Symptomatic Lumbar Spinal StenosisWALK-LSSNCT03951935
Muscle Function and Pelvic Stability While Walking in Patients With Symptomatic Lumbar Spinal Stenosis
An observational study of Symptomatic Lumbar Spinal Stenosis and Lumbar Spinal Stenosis, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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… Read more about this study
- Who is it for?
- Ages 30 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Symptomatic Lumbar Spinal Stenosis, Lumbar Spinal Stenosis
- What is being tested?
- Oswestry Disability Index (ODI) questionnaire and self-paced walking test (SPWT)
- How many people
- 39 participants
- Where
- 1 siteSwitzerland
- Study dates
- 17 Apr 2019to 31 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: * 20 patients diagnosed with sLSS scheduled for decompression surgery at the University Hospital Basel * 20 healthy, age-matched control subjects
Who may be able to join
- Diagnosed symptomatic lumbar spinal stenosis
- Availability of lumbar MR images
- Scheduled for decompressive surgery at the University Hospital Basel
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Department of Orthopaedics and Traumatology, University Hospital Basel
Basel, 4031
About this study
Official title: WALK-LSS - Muscle Function and Pelvic Stability While Walking in Patients With Symptomatic Lumbar Spinal Stenosis
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.
- Being tested
- Oswestry Disability Index (ODI) questionnaire, self-paced walking test (SPWT)
- Keywords
- pelvic stability, lumbo- pelvic- hip complex, lumbo-pelvic-hip muscles
- Medical subject headings
- Spinal Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oswestry Disability Index (ODI) questionnaireOther
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)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.
| Study group | Role | What they receive |
|---|---|---|
| sLSS | patients diagnosed with sLSS scheduled for decompression surgery Receives: Other: Oswestry Disability Index (ODI) questionnaire; Diagnostic Test: self-paced walking test (SPWT) | |
| control subjects | healthy, age-matched control subjects Receives: Other: Oswestry Disability Index (ODI) questionnaire; Diagnostic Test: self-paced walking test (SPWT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: the day before decompression surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2019
- Study start17 Apr 2019
- Primary completion27 Aug 2020
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Symptomatic Lumbar Spinal StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Annegret Muendermann, Prof. Dr. MD, Principal investigator, Department of Orthopaedics and Traumatology, University Hospital Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03951935
- Sponsor's protocol ID
- 2019-00331; ch19Muendermann2
- Other IDs
- 2019
- Acronym
- WALK-LSS
- Status last verified
- Mar 2022
- First submitted
- 6 May 2019
- Last updated
- 3 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- WALK-LSS - Muscle Function and Pelvic Stability While Walking in Patients With Symptomatic Lumbar Spinal Stenosis
- ClinicalTrials.gov ID
- NCT03951935
- Acronym / sponsor ID
- WALK-LSS / 2019-00331; ch19Muendermann2
- Keywords
- pelvic stability, lumbo- pelvic- hip complex, lumbo-pelvic-hip muscles
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 17 Apr 2019 (actual)
- Primary completion
- 27 Aug 2020 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 16 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sLSS | – | Other: Oswestry Disability Index (ODI) questionnaire, Diagnostic Test: self-paced walking test (SPWT)patients diagnosed with sLSS scheduled for decompression surgery |
| control subjects | – | Other: Oswestry Disability Index (ODI) questionnaire, Diagnostic Test: self-paced walking test (SPWT)healthy, age-matched control subjects |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- * 20 patients diagnosed with sLSS scheduled for decompression surgery at the University Hospital Basel * 20 healthy, age-matched control subjects
Key inclusion criteria (3 listed)
- Diagnosed symptomatic lumbar spinal stenosis
- Availability of lumbar MR images
- Scheduled for decompressive surgery at the University Hospital Basel
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oswestry Disability Index (ODI) questionnaireParticipant'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 | Other | control subjects, sLSS |
| 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. | Diagnostic test | control subjects, sLSS |
Primary outcome
Oswestry Disability Index (ODI) questionnaire
Time frame: the day before decompression surgery
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.
Muscle activation assessed by Electromyography (EMG)
Time frame: scheduled the day before decompression surgery
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)
Pelvic stability
Time frame: the day before decompression surgery
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.
Cross-sectional area (CSA) of lumbo-pelvic-hip muscles
Time frame: the day before decompression surgery
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.
Fatty atrophy of lumbo-pelvic-hip muscles
Time frame: the day before decompression surgery
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.
walking capacity assessed by self-paced walking test distance (SPWT)
Time frame: the day before decompression surgery
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.
Grading of Severity of Lumbar Spinal Stenosis using the classification by Schizas
Time frame: the day before decompression surgery
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Annegret Muendermann, Prof. Dr. MD principal investigator
Department of Orthopaedics and Traumatology, University Hospital Basel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Symptomatic Lumbar Spinal Stenosis and Lumbar Spinal Stenosis, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oswestry Disability Index (ODI) questionnaire (time frame: the day before decompression surgery). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2022.