Measurements of Angulation of the C-spine

NCT ID: NCT03958149

Last Updated: 2021-09-05

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-13

Study Completion Date

2019-06-02

Brief Summary

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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

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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

Conditions

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Cervical Spine

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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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.

Group Type OTHER

spinal collar

Intervention Type DEVICE

cervical collar to immobilise the cervical spine

Interventions

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spinal collar

cervical collar to immobilise the cervical spine

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Wellington Hospital

OTHER_GOV

Sponsor Role collaborator

Imperial College London

OTHER

Sponsor Role collaborator

Imperial College Healthcare NHS Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael Fertleman

Role: PRINCIPAL_INVESTIGATOR

Imperial College Healthcare NHS Trust/ The Wellington Hospital, London

Locations

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The Wellington Hospital

London, , United Kingdom

Site Status

Imperial College Healthcare NHS Trust

London, , United Kingdom

Site Status

Countries

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United Kingdom

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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19/SC/0059

Identifier Type: OTHER

Identifier Source: secondary_id

18SM4805

Identifier Type: -

Identifier Source: org_study_id

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