Rehabilitation of Acute Hamstring Injuries in Male Athletes

NCT02104258 | Completed DMC

• 2 other identifiers: HAR47CMO/000047/fj
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Strains

Keywords

Hamstring; Muscle; Injury; Treatment; Rehabilitation

Outcome Measures

Primary Outcomes (1)

• Time to Return to Sport (RTS)

  Number of days between initial injury and return to full unrestricted training and/or match play

  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

Secondary Outcomes (1)

• Re-injury within 2 months, 6 months and 12 months after RTS

  The patients will be monitored by phone 2 months, 6 months and 12 months after RTS

Other Outcomes (16)

• Subjective pain score assessed with visual analogue scale (VAS)

  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

• Pain during walking and jogging

  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

• Pain and restriction during with trunk flexion

  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

Study Arms (2)

Physiotherapy ASPETAR

ACTIVE COMPARATOR

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.

Other: Physiotherapy ASPETAR

Physiotherapy ASPETAR+

ACTIVE COMPARATOR

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.

Other: Physiotherapy ASPETAR+

Interventions

Physiotherapy ASPETAR+ OTHER

Standardized physiotherapy protocol including early lengthening exercises

Physiotherapy ASPETAR+

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Male athletes
• Age 18-50 years
• Acute onset posterior thigh pain when training or competing, identified as:
• Patient reported sudden event
• Patient reported pain in posterior thigh
• Clinical diagnosis of an acute hamstring muscle strain injury, defined as:
• Localised pain during palpation of hamstring muscle
• Increasing pain during isometric contraction
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aspetar: lead

Study Sites (1)

Aspetar Orthopaedic and Sports Medicine Hospital

Doha, 29222, Qatar

Location

Related Publications (13)

• 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: 22460740 BACKGROUND

• 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: 22622781 BACKGROUND

• 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: 22039218 BACKGROUND

• 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: 23235611 BACKGROUND

• 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: 17355322 BACKGROUND

• 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: 21825112 BACKGROUND

• 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: 23536466 BACKGROUND

• 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: 22685125 BACKGROUND

• 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: 22424705 BACKGROUND

• 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: 20852842 BACKGROUND

• 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: 24493666 BACKGROUND

• 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: 38729628 DERIVED

• 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.

  PMID: 29084725 DERIVED

MeSH Terms

Conditions

Sprains and Strains; Wounds and Injuries

Study Officials

• Rodney Whiteley, PhD, PT

  Aspetar Orthopaedic and Sports Medicine Hospital

  PRINCIPAL INVESTIGATOR

• Arnlaug Wangensteen, MSc

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

  STUDY DIRECTOR

• Roald Bahr, Prof. PhD MD

  Aspetar Orthopaedic and Sports Medicine Hospital

  STUDY DIRECTOR

• Erik Witvrouw, Prof. PhD PT

  Aspetar Orthopaedic and Sports Medicine Hoslpital

  STUDY DIRECTOR

• Johannes Tol, PhD MD

  Aspetar Orthopaedic and Sports Medicine Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2014
• First Posted: April 4, 2014
• Study Start: March 1, 2014
• Primary Completion: February 20, 2019
• Study Completion: February 20, 2020
• Last Updated: February 25, 2020

Record last verified: 2020-02

Locations

QA (1)