Role of Spinal Load in the Pathophysiology of Lumbar Spinal Stenosis

NCT ID: NCT05523388

Last Updated: 2025-04-17

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 122 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-09-01
• Study Completion Date: 2026-10-31

Brief Summary

This study is to improve the understanding of the role of postural and ambulatory biomechanics for symptoms in patients with sLSS and to correlate patient-reported outcome measures (PROMs) with dynamic compensation (difference between static and dynamic sagittal spinal alignment) in patients with symptomatic lumbar spinal stenosis sLSS).

Detailed Description

Lumbar spinal stenosis (LSS) is a common syndrome affecting the human spine characterized by age related degeneration of the lumbar discs, facet joints (FJs) and hypertrophy of the ligamentum flavum resulting in pain, limited function and compromised quality of life. Understanding the interrelationship between spinal load, kinematics and functional disability is one of the key factors in the prevention of this disease. This project assesses sagittal spinal balance and motion in patients with sLSS using an optoelectronic method based on infrared cameras and retroreflective markers and elicits paraspinal muscle fatigue using a modified version of the Biering-Sørensen test and compares sagittal spinal balance and motion before and after the fatigue exercise, which will allow to associate sLSS-specific motion patterns to paraspinal muscle fatigue. Additional data generated using magnetic resonance imaging (MRI) allows detecting associations between sLSS, muscle degeneration and fatty infiltration. Radiological images from the spine will be obtained in upright position using EOS®, a specialized low-dose x-ray unit. These images will allow the calculation of the anatomical global and local sagittal spinal balance, enabling a characterization of spinal kinematics in patients with sLSS and a validation of the workflow based on the optoelectronic method. Coded data obtained from EOS and motion analysis will allow optimizing existing biomechanical musculoskeletal models of the human spine. The results of this study will provide first mechanistic evidence of the role of clinical, radiological, functional and biomechanical factors in spine load. The combination of in vivo experiments with in silico experiments represents a unique opportunity of translating knowledge gained from systematic experiments considering biological measurements back to the patient. This study is to improve the understanding of the role of postural and ambulatory biomechanics for symptoms in patients with sLSS.

Conditions

Lumbar Spinal Stenosis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Collection of health-related data

A multimodal set of data including experimental, clinical, functional, radiological and biomechanical data is compiled before and after routine surgical intervention at baseline and at one-year follow-up.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• age > 30 years
• BMI < 35 kg/m2
• diagnosed sLSS
• clinical symptoms for at least 6 months
• intermittent neurogenic claudication with limitations of their walking ability due to symptoms in the lower back and or in one or both legs
• unsuccessful conservative treatment
• confirmation of the LSS through MRI
• scheduled for surgery

Exclusion Criteria

• inability to provide informed consent
• previous spine surgery
• use of walking aids
• other neurologic disorders affecting gait
• MRI incompatibility
• pregnancy

• Minimum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Swiss National Science Foundation

OTHER

Sponsor Role: collaborator

University Hospital, Basel, Switzerland

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Cordula Netzer, PD Dr. med.

Role: PRINCIPAL_INVESTIGATOR

Department of Spine Surgery, University Hospital Basel

Locations

Department of Spine Surgery, University Hospital Basel

Basel, , Switzerland

Countries

Switzerland

References

Koch D, Nuesch C, Ignasiak D, Aghlmandi S, Caimi A, Perrot G, Prufer F, Harder D, Santini F, Scharen S, Ferguson S, Mundermann A, Netzer C. 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. PLoS One. 2023 Oct 27;18(10):e0293435. doi: 10.1371/journal.pone.0293435. eCollection 2023.

Reference Type: DERIVED

PMID: 37889898 (View on PubMed)

Other Identifiers

2022-01170; mu22Netzer3

Identifier Type: -

Identifier Source: org_study_id