Ignite Creation Date:
2025-12-25 @ 12:02 AM
Ignite Modification Date:
2026-01-04 @ 2:54 AM
Study NCT ID:
NCT02104258
Status:
COMPLETED
Last Update Posted:
2020-02-25
First Post:
2014-03-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Rehabilitation of Acute Hamstring Injuries in Male Athletes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013180', 'term': 'Sprains and Strains'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2020-02-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-24', 'studyFirstSubmitDate': '2014-03-22', 'studyFirstSubmitQcDate': '2014-04-02', 'lastUpdatePostDateStruct': {'date': '2020-02-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-04-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-02-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Subjective pain score assessed with visual analogue scale (VAS)', 'timeFrame': 'Measured initial at inclusion, daily up to 5 days a week throughout the rehabilitation period and at RTS with an expected average of 25 days up to 1 year', 'description': 'pain evaluation'}, {'measure': 'Pain during walking and jogging', 'timeFrame': 'Measured initial at inclusion, daily up to 5 days a week throughout the rehabilitation period and at RTS with an expected average of 25 days up to 1 year', 'description': 'pain evaluation'}, {'measure': 'Pain and restriction during with trunk flexion', 'timeFrame': 'Measured initial at inclusion, daily up to 5 days a week throughout the rehabilitation period and at RTS with an expected average of 25 days up to 1 year', 'description': 'pain evaluation'}, {'measure': 'Length and width of painful area with palpation', 'timeFrame': 'Measured initial at inclusion, daily up to 5 days a week throughout the rehabilitation period and at RTSwith an expected average of 25 days up to 1 year', 'description': 'palpation evaluation'}, {'measure': 'Distance from tuber to maximal painful area identified with palpation', 'timeFrame': 'Measured initial at inclusion and at RTS with an expected average of 25 days up to 1 year', 'description': 'palpation evaluation'}, {'measure': 'Hamstring force', 'timeFrame': 'Mid range, outer range measured initial at inclusion, daily up to 5 days/w throughout the rehab. period and at RTS with expected average 25 days - up to 1 year. Inner range measured at initial inclusion and RTS with expected 25 days up to 1 year', 'description': 'Inner range, mid range and outer range hamstring force measured with handheld dynamometry (HHD) \\[9\\]'}, {'measure': 'Hamstring flexibility', 'timeFrame': 'SLR and MHFAKE measured initial at inclusion, daily up to 5 days a week throughout the rehabilitation period and at RTS with expected average 25 days up to 1 year. PKET measured initial at inclusion and at RTS with expected average 25 days up to 1 year', 'description': 'Hamstring flexibility measured as passive straight leg raise (SLR), passive knee extension (PKET) and maximal hip flexion active knee extension (MHFAKE) with inclinometer'}, {'measure': 'Painful single leg bridge', 'timeFrame': 'Measured initial at inclusion, daily up to 5 days a week throughout the rehabilitation period and at RTS with an expected average of 25 days up to 1 year', 'description': 'functional pain evaluation'}, {'measure': 'Patient prediction', 'timeFrame': 'Measured initial at inclusion', 'description': 'Patient prediction on time to RTS and performance after RTS'}, {'measure': 'MRI parameters', 'timeFrame': 'Measured initial at inclusion', 'description': 'MRI evaluation'}, {'measure': 'Isokinetic knee flexor strength', 'timeFrame': 'Measured initial (uninjured leg) at inclusion and at RTS (both legs) with an expected average of 25 days up to 1 year', 'description': 'Isokinetic knee flexor strength assessed with BIODEX'}, {'measure': 'Eccentric knee flexor strength during Nordic Hamstring Exercise', 'timeFrame': 'Measured at RTS with an expected average of 25 days up to 1 year', 'description': 'Eccentric knee flexor strength measured during Nordic Hamstring Exercise performed on a Novel Device'}, {'measure': 'sEMG hamstring muscle activity', 'timeFrame': 'Measured initial at inclusion and at RTS with an expected average of 25 days up to 1 year', 'description': 'sEMG is measured during isokinetic knee flexor strength testing with BIODEX initial on uninjured leg and at RTS on both legs. sEMG is measured during eccentric knee flexor strength test performed (Nordic Hamstring Exercise) at RTS.'