Thigh Muscle Injury, Thigh Injury, Musculoskeletal, Musculoskeletal Injury Trauma, Musculoskeletal Injuries
Conditions
Keywords
Thigh Muscle Injury, PPP, Platelet Poor Plasma, Corticosteroid, Sports Medicine, Orthopaedic, Orthopedic
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.
Interventions
DRUGCorticosteroid
Only drug in the study
BIOLOGICALPlatelet Poor Plasma
Only biologic in the study
Sponsors
Andrews Research & Education Foundation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
15 Years to 30 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Return to Play | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Modified BAMIC | 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. |
| Peak Strength | 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 |
Countries
United States
Outcome results
None listed