N/A
N=38
Measurements of Angulation of the C-spine
Cervical Spine
Bottom Line
View on ClinicalTrials.gov: NCT03958149 ↗Enrolled (actual)
38
Serious AEs
0.0%
Results posted
Sep 2021
Primary outcome: Primary: Measurements of Angulation of the Neck (C-spine) on MRI Scans — 10.6; 21.6; 5.5; 4.1 degrees — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- spinal collar (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Imperial College Healthcare NHS Trust
- Primary completion
- Jun 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Measurements of Angulation of the Neck (C-spine) on MRI Scans |
10.6; 21.6; 5.5; 4.1; 9.9; 18.7 | <0.001 sig |
| 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. |
0.14; 0.12; 0.11; 0.73; 0.1; 4.8 | <0.05 sig |
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.
Eligibility Criteria
Inclusion Criteria
- Persons aged 18yrs and over to those aged 30yrs
- Persons aged 70yrs and over
- Ability to give informed consent to participate in the study
Exclusion Criteria
- Persons under 18yrs of age and those aged 31yrs -69yrs
- Persons who lack capacity to consent for entry into the study
- 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.
- Persons unable to understand the information leaflet in English.
- Those with current neck pain, known previous C-spine injury or known medical condition affecting the spine.
- Persons who do not pass the safety questionnaire to undergo an MRI scan
- Persons who are unable to tolerate an MRI scan due to claustrophobia
- Persons who are unable to transfer to the scanner table independently
- Persons unable to lie flat and still for 10 minutes
- Persons who do not give consent to their General Practitioner being informed of scan results.
Data sourced from ClinicalTrials.gov (NCT03958149). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.