Warwick Spinal Immobiliser, stage2
Research type
Research Study
Full title
Evaluation of a new spinal immobiliser- the Warwick Spinal Immobiliser- stage2
IRAS ID
173771
Contact name
Matthew Cooke
Contact email
Sponsor organisation
University of Warwick
ISRCTN Number
ISRCTN55006384
Clinicaltrials.gov Identifier
CI/2013/0011, MHRA; 12/WM/0098, Stage 1 ethics
Duration of Study in the UK
0 years, 2 months, 30 days
Research summary
Traumatic spinal cord injury is rare but has devastating consequences on the quality of life of patients and their families. We estimate that 100,000 patients in England alone receive spinal immobilisation each year.
Current methods involve a semi-rigid collar with head blocks and tape, but research has shown that this does not adequately immobilise the neck, allowing movement of the spine. The rigid collar prevents opening of the mouth leading to feelings of claustrophobia, and potential danger of inhaling vomit. If the patient stops breathing, the collar must be removed to enable insertion of a breathing tube, increasing the risk of spinal cord damage. Pressure of the collar can cause pressure sores, and can increase pressure within the brain.
We have invented a new device to immobilise the spine.
We have already carried out stage one of a trial and have shown that the WSI was found to be effective in reducing movement of the spine in five out of the six directions/combinations that were tested. However, in one of the positions (the flexion/extension seated position) it was found that the WSI had increased movement of the spine compared to existing devices, which we believe to be due to the chin strap not fitting well enough in certain people. From these results the trial steering group conclude that a small modification of the chin strap may produce considerable improvement. Therefore we propose to undertake an additional study to assess the effectiveness of the amended device. The study will involve the redesign of the chin strap, application of the amended device to healthy volunteers, measurement of (a) movement of the cervical spine (b) tissue interface pressure (c) mouth opening, and assessment of volunteer comfort, anxiety and perception of movement.
REC name
West Midlands - South Birmingham Research Ethics Committee
REC reference
15/WM/0193
Date of REC Opinion
25 Jun 2015
REC opinion
Favourable Opinion