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Completed

NCT Number: NCT03676205

Platelet-Rich Plasma in Acute Muscle Injuries

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.

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Key information

Conditions

Muscle Injury

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Javier Gonzalez Iglesias

Bilbao, Bizkaia, 48415, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PRP

Biological

Platelet-Rich Plasma

Traumeel

Other

Homeophatic Treatment

Primary outcomes

  1. Return to play (recovery period)

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

    Days elapsed since muscular injury apperars until the return to play

  2. Pain intensity

    Time frame: 3 months since the injury

    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).

Secondary outcomes

  1. Incidence of Recurrences

    Time frame: Less than 6 months since the first injury

    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).

  2. Number of adverse effects

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

    Any reaction with the product injected

Sponsors and collaborators

Lead sponsor

University of the Basque Country (UPV/EHU)

Other

Registry information

Official study title

Randomized Clinical Trial About the Therapeutic Use of Platelet-Rich Plasma (PRP) for the Treatment of Acute Muscular Injuries in Football Players.

Important dates

Study start
2016
Primary completion
2019
Study completion
2020
First posted
Sep 18, 2018
Registry last updated
Jan 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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