A New Treatment Modality For Skeletal Muscles Sports Injuries; Losartan Combination With PRP
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 主要终点
- tenderness
研究概览
简要总结
The aim of this comparative study is to determine whether or not LOSARTAN with its anti-fibrotic action has an added effect when administrated with platelet rich plasma injection on skeletal muscle healing and on decreasing the fibrous scar after muscle injuries in comparison with the sole administration of platelet rich plasma.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult age. (18 - 40 year old).
- •Clinically diagnosed acute skeletal muscle injury with maximum 3 days duration and ultrasonographically confirmed grade II according to Woodhouse et al.
- •Understanding the study and accepting the participation
排除标准
- •Any connective tissue disease (e.g. rheumatoid arthritis, systemic lupus erythematous, etc.)
- •Hypertension or hypotension
- •Diabetes mellitus
- •Any cardiac or pulmonary disease
- •NSAIDs use in less than a week prior to the beginning of the study.
- •Muscle injuries requiring surgical interference.
- •No detectable injury ultrasonographically.
- •Thrombocytopenia or any platelet disorder.
- •Pregnancy or lactation.
- •Local infection
研究组 & 干预措施
10 patients with acute skeletal muscle injury underwent PRP injection
Patients with acute skeletal muscle injury received a single ultrasound guided local PRP injection in the site of injury in day 1 or 2 of the injury.
干预措施: Autologous platelets rich plasma (Biological)
10 patients with acute skeletal muscle injury underwent PRP injection and oral LOSARTAN
Patients with acute skeletal muscle injury received a single ultrasound guided local PRP injection in day 1 or 2 of injury in addition to administration of oral (50mg LOSARTAN /day) from day 5 to day 30.
干预措施: Autologous platelets rich plasma + oral LOSARTAN administration (Combination Product)
结局指标
主要结局
tenderness
时间窗: 3 months after injury.
at the site of injury "present or absent"
pain with passive muscle stretches
时间窗: 3 months after injury.
"present or absent"
Pain at site of injury
时间窗: 3 months after injury.
pain at site of injury using visual analog score "VAS" where 0 is lowest and 100 is highest pain
spasm
时间窗: 3 months after injury.
spasm in the injured muscle "present or absent"
Pain with passive muscle stretches
时间窗: 1month after injury.
"present or absent"
ecchymosis
时间窗: 3 months after injury.
locally at the site of injury "present or absent"
Pain with active muscle stretches
时间窗: 3 months after injury.
"present or absent"
pain with active muscle contraction
时间窗: 3 months after injury.
"present or absent"
hematoma
时间窗: 3 months after injury.
"present or absent" using ultrasound
deformity
时间窗: 3 months after injury.
palpable defects at the site of injury "present or absent"
size of injury
时间窗: 3 months after injury.
in cm2 using ultrasound
Doppler signal
时间窗: 3 months after injury.
"present or absent" using ultrasound
pain with against resistance muscle contraction
时间窗: 3 months after injury.
"present or absent"
disorganized fibrous tissue
时间窗: 3 months after injury.
"present or absent" using ultrasound
ecchymosis
时间窗: 1or 2 days after injury
locally at the site of injury "present or absent"
ecchymosis
时间窗: 2 weeks after injury.
locally at the site of injury "present or absent"
ecchymosis
时间窗: 1month after injury.
locally at the site of injury "present or absent"
Pain with active muscle stretches
时间窗: 1or 2 days after injury.
"present or absent"
deformity
时间窗: 1 or 2 days after injury
palpable defects at the site of injury "present or absent"
deformity
时间窗: 2 weeks after injury.
palpable defects at the site of injury "present or absent"
deformity
时间窗: 1month after injury.
palpable defects at the site of injury "present or absent"
tenderness
时间窗: 1 or 2 days after injury
at the site of injury "present or absent"
tenderness
时间窗: 2 weeks after injury.
at the site of injury "present or absent"
tenderness
时间窗: 1month after injury.
at the site of injury "present or absent"
Pain at site of injury
时间窗: 1 or 2 days after injury
pain at site of injury using visual analog score "VAS" where 0 is lowest and 100 is highest pain
Pain at site of injury
时间窗: 2 weeks after injury.
pain at site of injury using visual analog score "VAS" where 0 is lowest and 100 is highest pain
Pain at site of injury
时间窗: 1month after injury.
pain at site of injury using visual analog score "VAS" where 0 is lowest and 100 is highest pain
spasm
时间窗: 1or 2 days after injury.
spasm in the injured muscle "present or absent"
spasm
时间窗: 2 weeks after injury.
spasm in the injured muscle "present or absent"
spasm
时间窗: 1month after injury.
spasm in the injured muscle "present or absent"
Pain with active muscle stretches
时间窗: 2 weeks after injury.
"present or absent"
Pain with active muscle stretches
时间窗: 1month after injury.
"present or absent"
Pain with passive muscle stretches
时间窗: 1 or 2 days after injury.
"present or absent"
Pain with passive muscle stretches
时间窗: 2 weeks after injury.
"present or absent"
pain with active muscle contraction
时间窗: 1 or 2 days after injury.
"present or absent"
pain with active muscle contraction
时间窗: 2 weeks after injury.
"present or absent"
pain with active muscle contraction
时间窗: 1month after injury.
"present or absent"
pain with against resistance muscle contraction
时间窗: 1 or 2 days after injury.
"present or absent"
pain with against resistance muscle contraction
时间窗: 2 weeks after injury.
"present or absent"
pain with against resistance muscle contraction
时间窗: 1month after injury.
"present or absent"
size of injury
时间窗: 1 or 2 days after injury.
in cm2 using ultrasound
size of injury
时间窗: 2 weeks after injury.
in cm2 using ultrasound
size of injury
时间窗: 1month after injury.
in cm2 using ultrasound
disorganized fibrous tissue
时间窗: 1 or 2 days after injury.
"present or absent" using ultrasound
disorganized fibrous tissue
时间窗: 2 weeks after injury.
"present or absent" using ultrasound
disorganized fibrous tissue
时间窗: 1month after injury.
"present or absent" using ultrasound
hematoma
时间窗: 1 or 2 days after injury.
"present or absent" using ultrasound
hematoma
时间窗: 2 weeks after injury.
"present or absent" using ultrasound
hematoma
时间窗: 1month after injury.
"present or absent" using ultrasound
Doppler signal
时间窗: 1 or 2 days after injury.
"present or absent" using ultrasound
Doppler signal
时间窗: 2 weeks after injury.
"present or absent" using ultrasound
Doppler signal
时间窗: 1month after injury.
"present or absent" using ultrasound
次要结局
未报告次要终点
研究者
Mostafa Hassanein, Msc
principal investigator
Ain Shams University