Measurements of Angulation of the C-spine

Not Applicable

Completed

• Conditions: Cervical Spine
• Interventions: Device: spinal collar

• Registration Number: NCT03958149
• Lead Sponsor: Imperial College Healthcare NHS Trust

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 Timeline

• Study First Submitted: 2019-03-14
• Study Start: 2019-04-13
• Study First Submitted QC: 2019-05-20
• Study First Posted: 2019-05-21
• Primary Completion: 2019-06-02
• Study Completion: 2019-06-02
• Results First Submitted: 2021-05-17
• Status Verified: 2021-08
• Results First Submitted QC: 2021-08-11
• Last Update Submitted: 2021-08-11
• Results First Posted: 2021-09-05
• Last Update Posted: 2021-09-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

1. Persons aged 18yrs and over to those aged 30yrs
2. Persons aged 70yrs and over
3. Ability to give informed consent to participate in the study

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Exclusion Criteria

1. Persons under 18yrs of age and those aged 31yrs -69yrs
2. Persons who lack capacity to consent for entry into the study
3. 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.
4. Persons unable to understand the information leaflet in English.
5. Those with current neck pain, known previous C-spine injury or known medical condition affecting the spine.
6. Persons who do not pass the safety questionnaire to undergo an MRI scan
7. Persons who are unable to tolerate an MRI scan due to claustrophobia
8. Persons who are unable to transfer to the scanner table independently
9. Persons unable to lie flat and still for 10 minutes
10. Persons who do not give consent to their General Practitioner being informed of scan results.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Spinal collar	spinal collar	Participants will undergo MRI scans in and out a spinal collar to assess whether the measurements of angulation of the C-spine change whilst wearing a spinal collar.

Primary Outcome Measures

Name	Time	Method
Measurements of Angulation of the Neck (C-spine) on MRI Scans	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 Outcome Measures

Name	Time	Method
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.	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.

Trial Locations

Locations (2)

The Wellington Hospital; 🇬🇧 London, United Kingdom

Imperial College Healthcare NHS Trust; 🇬🇧 London, United Kingdom