Clinical trial NCT05523388: Role of Spinal Load in the Pathophysiology of Lumbar Spinal Stenosis
Official title: RoLSSroice - Role of Spinal Load in the Pathophysiology of Lumbar Spinal Stenosis: A Translational Approach Combining Clinical and Radiological Parameters, in Vivo Biomechanical Experiments and Advanced in Silico Musculoskeletal Modeling
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Lumbar Spinal Stenosis
Keywords: patient-reported outcome measures (PROMs)
symptomatic lumbar spinal stenosis sLSS)
Oswestry disability index (ODI)
postural biomechanical analysis
ambulatory biomechanical analysis
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
Collaborators: name: Swiss National Science Foundation
First posted: 2022-08-31
Enrollment: 122
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients will be recruited at the Department of Spine Surgery at the University Hospital Basel. The surgical procedure is not affected by the study and is not subject of investigation.

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.

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

Primary outcomes:
measure: Change in Oswestry disability index (ODI)
timeFrame: At baseline and at one-year follow-up
measure: Change in Dynamic compensation
timeFrame: At baseline and at one-year follow-up
Secondary outcomes:
measure: Change in Sagittal spinal balance assessed using motion capture
timeFrame: At baseline and at one-year follow-up
measure: Change in Sagittal Spinal Balance assessed using EOS
timeFrame: At baseline and at one-year follow-up
measure: Change in Muscle fatigue assessed using electromyography (EMG)
timeFrame: At baseline and at one-year follow-up
measure: Change in Muscle fatigue assessed by fatigue exercise duration
timeFrame: At baseline and at one-year follow-up
measure: Change in Radiological parameter: Muscle atrophy
timeFrame: At baseline and at one-year follow-up
measure: Change in Radiological parameter: Fatty infiltration
timeFrame: At baseline and at one-year follow-up
measure: Change in Radiological parameter: Muscle cross-sectional area (CSA)
timeFrame: At baseline and at one-year follow-up
measure: Change in Radiological parameter: Stenosis severity
timeFrame: At baseline and at one-year follow-up
measure: Change in Radiological parameter: Segmental instability
timeFrame: At baseline and at one-year follow-up
Other outcomes:
measure: Change in Quality of life (EQ-5D-5L)
timeFrame: At baseline and at one-year follow-up
measure: Change in Swiss spinal stenosis score
timeFrame: At baseline and at one-year follow-up
measure: Change in Tampa scale of kinesiophobia
timeFrame: At baseline and at one-year follow-up
measure: Change in Core Outcome Measures Index for the back (COMI back)
timeFrame: At baseline and at one-year follow-up
measure: Change in Upper body motion (inertial sensor data)
timeFrame: At baseline and at one-year follow-up
measure: Change in Manual testing for muscle strength
timeFrame: At baseline and at one-year follow-up
measure: Change in Physical activity level
timeFrame: first assessment period: 9 days after the baseline measurement on test day 1; second period: 6 months after the spine surgery; third period: for 9 days at the one-year follow-up visit
measure: Change in Back performance scale
timeFrame: At baseline and at one-year follow-up
Locations:
city: Basel
country: Switzerland
facility: Department of Spine Surgery, University Hospital Basel
Study officials:
affiliation: Department of Spine Surgery, University Hospital Basel
name: Cordula Netzer, PD Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: