Department of Spine Surgery, University Hospital Basel, Basel, Switzerland.
Department of Biomedical Engineering, University of Basel, Basel, Switzerland.
PLoS One. 2023 Oct 27;18(10):e0293435. doi: 10.1371/journal.pone.0293435. eCollection 2023.
OBJECTIVE: To describe a study protocol for investigating the functional association between posture, spinal balance, ambulatory biomechanics, paraspinal muscle fatigue, paraspinal muscle quality and symptoms in patients with symptomatic lumbar spinal stenosis (sLSS) before and 1-year after elective surgical intervention. DESIGN: Single-centre prospective, experimental, multimodal (clinical, biomechanical, radiological) study with three instances of data collection: baseline (study visit 1), 6-month follow-up (remote) and 1-year follow-up (study visit 2). Both study visits include an in vivo experiment aiming to elicit paraspinal muscle fatigue for postural assessment in a non-fatigued and fatigued state. EXPERIMENTAL PROTOCOL: At baseline and 1-year follow-up, 122 patients with sLSS will be assessed clinically, perform the back-performance scale assessment and complete several patient-reported outcome measure (PROMs) questionnaires regarding overall health, disease-related symptoms and kinesiophobia. Posture and biomechanical parameters (joint kinematics, kinetics, surface electromyography, back curvature) will be recorded using an optoelectronic system and retroreflective markers during different tasks including overground walking and movement assessments before and after a modified Biering-Sørensen test, used to elicit paraspinal muscle fatigue. Measurements of muscle size and quality and the severity of spinal stenosis will be obtained using magnetic resonance imaging (MRI) and sagittal postural alignment data from EOS radiographies. After each study visit, physical activity level will be assessed during 9 days using a wrist-worn activity monitor. In addition, physical activity level and PROMs will be assessed remotely at 6-month follow-up. CONCLUSION: The multimodal set of data obtained using the study protocol described in this paper will help to expand our current knowledge on the pathophysiology, biomechanics, and treatment outcome of degenerative sLSS. The results of this study may contribute to defining and/or altering patient treatment norms, surgery indication criteria and post-surgery rehabilitation schedules. TRIAL REGISTRATION: The protocol was approved by the regional ethics committee and has been registered at clinicaltrials.gov (NCT05523388).
目的:描述一项研究方案,以调查有症状的腰椎管狭窄症(sLSS)患者在选择性手术干预前后的姿势、脊柱平衡、步态生物力学、腰背肌肉疲劳、腰背肌肉质量和症状之间的功能关联。
设计:单中心前瞻性、实验性、多模态(临床、生物力学、影像学)研究,共进行三次数据采集:基线(研究访问 1)、6 个月随访(远程)和 1 年随访(研究访问 2)。两次研究访问均包括一项旨在诱发腰背肌肉疲劳的体内实验,以在非疲劳和疲劳状态下进行姿势评估。
实验方案:在基线和 1 年随访时,将对 122 名 sLSS 患者进行临床评估、进行腰背表现量表评估,并完成多项与整体健康、疾病相关症状和运动恐惧相关的患者报告结局(PROM)问卷。使用光电系统和反射标记,在不同任务中记录姿势和生物力学参数(关节运动学、动力学、表面肌电图、背部曲率),包括在改良 Biering-Sørensen 试验前后进行的地面行走和运动评估,该试验用于诱发腰背肌肉疲劳。使用磁共振成像(MRI)和 EOS 射线照相的矢状位姿势数据测量肌肉大小和质量以及脊柱狭窄的严重程度。每次研究访问后,使用腕戴活动监测器在 9 天内评估体力活动水平。此外,在 6 个月随访时还将远程评估体力活动水平和 PROM。
结论:本研究方案中获得的多模态数据集将有助于扩展我们对退行性 sLSS 的病理生理学、生物力学和治疗结果的现有认识。该研究的结果可能有助于定义和/或改变患者的治疗规范、手术指征标准和术后康复计划。
试验注册:该方案已获得区域伦理委员会的批准,并在 clinicaltrials.gov 上注册(NCT05523388)。
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