Hamstring InjuryNCT03745482
The Impact of Unilateral Lumbar Mobilisations on Hamstring Strength and Failure Point of the Hamstring Nordic Exercise
A study testing Lumbar Mobilisations in people with Hamstring Injury, run by Teesside University at 1 site in United Kingdom.
Trial summary
The aim of this study is to build on previous published work, which has indicated lumbar mobilisations have the ability to increase hamstring extensibility and decrease muscle activity. The primary aim of this project is investigate if lumbar mobilisations have an affect on the Nordic Hamstring exercise. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Hamstring Injury
- What is being tested?
- Lumbar Mobilisations
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 4 Jan 2019to 10 Jan 2020
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Current Teesside University Students/Staff 18+ years Engaged in Football related activity once a week Provide Informed Consent No current musculoskeletal Injury
Who cannot join
- Current symptomatic low back pain or lower limb pathology including any injuries to the lower limb/lumbar spine within the last 6 months Previous ACL/Hamstring Rupture tear or diagnosed anterior knee pain. Under supervision of another health clinician Medical questionnaire not completed Red flags on medical questionnaire Any neurological problems Contraindications or precautions to spinal mobilisation
- malignancy, inflammatory or infectious processes involving the spine or peripheral joints,
- osteoporosis,
- spinal disorders including spondylolisthesis, ankylosing spondylitis, spinal fusion
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
School of Social Sciences, Humanities and Law
Middlesbrough, Tyne and Wear, TS1 3BA
About this study
Official title: The Impact of Unilateral Lumbar Mobilisations on Hamstring Strength, sEMG Activity and Failure Point of the Hamstring Nordic Exercise
The aim of this study is to build on previous published work, which has indicated lumbar mobilisations have the ability to increase hamstring extensibility and decrease muscle activity. The primary aim of this project is investigate if lumbar mobilisations have an affect on the Nordic Hamstring exercise.
Aim: To investigate the short-term effects L4 and L5 Unilateral Posterior Anterior (UPA) Mobilisations on the lumbar spine on the Nordic Hamstring Exercise. Measures will include hamstring peak torque, sEMG activity and knee angle at first rapid change in angular acceleration.
Read the detailed description
The study aims to investigate the short-term effects L4 and L5 Unilateral Posterior Anterior (UPA) Mobilisations on the lumbar spine on the Nordic Hamstring Exercise. Measures will include hamstring peak torque, sEMG activity and knee angle at first rapid change in angular acceleration.
Recruitment will take place via flyer and email. All testing will take place in the biodex laboratory at Teesside University. Due to the nature of the cross-over design participants will attend the laboratory six times, two for familiarisation sessions, and a remaining four testing session all 72 hours apart. The four testing sessions will contain two control and two intervention sessions attended in a randomised order.
Following recruitment participants will be required to complete a medical questionnaire and sign a consent form following reading the participant information sheet.
The Nordic Hamstring exercise will be performed by each participant across the intervention and control conditions. Participants will watch a video of a subject completing the Nordic exercise program. They will also receive the following verbal instructions:
'Players start in a kneeling position, with the torso from the knees upward held rigid and straight. The training partner ensures that the player's feet are in contact with the ground throughout the exercise by applying pressure to the player's heels/lower legs. The player then lowers his upper body to the ground, as slowly as possible to maximize loading in the eccentric phase. Hands and arms are used to break his forward fall and to push him back up after the chest has touched the ground, to minimize loading in the concentric phase (Mjølsne et al, 2005; Petersen et al, 2011).
All participants will be given the opportunity to ask questions as necessary.
A standardised warm-up on an ergometer will be undertaken for 5 minutes at 60% max resting heart rate.
Following the warm-up all participants will familiarise themselves with the Nordic Hamstring Exercise on the hamstring solo equipment. They will be able to practice up to 8 repetitions. This data will be used for a reliability study to understand the number of required repetitions for the main study.
During testing participants will attend the same laboratory for the remaining four testing sessions. They will receive two intervention sessions, when the lumbar mobilisations will be performed, and two when the control is administered.
The same warm-up undertaken during the familiarisation session will be undertaken prior to testing.
The intervention will consist of unilateral lumbar mobilisations at the L4 and L5 level in a Posterior Anterior direction. The side of the mobilisation will be determined by dominate leg - considered the kicking foot. The mobilisations will be administered by a physiotherapist with at least 12 years clinical experience. Teksan grip sensors will be worn by the physiotherapist to calculate the force applied to the participant. Grade three mobilisations will be applied for a one minute period three times at both L4 and L5 level.
For the control, all participants will be laid prone on the medical plinth in the same position will no mobilisations administered.
Outcome measures will include collection of hamstring peak force data, sEMG of the Biceps Femoris, 3D Motion capture data and subjective likert scale of exercise difficulty.
- Conditions
- Hamstring Injury
- Being tested
- Lumbar Mobilisations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lumbar MobilisationsOther
The intervention will consist of unilateral lumbar mobilisations at the L4 and L5 level in a Posterior Anterior direction. The side of the mobilisation will be determined by dominant leg - considered the kicking foot. The mobilisations will be administered by a physiotherapist with at least 10 years clinical experience. Teksan grip sensors will be worn by the physiotherapist to calculate the force applied to the participant. Grade three mobilisations will be applied for a one minute period three times at both L4 and L5 level. Each level will be determined by a passive physiological intervertebral movement. Participants will receive the mobilisations at L5 first for one minute followed by L4. This is an appropriate dose for mobilisation application (Maitland, 2013). This process will be carried out three times.
| Study group | Role | What they receive |
|---|---|---|
| Mobilisations | Experimental | The intervention will consist of unilateral lumbar mobilisations at the L4 and L5 level in a Posterior Anterior direction. The plinth will rest on force plates to allow the authors to analyse the force placed through the vertebrae. Grade three mobilisations will be applied for a one minute period three times at both L4 and L5 level. Each level will be determined by a passive physiological intervertebral movement. Participants will receive the mobilisations at L5 first for one minute followed by L4. This is an appropriate dose for mobilisation application (Maitland, 2013). This process will be carried out three times.
Following application of the mobilisations outcome measures including hamstring strength, sEMG activity and 3D motion analysis will take place. Receives: Other: Lumbar Mobilisations |
| Control | No intervention | The control condition will consist of the participant lying prone on a plinth for the same time if takes for intervention to be applied approximately 10 minutes. Following the control condition outcome measures including hamstring strength, sEMG activity and 3D motion analysis will take place. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hamstring Peak Force
Peak Force of the Hamstring as measured by the Hamstring Solo Device during a Nordic eccentric hamstring exercise The hamstring solo device calculates Force (N), time of exercise (secs), Torque (Nm) and Torque per kg. This is collected in real-time.
The hamstring solo calculates the eccentric force of the hamstring in real time. Participants are placed on the board with their ankle strapped. They follow previously discussed instructions to eccentrically lower themselves to the ground from a kneeling position.
Measured: Immediate data collection during Nordic Hamstring Exercise
sEMG of Biceps Femoris
Record electromyography (SEMG) activity in the muscles of the participants in this study the Zerowire Cometa system will be used. Every electrode unit is equipped with a small unit for signal processing and transmission to the data receiver. The electrodes are single use disposable, self-adhesive silver chloride dual snap on electrodes pre-set at a distance of 20mm. All participants will have the skin prepared prior to the noraxon electrode being placed on their skin. Electrodes will be attached according to European recommendation (seniam) to the Biceps Femoris of both limbs. The electrode placement and sEMG recording will be taken by a qualified laboratory technician employed by Teesside University.
Measured: Immediate data collection during Nordic Hamstring Exercise
Vicon 3D Motion Capture
Participants will have their mass (kg), height (cm), knee joint (between the medial and lateral epicondyle), ankle joint width (malleoli) and leg length (ASIS to medial malleolus) measured prior to recording.Widths will be measured using anthropometric calipers. Stretch height will be performed to improve the accuracy of the measurement.
Six wall-mounted Vicon MX13 infrared cameras (Vicon) will collect 3D motion capture data at a sampling frequency of 100 Hz.. 3D motion capture data will be processed via Vicon Nexus version 1.8.5 using inbuilt pipeline functions to calculate 3D kinematic data (hip,pelvis, knee). Participants will have retroflective markers (14 mm) attached to the following landmarks on both the right and left side of the body; ASIS, PSIS, greater trochanter, mid-thigh, lateral epicondyle (of the knee), mid-tibia, lateral malleolus, calcaneus, and 2nd toe. The markers will be affixed with double-sided tape placed on the overlaying skin of the bony landmark.
Measured: Immediate data collection during Nordic Hamstring Exercise
Secondary outcomes (1)
Subjective Likert Scale
Following the Nordic exercise participants will be asked to rate the difficulty of the exercise on a 0-10 likert scale.
Measured: Immediate post Nordic hamstring Exercise
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2018
- Study start4 Jan 2019
- Primary completion8 Sep 2019
- Study completion10 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hamstring InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Teesside University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paul Chesterton, Teesside University
- Investigators
- Paul Chesterton, MSc, Principal investigator, Teesside University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03745482
- Sponsor's protocol ID
- TeessideUniversity
- Status last verified
- Mar 2020
- First submitted
- 14 Nov 2018
- Last updated
- 10 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Chesterton P, Payton S, McLaren S. Acute effects of centrally- and unilaterally-applied posterior-anterior mobilizations of the lumbar spine on lumbar range of motion, hamstring extensibility and muscle activation. J Back Musculoskelet Rehabil. 2018;31(6):1013-1023. doi: 10.3233/BMR-171000.
PubMed 30347590Chesterton P & Payton S (2017) Effects of spinal mobilisations on lumbar and hamstring ROM and sEMG: A randomised control trial. Physiotherapy Practice and Research, 38, 17-25
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Unilateral Lumbar Mobilisations on Hamstring Strength, sEMG Activity and Failure Point of the Hamstring Nordic Exercise
- ClinicalTrials.gov ID
- NCT03745482
- Acronym / sponsor ID
- TeessideUniversity
- Conditions
- Hamstring Injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Teesside UniversityUniversity, hospital or other
- Study start
- 4 Jan 2019 (actual)
- Primary completion
- 8 Sep 2019 (actual)
- Study completion
- 10 Jan 2020 (actual)
- First posted
- 19 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to build on previous published work, which has indicated lumbar mobilisations have the ability to increase hamstring extensibility and decrease muscle activity. The primary aim of this project is investigate if lumbar mobilisations have an affect on the Nordic Hamstring exercise.
Aim: To investigate the short-term effects L4 and L5 Unilateral Posterior Anterior (UPA) Mobilisations on the lumbar spine on the Nordic Hamstring Exercise. Measures will include hamstring peak torque, sEMG activity and knee angle at first rapid change in angular acceleration.
Detailed description
The study aims to investigate the short-term effects L4 and L5 Unilateral Posterior Anterior (UPA) Mobilisations on the lumbar spine on the Nordic Hamstring Exercise. Measures will include hamstring peak torque, sEMG activity and knee angle at first rapid change in angular acceleration.
Recruitment will take place via flyer and email. All testing will take place in the biodex laboratory at Teesside University. Due to the nature of the cross-over design participants will attend the laboratory six times, two for familiarisation sessions, and a remaining four testing session all 72 hours apart. The four testing sessions will contain two control and two intervention sessions attended in a randomised order.
Following recruitment participants will be required to complete a medical questionnaire and sign a consent form following reading the participant information sheet.
The Nordic Hamstring exercise will be performed by each participant across the intervention and control conditions. Participants will watch a video of a subject completing the Nordic exercise program. They will also receive the following verbal instructions:
'Players start in a kneeling position, with the torso from the knees upward held rigid and straight. The training partner ensures that the player's feet are in contact with the ground throughout the exercise by applying pressure to the player's heels/lower legs. The player then lowers his upper body to the ground, as slowly as possible to maximize loading in the eccentric phase. Hands and arms are used to break his forward fall and to push him back up after the chest has touched the ground, to minimize loading in the concentric phase (Mjølsne et al, 2005; Petersen et al, 2011).
All participants will be given the opportunity to ask questions as necessary.
A standardised warm-up on an ergometer will be undertaken for 5 minutes at 60% max resting heart rate.
Following the warm-up all participants will familiarise themselves with the Nordic Hamstring Exercise on the hamstring solo equipment. They will be able to practice up to 8 repetitions. This data will be used for a reliability study to understand the number of required repetitions for the main study.
During testing participants will attend the same laboratory for the remaining four testing sessions. They will receive two intervention sessions, when the lumbar mobilisations will be performed, and two when the control is administered.
The same warm-up undertaken during the familiarisation session will be undertaken prior to testing.
The intervention will consist of unilateral lumbar mobilisations at the L4 and L5 level in a Posterior Anterior direction. The side of the mobilisation will be determined by dominate leg - considered the kicking foot. The mobilisations will be administered by a physiotherapist with at least 12 years clinical experience. Teksan grip sensors will be worn by the physiotherapist to calculate the force applied to the participant. Grade three mobilisations will be applied for a one minute period three times at both L4 and L5 level.
For the control, all participants will be laid prone on the medical plinth in the same position will no mobilisations administered.
Outcome measures will include collection of hamstring peak force data, sEMG of the Biceps Femoris, 3D Motion capture data and subjective likert scale of exercise difficulty.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mobilisations | Experimental | Other: Lumbar MobilisationsThe intervention will consist of unilateral lumbar mobilisations at the L4 and L5 level in a Posterior Anterior direction. The plinth will rest on force plates to allow the authors to analyse the force placed through the vertebrae. Grade three mobilisations will be applied for a one minute period three times at both L4 and L5 level. Each level will be determined by a passive physiological intervertebral movement. Participants will receive the mobilisations at L5 first for one minute followed by L4. This is an appropriate dose for mobilisation application (Maitland, 2013). This process will be carried out three times. Following application of the mobilisations outcome measures including hamstring strength, sEMG activity and 3D motion analysis will take place. |
| Control | No intervention | –The control condition will consist of the participant lying prone on a plinth for the same time if takes for intervention to be applied approximately 10 minutes. Following the control condition outcome measures including hamstring strength, sEMG activity and 3D motion analysis will take place. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Current Teesside University Students/Staff 18+ years Engaged in Football related activity once a week Provide Informed Consent No current musculoskeletal Injury
Key exclusion criteria (4 listed)
- Current symptomatic low back pain or lower limb pathology including any injuries to the lower limb/lumbar spine within the last 6 months Previous ACL/Hamstring Rupture tear or diagnosed anterior knee pain. Under supervision of another health clinician Medical questionnaire not completed Red flags on medical questionnaire Any neurological problems Contraindications or precautions to spinal mobilisation
- malignancy, inflammatory or infectious processes involving the spine or peripheral joints,
- osteoporosis,
- spinal disorders including spondylolisthesis, ankylosing spondylitis, spinal fusion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lumbar MobilisationsThe intervention will consist of unilateral lumbar mobilisations at the L4 and L5 level in a Posterior Anterior direction. The side of the mobilisation will be determined by dominant leg - considered the kicking foot. The mobilisations will be administered by a physiotherapist with at least 10 years clinical experience. Teksan grip sensors will be worn by the physiotherapist to calculate the force applied to the participant. Grade three mobilisations will be applied for a one minute period three times at both L4 and L5 level. Each level will be determined by a passive physiological intervertebral movement. Participants will receive the mobilisations at L5 first for one minute followed by L4. This is an appropriate dose for mobilisation application (Maitland, 2013). This process will be carried out three times. | Other | Mobilisations |
Primary outcome
Hamstring Peak Force
Time frame: Immediate data collection during Nordic Hamstring Exercise
Peak Force of the Hamstring as measured by the Hamstring Solo Device during a Nordic eccentric hamstring exercise The hamstring solo device calculates Force (N), time of exercise (secs), Torque (Nm) and Torque per kg. This is collected in real-time. The hamstring solo calculates the eccentric force of the hamstring in real time. Participants are placed on the board with their ankle strapped. They follow previously discussed instructions to eccentrically lower themselves to the ground from a kneeling position.
sEMG of Biceps Femoris
Time frame: Immediate data collection during Nordic Hamstring Exercise
Record electromyography (SEMG) activity in the muscles of the participants in this study the Zerowire Cometa system will be used. Every electrode unit is equipped with a small unit for signal processing and transmission to the data receiver. The electrodes are single use disposable, self-adhesive silver chloride dual snap on electrodes pre-set at a distance of 20mm. All participants will have the skin prepared prior to the noraxon electrode being placed on their skin. Electrodes will be attached according to European recommendation (seniam) to the Biceps Femoris of both limbs. The electrode placement and sEMG recording will be taken by a qualified laboratory technician employed by Teesside University.
Vicon 3D Motion Capture
Time frame: Immediate data collection during Nordic Hamstring Exercise
Participants will have their mass (kg), height (cm), knee joint (between the medial and lateral epicondyle), ankle joint width (malleoli) and leg length (ASIS to medial malleolus) measured prior to recording.Widths will be measured using anthropometric calipers. Stretch height will be performed to improve the accuracy of the measurement. Six wall-mounted Vicon MX13 infrared cameras (Vicon) will collect 3D motion capture data at a sampling frequency of 100 Hz.. 3D motion capture data will be processed via Vicon Nexus version 1.8.5 using inbuilt pipeline functions to calculate 3D kinematic data (hip,pelvis, knee). Participants will have retroflective markers (14 mm) attached to the following landmarks on both the right and left side of the body; ASIS, PSIS, greater trochanter, mid-thigh, lateral epicondyle (of the knee), mid-tibia, lateral malleolus, calcaneus, and 2nd toe. The markers will be affixed with double-sided tape placed on the overlaying skin of the bony landmark.
1 secondary outcome
Subjective Likert Scale
Time frame: Immediate post Nordic hamstring Exercise
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2020.
- Results publication: PubMed 30347590Chesterton P, Payton S, McLaren S. Acute effects of centrally- and unilaterally-applied posterior-anterior mobilizations of the lumbar spine on lumbar range of motion, hamstring extensibility and muscle activation. J Back Musculoskelet Rehabil. 2018;31(6):1013-1023. doi: 10.3233/BMR-171000.
- Results publicationChesterton P & Payton S (2017) Effects of spinal mobilisations on lumbar and hamstring ROM and sEMG: A randomised control trial. Physiotherapy Practice and Research, 38, 17-25
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul Chesterton, MSc principal investigator
Teesside University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lumbar Mobilisations in people with Hamstring Injury, run by Teesside University at 1 site in United Kingdom.
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 1 inclusion and 4 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: finished, as of the sponsor's last update on 10 Mar 2020. 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 United Kingdom. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hamstring Peak Force (time frame: Immediate data collection during Nordic Hamstring Exercise). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03745482, which also lists 2 linked publications.
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 10 Mar 2020.