Lumbar Spinal StenosisMuscLSSNCT05309447
Effect of Muscle Fatigue on Spinal Imbalance and Motion in Lumbar Spinal Stenosis
An observational study of Lumbar Spinal Stenosis, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
This study assesses spinal imbalance and motion in patients with sLSS and elicits fatigue via back exercises and compares spinal imbalance and motion before and after the fatigue exercise and compares these to healthy controls, allowing to associate sLSS-specific motion patterns to paraspinal muscle fatigue. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lumbar Spinal Stenosis
- What is being tested?
- data collection
- How many people
- 30 participants
- Where
- 1 siteSwitzerland
- Study dates
- 11 Nov 2021to 31 Dec 2024
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with sLSS will be recruited at the Department of Spine Surgery at the University Hospital Basel. Healthy participants will be recruited via advertisement on the institutional website and the University of Basel marketplace.
Who may be able to join
- age > 30 years
- BMI < 35kg/m2
- diagnosed symptomatic lumbar spinal stenosis
- clinical symptoms for at least 6 months
- intermittent neurogenic claudication with limitations of their walking ability due to symptoms in the lower back and or in one or both legs
- unsuccessful conservative treatment
Show all 12Show fewer
- confirmation of the LSS through MRI
- Inclusion criteria for age-matched healthy control subjects
- age > 30 years
- BMI < 35kg/m2
- 18 years ≤ age ≤ 30 years
- BMI < 35kg/m2
Who cannot join
- inability to provide informed consent
- previous spine surgery
- use of walking aids
- other neurologic disorders affecting gait
- MRI incompatibility
- Exclusion criteria for age-matched healthy control subjects
Show all 16Show fewer
- inability to provide informed consent
- previous spine surgery
- history of claudications
- use of walking aids
- other neurological or orthopaedic conditions that may affect gait
- MRI incompatibility
- inability to provide informed consent
- previous back injury; previous spine surgery
- use of walking aids
- current injury of any kind
Trial locations and contacts
1 site in 1 country.
About this study
Official title: MuscLSS: Effect of Muscle Fatigue on Spinal Imbalance and Motion in Lumbar Spinal Stenosis: Single Center Observational Pilot Study
This study assesses spinal imbalance and motion in patients with sLSS and elicits fatigue via back exercises and compares spinal imbalance and motion before and after the fatigue exercise and compares these to healthy controls, allowing to associate sLSS-specific motion patterns to paraspinal muscle fatigue.
Read the detailed description
Symptomatic lumbar spinal stenosis (sLSS) is a common syndrome affecting the human spine characterized by age related degeneration of the lumbar discs and facet joints resulting in pain, limited function and compromised quality of life. In a healthy spine, global and local spinal loads during static posture and dynamic motion will have minimal effects on the spinal canal. However, spinal loads altered by the presence of sLSS may result in further narrowing of the spinal canal and compression of the neural elements or in overloading of the already degenerated lumbar segments possibly eliciting typical pain symptoms. This study assesses spinal imbalance and motion in patients with sLSS and elicits fatigue via back exercises and compares spinal imbalance and motion before and after the fatigue exercise and compares these to healthy controls, allowing to associate sLSS-specific motion patterns to paraspinal muscle fatigue. Additional data generated using magnetic resonance tomography allows detecting and assessing differences in muscle degeneration between sLSS patients and healthy controls. Radiological images from the spine in upright position using EOS, a specialized low-dose x-ray unit will be obtained to allow the calculation of the actual clinical global and local spinal imbalance. Furthermore, this study investigates the outcome of the decompression surgery during a second study visit scheduled 1 year postoperatively. The data obtained here are pilot data that will be critical for designing a larger clinical trial and produce important information for adapting musculoskeletal spine models to simulate spinal imbalance and motion and further defining meaningful outcome parameters.
