Clinical trial NCT02104258: Rehabilitation of Acute Hamstring Injuries in Male Athletes
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Strains
Keywords: Hamstring
Muscle
Injury
Treatment
Rehabilitation
Lead sponsor: Aspetar
Sponsor class: OTHER
First posted: 2014-04-04
Enrollment: 90
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Time to Return to Sport (RTS)
timeFrame: 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:
measure: Re-injury within 2 months, 6 months and 12 months after RTS
timeFrame: The patients will be monitored by phone 2 months, 6 months and 12 months after RTS
Other outcomes:
measure: Subjective pain score assessed with visual analogue scale (VAS)
timeFrame: 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
measure: Pain during walking and jogging
timeFrame: 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
measure: Pain and restriction during with trunk flexion
timeFrame: 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
measure: Length and width of painful area with palpation
timeFrame: 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
measure: Distance from tuber to maximal painful area identified with palpation
timeFrame: Measured initial at inclusion and at RTS with an expected average of 25 days up to 1 year
measure: Hamstring force
timeFrame: 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
measure: Hamstring flexibility
timeFrame: 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
measure: Painful single leg bridge
timeFrame: 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
measure: Patient prediction
timeFrame: Measured initial at inclusion
measure: MRI parameters
timeFrame: Measured initial at inclusion
measure: Isokinetic knee flexor strength
timeFrame: Measured initial (uninjured leg) at inclusion and at RTS (both legs) with an expected average of 25 days up to 1 year
measure: Eccentric knee flexor strength during Nordic Hamstring Exercise
timeFrame: Measured at RTS with an expected average of 25 days up to 1 year
measure: sEMG hamstring muscle activity
timeFrame: Measured initial at inclusion and at RTS with an expected average of 25 days up to 1 year
measure: Insecurity with dynamic flexibility test (H-test) [10]
timeFrame: Measured at RTS with an expected average of 25 days up to 1 year
measure: RTS questions
timeFrame: Measured at RTS with an expected average of 25 days up to 1 year
measure: Days between injury and 1st training with the club team and 1st match played
timeFrame: The patients are monitored by phone after RTS with an expected average of 25 days up to 1 year
Locations:
city: Doha
country: Qatar
facility: Aspetar Orthopaedic and Sports Medicine Hospital
Study officials:
affiliation: Aspetar Orthopaedic and Sports Medicine Hospital
name: Rodney Whiteley, PhD, PT
role: PRINCIPAL_INVESTIGATOR
affiliation: Aspetar Orthopaedic and Sports Medicine Hospital, Norwegian School for Sports Science
name: Arnlaug Wangensteen, MSc
role: STUDY_DIRECTOR
affiliation: Aspetar Orthopaedic and Sports Medicine Hospital
name: Roald Bahr, Prof. PhD MD
role: STUDY_DIRECTOR
affiliation: Aspetar Orthopaedic and Sports Medicine Hoslpital
name: Erik Witvrouw, Prof. PhD PT
role: STUDY_DIRECTOR
affiliation: Aspetar Orthopaedic and Sports Medicine Hospital
name: Johannes Tol, PhD MD
role: STUDY_DIRECTOR
References:
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citation: 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.