Spine Center, University Hospital Basel
Basel, 4031, Switzerland
NCT Number: NCT05309447
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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Notify Me18 year and older
All sexes
Observational
Basel, 4031, Switzerland
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
for patients with sLSS
Exclusion criteria
for patients with sLSS
The study entails the collection of clinical, functional, radiological, and biomechanical data.
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.
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.
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.
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.
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
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).
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.
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.
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.
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.
University Hospital, Basel, Switzerland
Other
MuscLSS: Effect of Muscle Fatigue on Spinal Imbalance and Motion in Lumbar Spinal Stenosis: Single Center Observational Pilot Study
Acronym: MuscLSS
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