Losartan, Muscle Injury, PRP, Sport Injury
Conditions
Brief summary
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.
Interventions
BIOLOGICALAutologous platelets rich plasma
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.
COMBINATION_PRODUCTAutologous platelets rich plasma + oral LOSARTAN administration
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.
Sponsors
Mostafa Hassanein, Msc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ecchymosis | 1or 2 days after injury | locally at the site of injury present or absent |
| deformity | 1 or 2 days after injury | palpable defects at the site of injury present or absent |
| tenderness | 1 or 2 days after injury | at the site of injury present or absent |
| Pain at site of injury | 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 |
| spasm | 1or 2 days after injury. | spasm in the injured muscle present or absent |
| Pain with active muscle stretches | 1or 2 days after injury. | present or absent |
| Pain with passive muscle stretches | 1 or 2 days after injury. | present or absent |
| pain with passive muscle stretches | 3 months after injury. | present or absent |
| pain with active muscle contraction | 1 or 2 days after injury. | present or absent |
| pain with against resistance muscle contraction | 1 or 2 days after injury. | present or absent |
| size of injury | 1 or 2 days after injury. | in cm2 using ultrasound |
| disorganized fibrous tissue | 1 or 2 days after injury. | present or absent using ultrasound |
| hematoma | 1 or 2 days after injury. | present or absent using ultrasound |
| Doppler signal | 1 or 2 days after injury. | present or absent using ultrasound |
Outcome results
None listed