Platelet-Rich Plasma in Acute Muscle Injuries

University of the Basque Country (UPV/EHU)41 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Muscle Injury

Interventions

PRPBIOLOGICAL

Platelet-Rich Plasma

TraumeelOTHER

Homeophatic Treatment

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Javier Gonzalez Iglesias

Bilbao, Bizkaia, Spain

Outcomes

Primary Outcomes

Return to play (recovery period)

Days elapsed since muscular injury apperars until the return to play

Time frame: average of 3-6 weeks. Until play again a football match (training or competition)

Pain intensity

Pain after the muscle injury, and after the injections, with: -Funtional outcomes: pain (0 no pain; 10 unbearable pain) at rest, walking and going up and down the stairs. The Brief Pain Inventory - Short Form. Pain intensity (0, no pain - 10 unbearable) and interferences with the daily activities (0, does not interfere; 10, completely interferes).

Time frame: 3 months since the injury

Secondary Outcomes

Incidence of Recurrences

Recurrence: other injury in the same muscle group during the 6 months after the first injury Complication: other injurie or disease in other location of the body (no in the same muscular group).

Time frame: Less than 6 months since the first injury

Number of adverse effects

Any reaction with the product injected

Time frame: Through study completion, an average of 1 year

Data from ClinicalTrials.gov

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