Clinical trial NCT03951935: Muscle Function and Pelvic Stability While Walking in Patients With Symptomatic Lumbar Spinal Stenosis
Official title: WALK-LSS - Muscle Function and Pelvic Stability While Walking in Patients With Symptomatic Lumbar Spinal Stenosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Symptomatic Lumbar Spinal Stenosis
Lumbar Spinal Stenosis
Keywords: pelvic stability
lumbo- pelvic- hip complex
lumbo-pelvic-hip muscles
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
Collaborators: name: Klinik für Radiologie und Nuklearmedizin, University Hospital Basel
First posted: 2019-05-16
Enrollment: 39
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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

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.


Eligibility criteria: 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

Primary outcomes:
measure: Oswestry Disability Index (ODI) questionnaire
timeFrame: the day before decompression surgery
measure: Muscle activation assessed by Electromyography (EMG)
timeFrame: scheduled the day before decompression surgery
measure: Pelvic stability
timeFrame: the day before decompression surgery
measure: Cross-sectional area (CSA) of lumbo-pelvic-hip muscles
timeFrame: the day before decompression surgery
measure: Fatty atrophy of lumbo-pelvic-hip muscles
timeFrame: the day before decompression surgery
measure: walking capacity assessed by self-paced walking test distance (SPWT)
timeFrame: the day before decompression surgery
measure: Grading of Severity of Lumbar Spinal Stenosis using the classification by Schizas
timeFrame: the day before decompression surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Department of Orthopaedics and Traumatology, University Hospital Basel
Study officials:
affiliation: Department of Orthopaedics and Traumatology, University Hospital Basel
name: Annegret Muendermann, Prof. Dr. MD
role: PRINCIPAL_INVESTIGATOR
References: