Study Results
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Basic Information
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COMPLETED
PHASE2
41 participants
INTERVENTIONAL
2016-10-03
2020-01-08
Brief Summary
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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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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Platelet-Rich Plasma
24-72 hours after having a muscular lesion, the doctor injects an intramuscular ecoguided infiltration of 6-7 ml of PRP .
After 4-5 days from the injury the patient starts physiotherapy adapted by stages, according to the muscular group affected.
After 7 days from the first infiltration, the patient will recived the second infiltration of 6-7 ml of PRP.
PRP
Platelet-Rich Plasma
Traumel ®
24-72 hours after having a muscular lesion, the doctor injects an intramuscular ecoguided infiltration of 4 ml of a homeopathic product (Traumeel ®) After 4-5 days from the date of injury, the patient starts physiotherapy adapted by stages, according to the muscular group affected.
After 7 days from the first infiltration, the patient will receive the second infiltration of 4 ml of a homeopathic product.
Traumeel
Homeophatic Treatment
Interventions
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PRP
Platelet-Rich Plasma
Traumeel
Homeophatic Treatment
Eligibility Criteria
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Inclusion Criteria
* Acute muscular Injury Type 3a-3b (Múnich classification) in hamstring muscles
* Informed consent signed
Exclusion Criteria
* Previous infiltration in hamstring.
18 Years
ALL
No
Sponsors
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University of the Basque Country (UPV/EHU)
OTHER
Responsible Party
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Javier González Iglesias
Medical Doctor (orthopedic surgeon)
Principal Investigators
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Javier Gonzalez Iglesias, Dr
Role: PRINCIPAL_INVESTIGATOR
Basque Health System - Osakidetza
Locations
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Javier Gonzalez Iglesias
Bilbao, Bizkaia, Spain
Countries
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References
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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.
Other Identifiers
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PRP-MUSCULO-2014-2019
Identifier Type: -
Identifier Source: org_study_id
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