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Hamstring InjuryNCT04246515

The Effect of Blood Flow Restriction Training on Hamstring Elasticity After Injury

A study testing Blood Flow Restriction Training and Classic rehabilitation in people with Hamstring Injury, run by University Ghent at 1 site in Belgium.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The aim of this study is to investigate the effect of Blood Flow Restriction Training on the elasticity of the hamstring muscle after an acute injury. Therefore a group of football players with a recent hamstring strain injury (HSI) will be recruited and randomly assigned in one of the three following groups… Read more about this study

Who is it for?
Ages 18 to 35 years, men only
Conditions the study is for
Hamstring Injury
What is being tested?
Blood Flow Restriction Training and Classic rehabilitation
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
90 participants
Where
1 siteBelgium
Study dates
1 Feb 2020to 31 Dec 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 35 years
  • Men only
  • No healthy volunteers
  • Adult

Who may be able to join

  • Acute hamstring strain injury
  • Male
  • Adult (18+) between 18 and 35 years old

Who cannot join

  • History of hamstring injuries
  • Recent severe trauma or surgery in the lower extremity
  • Any contra-indication for occluding vascular flow (such as hypertension, risk factors for and/or history of cardiovascular pathologies or thromboembolism, surgery, fractures, severe obesity,…)

Trial locations and contacts

1 site in 1 country.

Belgium1 site, 1 recruiting
  • Department of rehabilitation sciences

    Ghent, 9000

    Dries Pieters

    Recruiting

Other trials in Belgium

About this study

Official title: The Effect of Blood Flow Restriction Training on the Mechanical Properties of Hamstring Injuries: A Prospective, Randomised Clinical Trial Using Supersonic Shear Wave Elastography

The aim of this study is to investigate the effect of Blood Flow Restriction Training on the elasticity of the hamstring muscle after an acute injury. Therefore a group of football players with a recent hamstring strain injury (HSI) will be recruited and randomly assigned in one of the three following groups:

Experimental group: Classic rehabilitation + Blood Flow Restriction Training

Read more

Sham group: Classic rehabilitation + sham Blood Flow Restriction Training

Control group: Classic rehabilitation

The study procedure will be as followed:

  1. HSI (onset) -> recruitment via football clubs, physiotherapy practices, leaflets,…
  2. MRI scan (day 0-4) -> injury location, grade and extend (The British Athletics Medical Team Classification)
  3. Shear Wave Elastography (SWE) measurement (day 0-4) of the injured site and the exact same location at the contralateral leg.
  4. Rehabilitation in one of the three groups + Testing At the first therapy session a standardized initial assessment sheet will be filled in comprising of all the necessary information regarding patient information and history (recent hamstring injury and past injuries) . Furthermore, a weekly assessment of the strongest predictors of rehabilitation duration will be conducted. Between day 12 and 16 a second shear wave elastographic measurement will be performed.
  5. Return to play (RTP) The RTP decision will be made by the head physician and the attending physiotherapist. The decision will be based on clearly predefined criteria. At moment of RTP a third shear wave elastographic measurement will be performed.
  6. Follow-up

The football players will be contacted regularly by phone to inquire about possible re-injuries, this for a period of 6 months after injury onset. At week 12 after injury onset, a fourth and last shear wave elastographic measurement will be performed.

The evolution of the hamstring elasticity and other outcome measures will be compared between groups and also within groups between the injured leg and the healthy contralateral leg.

Read the detailed description

In this study, 90 participants with an acute hamstring strain injury will participate. Age restrictions will be delimited between 18 and 35 years old to rule out age-related confounding factors. Potential participants will be excluded from this study if they had a history of hamstring injuries, or a recent severe trauma or surgery in the lower extremity. A hamstring injury is defined as a football-related injury in the posterior thigh muscle region, preventing a player from participating in training or competition for at least 1 week. In addition, any contra-indication for occluding vascular flow (such as hypertension, risk factors for and/or history of cardiovascular pathologies or thromboembolism, surgery, fractures, severe obesity,…) will entail an immediate exclusion from the study.

