Ignite Creation Date:
2025-12-24 @ 9:11 PM
Ignite Modification Date:
2026-01-02 @ 11:24 AM
Study NCT ID:
NCT05773404
Status:
COMPLETED
Last Update Posted:
2025-09-03
First Post:
2023-03-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prevention of Hamstring Injuries in Football Players.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D005081', 'term': 'Exercise Therapy'}], 'ancestors': [{'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 66}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2024-04-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-02', 'studyFirstSubmitDate': '2023-03-06', 'studyFirstSubmitQcDate': '2023-03-06', 'lastUpdatePostDateStruct': {'date': '2025-09-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-03-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'range of movements measurements', 'timeFrame': '1 month', 'description': 'Observe the degrees of mobility of the lower limb joints.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['physiotherapies techniques', 'Range of Motion', 'Hamstring Muscles', 'Prevention and Control', 'Muscuoeskeletal Manipulations.'], 'conditions': ['Hamstring Injuries']}, 'referencesModule': {'references': [{'pmid': '15911599', 'type': 'BACKGROUND', 'citation': 'Petersen J, Holmich P. Evidence based prevention of hamstring injuries in sport. Br J Sports Med. 2005 Jun;39(6):319-23. doi: 10.1136/bjsm.2005.018549.'}, {'pmid': '15911608', 'type': 'BACKGROUND', 'citation': 'Verrall GM, Slavotinek JP, Barnes PG. The effect of sports specific training on reducing the incidence of hamstring injuries in professional Australian Rules football players. Br J Sports Med. 2005 Jun;39(6):363-8. doi: 10.1136/bjsm.2005.018697.'}, {'pmid': '27015858', 'type': 'RESULT', 'citation': 'Hagglund M, Walden M, Ekstrand J. Injury recurrence is lower at the highest professional football level than at national and amateur levels: does sports medicine and sports physiotherapy deliver? Br J Sports Med. 2016 Jun;50(12):751-8. doi: 10.1136/bjsports-2015-095951. Epub 2016 Mar 25.'}, {'pmid': '21335353', 'type': 'RESULT', 'citation': 'Ekstrand J, Hagglund M, Walden M. Epidemiology of muscle injuries in professional football (soccer). Am J Sports Med. 2011 Jun;39(6):1226-32. doi: 10.1177/0363546510395879. Epub 2011 Feb 18.'}, {'pmid': '23263293', 'type': 'RESULT', 'citation': 'Hagglund M, Walden M, Ekstrand J. Risk factors for lower extremity muscle injury in professional soccer: the UEFA Injury Study. Am J Sports Med. 2013 Feb;41(2):327-35. doi: 10.1177/0363546512470634. Epub 2012 Dec 21.'}, {'pmid': '36726776', 'type': 'RESULT', 'citation': 'Ekstrand J, Ueblacker P, Van Zoest W, Verheijen R, Vanhecke B, van Wijk M, Bengtsson H. Risk factors for hamstring muscle injury in male elite football: medical expert experience and conclusions from 15 European Champions League clubs. BMJ Open Sport Exerc Med. 2023 Jan 24;9(1):e001461. doi: 10.1136/bmjsem-2022-001461. eCollection 2023.'}, {'pmid': '14751943', 'type': 'RESULT', 'citation': 'Woods C, Hawkins RD, Maltby S, Hulse M, Thomas A, Hodson A; Football Association Medical Research Programme. The Football Association Medical Research Programme: an audit of injuries in professional football--analysis of hamstring injuries. Br J Sports Med. 2004 Feb;38(1):36-41. doi: 10.1136/bjsm.2002.002352.'}, {'pmid': '17355322', 'type': 'RESULT', 'citation': 'Arnason A, Andersen TE, Holme I, Engebretsen L, Bahr R. Prevention of hamstring strains in elite soccer: an intervention study. Scand J Med Sci Sports. 2008 Feb;18(1):40-8. doi: 10.1111/j.1600-0838.2006.00634.x. Epub 2007 Mar 12.'}]}, 'descriptionModule': {'briefSummary': 'Introduction: The prevalence of hamstring injuries in football is high, causing an increase in the number of casualties and a high socio-economic cost. Currently there are different treatment protocols for this muscle group, but there are often no comparisons of different types of passive, active and combined therapies, and their potential efficacy, in professional football players.