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

Phase 4

Completed

• Conditions: Losartan; Muscle Injury; PRP; Sport Injury
• Interventions: Biological: Autologous platelets rich plasma; Combination Product: Autologous platelets rich plasma + oral LOSARTAN administration

• Registration Number: NCT05827484
• Lead Sponsor: Mostafa Hassanein, Msc

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-10-10
• Primary Completion: 2017-09-05
• Study Completion: 2017-12-12
• Study First Submitted: 2023-04-01
• Study First Submitted QC: 2023-04-12
• Study First Posted: 2023-04-25
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-13
• Last Update Posted: 2023-07-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
10 patients with acute skeletal muscle injury underwent PRP injection	Autologous platelets rich plasma	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.
10 patients with acute skeletal muscle injury underwent PRP injection and oral LOSARTAN	Autologous platelets rich plasma + oral LOSARTAN administration	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.

Primary Outcome Measures

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