Evaluation on the Level of Discomfort and Restriction on Activities of Daily Living (ADLs) Whilst C-spine Immobilised in a Spinal Collar After C-spine Injury.
Conditions: Neck Injuries
Sponsor: Imperial College Healthcare NHS Trust

IRAS number: 249057 
Version 2: 16/08/2018  
Evaluation on the level of discomfort and restriction on 
activities of daily living (ADLs) whilst C-spine 
immobilised in a spinal collar after C-spine injury. 
 
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 Management: 
 
 
 
Study Coordination Centre n/a 
 
For general queries, supply of study documentation, and collection of data, please 
contact: 
 
Study Coordinator: 
 
Address: 
 
 
 
 
 
 
Registration: 
 
Tel: 
  
 
 
 
 
 
 
E-mail:  
 
Fax:  
 
 
 
 
 
 
 
Web address: 
 
 
 
 
 
 
 
 
 
 
 
 
 

IRAS number: 24905 
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Version 2: 16/08/2018  
 
Clinical Queries 
 
Clinical queries should be directed to Dr Michael Fertleman 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: 0207 594 1862 
 
 
Funder 
 
None required 
 
 
 
 
This protocol describes the assessment of comfort in a spinal collar study 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 NHS Research Governance 
Framework for Health and Social Care (2nd edition). It will be conducted in 
compliance with the protocol, the Data Protection Act and other regulatory 
requirements as appropriate.  
 
 
 

IRAS number: 249057 
Version 2: 16/08/2018  
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  
ADLs 
Activities of daily living  
C-spine 
Cervical spine 
 
Keywords: Spinal collar, pain, activities of daily living.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

IRAS number: 24905 
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Version 2: 16/08/2018  
 
 
 
Study Summary 
   Title 
 
Assessment of comfort in a spinal collar  
   Design 
 
Observational study 
Aims 
 
Determine the level of discomfort produced by the spinal 
collar in adults with a C-spine (neck) injury.  
Establish whether the spinal collar impedes activities of 
daily living 
Outcome measures  
 
Visual analogue scale for pain 
Neck disability index questionnaire 
 
Population 
 
Adults aged 18yrs and older  
Eligibility 
 
Patients who are wearing a spinal collar for acute neck 
injury.  
 
Duration  12 months  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

IRAS number: 249057 
Version 2: 16/08/2018  
 
 
1. Introduction 
 
1.1 Background  
Through our own experience we have noticed that older people find wearing spinal 
immobilisation collars uncomfortable and that these collars restrict activities of 
daily living. For this reason they are poorly tolerated and can hamper progress 
therapy thereby delaying recovery.  
 
1.2 Rationale for current study  
Limited research has been performed in this area; our proposed study will assess 
the comfort of the spinal collar in the young and old who are wearing the collar due 
to traumatic injury. We will also assess the ability to complete activities of daily 
living whilst wearing the collar. 
 
2. Study Objectives  
 
a) Determine the level of discomfort produced by the spinal collar adults with 
a C-spine (neck) injury.  
b) Establish whether the spinal collar impedes activities of daily living 
 
3. Study design  
Observational study using patient questionnaires.  
 
3.1 Participant identification  
Patients will be identified daily at the morning Major Trauma Meeting where all 
new admissions are discussed.   
 
3.2 Methodology 
A member of the research team will approach all patients meeting the inclusion 
criteria on the ward. A patient information leaflet will be provided and at least 
24hrs will be allowed prior to consenting to the study. Patient will be required to 
provide written consent prior to participation.  
 
The following demographic information will be collected: age, sex and ethnicity. 
The study will also record the injuries sustained following trauma and prescribed 
analgesia with records of the most recent time and dose administered. 
 
Any C-spine (neck) imaging performed as part of standard clinical care will be 
anonymised by the PACS team before being downloaded to CD. This CD will be 
hand delivered to an expert in Imperial College to allow measurements of 
angulation to be analysed.  
 
 
 

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Participants will be asked to fill out a questionnaire on five occasions during their 
inpatient treatment. The questionnaire will consist of the visual analogue score 
(validated pain scoring system for scoring pain severity from 0-10) and the neck 
disability index (10 point questionnaire).   
 
The time points for the questionnaire to be filled out will be:  
1. In retrospect for pre-admission state  
2. On admission  
3. On walking  
4. On eating  
5. On discharge 
 
The study follows the patient journey including long -term follow up (up to 120 
days following admission).  
 
3.3 Study outcome measures 
Visual Analogue Scale Scoring (pain severity score) and Neck Disability Index 
questionnaire (functional assessment) scores  
 
4. Participant Entry   
 
4.1 Pre-registration evaluations  
Demographic values (age, sex, ethnicity, functional status [assessed by neck 
disability index]), documentation of injuries in addition to C-sine injury.  
 
4.2 Inclusion criteria 
1. All patients aged 18yrs and over with a C-spine injury immobilised in a spinal 
collar  
2. Patients must be nursed on Major Trauma Ward 
3. Ability to give informed consent to participate in the study. 
 
4.3 Exclusion criteria 
1. Patients under 18yrs age  
 
2. Patients who lack capacity to consent for entry into the study  
3. Patients who are receiving level 2 (High dependency unit) or level 3 (Intensive 
care unit) clinical care  
4. Patients who are unable to complete the visual analogue score or questionnaire 
due to co-existent severe hearing and visual impairment. 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. 
5. Patients unable to understand the patient leaflet in English. 
 
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.  

IRAS number: 249057 
Version 2: 16/08/2018  
 
5. Adverse Events 
n/a – observational study 
 
6. Assessment and follow up 
Participants will receive standard clinical follow up.  
 
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 has gained support from [insert ethics board]. Every patient must hold 
capacity to consent to the study and have provided written consent. 
 
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.  The right of the participant to refuse to 
participate without giving reasons must be respected.  After the participant has 
entered the study the clinician remains free to give alternative treatment to that 
specified in the protocol at any stage if he/she feels it is in the participant’s best 
interest, but the reasons for doing so should be recorded.  In these cases the 
participants remain within the study for the purposes of follow-up and data 
analysis.  All participants are free to withdraw at any time from the protocol 
treatment without giving reasons and without prejudicing further treatment. 
 
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.  
On re-gaining capacity participants must be re-consented into the study using the 
original consent form and patient information sheet.  
 
8.3 Confidentiality  
The research team also forms part of the standard care team. Patient records will 
therefore, only be accessed by the standard care team.  
 
Paper documentation i.e. signed consent forms will be kept in a filling cabinet 
within a locked office. All participants will be allocated a non-identifiable study 
number on consenting to the study. Any written documentation (patient 
questionnaires) following allocation of a study number will use this number only 
for identification. Anonymised data collected from the study will be analysed by the 
research team.  

IRAS number: 24905 
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Version 2: 16/08/2018  
 
 
Any imaging of the neck done as part of standard clinical care will be anonymised 
by the on site PACS team prior to being downloaded onto a CD and hand delivered 
an expert at Imperial College to allow analysis of measurements of angulation. 
Scientists will only be analysing anonymised scans and will not have access to any 
confidential personal data.  
 
The Chief Investigator will preserve the confidentiality of participants taking part 
in the study and is registered 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. Patients will not receive any payment for 
participation.  
 
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. 
 
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: 249057 
Version 2: 16/08/2018