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

NCT05827484 | Completed Phase 4

• 1 other identifier: FMASU MS 22/2016
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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.

Conditions

PRP; Losartan; Muscle Injury; Sport Injury

Outcome Measures

Primary Outcomes (52)

• 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.

Study Arms (2)

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.

Biological: Autologous platelets rich plasma

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.

Combination Product: Autologous platelets rich plasma + oral LOSARTAN administration

Interventions

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.

Also known as: PRP

10 patients with acute skeletal muscle injury underwent PRP injection

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.

Also known as: PRP + LOSARTAN

10 patients with acute skeletal muscle injury underwent PRP injection and oral LOSARTAN

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mostafa Hassanein, Msc: lead

Related 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.

  PMID: 21414545 BACKGROUND

MeSH Terms

Interventions

Losartan

Intervention Hierarchy (Ancestors)

Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Tetrazoles

Study Officials

• 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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: April 1, 2023
• First Posted: April 25, 2023
• Study Start: October 10, 2016
• Primary Completion: September 5, 2017
• Study Completion: December 12, 2017
• Last Updated: July 14, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share