SOFTLY: Comparison of outcomes of rigid versus soft collar during emergency department investigation for potential cervical spine injury in low-risk blunt trauma patients - A pilot study.

Objective: Blunt trauma patients with potential cervical spine injury are traditionally immobilised in rigid collars. Recently, this has been challenged. The present study's objective was comparison of the rate of patient-oriented adverse events in stable, alert, low-risk patients with potential cervical spine injuries immobilised in rigid versus soft collars.

Methods: Unblinded, prospective quasi-randomised clinical trial of neurologically intact, adult, blunt trauma patients assessed as having potential cervical spine injury. Patients were randomised to collar type. All other aspects of care were unchanged. Primary outcome was patient-reported discomfort related to neck immobilisation by collar type. Secondary outcomes included adverse neurological events, agitation and clinically important cervical spine injuries (clinical trial registration number: ACTRN12621000286842).

Results: A total of 137 patients were enrolled: 59 patients allocated to a rigid collar and 78 to a soft collar. Most injuries were from a fall <1 m (54%) or a motor vehicle crash (21.9%). Median neck pain score of collar immobilisation was lower in the soft collar group (3.0 [interquartile range 0-6.1] vs 6.0 [interquartile range 3-8.8], P < 0.001). The proportion of patients with clinician-identified agitation was lower in the soft collar group (5% vs 17%, P = 0.04). There were four clinically important cervical spine injuries (two in each group). All were treated conservatively. There were no adverse neurological events.

Conclusions: Use of soft rather than rigid collar immobilisation for low-risk blunt trauma patients with potential cervical spine injury is significantly less painful for patients and results in less agitation. A larger study is needed to determine the safety of this approach or whether collars are required at all.