Role of Spinal Load in the Pathophysiology of Lumbar Spinal Stenosis

NCT05523388 | Active Not Recruiting

• 1 other identifier: 2022-01170; mu22Netzer3
• Study Type: observational
• Target: 122
• Locations: 1 country
• Sites: 1

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).

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

Outcome Measures

Primary Outcomes (2)

• 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.

  At baseline and at one-year follow-up

• 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.

  At baseline and at one-year follow-up

Secondary Outcomes (9)

• 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 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

Other Outcomes (8)

• Change in Quality of life (EQ-5D-5L)

  At baseline and at one-year follow-up

• Change in Swiss spinal stenosis score

  At baseline and at one-year follow-up

• Change in Tampa scale of kinesiophobia

  At baseline and at one-year follow-up

Interventions

Collection of health-related data OTHER

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.

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead
• Swiss National Science Foundation: collaborator

Study Sites (1)

Department of Spine Surgery, University Hospital Basel

Basel, 4031, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 37889898 DERIVED

MeSH Terms

Conditions

Spinal Stenosis

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Cordula Netzer, PD Dr. med.

  Department of Spine Surgery, University Hospital Basel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2022
• First Posted: August 31, 2022
• Study Start: September 1, 2022
• Primary Completion: December 31, 2025
• Study Completion (Estimated): October 1, 2026
• Last Updated: April 17, 2025

Record last verified: 2025-04

Locations

CH (1)