Clinical trial NCT05827484: The Effect of Combined Use of Anti-fibrotic Agent With Platelet Rich Plasma on Skeletal Muscle Healing After Acute Injuries
Official title: A New Treatment Modality For Skeletal Muscles Sports Injuries; Losartan Combination With PRP
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: PRP
Losartan
Muscle Injury
Sport Injury
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2023-04-25
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: ecchymosis
timeFrame: 1or 2 days after injury
measure: ecchymosis
timeFrame: 2 weeks after injury.
measure: ecchymosis
timeFrame: 1month after injury.
measure: ecchymosis
timeFrame: 3 months after injury.
measure: deformity
timeFrame: 1 or 2 days after injury
measure: deformity
timeFrame: 2 weeks after injury.
measure: deformity
timeFrame: 1month after injury.
measure: deformity
timeFrame: 3 months after injury.
measure: tenderness
timeFrame: 1 or 2 days after injury
measure: tenderness
timeFrame: 2 weeks after injury.
measure: tenderness
timeFrame: 1month after injury.
measure: tenderness
timeFrame: 3 months after injury.
measure: Pain at site of injury
timeFrame: 1 or 2 days after injury
measure: Pain at site of injury
timeFrame: 2 weeks after injury.
measure: Pain at site of injury
timeFrame: 1month after injury.
measure: Pain at site of injury
timeFrame: 3 months after injury.
measure: spasm
timeFrame: 1or 2 days after injury.
measure: spasm
timeFrame: 2 weeks after injury.
measure: spasm
timeFrame: 1month after injury.
measure: spasm
timeFrame: 3 months after injury.
measure: Pain with active muscle stretches
timeFrame: 1or 2 days after injury.
measure: Pain with active muscle stretches
timeFrame: 2 weeks after injury.
measure: Pain with active muscle stretches
timeFrame: 1month after injury.
measure: Pain with active muscle stretches
timeFrame: 3 months after injury.
measure: Pain with passive muscle stretches
timeFrame: 1 or 2 days after injury.
measure: Pain with passive muscle stretches
timeFrame: 2 weeks after injury.
measure: pain with passive muscle stretches
timeFrame: 3 months after injury.
measure: Pain with passive muscle stretches
timeFrame: 1month after injury.
measure: pain with active muscle contraction
timeFrame: 1 or 2 days after injury.
measure: pain with active muscle contraction
timeFrame: 2 weeks after injury.
measure: pain with active muscle contraction
timeFrame: 1month after injury.
measure: pain with active muscle contraction
timeFrame: 3 months after injury.
measure: pain with against resistance muscle contraction
timeFrame: 1 or 2 days after injury.
measure: pain with against resistance muscle contraction
timeFrame: 2 weeks after injury.
measure: pain with against resistance muscle contraction
timeFrame: 1month after injury.
measure: pain with against resistance muscle contraction
timeFrame: 3 months after injury.
measure: size of injury
timeFrame: 1 or 2 days after injury.
measure: size of injury
timeFrame: 2 weeks after injury.
measure: size of injury
timeFrame: 1month after injury.
measure: size of injury
timeFrame: 3 months after injury.
measure: disorganized fibrous tissue
timeFrame: 1 or 2 days after injury.
measure: disorganized fibrous tissue
timeFrame: 2 weeks after injury.
measure: disorganized fibrous tissue
timeFrame: 1month after injury.
measure: disorganized fibrous tissue
timeFrame: 3 months after injury.
measure: hematoma
timeFrame: 1 or 2 days after injury.
measure: hematoma
timeFrame: 2 weeks after injury.
measure: hematoma
timeFrame: 1month after injury.
measure: hematoma
timeFrame: 3 months after injury.
measure: Doppler signal
timeFrame: 1 or 2 days after injury.
measure: Doppler signal
timeFrame: 2 weeks after injury.
measure: Doppler signal
timeFrame: 1month after injury.
measure: Doppler signal
timeFrame: 3 months after injury.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Ain Shams University hospitals
name: Mostafa M. Hassanein, Msc
role: PRINCIPAL_INVESTIGATOR
affiliation: Ain Shams University hospitals
name: Wael A.M. Nassar, MD
role: STUDY_DIRECTOR
affiliation: Ain Shams University hospitals
name: Medhat M. Magdy, Msc
role: PRINCIPAL_INVESTIGATOR
affiliation: Ain Shams University hospitals
name: Amr G. Gendya, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ain Shams University hospitals
name: Haitham Adel A. A. El Dessokey, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.