Cervical Spine
Conditions
Keywords
Cervical spine
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.
Detailed description
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: 1. The shape of the neck is different when comparing the young and old populations 2. The spinal collar does not alter the shape of the spine 3. The spinal collars are uncomfortable in the elderly population
Interventions
DEVICEspinal collar
cervical collar to immobilise the cervical spine
Sponsors
Wellington Hospital
Imperial College London
Imperial College Healthcare NHS Trust
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Persons aged 18yrs and over to those aged 30yrs 2. Persons aged 70yrs and over 3. Ability to give informed consent to participate in the study
Exclusion criteria
1. Persons under 18yrs of age and those aged 31yrs -69yrs 2. Persons who lack capacity to consent for entry into the study 3. 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. 4. Persons unable to understand the information leaflet in English. 5. Those with current neck pain, known previous C-spine injury or known medical condition affecting the spine. 6. Persons who do not pass the safety questionnaire to undergo an MRI scan 7. Persons who are unable to tolerate an MRI scan due to claustrophobia 8. Persons who are unable to transfer to the scanner table independently 9. Persons unable to lie flat and still for 10 minutes 10. Persons who do not give consent to their General Practitioner being informed of scan results.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Measurements of Angulation of the Neck (C-spine) on MRI Scans | Baseline MRI image, approximately 30 minutes and second MRI image (with collar on), after one hour of wearing collar. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Level of Comfort in and Out of a Spinal Collar. | Baseline, approximately 30 minutes and after wearing a collar for one hour | 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) |
Countries
United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 20 |
| Older Group Aged 70 Years and Over 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 | 18 |
| Total | 38 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Young Group Aged 18-30 Years | Total | Older Group Aged 70 Years and Over |
|---|---|---|---|
| Age, Continuous | 25.3 years | 51.8 years | 77.3 years |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United Kingdom | 20 participants | 38 participants | 18 participants |
| Sex: Female, Male Female | 10 Participants | 18 Participants | 8 Participants |
| Sex: Female, Male Male | 10 Participants | 20 Participants | 10 Participants |
| Visual analogue scale of pain | 0.75 units on a scale | 0.81 units on a scale | 0.87 units on a scale |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 18 |
| other Total, other adverse events | 0 / 20 | 0 / 18 |
| serious Total, serious adverse events | 0 / 20 | 0 / 18 |
Outcome results
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.
Time frame: Baseline MRI image, approximately 30 minutes and second MRI image (with collar on), after one hour of wearing collar.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Measurements of Angulation of the Young Group Neck (C-spine) | Measurements of Angulation of the Neck (C-spine) on MRI Scans | Individual vertebral angle of C4 | -2.4 degrees | Standard Deviation 7.1 |
| Measurements of Angulation of the Young Group Neck (C-spine) | Measurements of Angulation of the Neck (C-spine) on MRI Scans | Total lordosis angle | 10.6 degrees | Standard Deviation 8.7 |
| Measurements of Angulation of the Young Group Neck (C-spine) | Measurements of Angulation of the Neck (C-spine) on MRI Scans | Upper cervical lordosis angle | 5.5 degrees | Standard Deviation 4 |
| Measurements of Angulation of the Young Group Neck (C-spine) | Measurements of Angulation of the Neck (C-spine) on MRI Scans | Lower cervical lordosis angle | 9.9 degrees | Standard Deviation 6.9 |
| Measurements of Angulation of the Young Group Neck (C-spine) | Measurements of Angulation of the Neck (C-spine) on MRI Scans | T1 slope angle | 62.4 degrees | Standard Deviation 5.6 |
| Measurements of Angulation of the Young Group Neck (C-spine) | Measurements of Angulation of the Neck (C-spine) on MRI Scans | Neck tilt angle | 44.0 degrees | Standard Deviation 10.3 |
| Measurements of Angulation of the Young Group Neck (C-spine) | Measurements of Angulation of the Neck (C-spine) on MRI Scans | Thoracic inlet angle | 106.4 degrees | Standard Deviation 10.9 |
