Comparison of Measurements of the Cervical Spine in Adults With and Without Immobilisation
Phase: NA
Conditions: Cervical Spine
Sponsor: Imperial College Healthcare NHS Trust

IRAS number: 251708 
Version 1:  05/01/2019 
 
Comparison of measurements of the cervical spine in 
adults with and without immobilisation. 
 
 
MAIN SPONSOR: Imperial College Healthcare NHS Trust 
FUNDERS: n/a 
STUDY COORDINATION CENTRE:  
NRES reference:  
 
Protocol authorised by: 
 
Name & Role 
Date 
Signature 
 
 
 
Study Management Group 
 
Chief Investigator: Dr Michael Fertleman 
 
Co-investigators: Dr Annabelle Lee, Dr Louis Koizia 
 
Statistician: n/a 
 
 
 
Study Coordination Centre n/a 
 
For general queries, supply of study documentation, and collection of data, please 
contact:  
 
Study Coordinator: Dr Annabelle Lee, Research Registrar. 
Address: C/O DOME Offices, ST Mary’s Hospital, Praed Street, W1 2NY. 
 
E-mail:  annabellelee@nhs.net 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Clinical Queries 
 
Clinical queries should be directed to Dr Annabelle Lee who will direct the query 
to the appropriate person. 
 
 
Sponsor 
 
Imperial College Healthcare NHS Trust is the main research Sponsor for this 
study.  For further information regarding the sponsorship conditions, please 
contact the Head of Regulatory Compliance at: 
 
 
 
Joint Research Compliance Office 
Imperial College London & Imperial College Healthcare NHS Trust 
2nd Floor Medical School Building 
St Mary’s Hospital 
Praed Street 
London 
W2 1NY 
Tel: 020759 41862 
 
 
Funder 
 
None required 
 
 
 
 
This protocol describes the assessment of measurements of angulation of the C-
spine and provides information about procedures for entering participants.  Every 
care was taken in its drafting, but corrections or amendments may be necessary. 
These will be circulated to investigators in the study.  Problems relating to this 
study should be referred, in the first instance, to the Chief Investigator.  
 
This study will adhere to the principles outlined in the UK Policy Frame Work for 
Health and Social Care Research. It will be conducted in compliance with the 
protocol, the Data Protection Act and other regulatory requirements as 
appropriate.  
 
 
 

IRAS number: 251708 
Version 1:  05/01/2019 
Table of Contents 
1. INTRODUCTION 
1.1 Background 
2. STUDY OBJECTIVES 
3. STUDY DESIGN 
3.1 Participant identification 
3.2 Methodology 
3.3 Study outcome measures  
4. PARTICIPANT ENTRY 
4.1 Pre-registration evaluations 
4.2 Inclusion Criteria 
4.3 Exclusion Criteria 
4.4 Withdrawal criteria 
5. ADVERSE EVENTS 
6. ASSESSMENT AND FOLLOW UP 
7. STATISTICS AND DATA ANALYSIS 
8. REGULATORY ISSUES 
8.1 Ethics Approval 
8.2 Consent  
8.3 Confidentiality 
8.4 Indemnity 
8.5 Sponsor 
8.6 Funding 
8.7 Audits and Inspections 
9. STUDY MANAGEMENT 
10. PUBLICATION POLICY 
11. REFERENCES 
 
Glossary of Abbreviations  
C-spine 
Cervical spine  
MRI 
Magnetic resolution imaging  
 
Keywords: Comfort, measurements of angulation, MRI, spinal collar  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Study Summary 
   Title 
 
Comparison of measurements of the cervical spine in 
adults with and without immobilisation. 
 
