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Clinical Trials/NCT03958149
NCT03958149CompletedNot Applicable

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

Imperial College Healthcare NHS Trust4 sites in 1 country38 target enrollmentStarted: April 13, 2019Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
38
Locations
4
Primary Endpoint
Measurements of Angulation of the Neck (C-spine) on MRI Scans

Study Overview

Brief Summary

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.

Detailed Description

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:

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

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Basic Science
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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.

Outcomes

Primary Outcomes

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

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

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (4)

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