| Measurements of Angulation of the Young Group Neck (C-spine) | Measurements of Angulation of the Neck (C-spine) on MRI Scans | Individual vertebral angle of C1 | 0.5 degrees | Standard Deviation 11.3 |
| Measurements of Angulation of the Young Group Neck (C-spine) | Measurements of Angulation of the Neck (C-spine) on MRI Scans | Individual vertebral angle of C2 | 1.5 degrees | Standard Deviation 7 |
| Measurements of Angulation of the Young Group Neck (C-spine) | Measurements of Angulation of the Neck (C-spine) on MRI Scans | Individual vertebral angle of C3 | -1.3 degrees | Standard Deviation 6.1 |
| Measurements of Angulation of the Young Group Neck (C-spine) | Measurements of Angulation of the Neck (C-spine) on MRI Scans | Individual vertebral angle of C5 | -2.2 degrees | Standard Deviation 8.8 |
| Measurements of Angulation of the Young Group Neck (C-spine) | Measurements of Angulation of the Neck (C-spine) on MRI Scans | Individual vertebral angle of C6 | -0.9 degrees | Standard Deviation 9.7 |
| Measurements of Angulation of the Young Group Neck (C-spine) | Measurements of Angulation of the Neck (C-spine) on MRI Scans | Individual vertebral angle of C7 | -1.3 degrees | Standard Deviation 10.9 |
| Measurements of Angulation of the Young Group Neck (C-spine) | Measurements of Angulation of the Neck (C-spine) on MRI Scans | Individual vertebral angle of T1 | -0.3 degrees | Standard Deviation 9.5 |
| Measurements of Angulation of the Young Group Neck (C-spine) | Measurements of Angulation of the Neck (C-spine) on MRI Scans | Individual vertebral angle of T2 | -0.9 degrees | Standard Deviation 11.1 |
| Measurements of Angulation of the Older Group Neck (C-spine) | Measurements of Angulation of the Neck (C-spine) on MRI Scans | Individual vertebral angle of C6 | -4.5 degrees | Standard Deviation 2.9 |
| Measurements of Angulation of the Older Group Neck (C-spine) | Measurements of Angulation of the Neck (C-spine) on MRI Scans | Individual vertebral angle of C2 | -1.0 degrees | Standard Deviation 4.6 |
| Measurements of Angulation of the Older Group Neck (C-spine) | Measurements of Angulation of the Neck (C-spine) on MRI Scans | Total lordosis angle | 21.6 degrees | Standard Deviation 11.9 |
| Measurements of Angulation of the Older Group Neck (C-spine) | Measurements of Angulation of the Neck (C-spine) on MRI Scans | Individual vertebral angle of T1 | -5.6 degrees | Standard Deviation 6.5 |
| Measurements of Angulation of the Older Group Neck (C-spine) | Measurements of Angulation of the Neck (C-spine) on MRI Scans | Upper cervical lordosis angle | 4.1 degrees | Standard Deviation 3.5 |
| Measurements of Angulation of the Older Group Neck (C-spine) | Measurements of Angulation of the Neck (C-spine) on MRI Scans | Individual vertebral angle of C3 | -0.6 degrees | Standard Deviation 3.5 |
| Measurements of Angulation of the Older Group Neck (C-spine) | Measurements of Angulation of the Neck (C-spine) on MRI Scans | Lower cervical lordosis angle | 18.7 degrees | Standard Deviation 11.7 |
| Measurements of Angulation of the Older Group Neck (C-spine) | Measurements of Angulation of the Neck (C-spine) on MRI Scans | Individual vertebral angle of C4 | -1.4 degrees | Standard Deviation 3.8 |
| Measurements of Angulation of the Older Group Neck (C-spine) | Measurements of Angulation of the Neck (C-spine) on MRI Scans | T1 slope angle | 54.6 degrees | Standard Deviation 9.5 |
| Measurements of Angulation of the Older Group Neck (C-spine) | Measurements of Angulation of the Neck (C-spine) on MRI Scans | Individual vertebral angle of C7 | -5.0 degrees | Standard Deviation 6.2 |
| Measurements of Angulation of the Older Group Neck (C-spine) | Measurements of Angulation of the Neck (C-spine) on MRI Scans | Neck tilt angle | 52.8 degrees | Standard Deviation 13.5 |
| Measurements of Angulation of the Older Group Neck (C-spine) | Measurements of Angulation of the Neck (C-spine) on MRI Scans | Individual vertebral angle of C5 | -1.3 degrees | Standard Deviation 4 |
| Measurements of Angulation of the Older Group Neck (C-spine) | Measurements of Angulation of the Neck (C-spine) on MRI Scans | Thoracic inlet angle | 107.4 degrees | Standard Deviation 20.1 |
| Measurements of Angulation of the Older Group Neck (C-spine) | Measurements of Angulation of the Neck (C-spine) on MRI Scans | Individual vertebral angle of T2 | -3.8 degrees | Standard Deviation 7 |
| Measurements of Angulation of the Older Group Neck (C-spine) | Measurements of Angulation of the Neck (C-spine) on MRI Scans | Individual vertebral angle of C1 | 0.2 degrees | Standard Deviation 6.2 |
p-value: <0.001Independent t-test
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.
Time frame: Baseline MRI image, approximately 30 minutes and second MRI image (with collar on), after one hour of wearing collar.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Measurements of Angulation of the Young Group Neck (C-spine) | 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. | Individual vertebral angles of T2 | 0.2 degrees | Standard Deviation 0.1 |
| Measurements of Angulation of the Young Group Neck (C-spine) | 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. | Individual vertebral angles of C1 | 0.14 degrees | Standard Deviation 0.16 |
| Measurements of Angulation of the Young Group Neck (C-spine) | 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. | Individual vertebral angles of C2 | 0.11 degrees | Standard Deviation 0.15 |
| Measurements of Angulation of the Young Group Neck (C-spine) | 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. | Individual vertebral angles of C3 | 0.1 degrees | Standard Deviation 0.2 |
| Measurements of Angulation of the Young Group Neck (C-spine) | 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. | Individual vertebral angles of C4 | 0.2 degrees | Standard Deviation 0.1 |
| Measurements of Angulation of the Young Group Neck (C-spine) | 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. | Individual vertebral angles of C5 | 0.2 degrees | Standard Deviation 0.1 |
| Measurements of Angulation of the Young Group Neck (C-spine) | 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. | Individual vertebral angles of C6 | 0.2 degrees | Standard Deviation 0.1 |
| Measurements of Angulation of the Young Group Neck (C-spine) | 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. | Individual vertebral angles of C7 | 0.2 degrees | Standard Deviation 0.1 |
| Measurements of Angulation of the Young Group Neck (C-spine) | 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. | Individual vertebral angles of T1 | 0.2 degrees | Standard Deviation 0.1 |
| Measurements of Angulation of the Older Group Neck (C-spine) | 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. | Individual vertebral angles of C7 | 18.7 degrees | Standard Deviation 8.9 |
| Measurements of Angulation of the Older Group Neck (C-spine) | 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. | Individual vertebral angles of C5 | 14.7 degrees | Standard Deviation 7.1 |
| Measurements of Angulation of the Older Group Neck (C-spine) | 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. | Individual vertebral angles of C1 | 0.12 degrees | Standard Deviation 10.8 |
| Measurements of Angulation of the Older Group Neck (C-spine) | 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. | Individual vertebral angles of T2 | 16.1 degrees | Standard Deviation 11.9 |
| Measurements of Angulation of the Older Group Neck (C-spine) | 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. | Individual vertebral angles of C2 | 0.73 degrees | Standard Deviation 9.24 |
| Measurements of Angulation of the Older Group Neck (C-spine) | 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. | Individual vertebral angles of C6 | 15.9 degrees | Standard Deviation 6.9 |
| Measurements of Angulation of the Older Group Neck (C-spine) | 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. | Individual vertebral angles of C3 | 4.8 degrees | Standard Deviation 7.7 |
| Measurements of Angulation of the Older Group Neck (C-spine) | 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. | Individual vertebral angles of T1 | 16.5 degrees | Standard Deviation 9.4 |
| Measurements of Angulation of the Older Group Neck (C-spine) | 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. | Individual vertebral angles of C4 | 10.7 degrees | Standard Deviation 6.1 |
p-value: <0.05Factorial Mixed ANOVA
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)
Time frame: Baseline, approximately 30 minutes and after wearing a collar for one hour
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Measurements of Angulation of the Young Group Neck (C-spine) | Level of Comfort in and Out of a Spinal Collar. | 2.91 units on a scale |
| Measurements of Angulation of the Older Group Neck (C-spine) | Level of Comfort in and Out of a Spinal Collar. | 1.35 units on a scale |