Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Rehabilitation of Acute Hamstring Injuries in Male Athletes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02104258
Recruitment Status : Recruiting
First Posted : April 4, 2014
Last Update Posted : July 2, 2017
Sponsor:
Information provided by (Responsible Party):
Aspetar

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.


Condition or disease Intervention/treatment Phase
Strains Other: Physiotherapy ASPETAR Other: Physiotherapy ASPETAR+ Not Applicable

Detailed 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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : March 2014
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arm Intervention/treatment
Active Comparator: 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.

Other: Physiotherapy ASPETAR
Standardized physiotherapy protocol

Active Comparator: 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.

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




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02104258


Contacts
Layout table for location contacts
Contact: Rodney Whiteley, PhD, PT rodney.whiteley@aspetar.com
Contact: Johannes Tol, MD PhD +974 6616 5380 johannes.tol@aspetar.com

Locations
Layout table for location information
Qatar
Aspetar Orthopaedic and Sports Medicine Hospital Recruiting
Doha, Qatar, 29222
Principal Investigator: Arnlaug Wangensteen, MSc         
Sponsors and Collaborators
Aspetar
Investigators
Layout table for investigator information
Principal Investigator: Rodney Whiteley, PhD, PT Aspetar Orthopaedic and Sports Medicine Hospital
Study Director: 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

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Aspetar
ClinicalTrials.gov Identifier: NCT02104258     History of Changes
Other Study ID Numbers: HAR47
CMO/000047/fj ( Other Identifier: Aspetar )
First Posted: April 4, 2014    Key Record Dates
Last Update Posted: July 2, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Aspetar:
Hamstring
Muscle
Injury
Treatment
Rehabilitation
Additional relevant MeSH terms:
Layout table for MeSH terms
Sprains and Strains
Wounds and Injuries