\n\nObjectives: To compare the efficacy of three different interventions; passive manual therapy, active therapy based on therapeutic exercise and combined therapy, in relation to hamstring injuries in professional football players.\n\nMethodology: A simple Randomised Clinical Trial (RCT) was conducted (NCT04935398). After applying the selection criteria, a sample of 66 professional football players was obtained. They were divided into 3 intervention groups (A, B and C) with 22 participants in each group and were given passive manual therapy, active therapy (exercise) and combined therapy (sum of the above). The corresponding tests and questionnaires were evaluated to obtain data on hamstring flexibility and hip range of movement at three time periods: pre, post and post2.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Female footballers', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Professional football athletes.\n* Between 18-40 years of age.\n* Female gender.\n* Active in competitive season.\n\nExclusion Criteria:\n\n* Neurological signs.\n* Inability to follow the evaluator's instructions.\n* Physical activity of less than 2 hours per week.\n* Serious lower limb injury during the study period."}, 'identificationModule': {'nctId': 'NCT05773404', 'briefTitle': 'Prevention of Hamstring Injuries in Football Players.', 'organization': {'class': 'OTHER', 'fullName': 'Universidad Católica de Ávila'}, 'officialTitle': 'Efficacy of Passive Manual Therapy, Active Therapy and Combined Therapy in Relation to the Prevention of Hamstring Injuries in Football Players. Randomised Clinical Trial.', 'orgStudyIdInfo': {'id': '313'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'passive manual therapy', 'description': 'The physiotherapist performs passive techniques on the hamstring muscles of the footballers.', 'interventionNames': ['Other: Passive Neurodynamics and Passive axial hip mobilisation/distraction']}, {'type': 'EXPERIMENTAL', 'label': 'active therapy (exercise)', 'description': 'The physiotherapist does not perform passive techniques and it is the player who performs active techniques on the hamstring muscles.', 'interventionNames': ['Other: Active therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'combined therapy', 'description': 'The physiotherapist performs passive techniques and in addition the player performs active techniques on the hamstring muscles.', 'interventionNames': ['Other: 2.5.3. Combined therapy']}], 'interventions': [{'name': 'Passive Neurodynamics and Passive axial hip mobilisation/distraction', 'type': 'OTHER', 'description': 'The physiotherapist performs passive techniques on the hamstring muscles and the nerve that innervates the hamstring muscles.', 'armGroupLabels': ['passive manual therapy']}, {'name': 'Active therapy', 'type': 'OTHER', 'otherNames': ['Active Neurodynamics and Therapeutic exercise'], 'description': 'Active lumbopelvic CORE control exercises and active stretching of the ischiopelvic nerves', 'armGroupLabels': ['active therapy (exercise)']}, {'name': '2.5.3. Combined therapy', 'type': 'OTHER', 'otherNames': ['Passive and Active therapy'], 'description': 'The physiotherapist performs passive techniques on the hamstring muscles and the nerve that innervates the hamstring muscles and active lumbopelvic CORE control exercises and active stretching of the ischiopelvic nerves.', 'armGroupLabels': ['combined therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '05005', 'city': 'Ávila', 'country': 'Spain', 'facility': 'Universidad Católica de Ávila', 'geoPoint': {'lat': 40.65724, 'lon': -4.69951}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad Católica de Ávila', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'JORGE VELAZQUEZ SAORNIL', 'investigatorAffiliation': 'Universidad Católica de Ávila'}}}}