Measurements of Angulation of the C-spine

Imperial College Healthcare NHS Trust

Status: Completed

Conditions: Cervical Spine

Treatments: Device: spinal collar

Study type: Interventional

Funder types: Other

Identifiers

NCT03958149

19/SC/0059 (Other Identifier)

18SM4805

Details and patient eligibility

About

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.

Full 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

Enrollment: 38 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

38 participants in 1 patient group

Spinal collar

Other group

Description:

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.

Treatment:

Device: spinal collar