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Enrolling by Invitation

NCT Number: NCT07513142

PPP Versus Corticosteroid for Thigh Muscle Injuries

The purpose of this study is to compare the number of days it takes for a sport participant to return to play between ultrasound guided intramuscular corticosteroid injections and platelet-poor plasma (PPP) injections for thigh muscle injuries.

Enrolling by Invitation

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Key information

Conditions

Thigh Muscle Injury Musculoskeletal Musculoskeletal Injuries Musculoskeletal Injury Trauma Thigh Injury

Age range

15 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Andrews Research and Education Foundation

Gulf Breeze, Florida, 32561, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 15-30 years of age (and)
  • Participant in a sport (and)
  • Confirmed thigh muscle injury

Exclusion criteria

  • Patient is incapable or unwilling to provide informed consent.
  • Patient is not within the age range
  • Patient does not have a thigh injury
  • Patient's thigh injury occurred more than 4 weeks prior to treatment
  • Patient's thigh injury requires surgical intervention
  • Patient has had an injection for their thigh injury within the past 30 days
  • Patient has thrombocytosis or other platelet abnormality in whole blood

Treatment and study plan

Corticosteroid

Drug

Only drug in the study

Platelet Poor Plasma

Biological

Only biologic in the study

Primary outcomes

  1. Return to Play

    Time frame: Up to 1 year

    Number of days required for a patient to resume full, unrestricted, and asymptomatic participation in sports following the injection.

  2. VAS Pain Scale

    Time frame: Up to 1 year

    Visual Analog Scale (VAS) scores will be collected and analyzed at the following time points: immediately post-procedure, 24 hours, 2 weeks, 6 weeks, 12 weeks, and 1 year after the procedure. The Visual Analog Scale is a pain measurement to be obtained from the patient that ranges from 0 (no pain at all) to 10 (worst pain you can ever imagine).

Secondary outcomes

  1. Modified BAMIC

    Time frame: Pre-Injection

    A secondary endpoint of this study includes characterization of the thigh injury using a modified version of the British Athletics Muscle Injury Classification (BAMIC) system.

  2. Peak Strength

    Time frame: Up to 1 year post-injection

    Comparison of peak strength between the injured and uninjured thigh using a digital handheld dynamometer at the time of return-to-play clearance

Sponsors and collaborators

Lead sponsor

Andrews Research & Education Foundation

Other

Registry information

Official study title

A Single Blind, Randomized Controlled Trial Evaluating Platelet Poor Plasma Versus Corticosteroid Injections as A Control for Thigh Muscle Injuries

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Apr 6, 2026
Registry last updated
Apr 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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