Measurements of Angulation of the C-spine

Cervical Spine Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03958149
• Other study ID #: 18SM4805
• Secondary ID: 19/SC/0059
• Status: Completed
• Phase: N/A
• Start date: April 13, 2019
• Est. completion date: June 2, 2019

Study information

• Verified date: August 2021
• Source: Imperial College Healthcare NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: June 2, 2019
• Est. primary completion date: June 2, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

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.

Related Conditions & MeSH terms

• Cervical Spine

Intervention

Device:
• spinal collar
cervical collar to immobilise the cervical spine

Locations

Country	Name	City	State
United Kingdom	Imperial College Healthcare NHS Trust	London
United Kingdom	The Wellington Hospital	London

Sponsors (3)

Lead Sponsor	Collaborator
Imperial College Healthcare NHS Trust	Imperial College London, The Wellington Hospital, London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Level of Comfort in and Out of a Spinal Collar.	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)	Baseline, approximately 30 minutes and after wearing a collar for one hour
Primary	Measurements of Angulation of the Neck (C-spine) on MRI Scans	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.	Baseline MRI image, approximately 30 minutes and second MRI image (with collar on), after one hour of wearing collar.
Secondary	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.	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.	Baseline MRI image, approximately 30 minutes and second MRI image (with collar on), after one hour of wearing collar.