Cervical SpineNCT03958149
Measurements of Angulation of the C-spine
A study testing spinal collar in people with Cervical Spine, run by Imperial College Healthcare NHS Trust at 2 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cervical Spine
- What is being tested?
- spinal collar
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 13 Apr 2019to 2 Jun 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Persons aged 18yrs and over to those aged 30yrs
- Persons aged 70yrs and over
- Ability to give informed consent to participate in the study
Who cannot join
- 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
Show all 10Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
The Wellington Hospital
London, NW8 9LE
Imperial College Healthcare NHS Trust
London, W2 1NY
About this study
Official title: Comparison of Measurements of the Cervical Spine in Adults With and Without Immobilisation
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.
Read the 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:
- The shape of the neck is different when comparing the young and old populations
- The spinal collar does not alter the shape of the spine
- The spinal collars are uncomfortable in the elderly population
- Conditions
- Cervical Spine
- Being tested
- spinal collar
- Keywords
- Cervical spine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
spinal collarDevice
cervical collar to immobilise the cervical spine
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: spinal collar |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline MRI image, approximately 30 minutes and second MRI image (with collar on), after one hour of wearing collar.
Secondary outcomes (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.
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.
Measured: Baseline MRI image, approximately 30 minutes and second MRI image (with collar on), after one hour of wearing collar.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2019
- Study start13 Apr 2019
- Primary completion2 Jun 2019
- Study completion2 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cervical SpineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College Healthcare NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Wellington Hospital, Imperial College London
- Responsible party
- Sponsor
- Investigators
- Michael Fertleman, Principal investigator, Imperial College Healthcare NHS Trust/ The Wellington Hospital, London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03958149
- Sponsor's protocol ID
- 18SM4805
- Other IDs
- 19/SC/0059
- Status last verified
- Aug 2021
- First submitted
- 14 Mar 2019
- Last updated
- 5 Sep 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Measurements of the Cervical Spine in Adults With and Without Immobilisation
- ClinicalTrials.gov ID
- NCT03958149
- Acronym / sponsor ID
- 18SM4805
- Conditions
- Cervical Spine
- Keywords
- Cervical spine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Imperial College Healthcare NHS TrustUniversity, hospital or other
- Collaborators
- Wellington Hospital, Imperial College London
- Study start
- 13 Apr 2019 (actual)
- Primary completion
- 2 Jun 2019 (actual)
- Study completion
- 2 Jun 2019 (actual)
- First posted
- 21 May 2019 (actual)
- Results
- Posted 5 Sep 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- The shape of the neck is different when comparing the young and old populations
- The spinal collar does not alter the shape of the spine
- The spinal collars are uncomfortable in the elderly population
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Spinal collar | Other | Device: spinal collarParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Persons aged 18yrs and over to those aged 30yrs
- Persons aged 70yrs and over
- Ability to give informed consent to participate in the study
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| spinal collarcervical collar to immobilise the cervical spine | Device | Spinal collar |
Primary outcome
Measurements of Angulation of the Neck (C-spine) on MRI Scans
Time frame: 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.
1 secondary outcome
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.
Time frame: Baseline MRI image, approximately 30 minutes and second MRI image (with collar on), after one hour of wearing collar.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Fertleman principal investigator
Imperial College Healthcare NHS Trust/ The Wellington Hospital, London
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing spinal collar in people with Cervical Spine, run by Imperial College Healthcare NHS Trust at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Sep 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurements of Angulation of the Neck (C-spine) on MRI Scans (time frame: Baseline MRI image, approximately 30 minutes and second MRI image (with collar on), after one hour of wearing collar.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2021.