PPP Versus Corticosteroid for Thigh Muscle Injuries

NCT07513142 | Enrolling By Invitation Phase 4 FDA Drug

• 1 other identifier: PPP versus Corticosteroid
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Thigh Muscle Injury; Thigh Injury; Musculoskeletal; Musculoskeletal Injury Trauma; Musculoskeletal Injuries

Keywords

Thigh Muscle Injury; PPP; Platelet Poor Plasma; Corticosteroid; Sports Medicine; Orthopaedic; Orthopedic

Outcome Measures

Primary Outcomes (2)

• Return to Play

  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

  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 Outcomes (2)

• Modified BAMIC

  Pre-Injection

• Peak Strength

  Up to 1 year post-injection

Study Arms (2)

Corticosteroid Injection

ACTIVE COMPARATOR

Drug: Corticosteroid

Platelet Poor Plasma

EXPERIMENTAL

Biological: Platelet Poor Plasma

Interventions

Corticosteroid DRUG

Only drug in the study

Corticosteroid Injection

Platelet Poor Plasma BIOLOGICAL

Only biologic in the study

Platelet Poor Plasma

Eligibility Criteria

• Age: 15 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Andrews Research & Education Foundation: lead

Study Sites (1)

Andrews Research and Education Foundation

Gulf Breeze, Florida, 32561, United States

Location

MeSH Terms

Interventions

Adrenal Cortex Hormones

Intervention Hierarchy (Ancestors)

Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2026
• First Posted: April 6, 2026
• Study Start: March 25, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2028
• Last Updated: April 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

US (1)