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

Sport Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05827484
• Other study ID #: FMASU MS 22/2016
• Status: Completed
• Phase: Phase 4
• Start date: October 10, 2016
• Est. completion date: December 12, 2017

Study information

• Verified date: July 2023
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 12, 2017
• Est. primary completion date: September 5, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Athletic Injuries
• Muscle Injury
• PRP
• Sport Injury
• Wounds and Injuries

Intervention

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.

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mostafa Hassanein, Msc

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ecchymosis	locally at the site of injury "present or absent"	1or 2 days after injury
Primary	ecchymosis	locally at the site of injury "present or absent"	2 weeks after injury.
Primary	ecchymosis	locally at the site of injury "present or absent"	1month after injury.
Primary	ecchymosis	locally at the site of injury "present or absent"	3 months after injury.
Primary	deformity	palpable defects at the site of injury "present or absent"	1 or 2 days after injury
Primary	deformity	palpable defects at the site of injury "present or absent"	2 weeks after injury.
Primary	deformity	palpable defects at the site of injury "present or absent"	1month after injury.
Primary	deformity	palpable defects at the site of injury "present or absent"	3 months after injury.
Primary	tenderness	at the site of injury "present or absent"	1 or 2 days after injury
Primary	tenderness	at the site of injury "present or absent"	2 weeks after injury.
Primary	tenderness	at the site of injury "present or absent"	1month after injury.
Primary	tenderness	at the site of injury "present or absent"	3 months after injury.
Primary	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
Primary	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.
Primary	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.
Primary	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.
Primary	spasm	spasm in the injured muscle "present or absent"	1or 2 days after injury.
Primary	spasm	spasm in the injured muscle "present or absent"	2 weeks after injury.
Primary	spasm	spasm in the injured muscle "present or absent"	1month after injury.
Primary	spasm	spasm in the injured muscle "present or absent"	3 months after injury.
Primary	Pain with active muscle stretches	"present or absent"	1or 2 days after injury.
Primary	Pain with active muscle stretches	"present or absent"	2 weeks after injury.
Primary	Pain with active muscle stretches	"present or absent"	1month after injury.
Primary	Pain with active muscle stretches	"present or absent"	3 months after injury.
Primary	Pain with passive muscle stretches	"present or absent"	1 or 2 days after injury.
Primary	Pain with passive muscle stretches	"present or absent"	2 weeks after injury.
Primary	pain with passive muscle stretches	"present or absent"	3 months after injury.
Primary	Pain with passive muscle stretches	"present or absent"	1month after injury.
Primary	pain with active muscle contraction	"present or absent"	1 or 2 days after injury.
Primary	pain with active muscle contraction	"present or absent"	2 weeks after injury.
Primary	pain with active muscle contraction	"present or absent"	1month after injury.
Primary	pain with active muscle contraction	"present or absent"	3 months after injury.
Primary	pain with against resistance muscle contraction	"present or absent"	1 or 2 days after injury.
Primary	pain with against resistance muscle contraction	"present or absent"	2 weeks after injury.
Primary	pain with against resistance muscle contraction	"present or absent"	1month after injury.
Primary	pain with against resistance muscle contraction	"present or absent"	3 months after injury.
Primary	size of injury	in cm2 using ultrasound	1 or 2 days after injury.
Primary	size of injury	in cm2 using ultrasound	2 weeks after injury.
Primary	size of injury	in cm2 using ultrasound	1month after injury.
Primary	size of injury	in cm2 using ultrasound	3 months after injury.
Primary	disorganized fibrous tissue	"present or absent" using ultrasound	1 or 2 days after injury.
Primary	disorganized fibrous tissue	"present or absent" using ultrasound	2 weeks after injury.
Primary	disorganized fibrous tissue	"present or absent" using ultrasound	1month after injury.
Primary	disorganized fibrous tissue	"present or absent" using ultrasound	3 months after injury.
Primary	hematoma	"present or absent" using ultrasound	1 or 2 days after injury.
Primary	hematoma	"present or absent" using ultrasound	2 weeks after injury.
Primary	hematoma	"present or absent" using ultrasound	1month after injury.
Primary	hematoma	"present or absent" using ultrasound	3 months after injury.
Primary	Doppler signal	"present or absent" using ultrasound	1 or 2 days after injury.
Primary	Doppler signal	"present or absent" using ultrasound	2 weeks after injury.
Primary	Doppler signal	"present or absent" using ultrasound	1month after injury.
Primary	Doppler signal	"present or absent" using ultrasound	3 months after injury.