NCT03273400

Brief Summary

To compare the immediate and short-term effects of L4 and L5 Unilateral Posterior Anterior (UPA) Mobilisations on the lumbar and hamstring range of motion and EMG activity of the Erector Spinae and Hamstring muscles. Using a pre-test post-test crossover design subjects lumbar flexion and active knee extension with be recorded prior to and following unilateral zygapophyseal joint mobilisations. Measures will be taken immediately after and then 5, 10, 15, 20, 30 and 60 minutes intervals post intervention. Mobilisation force will be measured via force plates to ensure consistent mobilisation pressure. Following data collection statistical analysis will be undertaken to analyse any potential benefit of lumbar mobilisations to influence the EMG activity of the Erector Spinae and Hamstrings. Functional assessment of lumbar range of motion and hamstring range of motion to be conducted and analyse any effect on movement

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2017

Shorter than P25 for not_applicable

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

September 1, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 6, 2017

Completed
16 days until next milestone

Study Start

First participant enrolled

September 22, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2018

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

April 24, 2018

Status Verified

April 1, 2018

Enrollment Period

5 months

First QC Date

September 1, 2017

Last Update Submit

April 23, 2018

Conditions

Keywords

Lumbar, Hamstring, Mobilisation

Outcome Measures

Primary Outcomes (4)

  • Lumbar Range of Motion

    During lumbar flexion participants will be asked to stand with their arms at their side (anatomical position) and feet 8cm part. The tester will demonstrate the flexion motion then request the subject bends forwards are far as is possible, maintaining knee extension. A previous reliability study (Page 2012) has indicated four lumbar flexion movements repetitions were required to prevent the effects of passive stiffness improving the range. On the fourth trial the measurement via the modified schober test. This requires skin markers to be placed 10cm above and 5cm below the lumbar-sacral junction and the change distance calculated at end range.

    5, 10, 15, 20, 30, 60 minutes post application as a single test.

  • Hamstring Range of Motion

    Hamstring extensibility will be measured via the active knee extension test. Test leg will be determined by dominant/kicking leg. Subjects will be secured into anterior pelvic tilt via a belt and asked to extend the knee to maximal length. A purpose made wooden wedge will provide a right angle surface to ensure the hip is held at 90 degrees. The digital inclinometer will record the change in degrees of active knee extension post-test. The knee will be extended to end range, determined by the subject, with the hip, knee and ankle maintained in neutral. The non-dominant leg will be secured to the bed via a belt.

    5, 10, 15, 20, 30, 60 minutes post application as a single test.

  • Electromyography of Erector Spinae

    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) at the Paraspinal muscles (L1 region). A baseline sEMG will then be taken whilst the participant is at rest for 60seconds. The electrode placement and sEMG recording will be taken by a qualified laboratory technician employed by Teesside University.

    5, 10, 15, 20, 30, 60 minutes post application as a single test.

  • Electromyography 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 the dominate leg. A baseline sEMG will then be taken whilst the participant is at rest for 60seconds. The electrode placement and sEMG recording will be taken by a qualified laboratory technician employed by Teesside University.

    5, 10, 15, 20, 30, 60 minutes post application as a single test.

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 the intervention all measure lumbar flexion, hamstring extensibility and sEMG activity will be recorded immediately, 5, 10, 15, 20, 30, 60 minutes post application as a single test.

Other: Lumbar Mobilisations

Control

NO INTERVENTION

All outcome measures (lumbar/hamstring range of motion; EMG activity of the Biceps Femoris and Erector Spinae) will be measured. The control group will then receive no intervention and be asked to lie supine on a plinth for the treatment duration before having the outcome measures reassessed.

Interventions

Please see arm (intervention) description

Mobilisations

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age between 18-65. Participants willing to provide inform consent. Participants who successfully complete the medical questionnaire. No current lower back or lower limb pathology.

You may not qualify if:

  • Current symptomatic low back pain or lower limb pathology. Participants with altered neurodynamic symptoms. Previous lumbar surgery. Under supervision of another health practionare Pregnant participants 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)

Social Sciences, Business and Law

Middlesbrough, Teesside, TS1 3BA, United Kingdom

Location

Related Publications (3)

  • 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

    BACKGROUND
  • Szlezak AM, Georgilopoulos P, Bullock-Saxton JE, Steele MC. The immediate effect of unilateral lumbar Z-joint mobilisation on posterior chain neurodynamics: a randomised controlled study. Man Ther. 2011 Dec;16(6):609-13. doi: 10.1016/j.math.2011.06.004. Epub 2011 Jul 13.

    PMID: 21742541BACKGROUND
  • Chesterton P, Evans W, Livadas N, McLaren SJ. Time-course changes associated with PA lumbar mobilizations on lumbar and hamstring range of motion: a randomized controlled crossover trial. J Man Manip Ther. 2019 May;27(2):73-82. doi: 10.1080/10669817.2018.1542558. Epub 2018 Nov 13.

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: The study will be a cross-over design. A pre-test post-test design will be used to evaluate the sEMG activity of the Erector Spinae muscle group and the Hamstring muscle (Biceps Femoris). Lumbar flexion range of motion and hamstring length will be tested prior too mobilisations and post intervention immediate and at intervals of 5, 10, 15, 20, 30, 60 minutes. Participants will be receive non-intervention one week and mobilisations the following week.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Lecturer Sport and Exercise

Study Record Dates

First Submitted

September 1, 2017

First Posted

September 6, 2017

Study Start

September 22, 2017

Primary Completion

February 20, 2018

Study Completion

March 1, 2018

Last Updated

April 24, 2018

Record last verified: 2018-04

Locations