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
|Condition or disease||Intervention/treatment||Phase|
|Cervical Spine||Device: spinal collar||Not Applicable|
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 shape of the neck is different when comparing the young and old populations
- The spinal collar does not alter the shape of the spine
- The spinal collars are uncomfortable in the elderly population
|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|
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
- 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.
- 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.
- 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)
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
|Contact: Research Governance Manager||020759 email@example.com|
|The Wellington Hospital||Recruiting|
|London, United Kingdom, NW8 9LE|
|Contact: Principal Investigator firstname.lastname@example.org|
|Imperial College Healthcare NHS Trust||Not yet recruiting|
|London, United Kingdom, W2 1NY|
|Contact: Research Integrity Officer 02075941872 email@example.com|
|Principal Investigator: Fertleman|
|Principal Investigator:||Michael Fertleman||Imperial College Healthcare NHS Trust/ The Wellington Hospital, London|