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Measurements of Angulation of the C-spine

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ClinicalTrials.gov Identifier: NCT03958149
Recruitment Status : Recruiting
First Posted : May 21, 2019
Last Update Posted : May 21, 2019
Sponsor:
Collaborators:
The Wellington Hospital, London
Imperial College London
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Cervical Spine Device: spinal collar Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Comparison of Measurements of the Cervical Spine in Adults With and Without Immobilisation
Actual Study Start Date : April 13, 2019
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Device: spinal collar
cervical collar to immobilise the cervical spine




Primary Outcome Measures :
  1. Measurements of angulation of the neck (C-spine) on MRI scans from 52 participants. [ Time Frame: 4 months ]
    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 :
  1. 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 in 52 participants. [ Time Frame: 4 months ]
    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.


Other Outcome Measures:
  1. Level of comfort in and out of a spinal collar. [ Time Frame: 4 months ]
    Comfort in and out of a spinal collar measured by the visual analogue score (0=no pain at all, 10= worst pain imaginable)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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 the GP (General Practitioner) being informed of scan results.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03958149


Contacts
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Contact: Research Governance Manager 020759 41862 r.nicholson@imperial.ac.uk

Locations
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United Kingdom
The Wellington Hospital Recruiting
London, United Kingdom, NW8 9LE
Contact: Principal Investigator       m.fertleman@imperial.ac.uk   
Imperial College Healthcare NHS Trust Not yet recruiting
London, United Kingdom, W2 1NY
Contact: Research Integrity Officer    02075941872    jrco@imperial.ac.uk   
Principal Investigator: Fertleman         
Sponsors and Collaborators
Imperial College Healthcare NHS Trust
The Wellington Hospital, London
Imperial College London
Investigators
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Principal Investigator: Michael Fertleman Imperial College Healthcare NHS Trust/ The Wellington Hospital, London

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Responsible Party: Imperial College Healthcare NHS Trust
ClinicalTrials.gov Identifier: NCT03958149     History of Changes
Other Study ID Numbers: 18SM4805
19/SC/0059 ( Other Identifier: Health Research Authority, Research Ethics Committee )
First Posted: May 21, 2019    Key Record Dates
Last Update Posted: May 21, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No