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Completed

NCT Number: NCT05309447

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Spine Center, University Hospital Basel

Basel, 4031, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Data Collection

Other

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

Primary outcomes

  1. Global spinal imbalance assessed using motion capture

    Time frame: 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 outcomes

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

    Time frame: 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.

  2. Dynamic global spinal imbalance

    Time frame: 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.

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

    Time frame: 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.

Other outcomes

  1. Oswestry disability index (ODI)

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

    Disability related to LSS will be assessed using the validated German version of the ODI. The ODI is a standardized questionnaire comprising 10 self-administered parameters quantifying the impact of low back pain on daily life

  2. Quality of life (EQ-5D-5L)

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

    Overall health will be assessed using the validated German version of the EQ-5D-5L. The EQ-5D-5L is a generic health-related instrument frequently used in clinical environments to measure quality of life. It comprises 5 questions with Likert response options and a visual analogue scale where patients are asked to rate their overall health from 0 (the worst health imaginable) to 100 (the best health imaginable).

  3. Muscle cross sectional area (MRI))

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

    For L1 to L5, the cross-sectional area (CSA) of the abdominal and paraspinal muscles on each side and the CSA of the vertebral body will be measured. The relative CSA (rCSA) and the ratio of LeanCSA to the paraspinal muscle CSA (LeanCSA/CSA) will be calculated for each level and side. This measurement of muscle degeneration (atrophy and fatty infiltration) allows quantifying abdominal and paraspinal muscle degeneration.

  4. Muscle fatigue, assessed as the duration of the fatigue exercise from start until termination

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

    Muscle fatigue will be quantified as the slope of the mean frequency and the change in the signal intensity during the modified Biering-Sørensen test. The starting position is the patient/client adopting a half prone lying on a plinth with the superior edge of the iliac crest at the edge of the plinth and the arms crossed over the chest.

    The lower limbs are strategically stabilized with straps. The patient/client is asked to maintains the upper body in a horizontal position and the timer is started.

    The test ends if the patient/client can maintain the said position for 4 minutes (240 seconds) or can no longer maintain the set position before 4 minutes elapses. The stop time is recorded.

  5. Fatigue exercise duration

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

    Fatigue exercise duration will be recorded as the duration from start to end of the fatigue exercise.

  6. Local spinal imbalance

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

    Local spinal imbalance will be calculated from the reflective markers positioned on the spinous processes.

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Official study title

MuscLSS: Effect of Muscle Fatigue on Spinal Imbalance and Motion in Lumbar Spinal Stenosis: Single Center Observational Pilot Study

Acronym: MuscLSS

Important dates

Study start
2021
Primary completion
2023
Study completion
2024
First posted
Apr 4, 2022
Registry last updated
Mar 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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