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Completed

NCT Number: NCT02104258

Rehabilitation of Acute Hamstring Injuries in Male Athletes

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.

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Key information

Conditions

Strains Sprains and Strains Wounds and Injuries

Age range

18 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Aspetar Orthopaedic and Sports Medicine Hospital

Doha, 29222, Qatar

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

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

Treatment and study plan

Physiotherapy ASPETAR

Other

Standardized physiotherapy protocol

Physiotherapy ASPETAR+

Other

Standardized physiotherapy protocol including early lengthening exercises

Primary outcomes

  1. Time to Return to Sport (RTS)

    Time frame: 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

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

Secondary outcomes

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

    Time frame: The patients will be monitored by phone 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

Other outcomes

  1. Subjective pain score assessed with visual analogue scale (VAS)

    Time frame: 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 evaluation

  2. Pain during walking and jogging

    Time frame: 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 evaluation

  3. Pain and restriction during with trunk flexion

    Time frame: 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 evaluation

  4. Length and width of painful area with palpation

    Time frame: 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

    palpation evaluation

  5. Distance from tuber to maximal painful area identified with palpation

    Time frame: Measured initial at inclusion and at RTS with an expected average of 25 days up to 1 year

    palpation evaluation

  6. Hamstring force

    Time frame: 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

    Inner range, mid range and outer range hamstring force measured with handheld dynamometry (HHD) [9]

  7. Hamstring flexibility

    Time frame: 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

    Hamstring flexibility measured as passive straight leg raise (SLR), passive knee extension (PKET) and maximal hip flexion active knee extension (MHFAKE) with inclinometer

  8. Painful single leg bridge

    Time frame: 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

    functional pain evaluation

  9. Patient prediction

    Time frame: Measured initial at inclusion

    Patient prediction on time to RTS and performance after RTS

  10. MRI parameters

    Time frame: Measured initial at inclusion

    MRI evaluation

  11. Isokinetic knee flexor strength

    Time frame: Measured initial (uninjured leg) at inclusion and at RTS (both legs) with an expected average of 25 days up to 1 year

    Isokinetic knee flexor strength assessed with BIODEX

  12. Eccentric knee flexor strength during Nordic Hamstring Exercise

    Time frame: Measured at RTS with an expected average of 25 days up to 1 year

    Eccentric knee flexor strength measured during Nordic Hamstring Exercise performed on a Novel Device

  13. sEMG hamstring muscle activity

    Time frame: Measured initial at inclusion and at RTS with an expected average of 25 days up to 1 year

    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.

  14. Insecurity with dynamic flexibility test (H-test) [10]

    Time frame: Measured at RTS with an expected average of 25 days up to 1 year

    Htest evaluation

  15. RTS questions

    Time frame: Measured at RTS with an expected average of 25 days up to 1 year

    RTS questions including rate of recovery and fear of sustaining a new injury

  16. Days between injury and 1st training with the club team and 1st match played

    Time frame: The patients are monitored by phone after RTS with an expected average of 25 days up to 1 year

    evalaution number of days training

Sponsors and collaborators

Lead sponsor

Aspetar

Other

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2019
Study completion
2020
First posted
Apr 4, 2014
Registry last updated
Feb 25, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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