Within 4 days after the onset of a suspected HSI the participant will undergo a magnetic resonance (MR) scan in order to acquire more insight in the severity, location and extend of the injury. The British Athletics Medical Team Classification will be used to classify HSI on the basis of grade (1: small tear, 2: moderate tear, 3: extensive tear or 4: complete tear) and injury site (a: myofascial, b: MTJ or c: tendon). [Pollock et al.2014] Each participant will be assigned an unique number and subsequently randomly assigned to either the control, experimental treatment or sham group by using an online research randomizer (http://www.randomizer.org) which is already used in previous literature [van der Horst et al. 2015]. This will result in a total of 30 participants per treatment group. The experimental group will perform, on top of a classic rehabilitation protocol, exercises while occluding the vascular blood flow. The use of low-intensity exercises with vascular blood flow restriction (BFR) has been found, in previous studies, to induce the same hypertrophic muscle adaptations as high-intensity exercises without BFR. The combination of increased metabolic stress, due to an Ischemic and hypoxic muscular environment, and exercise induced mechanical tension is suggested to be responsible for this effect. [Hughes et al. 2017] The patients in the sham BFR group will receive the same protocol as the experimental group with the exception of not inflating the Blood flow restriction cuff, causing no real vascular occlusion. Furthermore, the intervention in the control group will consist out of a classic rehabilitation program suitable for treating a hamstring injury. Shortly after the MR scan, still in the first week after injury onset, a shear wave elastography measurement of the injured site and at exact same location at non-injured site will be performed. Appendicular to the first, three more elastographic measurements will be performed at fixed moments in time: between day 12 and 16, at moment of return to play (RTP) and at week 12 after injury onset. All the participants will undergo a standardized rehabilitation protocol in one of the three groups until the medical team cleared the patient for returning to sport participation, based on clearly defined and standardised criteria. Tests and questionnaires for evaluation of hamstring strength, flexibility, pain and functionality will be conducted at three major moments in the rehabilitation process: within the first therapy session, weekly during the complete rehabilitation process and at moment of return to play. After RTP, athletes will be contacted regularly, until six months after injury onset, to determine the number of re-injuries. A questionnaire concerning demographic and anthropometric data, sport activities and injury history will be completed by the participants, prior to the testing protocol, as these factors will be additionally investigated for their possible influence on the primary outcome measures. The aim of the study is to investigate the effect of vascular occlusion (Blood Flow Restriction Training), within the rehabilitation program, on the healing proces (outcome measures predictive for the duration of the rehabilitation: average pain at each therapy session, eccentric mid and outer range strength, total painful palpation length, maximal hip flexion active knee extension test) and especially on the elasticity of the injured hamstring muscle tissue (measured with shear wave elastography).

Being tested
Blood Flow Restriction Training, Sham Blood Flow Restriction Training, Classic rehabilitation
Keywords
Hamstring injury, Shear Wave Elastography, Blood Flow Restriction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Blood Flow Restriction TrainingDevice

    Also called Vascular occlusion Training

    Vascular occlusion of the injured limb.

  • Sham Blood Flow Restriction TrainingDevice

    Blood Flow Restriction material will be attached to the limb without vascular occlusion.

  • Classic rehabilitationOther

    Classic rehabilitation protocol after a hamstring injury consisiting out of stretching, strength, core stability,...

Study groups in NCT04246515
Study groupRoleWhat they receive
Blood Flow Restriction TrainingExperimentalAs from week 2 in the rehabilitation proces, this experimental group will receive exercises in combination with blood flow restriction. While occluding the vascular flow of the limb (startpoint = above the injury site), participants will perform 3 exercises: wall squat, leg press and bridge (3 sets of 30 repetitions). These blood flow restricted exercises are always on top of the classic rehabilitation.
Receives: Device: Blood Flow Restriction Training
Sham Blood Flow Restriction TrainingSham comparatorThe same description as the experimental arm is applicable here. However, The Blood Flow restriction material will be attached to the injured limb without occluding the vascular blood flow.
Receives: Device: Sham Blood Flow Restriction Training
Classic rehabilitationActive comparatorThis group will undergo the classic rehabilitation program.
Receives: Other: Classic rehabilitation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change of elasticity

    Change of the Shear Modulus of the injured site of the hamstring from onset untill 12 weeks.

    Measured: From date of randomization until 12 weeks.

  2. Time to return to play

    Time between injury onset and moment of return to play. Return to play is the moment when the athlete is cleared for sport participation by the medical staff based on 4 standardized criteria: 1. No pain on palpation 2. Pain free full Range of Motion (ROM) 3. Max (ecc) strength difference 10 % 4. Symptom-free completion of rehab program and repeated maximal (30m) sprinting.

    Measured: From injury onset until moment of return to play, up to an average of 3 weeks.

Secondary outcomes (3)
  1. Pain on palpation and average pain at each therapy session

    Pain Visual Analogue Scale (VAS). The pain VAS is a unidimensional measure of pain intensity with the use of a Likert scale from 0 to 10, with 0 = no pain and 10 = worst possible pain.

    Measured: Weekly from fist therapy session until moment of return to play, up to an average of 3 weeks.

  2. Eccentric strength

    Eccentric strength of the injured hamstring muscle

    Measured: Weekly from fist therapy session until moment of return to play, up to an average of 3 weeks.

  3. Flexibility

    Flexibility of the injured hamstring muscle using the Maximal Hip Flexion Active Knee Extension Test (MHFAKE)

    Measured: Weekly from fist therapy session until moment of return to play, up to an average of 3 weeks.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jan 2020
  2. Study start1 Feb 2020
  3. Primary completion31 Dec 2025 (estimated)
  4. Study completion31 Dec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04246515
Sponsor's protocol ID
B670201940629
Status last verified
Oct 2023
First submitted
21 Jan 2020
Last updated
3 Oct 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Blood Flow Restriction Training and Classic rehabilitation in people with Hamstring Injury, run by University Ghent at 1 site in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 3 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Dries Pieters (+32 9 332 6917, dries.pieters@ugent.be), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change of elasticity (time frame: From date of randomization until 12 weeks.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2023.

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