Effect of Muscle Fatigue on Spinal Imbalance and Motion in Lumbar Spinal Stenosis

NCT05309447 | Completed

• 1 other identifier: 2021-02012; mu22Netzer2
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This study assesses spinal imbalance and motion in patients with sLSS and elicits fatigue via back exercises and compares spinal imbalance and motion before and after the fatigue exercise and compares these to healthy controls, allowing to associate sLSS-specific motion patterns to paraspinal muscle fatigue.

Conditions

Lumbar Spinal Stenosis

Keywords

Symptomatic Lumbar spinal stenosis (sLSS); Spinal motion; Spinal loading; Spinal imbalance; Paraspinal muscle fatigue; Muscle degeneration; EOS medical imaging

Outcome Measures

Primary Outcomes (1)

• Global spinal imbalance assessed using motion capture

  Global spinal imbalance calculated from markers placed on specific anatomical landmarks: electromyographic (EMG) electrode placement bilaterally on the multifidus, erector spinae (longissimus), erector spinae (iliocostalis), transversus abdominis, gluteus medius, vastus medialis, tibialis anterior and gastrocnemius medialis muscles. The curvature of the lumbar region during natural stance, natural seated posture, maximum trunk flexion, maximum trunk extension and during walking will be computed from the marker data. A cubic polynomial function will be fit to the marker positions in each time frame, approximating an S-shaped spine curvature with thoracic kyphosis and lumbar lordosis curves and the curvature of the lumbar spine will be computed for each task.

  approximate duration: 30 minutes at baseline and at 1 year after decompression surgery for patients with sLSS

Secondary Outcomes (3)

• Global spinal imbalance assessed using EOS (upright standing sagittal plane EOS images of the full body including entire spine and pelvis)

  approximate duration: 10 minutes at baseline and at 1 year after decompression surgery for patients with sLSS

• Dynamic global spinal imbalance

  one time assessment at baseline and at 1 year after decompression surgery for patients with sLSS

• Difference in global spinal imbalance between the fatigued and non-fatigued state

  one time assessment at baseline and at 1 year after decompression surgery for patients with sLSS

Other Outcomes (6)

• Oswestry disability index (ODI)

  one time assessment at baseline and at 1 year after decompression surgery for patients with sLSS

• Quality of life (EQ-5D-5L)

  one time assessment at baseline and at 1 year after decompression surgery for patients with sLSS

• Muscle cross sectional area (MRI))

  one time assessment at baseline and at 1 year after decompression surgery for patients with sLSS (approximate duration: 30 minutes)

Study Arms (3)

Patients with sLSS

Patients with Symptomatic Lumbar Spinal Stenosis (n=10)

Other: data collection

Young Controls

Young healthy control subjects (n=10)

Other: data collection

Age-Matched Controls

Age-matched healthy control subjects (n=10)

Other: data collection

Interventions

data collection OTHER

The study entails the collection of clinical, functional, radiological, and biomechanical data.

Age-Matched Controls; Patients with sLSS; Young Controls

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with sLSS will be recruited at the Department of Spine Surgery at the University Hospital Basel. Healthy participants will be recruited via advertisement on the institutional website and the University of Basel marketplace.

You may qualify if:

• age \> 30 years
• BMI \< 35kg/m2
• diagnosed symptomatic lumbar spinal stenosis
• 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
• age \> 30 years
• BMI \< 35kg/m2
• years ≤ age ≤ 30 years
• BMI \< 35kg/m2

You may not qualify if:

• inability to provide informed consent
• previous spine surgery
• use of walking aids
• other neurologic disorders affecting gait
• MRI incompatibility
• inability to provide informed consent
• previous spine surgery
• history of claudications
• use of walking aids
• other neurological or orthopaedic conditions that may affect gait
• MRI incompatibility
• inability to provide informed consent
• previous back injury; previous spine surgery
• use of walking aids
• current injury of any kind

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

Spine Center, University Hospital Basel

Basel, 4031, Switzerland

Location

Related Publications (1)

• Koch D, Nuesch C, Ignasiak D, Scharen S, Ferguson SJ, Mundermann A, Netzer C. Age and activity but not lumbar spinal stenosis and muscle fatigue affect sagittal spinal alignment: A pilot study. Clin Biomech (Bristol). 2025 Jul;127:106577. doi: 10.1016/j.clinbiomech.2025.106577. Epub 2025 Jun 1.

  PMID: 40472708 DERIVED

MeSH Terms

Conditions

Spinal Stenosis

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Cordula Netzer, PD Dr. med.

  Spine Center, 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: March 22, 2022
• First Posted: April 4, 2022
• Study Start: November 11, 2021
• Primary Completion: May 30, 2023
• Study Completion: December 31, 2024
• Last Updated: March 3, 2025

Record last verified: 2025-02

Locations

CH (1)