The role of muscle degeneration and spinal balance in the pathophysiology of lumbar spinal stenosis: Study protocol of a translational approach combining in vivo biomechanical experiments with clinical and radiological parameters

Abstract

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).

Fig 1. Schedule of enrolment and assessments.

Fig 2. Study flow chart.

Fig 3. Placement of retroreflective marker and electromyography electrodes for the biomechanical assessment.

Anterior (left), lateral (middle) and posterior (right) view.

Fig 4. Setup for the modified Biering-Sørensen test.

Fig 5. Example of an EOS radiography (left: frontal plane; right: sagittal plane) with measures provided by the sterEOS software.

Fig 6. Marker positions (sagittal plane) and calculation of sagittal spinal balance parameters [49] SVA–sagittal vertical axis; LL–lumbar lordosis; TK–thoracal kyphosis; SSA–spino-sacral angle.

Fig 7. 3D optical digitalization with Artec EVA, https://www.artec3d.com, process (left), software output (right).