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

NCT ID: NCT05309447

Last Updated: 2025-03-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-11-11
• Study Completion Date: 2024-12-31

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.

Detailed Description

Symptomatic lumbar spinal stenosis (sLSS) is a common syndrome affecting the human spine characterized by age related degeneration of the lumbar discs and facet joints resulting in pain, limited function and compromised quality of life. In a healthy spine, global and local spinal loads during static posture and dynamic motion will have minimal effects on the spinal canal. However, spinal loads altered by the presence of sLSS may result in further narrowing of the spinal canal and compression of the neural elements or in overloading of the already degenerated lumbar segments possibly eliciting typical pain symptoms. 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. Additional data generated using magnetic resonance tomography allows detecting and assessing differences in muscle degeneration between sLSS patients and healthy controls. Radiological images from the spine in upright position using EOS, a specialized low-dose x-ray unit will be obtained to allow the calculation of the actual clinical global and local spinal imbalance. Furthermore, this study investigates the outcome of the decompression surgery during a second study visit scheduled 1 year postoperatively. The data obtained here are pilot data that will be critical for designing a larger clinical trial and produce important information for adapting musculoskeletal spine models to simulate spinal imbalance and motion and further defining meaningful outcome parameters.

Conditions

Lumbar Spinal Stenosis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients with sLSS

Patients with Symptomatic Lumbar Spinal Stenosis (n=10)

data collection

Intervention Type: OTHER

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

Young Controls

Young healthy control subjects (n=10)

data collection

Intervention Type: OTHER

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

Age-Matched Controls

Age-matched healthy control subjects (n=10)

data collection

Intervention Type: OTHER

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

Interventions

data collection

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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
• 18 years ≤ age ≤ 30 years
• BMI < 35kg/m2

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital, Basel, Switzerland

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Cordula Netzer, PD Dr. med.

Role: PRINCIPAL_INVESTIGATOR

Spine Center, University Hospital Basel

Locations

Spine Center, University Hospital Basel

Basel, , Switzerland

Countries

Switzerland

References

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.

Reference Type: DERIVED

PMID: 40472708 (View on PubMed)

Other Identifiers

2021-02012; mu22Netzer2

Identifier Type: -

Identifier Source: org_study_id