Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 19/SC/0059 | Other Identifier | Health Research Authority, Research Ethics Committee |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Wellington Hospital | OTHER_GOV |
| Imperial College London | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
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:
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| spinal collar | Device | cervical collar to immobilise the cervical spine |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Level of Comfort in and Out of a Spinal Collar. | Comfort after one hour of wearing a spinal collar measured by the 'Visual Analogue Scale' for pain (self reported: minimum 0=no pain at all, maximum 10= worst pain imaginable) | Baseline, approximately 30 minutes and after wearing a collar for one hour |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Michael Fertleman | Imperial College Healthcare NHS Trust/ The Wellington Hospital, London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Wellington Hospital | London | NW8 9LE | United Kingdom | |||
| Imperial College Healthcare NHS Trust |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Young Group Aged 18-30 Years | 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. Spinal collar: cervical collar to immobilise the cervical spine |
| FG001 | Older Group Aged 70 Years and Over | 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. Spinal collar: cervical collar to immobilise the cervical spine |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Young Group Aged 18-30 Years | Participants aged 18-30 years 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. Spinal collar: cervical collar to immobilise the cervical spine |
| BG001 | Older Group Aged 70 Years and Over |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | 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. | Posted | Mean | Standard Deviation | degrees | Baseline MRI image, approximately 30 minutes and second MRI image (with collar on), after one hour of wearing collar. |
|
Duration of time whilst actively participating in study (1 day)
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Young Group Aged 18-30 Years | Participants aged 18-30 years 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. Spinal collar: cervical collar to immobilise the cervical spine |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Key investigator | Imperial College Healthcare NHS Trust | 02033121077 | annabellelee@nhs.net |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 5, 2019 | Jun 12, 2021 | Prot_SAP_000.pdf |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Baseline MRI image, approximately 30 minutes and second MRI image (with collar on), after one hour of wearing collar. |
| London |
| W2 1NY |
| United Kingdom |
Participants aged 70 years and older 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. Spinal collar: cervical collar to immobilise the cervical spine |
| BG002 | Total | Total of all reporting groups |
| 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 |
|
| Visual analogue scale of pain | 'Visual Analogue Scale' for pain (self reported: minimum 0=no pain at all, maximum 10= worst pain imaginable) | Mean | Full Range | units on a scale |
|
Baseline angles: Total lordosis angle, Upper cervical lordosis angle, Lower cervical lordosis angle, T1 slope angle, Neck tilt angle, Thoracic inlet angle and the Individual vertebral angles from C1 to T2. |
|
|
|
| Secondary | 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. | 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. | Posted | Mean | Standard Deviation | degrees | Baseline MRI image, approximately 30 minutes and second MRI image (with collar on), after one hour of wearing collar. |
|
|
|
|
| Other Pre-specified | Level of Comfort in and Out of a Spinal Collar. | Comfort after one hour of wearing a spinal collar measured by the 'Visual Analogue Scale' for pain (self reported: minimum 0=no pain at all, maximum 10= worst pain imaginable) | Posted | Mean | Full Range | units on a scale | Baseline, approximately 30 minutes and after wearing a collar for one hour |
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | Older Group Aged 70 Years and Over | Participants aged 70 years and over 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. Spinal collar: cervical collar to immobilise the cervical spine | 0 | 18 | 0 | 18 | 0 | 18 |
Not provided
Not provided
Not provided
| Individual vertebral angles of C3 |
|
| Individual vertebral angles of C4 |
|
| Individual vertebral angles of C5 |
|
| Individual vertebral angles of C6 |
|
| Individual vertebral angles of C7 |
|
| Individual vertebral angles of T1 |
|
| Individual vertebral angles of T2 |
|