- Conditions
- Lumbar Spinal Stenosis
- Being tested
- data collection
- Keywords
- Symptomatic Lumbar spinal stenosis (sLSS), Spinal motion, Spinal loading, Spinal imbalance, Paraspinal muscle fatigue, Muscle degeneration, EOS medical imaging
- Medical subject headings
- Spinal Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
data collectionOther
The study entails the collection of clinical, functional, radiological, and biomechanical data.
| Study group | Role | What they receive |
|---|---|---|
| Patients with sLSS | Patients with Symptomatic Lumbar Spinal Stenosis (n=10) Receives: Other: data collection | |
| Young Controls | Young healthy control subjects (n=10) Receives: Other: data collection | |
| Age-Matched Controls | Age-matched healthy control subjects (n=10) Receives: Other: data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global spinal imbalance assessed using motion capture
Global spinal imbalance calculated from markers placed on specific anatomical landmarks: electromyographic (EMG) electrode placement bilaterally on the multifidus, erector spinae (longissimus), erector spinae (iliocostalis), transversus abdominis, gluteus medius, vastus medialis, tibialis anterior and gastrocnemius medialis muscles. The curvature of the lumbar region during natural stance, natural seated posture, maximum trunk flexion, maximum trunk extension and during walking will be computed from the marker data. A cubic polynomial function will be fit to the marker positions in each time frame, approximating an S-shaped spine curvature with thoracic kyphosis and lumbar lordosis curves and the curvature of the lumbar spine will be computed for each task.
Measured: approximate duration: 30 minutes at baseline and at 1 year after decompression surgery for patients with sLSS
Secondary outcomes (3)
Global spinal imbalance assessed using EOS (upright standing sagittal plane EOS images of the full body including entire spine and pelvis)
Static global and local spinal imbalance will be assessed on the EOS images as the C7 plumb line (C7PL), sagittal vertical axis (SVA) and spinosacral angle (SSA). The discrepancy between SSA and SVA are a sign of the prevalence of static compensation mechanism. The correction angle to a balanced situation will be measured using the full balance integrated method.
Measured: approximate duration: 10 minutes at baseline and at 1 year after decompression surgery for patients with sLSS
Dynamic global spinal imbalance
Dynamic spinal imbalance will be assessed as the difference between spinal imbalance during walking compared to standing.
Measured: one time assessment at baseline and at 1 year after decompression surgery for patients with sLSS
Difference in global spinal imbalance between the fatigued and non-fatigued state
The curvature of the lumbar region between the fatigued and non-fatigued state will be computed from the marker data.
Measured: one time assessment at baseline and at 1 year after decompression surgery for patients with sLSS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2022
- Study start11 Nov 2021
- Primary completion30 May 2023
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lumbar Spinal StenosisStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cordula Netzer, PD Dr. med., Principal investigator, Spine Center, University Hospital Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05309447
- Sponsor's protocol ID
- 2021-02012; mu22Netzer2
- Acronym
- MuscLSS
- Status last verified
- Feb 2025
- First submitted
- 22 Mar 2022
- Last updated
- 3 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Koch D, Nuesch C, Ignasiak D, Scharen S, Ferguson SJ, Mundermann A, Netzer C. Age and activity but not lumbar spinal stenosis and muscle fatigue affect sagittal spinal alignment: A pilot study. Clin Biomech (Bristol). 2025 Jul;127:106577. doi: 10.1016/j.clinbiomech.2025.106577. Epub 2025 Jun 1.
PubMed 40472708
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MuscLSS: Effect of Muscle Fatigue on Spinal Imbalance and Motion in Lumbar Spinal Stenosis: Single Center Observational Pilot Study
- ClinicalTrials.gov ID
- NCT05309447
- Acronym / sponsor ID
- MuscLSS / 2021-02012; mu22Netzer2
- Conditions
- Lumbar Spinal Stenosis
- Keywords
- Symptomatic Lumbar spinal stenosis (sLSS), Spinal motion, Spinal loading, Spinal imbalance, Paraspinal muscle fatigue, Muscle degeneration, EOS medical imaging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 11 Nov 2021 (actual)
- Primary completion
- 30 May 2023 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 4 Apr 2022 (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 assesses spinal imbalance and motion in patients with sLSS and elicits fatigue via back exercises and compares spinal imbalance and motion before and after the fatigue exercise and compares these to healthy controls, allowing to associate sLSS-specific motion patterns to paraspinal muscle fatigue.
