Clinical trial NCT03958149: Measurements of Angulation of the C-spine
Official title: Comparison of Measurements of the Cervical Spine in Adults With and Without Immobilisation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cervical Spine
Keywords: Cervical spine
Lead sponsor: Imperial College Healthcare NHS Trust
Sponsor class: OTHER
Collaborators: name: Wellington Hospital
name: Imperial College London
First posted: 2019-05-21
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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

Eligibility criteria: 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.

Primary outcomes:
measure: Measurements of Angulation of the Neck (C-spine) on MRI Scans
timeFrame: Baseline MRI image, approximately 30 minutes and second MRI image (with collar on), after one hour of wearing collar.
Secondary outcomes:
measure: 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.
timeFrame: Baseline MRI image, approximately 30 minutes and second MRI image (with collar on), after one hour of wearing collar.
Other outcomes:
measure: Level of Comfort in and Out of a Spinal Collar.
timeFrame: Baseline, approximately 30 minutes and after wearing a collar for one hour
Locations:
city: London
country: United Kingdom
facility: The Wellington Hospital
city: London
country: United Kingdom
facility: Imperial College Healthcare NHS Trust
Study officials:
affiliation: Imperial College Healthcare NHS Trust/ The Wellington Hospital, London
name: Michael Fertleman
role: PRINCIPAL_INVESTIGATOR
References: