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

Completed

• Conditions: Lumbar Spinal Stenosis
• Interventions: Other: data collection

• Registration Number: NCT05309447
• Lead Sponsor: University Hospital, Basel, Switzerland

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.

Study Timeline

• Study Start: 2021-11-11
• Study First Submitted: 2022-03-22
• Study First Submitted QC: 2022-03-31
• Study First Posted: 2022-04-04
• Primary Completion: 2023-05-30
• Study Completion: 2024-12-31
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-28
• Last Update Posted: 2025-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

for patients with sLSS

• 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
• Inclusion criteria for age-matched healthy control subjects
• age > 30 years
• BMI < 35kg/m2
• Inclusion criteria for young healthy control subjects
• 18 years ≤ age ≤ 30 years
• BMI < 35kg/m2

Exclusion Criteria

for patients with sLSS

• inability to provide informed consent
• previous spine surgery
• use of walking aids
• other neurologic disorders affecting gait
• MRI incompatibility
• Exclusion criteria for age-matched healthy control subjects
• 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
• Exclusion criteria for young healthy control subjects
• inability to provide informed consent
• previous back injury; previous spine surgery
• use of walking aids
• current injury of any kind

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Young Controls	data collection	Young healthy control subjects (n=10)
Age-Matched Controls	data collection	Age-matched healthy control subjects (n=10)
Patients with sLSS	data collection	Patients with Symptomatic Lumbar Spinal Stenosis (n=10)

Primary Outcome Measures

Name	Time	Method
Global spinal imbalance assessed using motion capture	approximate duration: 30 minutes at baseline and at 1 year after decompression surgery for patients with sLSS	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.

Secondary Outcome Measures

Name	Time	Method
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	The curvature of the lumbar region between the fatigued and non-fatigued state will be computed from the marker data.
Dynamic global spinal imbalance	one time assessment at baseline and at 1 year after decompression surgery for patients with sLSS	Dynamic spinal imbalance will be assessed as the difference between spinal imbalance during walking compared to standing.
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	Static global and local spinal imbalance will be assessed on the EOS images as the C7 plumb line (C7PL), sagittal vertical axis (SVA) and spinosacral angle (SSA). The discrepancy between SSA and SVA are a sign of the prevalence of static compensation mechanism. The correction angle to a balanced situation will be measured using the full balance integrated method.

Trial Locations

Locations (1)

Spine Center, University Hospital Basel; 🇨🇭 Basel, Switzerland