PPP Versus Corticosteroid for Thigh Muscle Injuries

April 6, 2026 updated by: Andrews Research & Education Foundation

A Single Blind, Randomized Controlled Trial Evaluating Platelet Poor Plasma Versus Corticosteroid Injections as A Control 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.

Study Overview

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Florida
      • Gulf Breeze, Florida, United States, 32561
        • Andrews Research and Education Foundation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Corticosteroid Injection
Only drug in the study
Experimental: Platelet Poor Plasma
Only biologic in the study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 1 year
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).
Up to 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Pre-Injection
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
Up to 1 year post-injection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 25, 2026

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

June 1, 2028

Study Registration Dates

First Submitted

April 1, 2026

First Submitted That Met QC Criteria

April 1, 2026

First Posted (Actual)

April 6, 2026

Study Record Updates

Last Update Posted (Actual)

April 9, 2026

Last Update Submitted That Met QC Criteria

April 6, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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