Evaluation of Comfort in a Spinal Collar
|ClinicalTrials.gov Identifier: NCT04066686|
Recruitment Status : Completed
First Posted : August 26, 2019
Last Update Posted : August 26, 2019
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||27 participants|
|Official Title:||Evaluation on the Level of Discomfort and Restriction on Activities of Daily Living (ADLs) Whilst C-spine Immobilised in a Spinal Collar After C-spine Injury.|
|Actual Study Start Date :||October 26, 2018|
|Actual Primary Completion Date :||May 29, 2019|
|Actual Study Completion Date :||May 29, 2019|
Participants recruited into one of two groups on age stratification. Young cohort defined as aged 18-65yrs old
Participants recruited into one of two groups on age stratification. Elderly cohort defined as over 65yrs of age.
- Measurement of the level of discomfort produced by the spinal collar in adult patient with a C-spine (neck) injury. [ Time Frame: throughout study completion, an average of 2 weeks ]'Visual Analogue Scale' for pain (self reported: minimum 0=no pain at all, maximum 10= worst pain imaginable)
- Measurement of change of impedance on activities of daily living produced by the spinal collar in adult patient with a C-spine (neck) injury. [ Time Frame: baseline, time of wearing the spinal collar after injury, an avarange of 2 weeks ]'Neck Disability Index' Questionnaire (Validated functional assessment which consists of ten questions in questionnaire format with multi-choice answer options). Maximum score is 50, best option score is 0, the worst is 5. The score is calculated as follows: Example - 16 (total scored) 50 (total possible score) x 100 = 32%. 100% means no improvement.
- Measurement of spinal angulation [ Time Frame: through study completion, up to one year ]Measurements of angulation between specified bony anatomical landmarks to investigate degree of curvature within the C-spine performed on any neck imaging completed as part of routine clinical care. Statistical analysis to allow comparison of young and elderly groups.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04066686
|Imperial College Heathcare NHS Trust|
|London, United Kingdom|
|Principal Investigator:||Michael Fertleman||Study Principal Investigator Imperial College Healthcare NHS Trust|