   Design 
 
Controlled study without randomisation  
Aims 
 
Determine if a young persons neck is the same shape as an 
older persons neck. 
Determine if a spinal collar alters the shape of the neck.  
Assess the level of discomfort in a spinal collar 
 
Outcome measures  
 
Measurements of angulation of the C-spine on MRI scan 
Visual analogue scale for pain 
 
Population 
 
Adults aged 18yrs – 30yrs and 70yrs and over.  
Eligibility 
 
Persons who have no discomfort in the neck, no known 
medical condition and no previous injury affecting the 
neck or spine. 
 
Duration  12 months  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Version 1:  05/01/2019 
1. Introduction 
 
1.1 Background  
Through our own experience we have noticed the external shape of an older 
persons neck appears to be different to that of a younger person with older patients 
necks being angled towards the floor rather than upright even when they do not 
have an obvious curvature (kyphosis) to the rest of their spine. We have also 
noticed that older patients do not tolerate wearing a spinal collar as well as 
younger ones and therefore would like to assess the level of comfort when wearing 
a spinal collar in healthy volunteers. This will help us to assess whether older 
patients do not tolerate the spinal collar as well as younger patients due to pain 
from their injury or from the collar itself. 
 
1.2 Rationale for current study  
Limited research has been performed in this area; our proposed study will assess 
the difference in the shape of the neck when comparing the younger population to 
the older population. Additionally we would like to assess whether the shape of the 
neck changes when wearing a spinal collar and how comfortable the device is to 
wear.  
 
2. Study Objectives  
 
a) Determine if a young persons neck is the same shape as an older persons 
neck. 
b) Determine if a spinal collar alters the shape of the neck.  
c) Assess the level of discomfort in a spinal collar  
 
3. Study design  
Non-randomised controlled study 
 
3.1 Participant identification  
Recruitment of volunteers will take place via poster advertisements displayed in 
public areas at St Mary’s Hospital, Paddington.  Interested persons will be able to 
contact the research team via the email address written on the poster. Following 
initiation of contact with the research team potential participants will be sent a 
patient information leaflet, which will include necessary requirements for inclusion 
and exclusion criteria.  
 
3.2 Methodology 
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. 
 
Age of participants to be recruited: 18yrs and over - 30yrs and 70yrs and over. 
Adult research participants will be recruited from the general public via poster. 
Interested persons will be asked to contact the research team via email. Patient 
information leaflets and an MRI safety questionnaire will be accessible via email 
correspondence.  

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On making contact with the research team interested persons will have the 
opportunity to ask any questions prior to agreeing to the study with a minimum of 
24hrs between having the opportunity to discuss participation with the research 
team and agreeing to the study. 
Participants must consent to the GP being contacted with the scan report to ensure 
appropriate record keeping especially in the event of an incidental finding.  
 
Participants will be required to attend the hospital for half a day on a specified 
weekend day.  
On arrival participants will be asked to fill in a validated questionnaire (Visual 
Analogue Score) about the level of discomfort in their neck. 
Participants will need to fill in a safety questionnaire prior to the neck scan and 
change into a hospital gown for the scan. Participants will undergo a neck scan, 
which requires the participant to spend approximately 5 minutes lying flat in the 
scanner. 
The participant will then have a spinal collar fitted by an expert (equivalent to that 
fitted in standard clinical practice) and spend one hour wearing the collar.  
Following one hour wearing the spinal collar the participants will be asked to 
repeat the same questionnaire regarding comfort and a second neck scan with 
participants wearing the spinal collar will be performed (requires the participant 
to spend approximately 5 minutes lying flat in the scanner).  
 
Scans will be reported by a medical expert (Radiologist) and reports sent to the GP. 
The annonymised scans will also be analysed by expert scientists at Imperial 
College for measurements of angulation. 
 
3.3 Study outcome measures 
 
Measurements of angulation of the neck taken from MRI scans. 
Visual Analogue Scale Scoring (pain severity score)  
 
4. Participant Entry   
 
4.1 Pre-registration evaluations  
Demographic values (age, sex, ethnicity).   
 
4.2 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 
 
4.3 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 severe hearing and visual loss. Severe hearing impairment will be 
defined as unable to hear the researcher with hearing aids if required. Severe visual 

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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 knowingly 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 the GP being informed of scan results.  
 
