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

Primary Purpose

PRP, Losartan, Muscle Injury

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Autologous platelets rich plasma
Autologous platelets rich plasma + oral LOSARTAN administration
Sponsored by
Mostafa Hassanein, Msc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for PRP

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    10 patients with acute skeletal muscle injury underwent PRP injection

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

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Full Information

    First Posted
    April 1, 2023
    Last Updated
    July 13, 2023
    Sponsor
    Mostafa Hassanein, Msc
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05827484
    Brief Title
    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

    2. Study Status

    Record Verification Date
    July 2023
    Overall Recruitment Status
    Completed
    Study Start Date
    October 10, 2016 (Actual)
    Primary Completion Date
    September 5, 2017 (Actual)
    Study Completion Date
    December 12, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Mostafa Hassanein, Msc

    4. Oversight

    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

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    PRP, Losartan, Muscle Injury, Sport Injury

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    20 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    10 patients with acute skeletal muscle injury underwent PRP injection
    Arm Type
    Active Comparator
    Arm Description
    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.
    Arm Title
    10 patients with acute skeletal muscle injury underwent PRP injection and oral LOSARTAN
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Biological
    Intervention Name(s)
    Autologous platelets rich plasma
    Other Intervention Name(s)
    PRP
    Intervention Description
    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.
    Intervention Type
    Combination Product
    Intervention Name(s)
    Autologous platelets rich plasma + oral LOSARTAN administration
    Other Intervention Name(s)
    PRP + LOSARTAN
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    ecchymosis
    Description
    locally at the site of injury "present or absent"
    Time Frame
    1or 2 days after injury
    Title
    ecchymosis
    Description
    locally at the site of injury "present or absent"
    Time Frame
    2 weeks after injury.
    Title
    ecchymosis
    Description
    locally at the site of injury "present or absent"
    Time Frame
    1month after injury.
    Title
    ecchymosis
    Description
    locally at the site of injury "present or absent"
    Time Frame
    3 months after injury.
    Title
    deformity
    Description
    palpable defects at the site of injury "present or absent"
    Time Frame
    1 or 2 days after injury
    Title
    deformity
    Description
    palpable defects at the site of injury "present or absent"
    Time Frame
    2 weeks after injury.
    Title
    deformity
    Description
    palpable defects at the site of injury "present or absent"
    Time Frame
    1month after injury.
    Title
    deformity
    Description
    palpable defects at the site of injury "present or absent"
    Time Frame
    3 months after injury.
    Title
    tenderness
    Description
    at the site of injury "present or absent"
    Time Frame
    1 or 2 days after injury
    Title
    tenderness
    Description
    at the site of injury "present or absent"
    Time Frame
    2 weeks after injury.
    Title
    tenderness
    Description
    at the site of injury "present or absent"
    Time Frame
    1month after injury.
    Title
    tenderness
    Description
    at the site of injury "present or absent"
    Time Frame
    3 months after injury.
    Title
    Pain at site of injury
    Description
    pain at site of injury using visual analog score "VAS" where 0 is lowest and 100 is highest pain
    Time Frame
    1 or 2 days after injury
    Title
    Pain at site of injury
    Description
    pain at site of injury using visual analog score "VAS" where 0 is lowest and 100 is highest pain
    Time Frame
    2 weeks after injury.
    Title
    Pain at site of injury
    Description
    pain at site of injury using visual analog score "VAS" where 0 is lowest and 100 is highest pain
    Time Frame
    1month after injury.
    Title
    Pain at site of injury
    Description
    pain at site of injury using visual analog score "VAS" where 0 is lowest and 100 is highest pain
    Time Frame
    3 months after injury.
    Title
    spasm
    Description
    spasm in the injured muscle "present or absent"
    Time Frame
    1or 2 days after injury.
    Title
    spasm
    Description
    spasm in the injured muscle "present or absent"
    Time Frame
    2 weeks after injury.
    Title
    spasm
    Description
    spasm in the injured muscle "present or absent"
    Time Frame
    1month after injury.
    Title
    spasm
    Description
    spasm in the injured muscle "present or absent"
    Time Frame
    3 months after injury.
    Title
    Pain with active muscle stretches
    Description
