The Effect of Combined Use of Anti-fibrotic Agent With Platelet Rich Plasma on Skeletal Muscle Healing After Acute Injuries

Study Overview
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Brief Summary
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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.

Official Title
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A New Treatment Modality For Skeletal Muscles Sports Injuries; Losartan Combination With PRP

Conditions
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PRP, Losartan, Muscle Injury, Sport Injury

Intervention / Treatment
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* Biological: Autologous platelets rich plasma
* Combination Product: Autologous platelets rich plasma + oral LOSARTAN administration


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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. Anemia Thrombocytopenia or any platelet disorder. Pregnancy or lactation. Local infection

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 10 patients with acute skeletal muscle injury underwent PRP injection<br>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. | Biological: Autologous platelets rich plasma<br>* 30 ml of venous blood were drawn from the participant by means of venipuncture. The collected blood was mixed with 3 ml anti-coagulant acid citrate dextrose in the centrifugation sterile tube. The blood sample was then centrifuged using the centrifugation machine. 3 ml of PRP from the buffy coat layer were loaded in a 5 ml syringe. After local sterilization and draping of the site of injection and under US guidance the hematoma was aspirated from the injury site and the freshly prepared PRP was injected.<br>* Other names: PRP;|
| Experimental: 10 patients with acute skeletal muscle injury underwent PRP injection and oral LOSARTAN<br>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. | Combination Product: Autologous platelets rich plasma + oral LOSARTAN administration<br>* in addition to local PRP injection, 50 mg / day of LOSARTAN (Cozaar® 50 mg film-coated tablets) were administrated to the study group orally every morning from day 5 and till day 30 after injury.<br>* Other names: PRP + LOSARTAN;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ecchymosis | locally at the site of injury present or absent | 1or 2 days after injury | 
| ecchymosis | locally at the site of injury present or absent | 2 weeks after injury. | 
| ecchymosis | locally at the site of injury present or absent | 1month after injury. | 
| ecchymosis | locally at the site of injury present or absent | 3 months after injury. | 
| deformity | palpable defects at the site of injury present or absent | 1 or 2 days after injury | 
| deformity | palpable defects at the site of injury present or absent | 2 weeks after injury. | 
| deformity | palpable defects at the site of injury present or absent | 1month after injury. | 
| deformity | palpable defects at the site of injury present or absent | 3 months after injury. | 
| tenderness | at the site of injury present or absent | 1 or 2 days after injury | 
| tenderness | at the site of injury present or absent | 2 weeks after injury. | 
| tenderness | at the site of injury present or absent | 1month after injury. | 
| tenderness | at the site of injury present or absent | 3 months after injury. | 
| Pain at site of injury | pain at site of injury using visual analog score VAS where 0 is lowest and 100 is highest pain | 1 or 2 days after injury | 
| Pain at site of injury | pain at site of injury using visual analog score VAS where 0 is lowest and 100 is highest pain | 2 weeks after injury. | 
| Pain at site of injury | pain at site of injury using visual analog score VAS where 0 is lowest and 100 is highest pain | 1month after injury. | 
| Pain at site of injury | pain at site of injury using visual analog score VAS where 0 is lowest and 100 is highest pain | 3 months after injury. | 
| spasm | spasm in the injured muscle present or absent | 1or 2 days after injury. | 
| spasm | spasm in the injured muscle present or absent | 2 weeks after injury. | 
| spasm | spasm in the injured muscle present or absent | 1month after injury. | 
| spasm | spasm in the injured muscle present or absent | 3 months after injury. | 
| Pain with active muscle stretches | present or absent | 1or 2 days after injury. | 
| Pain with active muscle stretches | present or absent | 2 weeks after injury. | 
| Pain with active muscle stretches | present or absent | 1month after injury. | 
| Pain with active muscle stretches | present or absent | 3 months after injury. | 
| Pain with passive muscle stretches | present or absent | 1 or 2 days after injury. | 
| Pain with passive muscle stretches | present or absent | 2 weeks after injury. | 
| pain with passive muscle stretches | present or absent | 3 months after injury. | 
| Pain with passive muscle stretches | present or absent | 1month after injury. | 
| pain with active muscle contraction | present or absent | 1 or 2 days after injury. | 
| pain with active muscle contraction | present or absent | 2 weeks after injury. | 
| pain with active muscle contraction | present or absent | 1month after injury. | 
| pain with active muscle contraction | present or absent | 3 months after injury. | 
| pain with against resistance muscle contraction | present or absent | 1 or 2 days after injury. | 
| pain with against resistance muscle contraction | present or absent | 2 weeks after injury. | 
| pain with against resistance muscle contraction | present or absent | 1month after injury. | 
| pain with against resistance muscle contraction | present or absent | 3 months after injury. | 
| size of injury | in cm2 using ultrasound | 1 or 2 days after injury. | 
| size of injury | in cm2 using ultrasound | 2 weeks after injury. | 
| size of injury | in cm2 using ultrasound | 1month after injury. | 
| size of injury | in cm2 using ultrasound | 3 months after injury. | 
| disorganized fibrous tissue | present or absent using ultrasound | 1 or 2 days after injury. | 
| disorganized fibrous tissue | present or absent using ultrasound | 2 weeks after injury. | 
| disorganized fibrous tissue | present or absent using ultrasound | 1month after injury. | 
| disorganized fibrous tissue | present or absent using ultrasound | 3 months after injury. | 
| hematoma | present or absent using ultrasound | 1 or 2 days after injury. | 
| hematoma | present or absent using ultrasound | 2 weeks after injury. | 
| hematoma | present or absent using ultrasound | 1month after injury. | 
| hematoma | present or absent using ultrasound | 3 months after injury. | 
| Doppler signal | present or absent using ultrasound | 1 or 2 days after injury. | 
| Doppler signal | present or absent using ultrasound | 2 weeks after injury. | 
| Doppler signal | present or absent using ultrasound | 1month after injury. | 
| Doppler signal | present or absent using ultrasound | 3 months after injury. |