4.4 Withdrawal criteria  
1. Loss of capacity during the study will result in automatic suspension from the 
study until capacity is regained. 
2. Participants may choose to withdraw from the study at any time. Withdrawal 
will not affect the clinical care delivered.  
 
5. Adverse Events 
The study does not involve any invasive intervention, spinal collars and MRI scans 
are used in usual clinical practice therefore we do not anticipate any adverse 
events as a result of participation in the study.  
 
6. Assessment and follow up 
All MRI scan reports will be sent to the participants General Practitioner (GP). In 
the event of any adverse incidental findings a clinic appointment will be offered at 
St Mary’s Hospital, Paddington. There will be no routine follow up for participants.  
 
7.  Statistics and Data Analysis  
Data analysis will be via standard parametric statistical analysis. Data will be kept 
for a maximum of 10 years following completion of the study.  
 
8. Regulatory Issues 
 
8.1 Ethics approval  
The Study Coordination Centre has obtained approval from the xxx Research Ethics 
Committee (REC) and Health Regulator Authority (HRA). The study must also 
receive confirmation of capacity and capability from each participating NHS Trust 
before accepting participants into the study or any research activity is carried out. 
The study will be conducted in accordance with the recommendations for 
physicians involved in research on human subjects adopted by the 18th World 
Medical Assembly, Helsinki 1964 and later revisions. 
 
8.2 Consent  
Participants must have capacity to consent. Consent to enter the study must be 
sought from each participant only after a full explanation has been given, an 
information leaflet offered and at least 24hours allowed for consideration.  Signed 
participant consent should be obtained. Participants must consent to their GP being 

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sent a copy of their MRI scan result.  The right of the person to refuse to participate 
without giving reasons must be respected.  All participants are free to withdraw at 
any time from the study.   
 
Consent will be taken by a physician who holds a Good Clinical Practice (GCP) 
qualification and is qualified to assess capacity for consent.  Should it come to 
the attention of the clinical or research team (research team form part of the 
clinical team) that a patient has lost capacity the participant will be suspended 
from the study.  
 
8.3 Confidentiality  
The Chief Investigator will preserve the confidentiality of participants taking part 
in the fulfil transparency requirements under the General Data Protection 
Regulation for health and care research 
 
8.4 Indemnity 
Imperial College Healthcare NHS Trust holds standard NHS Hospital Indemnity and 
insurance cover with NHS Litigation Authority for NHS Trusts in England, which 
apply to this study. 
 
8.5 Sponsor  
Imperial College Healthcare NHS Trust will act as the main Sponsor for this study.  
 
8.6 Funding  
No external funding has been applied for. Participants will not receive any payment 
for participation. Participants will be offered a picture of their neck imaging. 
 
8.7 Audits 
The study may be subject to inspection and audit by Imperial College London under 
their remit as sponsor and other regulatory bodies to ensure adherence to GCP and 
the NHS Research Governance Framework for Health and Social Care 
 
9. Study Management  
The day-to-day management of the study will be co-ordinated through Dr Michael 
Fertleman and the Research team.  
 
10. Publication Policy  
Completed research will be submitted to a peer-reviewed journal for publication 
 
11.References 
Karason S, Reynisson K, Sigvaldason K, Sigurdsson GH. 2014. Evaluation of clinical 
efficacy and safety of cervical trauma collars: differences in immobilization, effect 
on jugular venous pressure and patient comfort. Scand J Trauma Resusc Emerg Med. 
22, p37. 
 
Molinari RW, Khera OA, Gruhn WL, McAssey RW. 2012. Rigid cervical collar 
treatment for geriatric type II odontoid fractures. European Spine Journal. 21 (5), 
pp855-862.  

IRAS number: 251708 
Version 1:  05/01/2019