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Completed

NCT Number: NCT03958149

Measurements of Angulation of the C-spine

This is a prospective study aiming to assess the shape of the neck in adults. In addition the study will look at the shape of the neck in a spinal collar and the comfort while wearing a spinal collar.

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Key information

Conditions

Cervical Spine

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Imperial College Healthcare NHS Trust, London, United Kingdom

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About this study

The investigators aim to compare baseline scans of the neck in those aged 18yrs and older to a second neck scan where the participant is wearing a spinal collar. Experts will analyse the scans for measurements of angulations. In addition the study will collect demographic data and results from a validated patient questionnaire assessing comfort wearing the spinal collar.

The hypothesis:

  • The shape of the neck is different when comparing the young and old populations
  • The spinal collar does not alter the shape of the spine
  • The spinal collars are uncomfortable in the elderly population

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Persons aged 18yrs and over to those aged 30yrs
  • Persons aged 70yrs and over
  • Ability to give informed consent to participate in the study

Exclusion criteria

  • Persons under 18yrs of age and those aged 31yrs -69yrs
  • Persons who lack capacity to consent for entry into the study
  • Persons who are unable to complete the visual analogue score or questionnaire due to co-existent visual and hearing loss. Severe hearing impairment will be defined as unable to hear the researcher with hearing aids if required. Severe visual impairment will be defined as being unable to read the patient information sheet even with visual aids.
  • Persons unable to understand the information leaflet in English.
  • Those with current neck pain, known previous C-spine injury or known medical condition affecting the spine.
  • Persons who do not pass the safety questionnaire to undergo an MRI scan
  • Persons who are unable to tolerate an MRI scan due to claustrophobia
  • Persons who are unable to transfer to the scanner table independently
  • Persons unable to lie flat and still for 10 minutes
  • Persons who do not give consent to their General Practitioner being informed of scan results.

Treatment and study plan

spinal collar

Device

cervical collar to immobilise the cervical spine

Primary outcomes

  1. Measurements of Angulation of the Neck (C-spine) on MRI Scans

    Time frame: Baseline MRI image, approximately 30 minutes and second MRI image (with collar on), after one hour of wearing collar.

    Comparison of the measurements of angulation of the neck (assessed on MRI imaging) in the young person compared to the older person. Statistical analysis to allow comparison of groups.

Secondary outcomes

  1. The Degree of Change in Measurements of Angulation of the Neck (C-spine) on MRI Scans Whilst Wearing a Spinal Collar Compared to When Not Wearing a Spinal Collar.

    Time frame: Baseline MRI image, approximately 30 minutes and second MRI image (with collar on), after one hour of wearing collar.

    Comparison of the degree of change of measurements of angulation of the neck from MRI scans of a young persons neck (C-spine) in and out of a spinal collar to those of an older persons neck (C-spine) in and out of a spinal collar on MRI imaging. Statistical analysis to allow comparison of groups.

Other outcomes

  1. Level of Comfort in and Out of a Spinal Collar.

    Time frame: Baseline, approximately 30 minutes and after wearing a collar for one hour

    Comfort after one hour of wearing a spinal collar measured by the 'Visual Analogue Scale' for pain (self reported: minimum 0=no pain at all, maximum 10= worst pain imaginable)

Sponsors and collaborators

Lead sponsor

Imperial College Healthcare NHS Trust

Other

Collaborators

  • Imperial College London
  • Wellington Hospital

Registry information

Official study title

Comparison of Measurements of the Cervical Spine in Adults With and Without Immobilisation

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
May 21, 2019
Registry last updated
Sep 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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