds , self-perception test, muscle strength, flexibility, jump and run. It is compared the elapsed time in days in each of the groups: RETURN TO PLAY.
Furthermore, the PAIN, RECURRENCE RATE and ADVERSE REACTIONS are evaluated.
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
- Double (Participant, Outcomes Assessor)
盲法说明
The patient doesn't know the treatment. The person who analyze the data (outcomes assessor) doesn't know the treatment.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Over 18 years old.
- •Acute muscular Injury Type 3a-3b (Múnich classification) in hamstring muscles
- •Informed consent signed
排除标准
- •Hamstring injury (last 6 months).
- •Previous infiltration in hamstring.
结局指标
主要结局
Pain intensity
时间窗: 3 months since the injury
Pain after the muscle injury, and after the injections, with: -Funtional outcomes: pain (0 no pain; 10 unbearable pain) at rest, walking and going up and down the stairs. The Brief Pain Inventory - Short Form. Pain intensity (0, no pain - 10 unbearable) and interferences with the daily activities (0, does not interfere; 10, completely interferes).
Return to play (recovery period)
时间窗: average of 3-6 weeks. Until play again a football match (training or competition)
Days elapsed since muscular injury apperars until the return to play
次要结局
- Number of adverse effects(Through study completion, an average of 1 year)
- Incidence of Recurrences(Less than 6 months since the first injury)
研究者
Javier González Iglesias
Medical Doctor (orthopedic surgeon)
University of the Basque Country (UPV/EHU)