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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 10 patients with acute skeletal muscle injury underwent PRP injection | Active Comparator | 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. |
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| 10 patients with acute skeletal muscle injury underwent PRP injection and oral LOSARTAN | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autologous platelets rich plasma | Biological | 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mostafa M. Hassanein, Msc | Ain Shams University | Principal Investigator |
| Wael A.M. Nassar, MD | Ain Shams University | Study Director |
| Medhat M. Magdy, Msc | Ain Shams University | Principal Investigator |
| Amr G. Gendya, MD | Ain Shams University | Principal Investigator |
| Haitham Adel A. A. El Dessokey, MD | Ain Shams University | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21414545 | Background | Woodhouse JB, McNally EG. Ultrasound of skeletal muscle injury: an update. Semin Ultrasound CT MR. 2011 Apr;32(2):91-100. doi: 10.1053/j.sult.2010.12.002. |
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| Autologous platelets rich plasma + oral LOSARTAN administration | Combination Product | 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. |
|
|
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. |
| ID | Term |
|---|---|
| D019808 | Losartan |
| ID | Term |
|---|---|
| D001713 | Biphenyl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013777 | Tetrazoles |
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