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
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Lumbar Spinal Stenosis
- Sponsor
- University Hospital, Basel, Switzerland
- Enrollment
- 122
- Locations
- 1
- Primary Endpoint
- Change in Oswestry disability index (ODI)
- Status
- Active, Not Recruiting
- Last Updated
- last year
Overview
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.
Investigators
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
Outcomes
Primary Outcomes
Change in Oswestry disability index (ODI)
Time Frame: At baseline and at one-year follow-up
Disability related to sLSS will be assessed with the ODI, which is considered the gold standard of low back functional outcome tools. The ODI is a questionnaire comprising 10 self-administered items that quantify a patient's perceived level of functional disability. Each of the items relates to a different area of functional impairment and consists of six statements, which are scored from zero to five points.
Change in Dynamic compensation
Time Frame: At baseline and at one-year follow-up
Dynamic compensation is defined as the difference between static and dynamic sagittal spinal alignment. Six possible gait events are available to choose from for the definition of dynamic sagittal spinal balance (left and right; heel-strike, toe-off, midstance). Dynamic sagittal spinal balance may be defined as sagittal spinal balance during left/right midstance, left/right heel strike and/or left/right toe off. The most appropriate gait event to calculate dynamic sagittal spinal balance will be used.
Secondary Outcomes
- Change in Sagittal spinal balance assessed using motion capture(At baseline and at one-year follow-up)
- Change in Sagittal Spinal Balance assessed using EOS(At baseline and at one-year follow-up)
- Change in Radiological parameter: Segmental instability(At baseline and at one-year follow-up)
- Change in Muscle fatigue assessed using electromyography (EMG)(At baseline and at one-year follow-up)
- Change in Muscle fatigue assessed by fatigue exercise duration(At baseline and at one-year follow-up)
- Change in Radiological parameter: Muscle atrophy(At baseline and at one-year follow-up)
- Change in Radiological parameter: Fatty infiltration(At baseline and at one-year follow-up)
- Change in Radiological parameter: Muscle cross-sectional area (CSA)(At baseline and at one-year follow-up)
- Change in Radiological parameter: Stenosis severity(At baseline and at one-year follow-up)