NCT03745482

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 14, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 19, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

January 4, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 8, 2019

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2020

Completed
Last Updated

March 10, 2020

Status Verified

March 1, 2020

Enrollment Period

8 months

First QC Date

November 14, 2018

Last Update Submit

March 9, 2020

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    Immediate data collection during Nordic Hamstring Exercise

Secondary Outcomes (1)

  • Subjective Likert Scale

    Immediate post Nordic hamstring Exercise

Study Arms (2)

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.

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.

Interventions

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.

Mobilisations

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Current Teesside University Students/Staff 18+ years Engaged in Football related activity once a week Provide Informed Consent No current musculoskeletal Injury

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Social Sciences, Humanities and Law

Middlesbrough, Tyne and Wear, TS1 3BA, United Kingdom

Location

Related Publications (2)

  • 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.

  • Chesterton 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

    RESULT

Study Officials

  • Paul Chesterton, MSc

    Teesside University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Lecturer Sport and Exercise

Study Record Dates

First Submitted

November 14, 2018

First Posted

November 19, 2018

Study Start

January 4, 2019

Primary Completion

September 8, 2019

Study Completion

January 10, 2020

Last Updated

March 10, 2020

Record last verified: 2020-03

Locations