NCT03958149

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 14, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

April 13, 2019

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 21, 2019

Completed
12 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 2, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 2, 2019

Completed
2.3 years until next milestone

Results Posted

Study results publicly available

September 5, 2021

Completed
Last Updated

September 5, 2021

Status Verified

August 1, 2021

Enrollment Period

2 months

First QC Date

March 14, 2019

Results QC Date

May 17, 2021

Last Update Submit

August 11, 2021

Conditions

Cervical Spine

Keywords

Cervical spine

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (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.

    Baseline MRI image, approximately 30 minutes and second MRI image (with collar on), after one hour of wearing collar.

Other Outcomes (1)

  • Level of Comfort in and Out of a Spinal Collar.

    Baseline, approximately 30 minutes and after wearing a collar for one hour

Study Arms (1)

Spinal collar

OTHER

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

Interventions

spinal collarDEVICE

cervical collar to immobilise the cervical spine

Spinal collar

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Persons aged 18yrs and over to those aged 30yrs
  • Persons aged 70yrs and over
  • Ability to give informed consent to participate in the study

You may not qualify if:

  • Persons under 18yrs of age and those aged 31yrs -69yrs
  • Persons who lack capacity to consent for entry into the study
  • 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.
  • Persons unable to understand the information leaflet in English.
  • Those with current neck pain, known previous C-spine injury or known medical condition affecting the spine.
  • Persons who do not pass the safety questionnaire to undergo an MRI scan
  • Persons who are unable to tolerate an MRI scan due to claustrophobia
  • Persons who are unable to transfer to the scanner table independently
  • Persons unable to lie flat and still for 10 minutes
  • Persons who do not give consent to their General Practitioner being informed of scan results.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

The Wellington Hospital

London, NW8 9LE, United Kingdom

Location

Imperial College Healthcare NHS Trust

London, W2 1NY, United Kingdom

Location

Results Point of Contact

Title
Key investigator
Organization
Imperial College Healthcare NHS Trust
annabellelee@nhs.net
02033121077

Study Officials

  • Michael Fertleman

    Imperial College Healthcare NHS Trust/ The Wellington Hospital, London

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 14, 2019

First Posted

May 21, 2019

Study Start

April 13, 2019

Primary Completion

June 2, 2019

Study Completion

June 2, 2019

Last Updated

September 5, 2021

Results First Posted

September 5, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations

GB(2)