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

NCT03951935 | Completed

• 1 other identifier: 2019-00331; ch19Muendermann2
• Study Type: observational
• Target: 39
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Symptomatic Lumbar Spinal Stenosis; Lumbar Spinal Stenosis

Keywords

pelvic stability; lumbo- pelvic- hip complex; lumbo-pelvic-hip muscles

Outcome Measures

Primary Outcomes (7)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

Study Arms (2)

sLSS

patients diagnosed with sLSS scheduled for decompression surgery

Other: Oswestry Disability Index (ODI) questionnaire; Diagnostic Test: self-paced walking test (SPWT)

control subjects

healthy, age-matched control subjects

Other: Oswestry Disability Index (ODI) questionnaire; Diagnostic Test: self-paced walking test (SPWT)

Interventions

Oswestry Disability Index (ODI) questionnaire OTHER

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

control subjects; sLSS

self-paced walking test (SPWT) DIAGNOSTIC_TEST

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.

control subjects; sLSS

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

* 20 patients diagnosed with sLSS scheduled for decompression surgery at the University Hospital Basel * 20 healthy, age-matched control subjects

You may qualify if:

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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead
• Klinik für Radiologie und Nuklearmedizin, University Hospital Basel: collaborator

Study Sites (1)

Department of Orthopaedics and Traumatology, University Hospital Basel

Basel, 4031, Switzerland

Location

MeSH Terms

Conditions

Spinal Stenosis

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Annegret Muendermann, Prof. Dr. MD

  Department of Orthopaedics and Traumatology, University Hospital Basel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2019
• First Posted: May 16, 2019
• Study Start: April 17, 2019
• Primary Completion: August 27, 2020
• Study Completion: December 31, 2021
• Last Updated: March 3, 2022

Record last verified: 2022-03

Locations

CH (1)