EmergencyNCT02770638
Tissue Interface Pressures in Athlete Medical Extraction
A study testing Scoop Stretcher and Long Back Spinal board in people with Emergency and Pain, run by University of Nottingham at 1 site in United Kingdom.
Trial summary
This study aims to establish clinical evidence for the use of scoop stretchers in the sports setting for spinal immobilisation and transport compared to the traditionally used long back boards through measuring tissue interface pressures over forty five minutes. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Emergency, Pain, Medical Device Discomfort
- What is being tested?
- Scoop Stretcher and Long Back Spinal board
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2016to Sep 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy, uninjured - no current sports injury, male, 75kg (165 lb) in weight or over.
Who cannot join
- Female, weight less than 75kg (165 lb)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Nottingham
Nottingham, Nottinghamshire, NG72UH
About this study
Official title: A Comparison of Tissue Interface Pressures and Comfort Ratings of the Scoop Stretcher and Traditional Long Back Board in Rugby and University Athletes
This study aims to establish clinical evidence for the use of scoop stretchers in the sports setting for spinal immobilisation and transport compared to the traditionally used long back boards through measuring tissue interface pressures over forty five minutes. All participants will be placed on both the scoop stretcher and the long back board for forty five minutes each, with at least 45 minutes between the two tests. A special mat that measures the pressure of the body against the board will be used to determine the pressure forces at certain points of the body touching the board (in mmHg). The participants will also be asked every five minutes during the experiment to rate the comfort of the device. Pressure measures from each participant on each board will be collated and assessed along with each participant's reported pain scores and comfort rating. The measurements from the tissue pressures will be analysed in real-time from the software connected to the pressure-mat and therefore show if pressures increase over time. A comparison between boards will be made.
Read the detailed description
Background
In recent years the scoop stretcher, for a number of reasons, has been advocated by the Faculty for Pre-hospital Care (Royal College of Surgeons Edinburgh, United Kingdom) as the 'Gold Standard' method of extrication and transport in pre-hospital trauma and this has been extrapolated to extricating athletes from the field of play in sport who have sustained a potential spine injury. In addition they have advised that the conventional long back boards should no longer to be used as a stretcher, only a pure extrication device. This has an implication to the emergency care currently provided in sport and will affect every sports club financially and every medical team who require training in the use of the new device.
Previous research studies have looked at how much pressure lying on different spinal boards (e.g. the long back board or vacuum mattress) causes the athlete. This is because of a concern that lying on a board for too long may cause pressure sores or other medical complications. However, no research has been done to measure these tissue pressures using the scoop stretcher which is now indicated for general use in pre-hospital care in sport. Also there is no evidence to compare how comfortable athletes find the different spinal boards.
Aims
This observational study aims to measure the tissue interface pressures and perceived levels of comfort of rugby players and University participants (staff and students) immobilised on a scoop stretcher and on a long back board for forty five minutes. It will also enable the changes in pressures and comfort ratings over time to be assessed to evaluate the appropriate time cut off for such immobilisation.
Experimental Protocol and Methods
A prospective cross-over study. Players from Nottingham Rugby Football Club and the University of Nottingham (staff and students) will be invited to participate for the study (summer 2016). Participants will be randomly (block randomisation) assigned to start on either the scoop or long board. Participants will be log rolled onto each board and fully immobilised for forty five minutes. The wash out period will be a minimum of forty five minutes. All measurements will be collected on the same pressure mat.
Measureable end points/statistical power of the study
The pressure mat (provided by BES Rehab) will be laid on top of the spinal board and will automatically measure the tissue interface pressure readings (occiput, scapulae, sacrum, heels) every five minutes. Participant reported pain will be measured by a Visual Analogue Scale (VAS) and will be used to collect the comfort ratings data (occiput, scapulae, sacrum, heels, overall) every five minutes. Age, height, weight, sport team and position played and length of sporting participation will also be collected.
- Conditions
- Emergency, Pain, Medical Device Discomfort
- Being tested
- Scoop Stretcher, Long Back Spinal board
- Keywords
- Healthy, Sport, Athlete, Male, University, Adults, Rugby Football Union, Professional, Competitive sport, Scoop Stretcher, Ferno Scoop Stretcher, Long back spinal board, Emergency Medical Services, Long backboard, Patient Extrication, Triple Immobilisation, Pre hospital Medicine, Rigid Cervical Collar, Pressure Testing, Tissue Pressure Testing
- Medical subject headings
- Emergencies, Pain, Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scoop StretcherDevice
Also called Trade Name: Ferno Scoop Stretcher
Participants recruited by community advertisement. Participant will complete forty five minutes on scoop stretcher first, followed by forty five minute washout period, finished with forty five minutes on the long back spinal board. Tissue pressures will be automatically recorded throughout the forty five minute period laid on either spinal board. In addition, participants will be asked to report their comfort levels at five minute intervals.
Long Back Spinal boardDevice
Participants recruited by community advertisement. Participant will complete forty five minutes on the long back spinal board first, followed by forty five minute washout period, finished with forty five minutes on the scoop stretcher. Tissue pressures will be automatically recorded throughout the forty five minute period laid on either spinal board. In addition, participants will be asked to report their comfort levels at five minute intervals.
| Study group | Role | What they receive |
|---|---|---|
| Scoop Stretcher | Experimental | Participant wearing light sports clothing will start with forty five minutes laid supine on the scoop stretcher with 'triple immobilisation ' (rigid cervical collar, two headblocks and fastening straps). Followed by a forty five minute washout period (participant can mobilise freely). Participants will complete the observation with forty five minutes laid supine on the long back spinal board with 'triple immobilisation ' (rigid cervical collar, two headblocks and fastening straps). Receives: Device: Scoop Stretcher |
| Long Back Spinal Board | Active comparator | Participant wearing light sports clothing will start with forty five minutes laid supine on the long back spinal board with 'triple immobilisation ' (rigid cervical collar, two headblocks and fastening straps). Followed by a forty five minute washout period (participant can mobilise freely). Participants will complete the observation with forty five minutes laid supine on the scoop stretcher with 'triple immobilisation ' (rigid cervical collar, two headblocks and fastening straps). Receives: Device: Long Back Spinal board |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occiput tissue pressure in millimetres mercury (mmHg)
Measured: 1 day
Secondary outcomes (4)
Scapulae tissue pressure in millimetres mercury (mmHg)
Measured: 1 day
Sacrum tissue pressure in millimetres mercury (mmHg)
Measured: 1 day
Heels tissue pressure in millimetres mercury (mmHg)
Measured: 1 day
Subjective participant reported pain levels using visual analogue scale (VAS)
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2016 (estimated)
- Study startApr 2016
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for EmergencyStudies of the same condition, open and under way.
- More trials run by University of NottinghamThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kimberley Edwards, University of Nottingham
- Investigators
- Kimberley L Edwards, MMedSci PhD, Principal investigator, University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02770638
- Sponsor's protocol ID
- G10042014 SoM ROD
- Status last verified
- Jul 2022
- First submitted
- 9 May 2016
- Last updated
- 11 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Hanson JR, Carlin B. Sports prehospital-immediate care and spinal injury: not a car crash in sight. Br J Sports Med. 2012 Dec;46(16):1097-101. doi: 10.1136/bjsports-2012-091800. Epub 2012 Oct 18.
PubMed 23080314Krell JM, McCoy MS, Sparto PJ, Fisher GL, Stoy WA, Hostler DP. Comparison of the Ferno Scoop Stretcher with the long backboard for spinal immobilization. Prehosp Emerg Care. 2006 Jan-Mar;10(1):46-51. doi: 10.1080/10903120500366375.
PubMed 16418091Moss R, Porter K, Greaves I; consensus group. Minimal patient handling: a faculty of prehospital care consensus statement. Emerg Med J. 2013 Dec;30(12):1065-6. doi: 10.1136/emermed-2013-203205.
PubMed 24232010
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Tissue Interface Pressures and Comfort Ratings of the Scoop Stretcher and Traditional Long Back Board in Rugby and University Athletes
- ClinicalTrials.gov ID
- NCT02770638
- Acronym / sponsor ID
- G10042014 SoM ROD
- Conditions
- Emergency, Pain, Medical Device Discomfort
- Keywords
- Healthy, Sport, Athlete, Male, University, Adults, Rugby Football Union, Professional
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Study start
- Apr 2016 (actual)
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 12 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to establish clinical evidence for the use of scoop stretchers in the sports setting for spinal immobilisation and transport compared to the traditionally used long back boards through measuring tissue interface pressures over forty five minutes. All participants will be placed on both the scoop stretcher and the long back board for forty five minutes each, with at least 45 minutes between the two tests. A special mat that measures the pressure of the body against the board will be used to determine the pressure forces at certain points of the body touching the board (in mmHg). The participants will also be asked every five minutes during the experiment to rate the comfort of the device. Pressure measures from each participant on each board will be collated and assessed along with each participant's reported pain scores and comfort rating. The measurements from the tissue pressures will be analysed in real-time from the software connected to the pressure-mat and therefore show if pressures increase over time. A comparison between boards will be made.
Detailed description
Background
In recent years the scoop stretcher, for a number of reasons, has been advocated by the Faculty for Pre-hospital Care (Royal College of Surgeons Edinburgh, United Kingdom) as the 'Gold Standard' method of extrication and transport in pre-hospital trauma and this has been extrapolated to extricating athletes from the field of play in sport who have sustained a potential spine injury. In addition they have advised that the conventional long back boards should no longer to be used as a stretcher, only a pure extrication device. This has an implication to the emergency care currently provided in sport and will affect every sports club financially and every medical team who require training in the use of the new device.
Previous research studies have looked at how much pressure lying on different spinal boards (e.g. the long back board or vacuum mattress) causes the athlete. This is because of a concern that lying on a board for too long may cause pressure sores or other medical complications. However, no research has been done to measure these tissue pressures using the scoop stretcher which is now indicated for general use in pre-hospital care in sport. Also there is no evidence to compare how comfortable athletes find the different spinal boards.
