Thigh Muscle InjuryPhase 4NCT07513142
PPP Versus Corticosteroid for Thigh Muscle Injuries
A Phase 4 study testing Corticosteroid and Platelet Poor Plasma in people with Thigh Muscle Injury and Thigh Injury, run by Andrews Research & Education Foundation at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 30 years
- Conditions the study is for
- Thigh Muscle Injury, Thigh Injury, Musculoskeletal
- What is being tested?
- Corticosteroid and Platelet Poor Plasma
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Mar 2026to Jun 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 15-30 years of age (and)
- Participant in a sport (and)
- Confirmed thigh muscle injury
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Andrews Research and Education Foundation
Gulf Breeze, Florida, 32561
About this study
Official title: 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.
- Conditions
- Thigh Muscle Injury, Thigh Injury, Musculoskeletal, Musculoskeletal Injury Trauma, Musculoskeletal Injuries
- Being tested
- Corticosteroid, Platelet Poor Plasma
- Keywords
- Thigh Muscle Injury, PPP, Platelet Poor Plasma, Corticosteroid, Sports Medicine, Orthopaedic, Orthopedic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CorticosteroidDrug
Only drug in the study
Platelet Poor PlasmaBiological
Only biologic in the study
| Study group | Role | What they receive |
|---|---|---|
| Corticosteroid Injection | Active comparator | Not described Receives: Drug: Corticosteroid |
| Platelet Poor Plasma | Experimental | Not described Receives: Biological: Platelet Poor Plasma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Return to Play
Number of days required for a patient to resume full, unrestricted, and asymptomatic participation in sports following the injection.
Measured: 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).
Measured: Up to 1 year
Secondary outcomes (2)
Modified BAMIC
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.
Measured: Pre-Injection
Peak Strength
Comparison of peak strength between the injured and uninjured thigh using a digital handheld dynamometer at the time of return-to-play clearance
Measured: Up to 1 year post-injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2026
- Study start25 Mar 2026
- Primary completionJun 2027 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thigh Muscle InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Andrews Research & Education Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Brett J Kindle, M.D., Principal investigator, Andrews Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07513142
- Sponsor's protocol ID
- PPP versus Corticosteroid
- Status last verified
- Oct 2026
- First submitted
- 1 Apr 2026
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Blind, Randomized Controlled Trial Evaluating Platelet Poor Plasma Versus Corticosteroid Injections as A Control for Thigh Muscle Injuries
- ClinicalTrials.gov ID
- NCT07513142
- Acronym / sponsor ID
- PPP versus Corticosteroid
- 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
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Andrews Research & Education FoundationUniversity, hospital or other
- Study start
- 25 Mar 2026 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 6 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Corticosteroid Injection | Active comparator | Drug: Corticosteroid |
| Platelet Poor Plasma | Experimental | Biological: Platelet Poor Plasma |
Who may qualify
- Ages
- 15 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 15-30 years of age (and)
- Participant in a sport (and)
- Confirmed thigh muscle injury
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CorticosteroidOnly drug in the study | Drug | Corticosteroid Injection |
| Platelet Poor PlasmaOnly biologic in the study | Biological | Platelet Poor Plasma |
Primary outcome
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.
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).
2 secondary outcomes
Modified BAMIC
Time frame: Pre-Injection
Peak Strength
Time frame: Up to 1 year post-injection
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Brett J Kindle, M.D. principal investigator
Andrews Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Corticosteroid and Platelet Poor Plasma in people with Thigh Muscle Injury and Thigh Injury, run by Andrews Research & Education Foundation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Return to Play (time frame: Up to 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.