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This is an observational study which aims to assess the comfort of a spinal collar in patients who have them fitted as part of their clinical care due to neck injury.
The study follows the patient journey including long term follow up (up to 120 days following admission). The information gathered will be from the standard clinical care delivered and include demographics, baseline function, the injuries sustained following trauma and prescribed analgesia with records of the most recent time and dose administered. Any scans done of the neck for clinical purposes will be anonymised and analysed for measurements of angulation. In addition to this there will be a survey on the comfort of the collar and of their functional ability at the current time at various points during their inpatient admission.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Young | Participants recruited into one of two groups on age stratification. Young cohort defined as aged 18-65yrs old | ||
| Elderly | Participants recruited into one of two groups on age stratification. Elderly cohort defined as over 65yrs of age. |
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| Measure | Description | Time Frame |
|---|---|---|
| Measurement of the Level of Discomfort Produced by the Spinal Collar in Adult Patients With a C-spine (Neck) Injury. | 'Visual Analogue Scale' for pain (self reported: minimum 0=no pain at all, maximum 10= worst pain imaginable) | During inpatient admission (an average of two weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Measurement of Change of Impedance on Activities of Daily Living Produced by the Spinal Collar in Adult Patient With a C-spine (Neck) Injury. | 'Neck Disability Index' Questionnaire (Validated functional assessment which consists of ten questions to assess how that persons neck pain affects abilities in everyday life. It is a questionnaire format with multi-choice answer options). Minimum score = 0, Maximum score = 50. The overall percentage score is calculated as follows: e.g. 16 (total scored) divided by 50 (total possible score) x 100 = 32%. A higher percentage indicates a worse outcome i.e. higher disability. |
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Inclusion Criteria:
Exclusion Criteria:
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All patients aged 18yrs and over who are admitted to St Mary's Hospital with a C-spine injury will be invited to participate
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| Name | Affiliation | Role |
|---|---|---|
| Michael Fertleman | Study Principal Investigator Imperial College Healthcare NHS Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Imperial College Heathcare NHS Trust | London | United Kingdom |
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| ID | Title | Description |
|---|---|---|
| FG000 | Young | Participants recruited into one of two groups on age stratification. Young cohort defined as aged 18-65yrs old |
| FG001 | Elderly | Participants recruited into one of two groups on age stratification. Elderly cohort defined as over 65yrs of age. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Participant withdrawal led to a reduction in the overall number of participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Young | Participants recruited into one of two groups on age stratification. Young cohort defined as aged 18-65yrs old |
| BG001 | Elderly | Participants recruited into one of two groups on age stratification. Elderly cohort defined as over 65yrs of age. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Measurement of the Level of Discomfort Produced by the Spinal Collar in Adult Patients With a C-spine (Neck) Injury. | 'Visual Analogue Scale' for pain (self reported: minimum 0=no pain at all, maximum 10= worst pain imaginable) | 11 Young participants and 9 Elderly participants completed the visual analogue score (some participants chose not to complete the score). Visual analogue score was assessed at single time point during the study. | Posted | Median | Full Range | score on a scale | During inpatient admission (an average of two weeks) |
|
Duration of study - 7 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Young | Participants recruited into one of two groups on age stratification. Young cohort defined as aged 18-65yrs old |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Annabelle Lee | Imperial College Healthcare NHS Trust | 02033121077 | annabellelee@nhs.net |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 16, 2018 | Mar 15, 2021 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D019838 | Neck Injuries |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| At baseline (retrospectively) and at time of wearing the spinal collar after injury |
| Measurement of Spinal Angulation | 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. | Through study completion, up to one year |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Participants recruited into one of two groups on age stratification. Elderly cohort defined as over 65yrs of age. |
|
|
| Secondary | Measurement of Change of Impedance on Activities of Daily Living Produced by the Spinal Collar in Adult Patient With a C-spine (Neck) Injury. | 'Neck Disability Index' Questionnaire (Validated functional assessment which consists of ten questions to assess how that persons neck pain affects abilities in everyday life. It is a questionnaire format with multi-choice answer options). Minimum score = 0, Maximum score = 50. The overall percentage score is calculated as follows: e.g. 16 (total scored) divided by 50 (total possible score) x 100 = 32%. A higher percentage indicates a worse outcome i.e. higher disability. | Only 10 participants in the Young group and 6 participants in the Elderly group were able to complete the 'Neck Disability Index' Questionnaires (retrospectively for baseline and at the time of wearing the spinal collar after injury). | Posted | Mean | Full Range | percentage score on a scale | At baseline (retrospectively) and at time of wearing the spinal collar after injury |
|
|
|
| Secondary | Measurement of Spinal Angulation | 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. | Data not available | Posted | Through study completion, up to one year |
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| 0 |
| 14 |
| 0 |
| 14 |
| 0 |
| 14 |
| EG001 | Elderly | Participants recruited into one of two groups on age stratification. Elderly cohort defined as over 65yrs of age. | 0 | 13 | 0 | 13 | 0 | 13 |
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