Rehabilitation of Acute Hamstring Injuries in Male Athletes

Strains Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02104258
• Other study ID #: HAR47
• Secondary ID: CMO/000047/fj
• Status: Completed
• Phase: N/A
• Start date: March 2014
• Est. completion date: February 20, 2020

Study information

• Verified date: February 2020
• Source: Aspetar
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: February 20, 2020
• Est. primary completion date: February 20, 2019
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Sprains and Strains
• Strains

Intervention

Other:
• Physiotherapy ASPETAR
Standardized physiotherapy protocol
• Physiotherapy ASPETAR+
Standardized physiotherapy protocol including early lengthening exercises

Locations

Country	Name	City	State
Qatar	Aspetar Orthopaedic and Sports Medicine Hospital	Doha

Sponsors (1)

Lead Sponsor	Collaborator
Aspetar

Country where clinical trial is conducted

Qatar, 

References & Publications (11)

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. Epub 2007 Mar 12. — View 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. — View 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. — View Citation

Hamilton B. Hamstring muscle strain injuries: what can we learn from history? Br J Sports Med. 2012 Oct;46(13):900-3. Epub 2012 Mar 29. Erratum in: Br J Sports Med. 2012 Nov;46(14):1023. — View 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. Review. — View 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. Review. — View Citation

Mason DL, Dickens VA, Vail A. Rehabilitation for hamstring injuries. Cochrane Database Syst Rev. 2012 Dec 12;12:CD004575. doi: 10.1002/14651858.CD004575.pub3. Review. — View Citation

Petersen J, Thorborg K, Nielsen MB, Budtz-Jørgensen E, Hölmich 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. — View 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. Review. — View 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. — View 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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Subjective pain score assessed with visual analogue scale (VAS)	pain evaluation	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
Other	Pain during walking and jogging	pain evaluation	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
Other	Pain and restriction during with trunk flexion	pain evaluation	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
Other	Length and width of painful area with palpation	palpation evaluation	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
Other	Distance from tuber to maximal painful area identified with palpation	palpation evaluation	Measured initial at inclusion and at RTS with an expected average of 25 days up to 1 year
Other	Hamstring force	Inner range, mid range and outer range hamstring force measured with handheld dynamometry (HHD) [9]	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
Other	Hamstring flexibility	Hamstring flexibility measured as passive straight leg raise (SLR), passive knee extension (PKET) and maximal hip flexion active knee extension (MHFAKE) with inclinometer	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
Other	Painful single leg bridge	functional pain evaluation	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
Other	Patient prediction	Patient prediction on time to RTS and performance after RTS	Measured initial at inclusion
Other	MRI parameters	MRI evaluation	Measured initial at inclusion
Other	Isokinetic knee flexor strength	Isokinetic knee flexor strength assessed with BIODEX	Measured initial (uninjured leg) at inclusion and at RTS (both legs) with an expected average of 25 days up to 1 year
Other	Eccentric knee flexor strength during Nordic Hamstring Exercise	Eccentric knee flexor strength measured during Nordic Hamstring Exercise performed on a Novel Device	Measured at RTS with an expected average of 25 days up to 1 year
Other	sEMG hamstring muscle activity	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.	Measured initial at inclusion and at RTS with an expected average of 25 days up to 1 year
Other	Insecurity with dynamic flexibility test (H-test) [10]	Htest evaluation	Measured at RTS with an expected average of 25 days up to 1 year
Other	RTS questions	RTS questions including rate of recovery and fear of sustaining a new injury	Measured at RTS with an expected average of 25 days up to 1 year
Other	Days between injury and 1st training with the club team and 1st match played	evalaution number of days training	The patients are monitored by phone after RTS with an expected average of 25 days up to 1 year
Primary	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	Re-injury within 2 months, 6 months and 12 months after RTS	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	The patients will be monitored by phone 2 months, 6 months and 12 months after RTS