    "present or absent"
    Time Frame
    1or 2 days after injury.
    Title
    Pain with active muscle stretches
    Description
    "present or absent"
    Time Frame
    2 weeks after injury.
    Title
    Pain with active muscle stretches
    Description
    "present or absent"
    Time Frame
    1month after injury.
    Title
    Pain with active muscle stretches
    Description
    "present or absent"
    Time Frame
    3 months after injury.
    Title
    Pain with passive muscle stretches
    Description
    "present or absent"
    Time Frame
    1 or 2 days after injury.
    Title
    Pain with passive muscle stretches
    Description
    "present or absent"
    Time Frame
    2 weeks after injury.
    Title
    pain with passive muscle stretches
    Description
    "present or absent"
    Time Frame
    3 months after injury.
    Title
    Pain with passive muscle stretches
    Description
    "present or absent"
    Time Frame
    1month after injury.
    Title
    pain with active muscle contraction
    Description
    "present or absent"
    Time Frame
    1 or 2 days after injury.
    Title
    pain with active muscle contraction
    Description
    "present or absent"
    Time Frame
    2 weeks after injury.
    Title
    pain with active muscle contraction
    Description
    "present or absent"
    Time Frame
    1month after injury.
    Title
    pain with active muscle contraction
    Description
    "present or absent"
    Time Frame
    3 months after injury.
    Title
    pain with against resistance muscle contraction
    Description
    "present or absent"
    Time Frame
    1 or 2 days after injury.
    Title
    pain with against resistance muscle contraction
    Description
    "present or absent"
    Time Frame
    2 weeks after injury.
    Title
    pain with against resistance muscle contraction
    Description
    "present or absent"
    Time Frame
    1month after injury.
    Title
    pain with against resistance muscle contraction
    Description
    "present or absent"
    Time Frame
    3 months after injury.
    Title
    size of injury
    Description
    in cm2 using ultrasound
    Time Frame
    1 or 2 days after injury.
    Title
    size of injury
    Description
    in cm2 using ultrasound
    Time Frame
    2 weeks after injury.
    Title
    size of injury
    Description
    in cm2 using ultrasound
    Time Frame
    1month after injury.
    Title
    size of injury
    Description
    in cm2 using ultrasound
    Time Frame
    3 months after injury.
    Title
    disorganized fibrous tissue
    Description
    "present or absent" using ultrasound
    Time Frame
    1 or 2 days after injury.
    Title
    disorganized fibrous tissue
    Description
    "present or absent" using ultrasound
    Time Frame
    2 weeks after injury.
    Title
    disorganized fibrous tissue
    Description
    "present or absent" using ultrasound
    Time Frame
    1month after injury.
    Title
    disorganized fibrous tissue
    Description
    "present or absent" using ultrasound
    Time Frame
    3 months after injury.
    Title
    hematoma
    Description
    "present or absent" using ultrasound
    Time Frame
    1 or 2 days after injury.
    Title
    hematoma
    Description
    "present or absent" using ultrasound
    Time Frame
    2 weeks after injury.
    Title
    hematoma
    Description
    "present or absent" using ultrasound
    Time Frame
    1month after injury.
    Title
    hematoma
    Description
    "present or absent" using ultrasound
    Time Frame
    3 months after injury.
    Title
    Doppler signal
    Description
    "present or absent" using ultrasound
    Time Frame
    1 or 2 days after injury.
    Title
    Doppler signal
    Description
    "present or absent" using ultrasound
    Time Frame
    2 weeks after injury.
    Title
    Doppler signal
    Description
    "present or absent" using ultrasound
    Time Frame
    1month after injury.
    Title
    Doppler signal
    Description
    "present or absent" using ultrasound
    Time Frame
    3 months after injury.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    No
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Mostafa M. Hassanein, Msc
    Organizational Affiliation
    Ain Shams University hospitals
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Wael A.M. Nassar, MD
    Organizational Affiliation
    Ain Shams University hospitals
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Medhat M. Magdy, Msc
    Organizational Affiliation
    Ain Shams University hospitals
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Amr G. Gendya, MD
    Organizational Affiliation
    Ain Shams University hospitals
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Haitham Adel A. A. El Dessokey, MD
    Organizational Affiliation
    Ain Shams University hospitals
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    21414545
    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.
    Results Reference
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    The Effect of Combined Use of Anti-fibrotic Agent With Platelet Rich Plasma on Skeletal Muscle Healing After Acute Injuries

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