}, {'measure': 'Insecurity with dynamic flexibility test (H-test) [10]', 'timeFrame': 'Measured at RTS with an expected average of 25 days up to 1 year', 'description': 'Htest evaluation'}, {'measure': 'RTS questions', 'timeFrame': 'Measured at RTS with an expected average of 25 days up to 1 year', 'description': 'RTS questions including rate of recovery and fear of sustaining a new injury'}, {'measure': 'Days between injury and 1st training with the club team and 1st match played', 'timeFrame': 'The patients are monitored by phone after RTS with an expected average of 25 days up to 1 year', 'description': 'evalaution number of days training'}], 'primaryOutcomes': [{'measure': 'Time to Return to Sport (RTS)', 'timeFrame': 'After the initial injury, patients will be followed daily during working days for the duration of time until they return to RTS, with an expected average of 25 days up to 1 year', 'description': 'Number of days between initial injury and return to full unrestricted training and/or match play'}], 'secondaryOutcomes': [{'measure': 'Re-injury within 2 months, 6 months and 12 months after RTS', 'timeFrame': 'The patients will be monitored by phone 2 months, 6 months and 12 months after RTS', 'description': 'In the event of a clinical suspicion of re-injury, the player will be advised to immediately call the primary investigator and consult a physician'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Hamstring', 'Muscle', 'Injury', 'Treatment', 'Rehabilitation'], 'conditions': ['Strains']}, 'referencesModule': {'references': [{'pmid': '22460740', 'type': 'BACKGROUND', 'citation': 'Hamilton B. Hamstring muscle strain injuries: what can we learn from history? Br J Sports Med. 2012 Oct;46(13):900-3. doi: 10.1136/bjsports-2012-090931. Epub 2012 Mar 29. No abstract available.'}, {'pmid': '22622781', 'type': 'BACKGROUND', 'citation': 'Kerkhoffs GM, van Es N, Wieldraaijer T, Sierevelt IN, Ekstrand J, van Dijk CN. Diagnosis and prognosis of acute hamstring injuries in athletes. Knee Surg Sports Traumatol Arthrosc. 2013 Feb;21(2):500-9. doi: 10.1007/s00167-012-2055-x. Epub 2012 May 24.'}, {'pmid': '22039218', 'type': 'BACKGROUND', 'citation': 'Reurink G, Goudswaard GJ, Tol JL, Verhaar JA, Weir A, Moen MH. Therapeutic interventions for acute hamstring injuries: a systematic review. Br J Sports Med. 2012 Feb;46(2):103-9. doi: 10.1136/bjsports-2011-090447. Epub 2011 Oct 28.'}, {'pmid': '23235611', 'type': 'BACKGROUND', 'citation': 'Mason DL, Dickens VA, Vail A. Rehabilitation for hamstring injuries. Cochrane Database Syst Rev. 2012 Dec 12;12(12):CD004575. doi: 10.1002/14651858.CD004575.pub3.'}, {'pmid': '17355322', 'type': 'BACKGROUND', '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.'}, {'pmid': '21825112', 'type': 'BACKGROUND', 'citation': "Petersen J, Thorborg K, Nielsen MB, Budtz-Jorgensen E, Holmich P. Preventive effect of eccentric training on acute hamstring injuries in men's soccer: a cluster-randomized controlled trial. Am J Sports Med. 2011 Nov;39(11):2296-303. doi: 10.1177/0363546511419277. Epub 2011 Aug 8."}, {'pmid': '23536466', 'type': 'BACKGROUND', 'citation': 'Askling CM, Tengvar M, Thorstensson A. Acute hamstring injuries in Swedish elite football: a prospective randomised controlled clinical trial comparing two rehabilitation protocols. Br J Sports Med. 2013 Oct;47(15):953-9. doi: 10.1136/bjsports-2013-092165. Epub 2013 Mar 27.'}, {'pmid': '22685125', 'type': 'BACKGROUND', 'citation': 'Malliaropoulos N, Mendiguchia J, Pehlivanidis H, Papadopoulou S, Valle X, Malliaras P, Maffulli N. Hamstring exercises for track and field athletes: injury and exercise biomechanics, and possible implications for exercise selection and primary prevention. Br J Sports Med. 2012 Sep;46(12):846-51. doi: 10.1136/bjsports-2011-090474. Epub 2012 Jun 9.'}, {'pmid': '22424705', 'type': 'BACKGROUND', 'citation': 'Whiteley R, Jacobsen P, Prior S, Skazalski C, Otten R, Johnson A. Correlation of isokinetic and novel hand-held dynamometry measures of knee flexion and extension strength testing. J Sci Med Sport. 2012 Sep;15(5):444-50. doi: 10.1016/j.jsams.2012.01.003. Epub 2012 Mar 15.'}, {'pmid': '20852842', 'type': 'BACKGROUND', 'citation': 'Askling CM, Nilsson J, Thorstensson A. A new hamstring test to complement the common clinical examination before return to sport after injury. Knee Surg Sports Traumatol Arthrosc. 2010 Dec;18(12):1798-803. doi: 10.1007/s00167-010-1265-3. Epub 2010 Sep 18.'