Clinical trial NCT05309447: Effect of Muscle Fatigue on Spinal Imbalance and Motion in Lumbar Spinal Stenosis
Official title: MuscLSS: Effect of Muscle Fatigue on Spinal Imbalance and Motion in Lumbar Spinal Stenosis: Single Center Observational Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lumbar Spinal Stenosis
Keywords: Symptomatic Lumbar spinal stenosis (sLSS)
Spinal motion
Spinal loading
Spinal imbalance
Paraspinal muscle fatigue
Muscle degeneration
EOS medical imaging
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2022-04-04
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Global spinal imbalance assessed using motion capture
timeFrame: approximate duration: 30 minutes at baseline and at 1 year after decompression surgery for patients with sLSS
Secondary outcomes:
measure: Global spinal imbalance assessed using EOS (upright standing sagittal plane EOS images of the full body including entire spine and pelvis)
timeFrame: approximate duration: 10 minutes at baseline and at 1 year after decompression surgery for patients with sLSS
measure: Dynamic global spinal imbalance
timeFrame: one time assessment at baseline and at 1 year after decompression surgery for patients with sLSS
measure: Difference in global spinal imbalance between the fatigued and non-fatigued state
timeFrame: one time assessment at baseline and at 1 year after decompression surgery for patients with sLSS
Other outcomes:
measure: Oswestry disability index (ODI)
timeFrame: one time assessment at baseline and at 1 year after decompression surgery for patients with sLSS
measure: Quality of life (EQ-5D-5L)
timeFrame: one time assessment at baseline and at 1 year after decompression surgery for patients with sLSS
measure: Muscle cross sectional area (MRI))
timeFrame: one time assessment at baseline and at 1 year after decompression surgery for patients with sLSS (approximate duration: 30 minutes)
measure: Muscle fatigue, assessed as the duration of the fatigue exercise from start until termination
timeFrame: one time assessment at baseline and at 1 year after decompression surgery for patients with sLSS
measure: Fatigue exercise duration
timeFrame: one time assessment at baseline and at 1 year after decompression surgery for patients with sLSS
measure: Local spinal imbalance
timeFrame: one time assessment at baseline and at 1 year after decompression surgery for patients with sLSS
Locations:
city: Basel
country: Switzerland
facility: Spine Center, University Hospital Basel
Study officials:
affiliation: Spine Center, University Hospital Basel
name: Cordula Netzer, PD Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: