- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07513142
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
Status
Enrolling by invitation
Conditions
Intervention / Treatment
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PPP versus Corticosteroid
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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