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SOFTLY: Comparison of patient-reported discomfort of rigid versus soft collar during ED investigation for potential cervical spine injury in low-risk blunt trauma patients

SOFTLY: Comparison of patient-reported discomfort of rigid versus soft collar during ED investigation for potential cervical spine injury in low-risk blunt trauma patients

Status
Terminated
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12621000286842
Acronym
SOFTLY
Enrollment
120
Registered
2021-03-16
Start date
2021-06-06
Completion date
2021-11-30
Last updated
2023-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Most traumatic spinal cord injuries (e.g. resulting in paraplegia and quadriplegia) happen at the time of the injury. A very small number might, in theory, be caused when an unstable fracture of the neck bones moves, injuring the spinal cord (delayed spinal cord injury). To address this risk, it is common for ambulance services and emergency departments to place patients who they think might have an injury to the bones of their neck (cervical spine) in a protective collar. The aim is to minimise neck movement until imaging (x-rays or CT scans) can be performed. The rationale is that if there is a fracture of the neck bones, neck movement could cause the bone fragments to move resulting in damage to the spinal cord. Historically, rigid neck collars have been, and are, used. There is however no high-quality research data showing clear benefit of this approach. This practice is now being questioned. Delayed spinal cord injury is an extremely rare event, there is no evidence that rigid collars prevent it and there is growing evidence of harm caused by rigid neck collars. This includes skin damage due to the pressure they apply, the risk of inhaling food or fluids when trying to eat or drink (aspiration) and damage to nerves in the neck. Anecdotally, patients report significant pain/discomfort and that eating or drinking is difficult. A proportion of patients are not able to tolerate the collar and remove it or loosen it such that it is ineffective. Some bodies have recommended a more selective strategy for limiting neck movement, including Norwegian and Danish guidelines and the Queensland Ambulance Service. This study aims, in a prospective study, to compare use of a rigid collar (as is current practice) against the application of a soft, foam collar with an emphasis on patients’ experience – in particular the amount of discomfort experienced – as well as clinical outcomes including pressure injuries and choking (aspiration) events.

Interventions

Patients will be assigned to care in either a rigid (Philadelphia) collar or a soft foam collar. The collar will be applied by a clinician (nurse or doctor) after arrival at the ED and before medical imaging. The collar will be removed after imaging and clinical assessment has ruled out a cervical spine injury. Adherence will; be checked by audit of medical records.

Sponsors

Western Health
Lead SponsorGovernment body

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Adults >18 Alert Blunt trauma Suspected neck injury No neurological symptoms or signs Stable vital signs

Exclusion criteria

Penetrating trauma Altered conscious state, including intoxication and significant dementia Abnormal physiological parameters (RR <8 or >20, HR <50 or >100, SBP <90, SpO2 <92%) Abnormal neurological findings on initial examination (including paraesthesia, sensory or motor abnormalities Pre-existing neurological disability Declined consent Unable to understand sufficient English to verbally consent and/or understand PICF

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 9, 2026