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:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C433370', 'term': 'Traumeel S'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': "The patient doesn't know the treatment. The person who analyze the data (outcomes assessor) doesn't know the treatment."}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Two homogeneus groups with 1:1 possibilities to receive PRP or a homeopathic product.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 41}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-10-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2020-01-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-01-19', 'studyFirstSubmitDate': '2018-09-13', 'studyFirstSubmitQcDate': '2018-09-16', 'lastUpdatePostDateStruct': {'date': '2020-01-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-09-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-04-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Return to play (recovery period)', 'timeFrame': 'average of 3-6 weeks. Until play again a football match (training or competition)', 'description': 'Days elapsed since muscular injury apperars until the return to play'}, {'measure': 'Pain intensity', 'timeFrame': '3 months since the injury', 'description': 'Pain after the muscle injury, and after the injections, with:\n\n-Funtional outcomes: pain (0 no pain; 10 unbearable pain) at rest, walking and going up and down the stairs.\n\nThe 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).'}], 'secondaryOutcomes': [{'measure': 'Incidence of Recurrences', 'timeFrame': 'Less than 6 months since the first injury', 'description': '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).'}, {'measure': 'Number of adverse effects', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Any reaction with the product injected'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Platelet-Rich Plasma', 'hamstrings', 'cuadriceps', 'football players'], 'conditions': ['Muscle Injury']}, 'referencesModule': {'references': [{'pmid': '23885648', 'type': 'RESULT', '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nEfficacy 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.', 'detailedDescription': 'STUDY DESIGN: Randomized Clinical Trial.\n\nMETHODS:\n\n41 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).\n\nOne 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.\n\nFurthermore, the PAIN, RECURRENCE RATE and ADVERSE REACTIONS are evaluated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Over 18 years old.\n* Acute muscular Injury Type 3a-3b (Múnich classification) in hamstring muscles\n* Informed consent signed\n\nExclusion Criteria:\n\n* Hamstring injury (last 6 months).\n* Previous infiltration in hamstring.'}, 'identificationModule': {'nctId': 'NCT03676205', 'briefTitle': 'Platelet-Rich Plasma in Acute Muscle Injuries', 'organization': {'class': 'OTHER', 'fullName': 'University of the Basque Country (UPV/EHU)'}, 'officialTitle': 'Randomized Clinical Trial About the Therapeutic Use of Platelet-Rich Plasma (PRP) for the Treatment of Acute Muscular Injuries in Football Players.', 'orgStudyIdInfo': {'id': 'PRP-MUSCULO-2014-2019'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Platelet-Rich Plasma', 'description': '24-72 hours after having a muscular lesion, the doctor injects an intramuscular ecoguided infiltration of 6-7 ml of PRP .\n\nAfter 4-5 days from the injury the patient starts physiotherapy adapted by stages, according to the muscular group affected.\n\nAfter 7 days from the first infiltration, the patient will recived the second infiltration of 6-7 ml of PRP.', 'interventionNames': ['Biological: PRP']}, {'type': 'OTHER', 'label': 'Traumel ®', 'description': '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.\n\nAfter 7 days from the first infiltration, the patient will receive the second infiltration of 4 ml of a homeopathic product.', 'interventionNames': ['Other: Traumeel']}], 'interventions': [{'name': 'PRP', 'type': 'BIOLOGICAL', 'description': 'Platelet-Rich Plasma', 'armGroupLabels': ['Platelet-Rich Plasma']}, {'name': 'Traumeel', 'type': 'OTHER', 'description': 'Homeophatic Treatment', 'armGroupLabels': ['Traumel ®']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48415', 'city': 'Bilbao', 'state': 'Bizkaia', 'country': 'Spain', 'facility': 'Javier Gonzalez Iglesias', 'geoPoint': {'lat': 43.26271, 'lon': -2.92528}}], 'overallOfficials': [{'name': 'Javier Gonzalez Iglesias, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Basque Health System - Osakidetza'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of the Basque Country (UPV/EHU)', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Doctor (orthopedic surgeon)', 'investigatorFullName': 'Javier González Iglesias', 'investigatorAffiliation': 'University of the Basque Country (UPV/EHU)'}}}}