Muscle Function and Pelvic Stability While Walking in Patients With Symptomatic Lumbar Spinal Stenosis

Lumbar Spinal Stenosis Clinical Trial

— WALK-LSS  

Official title:

WALK-LSS - Muscle Function and Pelvic Stability While Walking in Patients With Symptomatic Lumbar Spinal Stenosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03951935
• Other study ID #: 2019-00331; ch19Muendermann2
• Status: Completed
• Start date: April 17, 2019
• Est. completion date: December 31, 2021

Study information

• Verified date: March 2022
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study is to quantify changes in muscle activity and pelvic stability during prolonged walking in patients with symptomatic lumbar spinal stenosis (sLSS) and healthy control subjects and to determine their association with the severity of the stenosis and the crosssectional area and fatty atrophy of lumbo-pelvic-hip muscles.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: December 31, 2021
• Est. primary completion date: August 27, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 80 Years

Eligibility

Inclusion Criteria patients:

• Diagnosed symptomatic lumbar spinal stenosis
• Availability of lumbar MR images
• Scheduled for decompressive surgery at the University Hospital Basel

Exclusion Criteria patients:

• Prior decompressive surgery
• Body Mass Index (BMI) = 35 kg/m2
• Additional pathologies that influence the mobility of the pelvis
• Use of walking aids
• Inability to provide informed consent

Exclusion Criteria healthy control subjects:

• BMI = 35 kg/m2
• Pain in the lower extremity or lower back in the previous 6 months
• Prior surgery of the lumbo-pelvic-hip complex
• History of claudications
• Neurological or orthopaedic conditions that may influence gait
• Inability to provide informed consent

Related Conditions & MeSH terms

• Constriction, Pathologic
• Lumbar Spinal Stenosis
• Spinal Stenosis
• Symptomatic Lumbar Spinal Stenosis

Intervention

Other:
• Oswestry Disability Index (ODI) questionnaire
Participant's level of low back pain and the extent to which the pain impacts his/ her daily life activities and social life are estimated with the standardized Oswestry Disability Index questionnaire

Diagnostic Test:
• self-paced walking test (SPWT)
walking back and forth at a self-selected pace along a hallway at the University Hospital until the onset of claudication, pain or until reaching the time limit of 30 minutes. Kinematic and electromyographic (EMG) data will be recorded every 3 minutes.

Locations

Country	Name	City	State
Switzerland	Department of Orthopaedics and Traumatology, University Hospital Basel	Basel

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland	Klinik für Radiologie und Nuklearmedizin, University Hospital Basel

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oswestry Disability Index (ODI) questionnaire	Participant's level of low back pain and the extent to which the pain impacts his/ her daily life activities and social life; ten self-administered items compiling the ODI are: pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sexual life, social life, travelling. The resulting scores are presented as scores from 0 (no impact) to 100 (bed bound and extremely limited). Higher values represent a worse outcome.	the day before decompression surgery
Primary	Muscle activation assessed by Electromyography (EMG)	Muscle activation of the multifidus, gluteus medius, erector spinae (longissimus), transversus abdominis muscles will be measured bilaterally using a 12- channel EMG system (myon AG, Schwarzenberg, Switzerland). Surface electrodes will be placed on these muscles (sampling rate = 2000 Hz). For each muscle, the frequency spectrum will be computed for each recording. Muscle fatigue will be defined as the slope of the mean frequency during the self-paced walking test (SPWT)	scheduled the day before decompression surgery
Primary	Pelvic stability	Pelvic stability will be assessed using an inertial sensor-based gait analysis system, more precisely by the sensor attached to the posterior superior iliac spine (RehaGait, Hasomed GmbH, Magdeburg, Germany). Pelvic stability will be measured in three planes (sagittal, transversal, frontal). Each sensor comprises a 3-axis accelerometer (± 16 g), a 3-axisgyroscope (± 2000 °/s) and a 3-axis compass (± 1.3 Gs). Dynamic stability will be defined as the root mean square ratio of the pelvic acceleration in each direction (anteroposterior, medio-lateral, vertical) normalized to walking Speed.	the day before decompression surgery
Primary	Cross-sectional area (CSA) of lumbo-pelvic-hip muscles	Quantitative measurements of the CSA will be obtained from an axial T1 vibe Dixon transversal sequence and will be assessed by using an imaging software (syngo.via, Siemens Healthineers, Erlangen, Germany). The Dixon method represents a commonly used method to suppress the signal of fat in magnetic resonance imaging (MRI). The range of interest (ROI) will be defined manually on L3/L4- and on L4/L5-level and will include the CSA of the musculus (m.) erector spinae and the m. psoas major bilaterally. The CSA will be set in relation to the subject's Body mass. MRIs are routinely acquired in patients as diagnostics prior to surgery. The T1 vibe Dixon transversal sequence is not part of the standardized imaging protocol and will be added to the protocol for eligible patients for the purpose of this study.	the day before decompression surgery
Primary	Fatty atrophy of lumbo-pelvic-hip muscles	The fatty atrophy of the lumbo-pelvic-hip muscles will be assessed with an axial T2-weighted sequence enabling determining the fat fraction. The ROI will be defined manually on L3/L4- and on L4/L5-level and will include the erector spinae and the psoas major bilaterally. This sequence is part of the standardized imaging protocol.	the day before decompression surgery
Primary	walking capacity assessed by self-paced walking test distance (SPWT)	The SPWT will be conducted on a level surface in a hallway at the University Hospital. The duration, measured with a stopwatch by the administrator, and pain scores during walking, ranked between 0 and 10 and given every 5 minutes via oral feedback by the participant, will be assessed.	the day before decompression surgery
Primary	Grading of Severity of Lumbar Spinal Stenosis using the classification by Schizas	The stenosis grade will be assessed using the classification by Schizas.The 4-grade based classification is based on the morphology of the dural sac as observed on T2 axial MRI based on the rootlet/ cerebrospinal fluid ratio. Grade A stenosis: there is clearly cerebrospinal fluid (CSF) visible inside the dural sac, but its distribution is inhomogeneous.; Grade B stenosis: the rootlets occupy the whole of the dural sac, but they can still be individualized. Some CSF is still present.; Grade C stenosis: no rootlets can be recognized, the dural sac demonstrating a homogeneous gray signal with no CSF signal visible. There is epidural fat present posteriorly.; Grade D stenosis: in addition to no rootlets being recognizable there is no epidural fat posteriorly. Grade A is defined as no or minor stenosis, B as moderate stenosis, C as severe stenosis, and D as extreme stenosis.	the day before decompression surgery