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

NCT ID: NCT03951935

Last Updated: 2022-03-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

39 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-04-17

Study Completion Date

2021-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Symptomatic Lumbar Spinal Stenosis Lumbar Spinal Stenosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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sLSS

patients diagnosed with sLSS scheduled for decompression surgery

Oswestry Disability Index (ODI) questionnaire

Intervention Type 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

self-paced walking test (SPWT)

Intervention Type 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

healthy, age-matched control subjects

Oswestry Disability Index (ODI) questionnaire

Intervention Type 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

self-paced walking test (SPWT)

Intervention Type 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.

Interventions

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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

Intervention Type OTHER

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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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
Minimum Eligible Age

30 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Klinik für Radiologie und Nuklearmedizin, University Hospital Basel

UNKNOWN

Sponsor Role collaborator

University Hospital, Basel, Switzerland

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Annegret Muendermann, Prof. Dr. MD

Role: PRINCIPAL_INVESTIGATOR

Department of Orthopaedics and Traumatology, University Hospital Basel

Locations

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Department of Orthopaedics and Traumatology, University Hospital Basel

Basel, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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2019-00331; ch19Muendermann2

Identifier Type: -

Identifier Source: org_study_id

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