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Key information


SIS: Randomised controlled trial of the clinical and cost-effectiveness of cervical spine immobilisation following blunt trauma  

Chief Investigator: Prof Mark Wilson

Sponsor: Imperial College London

Funder: National Institute for Health and Care Research

Registration Number: ISRCTN13721611


Background and study aims

Cervical spine (c-spine) injuries often occur as a result of road traffic crashes, sports injuries or as a result of falling in frail people. Although c-spine injuries are rare, if they do occur, they can have a dramatic effect on an individual's quality of life and can lead to long-term disability or even death. In the UK, when potential c-spine injury occurs, the ambulance paramedics will usually stabilise the spine in one of two ways. Either, they will place the patient on a rigid board or mattress and strap across their forehead using tape supported by blocks and/or a hard neck collar. this reduces any movement, to prevent more damage to the spine during transfer to the hospital. This is known as triple spinal immobilisation. There is some concern that this can harm more than it helps patients. For example causing difficulty in breathing, skin or brain injury or in some rare instances making a spinal injury worse. Or, they will alter this slightly to introduce some flexibility, so that the patient is more comfortable and there may be fewer side effects. This is called movement minimisation. Currently, both of these immobilisation methods are used in the UK as normal practice, and patients can be given either method when their spine needs stabilising, but we don't know if movement minimisation will worsen spinal problems (such as paralysis) or improve potential complications of triple immobilisation such as breathing in vomit (aspiration), skin problems and brain injury. In this situation it is common to do a clinical trial.

Sample size:

Planned Sample Size 8316: UK Sample Size 8316.

Primary outcome:

The primary outcome measure is a Functional Independence Measure of motor (FIM-motor) score at hospital discharge and at 30 days post injury.


Overall trial start date 01/10/2021. Overall trial end date 01/05/2026

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EMAIL: sis at warwick dot ac dot uk