Department of Biomedical Engineering, Washington University in St. Louis, St. Louis, MO, USA.
LFR International, Los Angeles, CA, USA.
Spinal Cord. 2022 Aug;60(8):726-732. doi: 10.1038/s41393-022-00764-3. Epub 2022 Feb 22.
Non-inferiority trial.
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.
Washington University in St. Louis.
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.
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 = 0.89, CS = 0.47). Foam neck braces are inferior (CS = 2.35, CS = 2.10). CS > 1 surpassed the non-inferiority margin and were deemed inferior.
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.
非劣效性试验。
资源有限的中低收入国家（LMICs）对颈椎（c-spine）的限制固定效果有限，这表明需要为创伤性损伤患者提供替代方法。我们提出了一种使用折叠毛巾固定颈椎的新方法。
圣路易斯华盛顿大学。
采用非劣效性试验设计，纳入 30 名健康患者（中位年龄 22 岁），以测试折叠毛巾与刚性颈托、泡沫颈带和不固定相比的效果。我们测量了坐位和仰卧位时颈椎的六个方向的活动范围（CROM）。生成加权综合评分（CS）以比较固定方法。非劣效性的保留分数为 75%，这对应于对照（无固定）和 c 型颈托状态之间 CROM 中位数差值。
c 型颈托在坐位和仰卧位时使 CROM 在六个方向的中位数平均减少-36.83°（仰卧位为-17.75°），与无固定相比。折叠毛巾和泡沫颈带使 CROM 减少-27°（仰卧位-16.75°）和-14.25°（仰卧位-9.5°）。与 25%的非劣效性边界（允许六个方向的颈椎运动平均有 9.21°）相比，CS 确定折叠毛巾是非劣效的（CS=0.89，CS=0.47）。泡沫颈带则为劣效（CS=2.35，CS=2.10）。CS＞1 超过了非劣效性边界，被认为是劣效的。
折叠毛巾是一种非劣效的固定颈椎伸展和旋转的方法，但在屈曲方面不如 c 型颈托。我们建议在资源有限的环境中，可以尝试将折叠毛巾与背板结合使用，以提供经济实惠且有效的创伤性脊髓损伤院前管理。
