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Lumbar Spinal StenosisRoLSSroiceNCT05523388

Role of Spinal Load in the Pathophysiology of Lumbar Spinal Stenosis

An observational study of Lumbar Spinal Stenosis, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 30 years and older
Conditions the study is for
Lumbar Spinal Stenosis
What is being tested?
Collection of health-related data
How many people
122 participants
Where
1 siteSwitzerland
Study dates
1 Sep 2022to Oct 2026
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

  • Department of Spine Surgery, University Hospital Basel

    Basel, 4031

Other trials in Switzerland

About this study

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

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).

Read the 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.

Being tested
Collection of health-related data
Keywords
patient-reported outcome measures (PROMs), symptomatic lumbar spinal stenosis sLSS), Oswestry disability index (ODI), postural biomechanical analysis, ambulatory biomechanical analysis
Medical subject headings
Spinal Stenosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Collection of health-related dataOther

    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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Oswestry disability index (ODI)

    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.

    Measured: At baseline and at one-year follow-up

  2. Change in Dynamic compensation

    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.

    Measured: At baseline and at one-year follow-up

Secondary outcomes (9)

  1. Change in Sagittal spinal balance assessed using motion capture

    The curvature of the lumbar and thoracic spine during stance and during walking will be computed from the marker data using MATLAB™ software. A cubic polynomial function will be fitted to the marker positions in each time frame, approximating an S-shaped spine curvature with thoracic kyphosis (TK) and lumbar lordosis (LL) curves. The workflow used to calculate sagittal spinal balance parameters is based on the calculation methods for radiological sagittal spinal balance parameters. The set of marker-based sagittal spinal balance parameters comprises LL, TK, sagittal vertical axis (SVA), spino-sacral angle (SSA), spine inclination (SI). The data obtained using motion capture will be used to estimate spinal load using musculoskeletal modeling.

    Measured: At baseline and at one-year follow-up

  2. Change in Sagittal Spinal Balance assessed using EOS

    Sagittal spinal balance parameters from EOS radiological images are calculated semi-automatically using the sterEOS software provided by the EOS company. This workflow allows the calculation of four sagittal spinal balance parameters: SVA, SSA, LL and TK. LL is calculated as the angle between the tangents on the superior L1 and inferior L5 vertebral endplates. TK is calculated as the angle between the tangents on the superior T4 and inferior T12 vertebral endplates. SVA is measured as the horizontal distance between C7 plumb line and the posterior-superior corner of the S1 vertebra. SSA is defined as the angle between the line connecting the center of the C7 vertebra to the center of the S1 endplate and the line parallel to the superior S1 endplate.

    Measured: At baseline and at one-year follow-up

  3. Change in Muscle fatigue assessed using electromyography (EMG)

    Muscle fatigue will be assessed as the decrease in median EMG frequency.

    Measured: At baseline and at one-year follow-up

  4. Change in Muscle fatigue assessed by fatigue exercise duration

    The fatigue exercise duration will be measured using a stopwatch. Time is stopped from the point where the patients starts the exercise by no longer supporting the torso with their hands until the termination of the exercise by supporting the torso.

    Measured: At baseline and at one-year follow-up

  5. Change in Radiological parameter: Muscle atrophy

    The measurement of muscle atrophy allows quantifying abdominal and paraspinal muscle degeneration. The analysis will be performed using ImageJ image analysis software (Version 1.52t, National Institutes of Health, Bethesda, Maryland).

    Measured: At baseline and at one-year follow-up

  6. Change in Radiological parameter: Fatty infiltration

    The measurement of fatty infiltration allows quantifying abdominal and paraspinal muscle degeneration. The analysis will be performed using ImageJ image analysis software (Version 1.52t, National Institutes of Health, Bethesda, Maryland).

    Measured: At baseline and at one-year follow-up

  7. Change in Radiological parameter: Muscle cross-sectional area (CSA)

    For L1 to L5, the cross-sectional area (CSA) of the abdominal and paraspinal muscles on each side will be measured, including the multifidus and the erector spinae (longissimus and iliocostalis) muscles, and the CSA of the vertebral body. The relative CSA (rCSA) will be defined as the ratio between muscle CSA and vertebral body CSA and calculated for each level and side. The CSA of lean muscle in the region of interest will be defined as LeanCSA and measured on each side. The ratio of LeanCSA to the paraspinal muscle CSA will be defined as functional CSA (LeanCSA/CSA), represented as % muscle CSA and calculated for each level and side. Overall CSA, rCSA and LeanCSA will be computed as average CSA (aCSA), average rCSA (arCSA) and average LeanCSA (aLeanCSA) across all levels considering the muscle as a single unit for each side.

    Measured: At baseline and at one-year follow-up

  8. Change in Radiological parameter: Stenosis severity

    Stenosis severity will be classified according to Schizas (Grade A stenosis is the mildest, with abundant cerebrospinal fluid inside the dural sac. In grade B stenosis, the rootlets occupy the whole of the dural sac, but they can still be individualized. In grade C, no rootlets can be recognized but epidural fat can be visualized posteriorly. In grade D, in addition to no rootlets being recognizable, there is no epidural fat posteriorly).

    Measured: At baseline and at one-year follow-up

  9. Change in Radiological parameter: Segmental instability

    Segmental instability will be determined as a relative shift in anteroposterior position of two adjacent segments between the upright standing radiograph and the lying MRI of more than 3mm.

    Measured: At baseline and at one-year follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Aug 2022
  2. Study start1 Sep 2022
  3. Primary completion31 Dec 2025 (estimated)
  4. Study completionOct 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
122 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05523388
Sponsor's protocol ID
2022-01170; mu22Netzer3
Acronym
RoLSSroice
Status last verified
Apr 2025
First submitted
29 Aug 2022
Last updated
17 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 37889898

Questions about this trial

What is this clinical trial studying?

An observational study of Lumbar Spinal Stenosis, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 17 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Oswestry disability index (ODI) (time frame: At baseline and at one-year follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05523388, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2025.

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