}, {'pmid': '24493666', 'type': 'BACKGROUND', 'citation': 'Tol JL, Hamilton B, Eirale C, Muxart P, Jacobsen P, Whiteley R. At return to play following hamstring injury the majority of professional football players have residual isokinetic deficits. Br J Sports Med. 2014 Sep;48(18):1364-9. doi: 10.1136/bjsports-2013-093016. Epub 2014 Feb 3.'}, {'pmid': '38729628', 'type': 'DERIVED', 'citation': 'Zein MI, Mokkenstorm MJK, Cardinale M, Holtzhausen L, Whiteley R, Moen MH, Reurink G, Tol JL; Qatari and Dutch Hamstring Study Group. Baseline clinical and MRI risk factors for hamstring reinjury showing the value of performing baseline MRI and delaying return to play: a multicentre, prospective cohort of 330 acute hamstring injuries. Br J Sports Med. 2024 Jul 1;58(14):766-776. doi: 10.1136/bjsports-2023-107878.'}, {'pmid': '29084725', 'type': 'DERIVED', 'citation': 'Whiteley R, van Dyk N, Wangensteen A, Hansen C. Clinical implications from daily physiotherapy examination of 131 acute hamstring injuries and their association with running speed and rehabilitation progression. Br J Sports Med. 2018 Mar;52(5):303-310. doi: 10.1136/bjsports-2017-097616. Epub 2017 Oct 30.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to compare the effect of two rehabilitation protocols with different emphasis on eccentric exercises after acute hamstring muscle strain injuries on the time to return to sports (RTS) and the rate of re-injuries in male athletes.\n\nThe hypothesis is that the addition of early eccentric hamstring exercises being performed at longer muscle-tendon length towards end range of motion alter the outcomes RTS and re-injuries in a rehabilitation protocol after acute hamstring muscle strain injuries.', 'detailedDescription': 'Background and rationale:\n\nAcute hamstring muscle strain injuries represent the most prevalent non-contact muscle injury reported in sports. Despite the high prevalence and a rapidly expanding body of literature investigating hamstring muscle strain injuries, \\[1\\] occurrence and re-injury rates have not improved over the last three decades \\[2\\]. Therefore, rehabilitation and secondary prevention are of particular concern, and the primary objective of all rehabilitation protocols is to return an athlete to pre-injury level as soon as possible with a minimal risk of injury recurrence.There is still a lack of consensus and clinical research regarding the effectiveness of various rehabilitation protocols for acute hamstring injuries in athletes participating in sports with high sprinting demands \\[3,4\\]. To our knowledge, there are no prospective, randomised trials investigating the effect of different rehabilitation protocols in a Middle-Eastern athletic population. Eccentric strength training has shown to reduce the risk of both new acute hamstring injuries as well as re-injuries \\[5,6\\], whereas hamstring exercises being performed at longer muscle-tendon length, preferentially mimicking movements occuring simultaneously at both the knee and hip are reported to be more effective than a protocol containing conventional exercises \\[7\\], and are suggested to be a key strategy in the management of hamstring injuries. However, the preventive effect related to the eccentric training remains unclear and is still debated and the optimal intensity of eccentric training in rehabilitation of acute hamstring strain injuries and prevention of re-injuries is yet unknown \\[8\\].\n\nThe primary objective in this study is therefore to compare the effect of two rehabilitation protocols after acute hamstring muscle strain injuries on the time to return to sports (RTS) and the rate of re-injuries in male athletes in a prospective single-site randomized controlled trial.\n\nThe investigators aim to include 90 male athletes with clinical signs and MRI abnormalities consistent with an acute hamstring muscle strain injury. The injured athletes will be randomised into one of two different rehabilitation protocols with unlike emphasis on eccentric exercises.