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

Lumbar Spinal Stenosis Clinical Trial

— MuscLSS  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05309447
• Other study ID #: 2021-02012; mu22Netzer2
• Status: Active, not recruiting
• Start date: November 11, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: February 2024
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: December 31, 2024
• Est. primary completion date: May 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Constriction, Pathologic
• Fatigue
• Lumbar Spinal Stenosis
• Spinal Stenosis

Intervention

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

Locations

Country	Name	City	State
Switzerland	Spine Center, University Hospital Basel	Basel

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Oswestry disability index (ODI)	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	one time assessment at baseline and at 1 year after decompression surgery for patients with sLSS
Other	Quality of life (EQ-5D-5L)	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).	one time assessment at baseline and at 1 year after decompression surgery for patients with sLSS
Other	Muscle cross sectional area (MRI))	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.	one time assessment at baseline and at 1 year after decompression surgery for patients with sLSS (approximate duration: 30 minutes)
Other	Muscle fatigue, assessed as the duration of the fatigue exercise from start until termination	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.	one time assessment at baseline and at 1 year after decompression surgery for patients with sLSS
Other	Fatigue exercise duration	Fatigue exercise duration will be recorded as the duration from start to end of the fatigue exercise.	one time assessment at baseline and at 1 year after decompression surgery for patients with sLSS
Other	Local spinal imbalance	Local spinal imbalance will be calculated from the reflective markers positioned on the spinous processes.	one time assessment at baseline and at 1 year after decompression surgery for patients with sLSS
Primary	Global spinal imbalance assessed using motion capture	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.	approximate duration: 30 minutes at baseline and at 1 year after decompression surgery for patients with sLSS
Secondary	Global spinal imbalance assessed using EOS (upright standing sagittal plane EOS images of the full body including entire spine and pelvis)	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.	approximate duration: 10 minutes at baseline and at 1 year after decompression surgery for patients with sLSS
Secondary	Dynamic global spinal imbalance	Dynamic spinal imbalance will be assessed as the difference between spinal imbalance during walking compared to standing.	one time assessment at baseline and at 1 year after decompression surgery for patients with sLSS
Secondary	Difference in global spinal imbalance between the fatigued and non-fatigued state	The curvature of the lumbar region between the fatigued and non-fatigued state will be computed from the marker data.	one time assessment at baseline and at 1 year after decompression surgery for patients with sLSS