Clinical trial NCT03676205: Platelet-Rich Plasma in Acute Muscle Injuries
Official title: Randomized Clinical Trial About the Therapeutic Use of Platelet-Rich Plasma (PRP) for the Treatment of Acute Muscular Injuries in Football Players.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Muscle Injury
Keywords: Platelet-Rich Plasma
hamstrings
cuadriceps
football players
Lead sponsor: University of the Basque Country (UPV/EHU)
Sponsor class: OTHER
First posted: 2018-09-18
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two homogeneus groups with 1:1 possibilities to receive PRP or a homeopathic product.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

* Over 18 years old.
* Acute muscular Injury Type 3a-3b (Múnich classification) in hamstring muscles
* Informed consent signed

Exclusion Criteria:

* Hamstring injury (last 6 months).
* Previous infiltration in hamstring.

Primary outcomes:
measure: Return to play (recovery period)
timeFrame: average of 3-6 weeks. Until play again a football match (training or competition)
measure: Pain intensity
timeFrame: 3 months since the injury
Secondary outcomes:
measure: Incidence of Recurrences
timeFrame: Less than 6 months since the first injury
measure: Number of adverse effects
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: Bilbao
country: Spain
facility: Javier Gonzalez Iglesias
state: Bizkaia
Study officials:
affiliation: Basque Health System - Osakidetza
name: Javier Gonzalez Iglesias, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gonzalez-Iglesias J. [Therapeutic potential of platelet rich plasma. Reflections on its research and development]. Rev Esp Cir Ortop Traumatol. 2013 Jul-Aug;57(4):237-9. doi: 10.1016/j.recot.2013.04.001. Epub 2013 May 28. No abstract available. Spanish.