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male athletes\n* Age 18-50 years\n* Acute onset posterior thigh pain when training or competing, identified as:\n\n 1. Patient reported sudden event\n 2. Patient reported pain in posterior thigh\n* Clinical diagnosis of an acute hamstring muscle strain injury, defined as:\n\n 1. Localised pain during palpation of hamstring muscle\n 2. Increasing pain during isometric contraction\n 3. Localised pain when performing a passive straight leg raise test\n* MRI confirmed isolated hamstring lesion (increased high signal intensity on fat saturated sequences)\n* MRI performed ≤5 days from injury\n* Available for ≥3 physiotherapy sessions per week at Aspetar\n* Available for follow-up\n\nExclusion Criteria:\n\n* Patients with verified or suspected previous hamstring injury within the last 6 months in the same leg\n* Chronic hamstring complaints \\>2 months\n* Grade III injury including complete hamstring disruption or avulsion of all tendons\n* Contraindications to MRI\n* Patients that do not have an intention to return to full sport activity\n* Patients that do not want to receive one of the two therapies'}, 'identificationModule': {'nctId': 'NCT02104258', 'briefTitle': 'Rehabilitation of Acute Hamstring Injuries in Male Athletes', 'organization': {'class': 'OTHER', 'fullName': 'Aspetar'}, 'officialTitle': 'Rehabilitation of Acute Hamstring Injuries in Male Athletes: A Prospective Single-site Randomized Controlled Clinical Trial Comparing Two Rehabilitation Protocols With Different Emphasis on Eccentric Exercises', 'orgStudyIdInfo': {'id': 'HAR47'}, 'secondaryIdInfos': [{'id': 'CMO/000047/fj', 'type': 'OTHER', 'domain': 'Aspetar'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Physiotherapy ASPETAR', 'description': 'The patients will follow the ASPETAR Hamstring Rehabilitation Protocol, which is a standardised physiotherapy protocol, including range of motion exercises, progressive strengthening exercises, core stability training and agility exercises \\[10\\].\n\nThe ASPETAR protocol consist of predefined rehabilitation stages including sports specific stages. Specific functional based criteria for progression will be utilized for each of the six rehabilitation stages. No pain provocation when performing the exercises will be allowed.\n\nThe rehabilitation will be initiated as soon as possible after inclusion and the patients will be supervised by experienced physiotherapists in the Rehabilitation Department at Aspetar 3 to 5 days per week.', 'interventionNames': ['Other: Physiotherapy ASPETAR']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Physiotherapy ASPETAR+', 'description': 'The patients will follow the ASPETAR+ Hamstring Rehabilitation Protocol. ASPETAR+ is similar to ASPETAR, but consists of additional lengthening exercises which will be initiated early in the rehabilitation phase.\n\nASPETAR+ consist of predefined rehabilitation stages including sports specific stages. Specific functional based criteria for progression will be utilized for each of the six rehabilitation stages. No pain provocation when performing the exercises will be allowed.\n\nThe rehabilitation will be initiated as soon as possible after inclusion and the patients will be supervised by experienced physiotherapists in the Rehabilitation Department at Aspetar 3 to 5 days per week.', 'interventionNames': ['Other: Physiotherapy ASPETAR+']}], 'interventions': [{'name': 'Physiotherapy ASPETAR', 'type': 'OTHER', 'description': 'Standardized physiotherapy protocol', 'armGroupLabels': ['Physiotherapy ASPETAR']}, {'name': 'Physiotherapy ASPETAR+', 'type': 'OTHER', 'description': 'Standardized physiotherapy protocol including early lengthening exercises', 'armGroupLabels': ['Physiotherapy ASPETAR+']}]}, 'contactsLocationsModule': {'locations': [{'zip': '29222', 'city': 'Doha', 'country': 'Qatar', 'facility': 'Aspetar Orthopaedic and Sports Medicine Hospital', 'geoPoint': {'lat': 25.28545, 'lon': 51.53096}}], 'overallOfficials': [{'name': 'Rodney Whiteley, PhD, PT', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Aspetar Orthopaedic and Sports Medicine Hospital'}, {'name': 'Arnlaug Wangensteen, MSc', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Aspetar Orthopaedic and Sports Medicine Hospital, Norwegian School for Sports Science'}, {'name': 'Roald Bahr, Prof. PhD MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Aspetar Orthopaedic and Sports Medicine Hospital'}, {'name': 'Erik Witvrouw, Prof. PhD PT', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Aspetar Orthopaedic and Sports Medicine Hoslpital'}, {'name': 'Johannes Tol, PhD MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Aspetar Orthopaedic and Sports Medicine Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aspetar', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}