Trial Outcomes & Findings for Measurements of Angulation of the C-spine (NCT NCT03958149)
NCT ID: NCT03958149
Last Updated: 2021-09-05
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
38 participants
Primary outcome timeframe
Baseline MRI image, approximately 30 minutes and second MRI image (with collar on), after one hour of wearing collar.
Results posted on
2021-09-05
Participant Flow
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
18
|
|
Overall Study
COMPLETED
|
20
|
17
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Young Group Aged 18-30 Years
n=20 Participants
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
|
Older Group Aged 70 Years and Over
n=18 Participants
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
|
Total
n=38 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
25.3 years
n=20 Participants
|
77.3 years
n=18 Participants
|
51.8 years
n=38 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=20 Participants
|
8 Participants
n=18 Participants
|
18 Participants
n=38 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=20 Participants
|
10 Participants
n=18 Participants
|
20 Participants
n=38 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United Kingdom
|
20 participants
n=20 Participants
|
18 participants
n=18 Participants
|
38 participants
n=38 Participants
|
|
Visual analogue scale of pain
|
0.75 units on a scale
n=20 Participants
|
0.87 units on a scale
n=18 Participants
|
0.81 units on a scale
n=38 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Measurements of Angulation of the Young Group Neck (C-spine)
n=20 Participants
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.
|
Measurements of Angulation of the Older Group Neck (C-spine)
n=17 Participants
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.
|
|---|---|---|
|
Measurements of Angulation of the Neck (C-spine) on MRI Scans
Total lordosis angle
|
10.6 degrees
Standard Deviation 8.7
|
21.6 degrees
Standard Deviation 11.9
|
|
Measurements of Angulation of the Neck (C-spine) on MRI Scans
Upper cervical lordosis angle
|
5.5 degrees
Standard Deviation 4.0
|
4.1 degrees
Standard Deviation 3.5
|
|
Measurements of Angulation of the Neck (C-spine) on MRI Scans
Lower cervical lordosis angle
|
9.9 degrees
Standard Deviation 6.9
|
18.7 degrees
Standard Deviation 11.7
|
|
Measurements of Angulation of the Neck (C-spine) on MRI Scans
T1 slope angle
|
62.4 degrees
Standard Deviation 5.6
|
54.6 degrees
Standard Deviation 9.5
|
|
Measurements of Angulation of the Neck (C-spine) on MRI Scans
Neck tilt angle
|
44.0 degrees
Standard Deviation 10.3
|
52.8 degrees
Standard Deviation 13.5
|
|
Measurements of Angulation of the Neck (C-spine) on MRI Scans
Thoracic inlet angle
|
106.4 degrees
Standard Deviation 10.9
|
107.4 degrees
Standard Deviation 20.1
|
|
Measurements of Angulation of the Neck (C-spine) on MRI Scans
Individual vertebral angle of C1
|
0.5 degrees
Standard Deviation 11.3
|
0.2 degrees
Standard Deviation 6.2
|
|
Measurements of Angulation of the Neck (C-spine) on MRI Scans
Individual vertebral angle of C2
|
1.5 degrees
Standard Deviation 7.0
|
-1.0 degrees
Standard Deviation 4.6
|
|
Measurements of Angulation of the Neck (C-spine) on MRI Scans
Individual vertebral angle of C3
|
-1.3 degrees
Standard Deviation 6.1
|
-0.6 degrees
Standard Deviation 3.5
|
|
Measurements of Angulation of the Neck (C-spine) on MRI Scans
Individual vertebral angle of C4
|
-2.4 degrees
Standard Deviation 7.1
|
-1.4 degrees
Standard Deviation 3.8
|
|
Measurements of Angulation of the Neck (C-spine) on MRI Scans
Individual vertebral angle of C5
|
-2.2 degrees
Standard Deviation 8.8
|
-1.3 degrees
Standard Deviation 4.0
|
|
Measurements of Angulation of the Neck (C-spine) on MRI Scans
Individual vertebral angle of C6
|
-0.9 degrees
Standard Deviation 9.7
|
-4.5 degrees
Standard Deviation 2.9
|
|
Measurements of Angulation of the Neck (C-spine) on MRI Scans
Individual vertebral angle of C7
|
-1.3 degrees
Standard Deviation 10.9
|
-5.0 degrees
Standard Deviation 6.2
|
|
Measurements of Angulation of the Neck (C-spine) on MRI Scans
Individual vertebral angle of T1
|
-0.3 degrees
Standard Deviation 9.5
|
-5.6 degrees
Standard Deviation 6.5
|
|
Measurements of Angulation of the Neck (C-spine) on MRI Scans
Individual vertebral angle of T2
|
-0.9 degrees
Standard Deviation 11.1
|
-3.8 degrees
Standard Deviation 7.0
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Measurements of Angulation of the Young Group Neck (C-spine)
n=20 Participants
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.
|
Measurements of Angulation of the Older Group Neck (C-spine)
n=17 Participants
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.
|
|---|---|---|
|
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
|
0.12 degrees
Standard Deviation 10.80
|
|
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
|
0.73 degrees
Standard Deviation 9.24
|
|
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
|
4.8 degrees
Standard Deviation 7.7
|
|
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
|
10.7 degrees
Standard Deviation 6.1
|
|
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
|
14.7 degrees
Standard Deviation 7.1
|
|
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
|
15.9 degrees
Standard Deviation 6.9
|
|
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
|
18.7 degrees
Standard Deviation 8.9
|
|
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
|
16.5 degrees
Standard Deviation 9.4
|
|
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
|
16.1 degrees
Standard Deviation 11.9
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, approximately 30 minutes and after wearing a collar for one hourComfort 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)
Outcome measures
| Measure |
Measurements of Angulation of the Young Group Neck (C-spine)
n=20 Participants
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.
|
Measurements of Angulation of the Older Group Neck (C-spine)
n=17 Participants
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.
|
|---|---|---|
|
Level of Comfort in and Out of a Spinal Collar.
|
2.91 units on a scale
Interval 0.0 to 8.7
|
1.35 units on a scale
Interval 0.0 to 5.7
|
Adverse Events
Young Group Aged 18-30 Years
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Older Group Aged 70 Years and Over
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place