Evaluating a novel, low-cost technique for cervical-spine immobilization for application in resource-limited LMICs: a non-inferiority trial

Study design: Non-inferiority trial. Objective: Limited cervical spinal (c-spine) immobilization in resource-limited settings of LMICs suggests alternatives are necessary for patients with traumatic injuries. We propose a novel method of c-spine immobilization using folded towels. Setting: Washington University in St. Louis. Methods: Using non-inferiority trial design, thirty healthy patients (median age = 22) were enrolled to test the efficacy of folded towels in comparison with rigid cervical collars, foam neck braces, and no immobilization. We measured cervical range of motion (CROM) in six cardinal directions in seated and supine positions. A weighted composite score (CS) was generated to compare immobilization methods. A preserved fraction of 75% was determined for non-inferiority, corresponding to the difference between the median values for CROM between control (no immobilization) and c-collar states. Results: C-collars reduce median CROM in six cardinal directions in seated and supine positions by an average of −36.83° seated (−17.75° supine) vs. no immobilization. Folded towels and foam neck braces reduced CROM by −27° seated (−16.75° supine) and −14.25° seated (−9.5° supine), respectively. Compared to a 25% non-inferiority margin (permitting an average 9.21° of cervical movement across six cardinal directions), the CS determined folded towels are non-inferior (CS_seated = 0.89, CS_supine = 0.47). Foam neck braces are inferior (CS_seated = 2.35, CS_supine = 2.10). CS > 1 surpassed the non-inferiority margin and were deemed inferior. Conclusions: Folded towels are a non-inferior means of immobilizing c-spine in extension and rotation, but not flexion, vs. c-collars. We propose folded towels could be trialed in combination with backboards to deliver affordable and effective prehospital TSCI management in resource-limited settings.