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

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

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.

Study Overview

• Status: Completed
• Conditions: Sport Injury; Muscle Injury; PRP; Losartan
• Intervention / Treatment: Biological: Autologous platelets rich plasma; Combination product: Autologous platelets rich plasma + oral LOSARTAN administration

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 10 patients with acute skeletal muscle injury underwent PRP injection; 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; 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.; Other Names: PRP
Experimental: 10 patients with acute skeletal muscle injury underwent PRP injection and oral LOSARTAN; 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; 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.; Other Names: PRP + LOSARTAN

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Mostafa Hassanein, Msc
• Investigators: Principal Investigator: Mostafa M. Hassanein, Msc, Ain Shams University Hospitals; Study Director: Wael A.M. Nassar, MD, Ain Shams University Hospitals; Principal Investigator: Medhat M. Magdy, Msc, Ain Shams University Hospitals; Principal Investigator: Amr G. Gendya, MD, Ain Shams University Hospitals; Principal Investigator: Haitham Adel A. A. El Dessokey, MD, Ain Shams University Hospitals

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2016
• Primary Completion (Actual): September 5, 2017
• Study Completion (Actual): December 12, 2017

Study Registration Dates

• First Submitted: April 1, 2023
• First Submitted That Met QC Criteria: April 12, 2023
• First Posted (Actual): April 25, 2023

Study Record Updates

• Last Update Posted (Actual): July 14, 2023
• Last Update Submitted That Met QC Criteria: July 13, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Athletic Injuries; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Antihypertensive Agents; Angiotensin II Type 1 Receptor Blockers; Angiotensin Receptor Antagonists; Losartan
• Other Study ID Numbers: FMASU MS 22/2016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No