Does a neck collar keep the head and neck still when carrying a player off the football pitch on a stretcher?
| ISRCTN | ISRCTN16515969 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16515969 |
| EudraCT/CTIS number | Nil Known |
| Secondary identifying numbers | ID 1403 |
- Submission date
- 09/03/2021
- Registration date
- 11/03/2021
- Last edited
- 17/01/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Injury, Occupational Diseases, Poisoning
Plain English Summary
Background and study aims
In sport, a severe neck injury is rare but potentially very serious. Many sporting bodies provide mandatory emergency care training for medical staff, which includes how to assess and safely remove an athlete with a suspected neck injury from the field of play with either minimum head and neck movement or no movement at all. This widely accepted procedure to keep the neck still includes fitting a neck collar, but it is debatable whether the collar is necessary to provide sufficient head and neck support. Indeed, it has been suggested that fitting a collar to an injured player may result in an undesirable increase head and neck movement. This study's aim is to see whether there is any difference in head and neck movement from using a collar or not, when a player is removed from the field of play using a standard immobilization procedure. The results from this study will inform clinical practice in this important area of athlete care.
Who can participate?
Adults who are elite footballers at an English Premier League football club.
What does the study involve?
Test sessions will be performed over a period of 21 days in an indoor elite sporting facility. Each participant will act as their own control. The standard cervical spine immobilisation procedure will be applied to each participant with the two conditions - ‘cervical collar’ and ‘no cervical collar’ applied in a randomized order.
Possible risks and benefits of participating?
To ensure there is no risk of identifying the participants, any information we collect which may identify players will remain confidential, restricted and player confidentiality will be maintained at all times. All data will be made anonymous by using a unique study. There are no foreseen physical risks from the study. The benefits to the participants will be regarded as long term, in that the use (or not) of a cervical collar in sports clinical practice will ensure enhanced care for football players.
Where is the study run from?
The AON Training Complex, Carrington, Manchester (UK)
When is the study starting and how long is running for?
January 2021 to September 2021
Who is funding the study?
Manchester United Football Club Ltd (UK)
Who is the main contact?
Professor Michael Callaghan, michael.callaghan@manchester.ac.uk
Contact information
Scientific
AON Training Facility
Isherwood Road
Carrington
Manchester
M31 4BH
United Kingdom
 ORCID ID |
0000-0003-3540-2838 |
|---|---|
| Phone | +44 (0)161-868-8780 |
| michael.callaghan@manutd.co.uk |
Study information
| Study design | Interventional randomized cross over trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised cross over trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet. |
| Scientific title | The effect of a cervical collar on head and neck movement during emergency spinal immobilisation and extrication procedures in elite football (soccer) players. The Range of movement Evaluation using Stabilisation Techniques during extrication In Cervical Trauma (RESTRICT) |
| Study acronym | RESTRICT |
| Study hypothesis | A cervical hard collar used as part of a spinal immobilisation and extrication procedure will show a reduction in head and neck movement measures compared to the same procedure without a collar. |
| Ethics approval(s) | Approved 09/03/2021, University of Salford (Research & Knowledge Exchange, Maxwell Building, University of Salford, Manchester, M5 4WT, UK; no telephone number provided; ethics@salford.ac.uk), ref: 1403 |
| Condition | Healthy participants simulating acute neck injury requiring cervical immobilisation and extraction from the field of play |
| Intervention | Participants will act as their own controls. Each will receive in a random order a ‘cervical collar’ or ‘no collar’ as part of the simulated exercise. Measures of head and neck movement will be taken during the procedure using sensors placed on the head and chest. Each participant (assuming the role of an injured player) will adopt a supine lying position on artificial turf and a standardised immobilisation and extraction procedure will be applied. This will be divided into 12 components to facilitate the analysis and ensure a consistent protocol throughout. The procedure will take approximately 15 minutes for each condition for each participant (total time 30 minutes). Participants will act as their own controls. Each will receive in a random order a ‘cervical collar’ or ‘no collar’ as part of the simulated exercise. Randomized order created using the Research Randomizer online tool (www.randomizer.com). |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Cervical collar |
| Primary outcome measure | Head and neck movement measured during the entire procedure and will include 3-dimensional movement of head and neck in flexion, extension, rotation, side flexion, yaw, pitch and tilt and acceleration (measured during each condition). A Wireless 8 channel Delsys Trigno EMG unit (Delsys Inc, Natick, Massachusetts, USA) will be utilised. This device has 9 axis inertial measurement capability allowing acceleration, rotation and magnetic field information. The acceleration data has a span of +- 2g to +-16g. A three camera motion analysis system (Qualisys OQUS 300) will be used to collect three-dimensional range of motion of markers placed on the head and torso of the individual. |
| Secondary outcome measures | There are no secondary outcome measures |
| Overall study start date | 01/01/2021 |
| Overall study end date | 20/09/2021 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Sex | Male |
| Target number of participants | 34 |
| Participant inclusion criteria | Elite football players under contract at an English Premier League Football Club. |
| Participant exclusion criteria | Any player who is being treated for a head or neck injury or ongoing cervical pain or radiculopathy. |
| Recruitment start date | 21/04/2021 |
| Recruitment end date | 20/09/2021 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Carrington
Manchester
M31 4BH
United Kingdom
Sponsor information
Other
AON Training Facility
Carrington
Manchester
M31 4BH
United Kingdom
| Phone | +44 (0)161 8688750 |
|---|---|
| steve.mcnally@manutd.co.uk | |
| Website | https://www.manutd.co.uk |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 21/04/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Regardless of negative or positive outcomes, findings will be published in a peer-review journal and presented at scientific conferences. We will use several approaches for dissemination of the results including social media platforms and podcasts). These will be used to disseminate and communicate results to medical and academic staff internal and external to the Club, and also to the key stakeholders delivering ATMMiF or equivalent sports trauma management courses. These approaches will include utilisation of social media platforms, podcasts in addition to the presentation and publication of the results as stated above. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are available from Prof. Michael Callaghan Head of Medical Research & Innovation, Manchester United FC; email: michael.callaghan@manutd.co.uk The data will be in a data spreadsheet format and will be available after the study's publication in a peer reviewed journal. We would consider making the data available to share after production of ethical approval and a guarantee of data anonymisation, and recognition and acknowledgment of the origin of the data and of the original research team and participants. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | 10/03/2021 | 11/03/2021 | No | No | |
| Protocol article | 27/12/2021 | 17/01/2022 | Yes | No |
Additional files
- ISRCTN16515969_PROTOCOL_10Mar2021.pdf
- uploaded 11/03/2021
Editorial Notes
17/01/2022: Publication reference added.
11/03/2021: Uploaded protocol (not peer-reviewed) as an additional file. Version n/a, 10 March 2021.
10/03/2021: Trial's existence confirmed by University of Salford.