Aims
This observational study aims to measure the tissue interface pressures and perceived levels of comfort of rugby players and University participants (staff and students) immobilised on a scoop stretcher and on a long back board for forty five minutes. It will also enable the changes in pressures and comfort ratings over time to be assessed to evaluate the appropriate time cut off for such immobilisation.
Experimental Protocol and Methods
A prospective cross-over study. Players from Nottingham Rugby Football Club and the University of Nottingham (staff and students) will be invited to participate for the study (summer 2016). Participants will be randomly (block randomisation) assigned to start on either the scoop or long board. Participants will be log rolled onto each board and fully immobilised for forty five minutes. The wash out period will be a minimum of forty five minutes. All measurements will be collected on the same pressure mat.
Measureable end points/statistical power of the study
The pressure mat (provided by BES Rehab) will be laid on top of the spinal board and will automatically measure the tissue interface pressure readings (occiput, scapulae, sacrum, heels) every five minutes. Participant reported pain will be measured by a Visual Analogue Scale (VAS) and will be used to collect the comfort ratings data (occiput, scapulae, sacrum, heels, overall) every five minutes. Age, height, weight, sport team and position played and length of sporting participation will also be collected.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Scoop Stretcher | Experimental | Device: Scoop StretcherParticipant wearing light sports clothing will start with forty five minutes laid supine on the scoop stretcher with 'triple immobilisation ' (rigid cervical collar, two headblocks and fastening straps). Followed by a forty five minute washout period (participant can mobilise freely). Participants will complete the observation with forty five minutes laid supine on the long back spinal board with 'triple immobilisation ' (rigid cervical collar, two headblocks and fastening straps). |
| Long Back Spinal Board | Active comparator | Device: Long Back Spinal boardParticipant wearing light sports clothing will start with forty five minutes laid supine on the long back spinal board with 'triple immobilisation ' (rigid cervical collar, two headblocks and fastening straps). Followed by a forty five minute washout period (participant can mobilise freely). Participants will complete the observation with forty five minutes laid supine on the scoop stretcher with 'triple immobilisation ' (rigid cervical collar, two headblocks and fastening straps). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy, uninjured - no current sports injury, male, 75kg (165 lb) in weight or over.
Key exclusion criteria (1 listed)
- Female, weight less than 75kg (165 lb)
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 |
|---|---|---|
| Scoop StretcherAlso: Trade Name: Ferno Scoop StretcherParticipants recruited by community advertisement. Participant will complete forty five minutes on scoop stretcher first, followed by forty five minute washout period, finished with forty five minutes on the long back spinal board. Tissue pressures will be automatically recorded throughout the forty five minute period laid on either spinal board. In addition, participants will be asked to report their comfort levels at five minute intervals. | Device | Scoop Stretcher |
| Long Back Spinal boardParticipants recruited by community advertisement. Participant will complete forty five minutes on the long back spinal board first, followed by forty five minute washout period, finished with forty five minutes on the scoop stretcher. Tissue pressures will be automatically recorded throughout the forty five minute period laid on either spinal board. In addition, participants will be asked to report their comfort levels at five minute intervals. | Device | Long Back Spinal Board |
Primary outcome
Occiput tissue pressure in millimetres mercury (mmHg)
Time frame: 1 day
4 secondary outcomes
Scapulae tissue pressure in millimetres mercury (mmHg)
Time frame: 1 day
Sacrum tissue pressure in millimetres mercury (mmHg)
Time frame: 1 day
Heels tissue pressure in millimetres mercury (mmHg)
Time frame: 1 day
Subjective participant reported pain levels using visual analogue scale (VAS)
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2022.
- Background: PubMed 23080314Hanson JR, Carlin B. Sports prehospital-immediate care and spinal injury: not a car crash in sight. Br J Sports Med. 2012 Dec;46(16):1097-101. doi: 10.1136/bjsports-2012-091800. Epub 2012 Oct 18.
- Background: PubMed 16418091Krell JM, McCoy MS, Sparto PJ, Fisher GL, Stoy WA, Hostler DP. Comparison of the Ferno Scoop Stretcher with the long backboard for spinal immobilization. Prehosp Emerg Care. 2006 Jan-Mar;10(1):46-51. doi: 10.1080/10903120500366375.
- Background: PubMed 24232010Moss R, Porter K, Greaves I; consensus group. Minimal patient handling: a faculty of prehospital care consensus statement. Emerg Med J. 2013 Dec;30(12):1065-6. doi: 10.1136/emermed-2013-203205.
- 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.
Kimberley L Edwards, MMedSci PhD principal investigator
University of Nottingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Scoop Stretcher and Long Back Spinal board in people with Emergency and Pain, run by University of Nottingham at 1 site 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 1 inclusion and 1 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 11 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Occiput tissue pressure in millimetres mercury (mmHg) (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02770638, which also lists 3 linked publications.
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 11 Jul 2022; AzTrials last refreshed its copy on 6 Nov 2026.