Ignite Creation Date:
2025-12-25 @ 3:27 AM
Ignite Modification Date:
2026-02-11 @ 5:40 PM
Study NCT ID:
NCT03676205
Status:
COMPLETED
Last Update Posted:
2020-01-22
First Post:
2018-09-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Platelet-Rich Plasma in Acute Muscle Injuries
Sponsor:
University of the Basque Country (UPV/EHU)
Organization:
Study Overview
Official Title:
Randomized Clinical Trial About the Therapeutic Use of Platelet-Rich Plasma (PRP) for the Treatment of Acute Muscular Injuries in Football Players.
Status:
COMPLETED
Status Verified Date:
2020-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
OBJECTIVE: To evaluate the effect of Platelet Rich Plasma (PRP) injection in muscle injuries. The investigators check football players in the acute phase of hamstrings or quadriceps injuries.
Efficacy and safety are evaluated. There are two intramuscular infiltration of PRP (Ortho pras ® system) or a homeopathic product (Traumeel ®) in each of the football players. The number of days between the date of injury and the return to play, the pain, the recurrence and the adverse reactions are registered.
Efficacy and safety are evaluated. There are two intramuscular infiltration of PRP (Ortho pras ® system) or a homeopathic product (Traumeel ®) in each of the football players. The number of days between the date of injury and the return to play, the pain, the recurrence and the adverse reactions are registered.
Detailed Description:
STUDY DESIGN: Randomized Clinical Trial.
METHODS:
41 football players are included in the study. It is used randomly PRP injection or a homeopathic product in muscle injuries (hamstring), in the early stage (first 48-72 hours).
One week later, the investigators do a second infiltration with the same product, always ultrasound guided. 3-4 weeks after the injury, different variables are evaluated: the injurie with ultrasounds , self-perception test, muscle strength, flexibility, jump and run. It is compared the elapsed time in days in each of the groups: RETURN TO PLAY.
Furthermore, the PAIN, RECURRENCE RATE and ADVERSE REACTIONS are evaluated.
METHODS:
41 football players are included in the study. It is used randomly PRP injection or a homeopathic product in muscle injuries (hamstring), in the early stage (first 48-72 hours).
One week later, the investigators do a second infiltration with the same product, always ultrasound guided. 3-4 weeks after the injury, different variables are evaluated: the injurie with ultrasounds , self-perception test, muscle strength, flexibility, jump and run. It is compared the elapsed time in days in each of the groups: RETURN TO PLAY.
Furthermore, the PAIN, RECURRENCE RATE and ADVERSE REACTIONS are evaluated.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: