Rehabilitation of Acute Hamstring Injuries in Male Athletes

February 24, 2020 updated by: Aspetar

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Qatar
      • Doha, Qatar, 29222
        • Aspetar Orthopaedic and Sports Medicine Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
The patients will be monitored by phone 2 months, 6 months and 12 months after RTS

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
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
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
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
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
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
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
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
Measured initial at inclusion and at RTS with an expected average of 25 days up to 1 year
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]
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
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
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
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
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
Patient prediction
Time Frame: Measured initial at inclusion
Patient prediction on time to RTS and performance after RTS
Measured initial at inclusion
MRI parameters
Time Frame: Measured initial at inclusion
MRI evaluation
Measured initial at inclusion
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
Measured initial (uninjured leg) at inclusion and at RTS (both legs) with an expected average of 25 days up to 1 year
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
Measured at RTS with an expected average of 25 days up to 1 year
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.
Measured initial at inclusion and at RTS with an expected average of 25 days up to 1 year
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
Measured at RTS with an expected average of 25 days up to 1 year
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
Measured at RTS with an expected average of 25 days up to 1 year
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
The patients are monitored by phone after RTS with an expected average of 25 days up to 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aspetar

Investigators

  • 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 and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (Actual)

February 20, 2019

Study Completion (Actual)

February 20, 2020

Study Registration Dates

First Submitted

March 22, 2014

First Submitted That Met QC Criteria

April 2, 2014

First Posted (Estimate)

April 4, 2014

Study Record Updates

Last Update Posted (Actual)

February 25, 2020

Last Update Submitted That Met QC Criteria

February 24, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HAR47
  • CMO/000047/fj (Other Identifier: Aspetar)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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