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Completed

NCT Number: NCT02770638

Tissue Interface Pressures in Athlete Medical Extraction

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.

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Key information

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University of Nottingham

Nottingham, Nottinghamshire, NG72UH, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy, uninjured - no current sports injury, male, 75kg (165 lb) in weight or over.

Exclusion criteria

  • Female, weight less than 75kg (165 lb)

Treatment and study plan

Scoop Stretcher

Device

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.

Other names: Trade Name: Ferno Scoop Stretcher

Long Back Spinal board

Device

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.

Primary outcomes

  1. Occiput tissue pressure in millimetres mercury (mmHg)

    Time frame: 1 day

Secondary outcomes

  1. Scapulae tissue pressure in millimetres mercury (mmHg)

    Time frame: 1 day

  2. Sacrum tissue pressure in millimetres mercury (mmHg)

    Time frame: 1 day

  3. Heels tissue pressure in millimetres mercury (mmHg)

    Time frame: 1 day

  4. Subjective participant reported pain levels using visual analogue scale (VAS)

    Time frame: 1 day

Sponsors and collaborators

Lead sponsor

University of Nottingham

Other

Registry information

Official study title

A Comparison of Tissue Interface Pressures and Comfort Ratings of the Scoop Stretcher and Traditional Long Back Board in Rugby and University Athletes

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
May 12, 2016
Registry last updated
Jul 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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