Rehabilitation of Acute Hamstring Injuries in Male Athletes

NCT ID: NCT02104258

Last Updated: 2020-02-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2020-02-20

Brief Summary

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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.

The 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.

Detailed Description

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Background and rationale:

Acute 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 \[8\].

The 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.

The 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.

Conditions

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Strains

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Physiotherapy ASPETAR

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 \[10\].

The 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.

The 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.

Group Type ACTIVE_COMPARATOR

Physiotherapy ASPETAR

Intervention Type OTHER

Standardized physiotherapy protocol

Physiotherapy ASPETAR+

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.

ASPETAR+ 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.

The 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.

Group Type ACTIVE_COMPARATOR

Physiotherapy ASPETAR+

Intervention Type OTHER

Standardized physiotherapy protocol including early lengthening exercises

Interventions

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Physiotherapy ASPETAR

Standardized physiotherapy protocol

Intervention Type OTHER

Physiotherapy ASPETAR+

Standardized physiotherapy protocol including early lengthening exercises

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Male athletes
* Age 18-50 years
* Acute onset posterior thigh pain when training or competing, identified as:

1. Patient reported sudden event
2. Patient reported pain in posterior thigh
* Clinical diagnosis of an acute hamstring muscle strain injury, defined as:

1. Localised pain during palpation of hamstring muscle
2. Increasing pain during isometric contraction
3. Localised pain when performing a passive straight leg raise test
* MRI confirmed isolated hamstring lesion (increased high signal intensity on fat saturated sequences)
* MRI performed ≤5 days from injury
* Available for ≥3 physiotherapy sessions per week at Aspetar
* Available for follow-up

Exclusion Criteria

* Patients with verified or suspected previous hamstring injury within the last 6 months in the same leg
* Chronic hamstring complaints \>2 months
* Grade III injury including complete hamstring disruption or avulsion of all tendons
* Contraindications to MRI
* Patients that do not have an intention to return to full sport activity
* Patients that do not want to receive one of the two therapies
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Aspetar

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rodney Whiteley, PhD, PT

Role: PRINCIPAL_INVESTIGATOR

Aspetar Orthopaedic and Sports Medicine Hospital

Arnlaug Wangensteen, MSc

Role: STUDY_DIRECTOR

Aspetar Orthopaedic and Sports Medicine Hospital, Norwegian School for Sports Science

Roald Bahr, Prof. PhD MD

Role: STUDY_DIRECTOR

Aspetar Orthopaedic and Sports Medicine Hospital

Erik Witvrouw, Prof. PhD PT

Role: STUDY_DIRECTOR

Aspetar Orthopaedic and Sports Medicine Hoslpital

Johannes Tol, PhD MD

Role: STUDY_DIRECTOR

Aspetar Orthopaedic and Sports Medicine Hospital

Locations

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Aspetar Orthopaedic and Sports Medicine Hospital

Doha, , Qatar

Site Status

Countries

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Qatar

References

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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.

Reference Type BACKGROUND
PMID: 22460740 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22622781 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22039218 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23235611 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17355322 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21825112 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23536466 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22685125 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22424705 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20852842 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24493666 (View on PubMed)

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.

Reference Type DERIVED
PMID: 38729628 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29084725 (View on PubMed)

Other Identifiers

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CMO/000047/fj

Identifier Type: OTHER

Identifier Source: secondary_id

HAR47

Identifier Type: -

Identifier Source: org_study_id

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