Detailed description
Symptomatic lumbar spinal stenosis (sLSS) is a common syndrome affecting the human spine characterized by age related degeneration of the lumbar discs and facet joints resulting in pain, limited function and compromised quality of life. In a healthy spine, global and local spinal loads during static posture and dynamic motion will have minimal effects on the spinal canal. However, spinal loads altered by the presence of sLSS may result in further narrowing of the spinal canal and compression of the neural elements or in overloading of the already degenerated lumbar segments possibly eliciting typical pain symptoms. This study assesses spinal imbalance and motion in patients with sLSS and elicits fatigue via back exercises and compares spinal imbalance and motion before and after the fatigue exercise and compares these to healthy controls, allowing to associate sLSS-specific motion patterns to paraspinal muscle fatigue. Additional data generated using magnetic resonance tomography allows detecting and assessing differences in muscle degeneration between sLSS patients and healthy controls. Radiological images from the spine in upright position using EOS, a specialized low-dose x-ray unit will be obtained to allow the calculation of the actual clinical global and local spinal imbalance. Furthermore, this study investigates the outcome of the decompression surgery during a second study visit scheduled 1 year postoperatively. The data obtained here are pilot data that will be critical for designing a larger clinical trial and produce important information for adapting musculoskeletal spine models to simulate spinal imbalance and motion and further defining meaningful outcome parameters.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients with sLSS | – | Other: data collectionPatients with Symptomatic Lumbar Spinal Stenosis (n=10) |
| Young Controls | – | Other: data collectionYoung healthy control subjects (n=10) |
| Age-Matched Controls | – | Other: data collectionAge-matched healthy control subjects (n=10) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with sLSS will be recruited at the Department of Spine Surgery at the University Hospital Basel. Healthy participants will be recruited via advertisement on the institutional website and the University of Basel marketplace.
Key inclusion criteria (12 listed)
- age > 30 years
- BMI < 35kg/m2
- diagnosed symptomatic lumbar spinal stenosis
- clinical symptoms for at least 6 months
- intermittent neurogenic claudication with limitations of their walking ability due to symptoms in the lower back and or in one or both legs
Key exclusion criteria (16 listed)
- inability to provide informed consent
- previous spine surgery
- use of walking aids
- other neurologic disorders affecting gait
- MRI incompatibility
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 |
|---|---|---|
| data collectionThe study entails the collection of clinical, functional, radiological, and biomechanical data. | Other | Age-Matched Controls, Patients with sLSS, Young Controls |
Primary outcome
Global spinal imbalance assessed using motion capture
Time frame: approximate duration: 30 minutes at baseline and at 1 year after decompression surgery for patients with sLSS
Global spinal imbalance calculated from markers placed on specific anatomical landmarks: electromyographic (EMG) electrode placement bilaterally on the multifidus, erector spinae (longissimus), erector spinae (iliocostalis), transversus abdominis, gluteus medius, vastus medialis, tibialis anterior and gastrocnemius medialis muscles. The curvature of the lumbar region during natural stance, natural seated posture, maximum trunk flexion, maximum trunk extension and during walking will be computed from the marker data. A cubic polynomial function will be fit to the marker positions in each time frame, approximating an S-shaped spine curvature with thoracic kyphosis and lumbar lordosis curves and the curvature of the lumbar spine will be computed for each task.
3 secondary outcomes
Global spinal imbalance assessed using EOS (upright standing sagittal plane EOS images of the full body including entire spine and pelvis)
Time frame: approximate duration: 10 minutes at baseline and at 1 year after decompression surgery for patients with sLSS
Dynamic global spinal imbalance
Time frame: one time assessment at baseline and at 1 year after decompression surgery for patients with sLSS
Difference in global spinal imbalance between the fatigued and non-fatigued state
Time frame: one time assessment at baseline and at 1 year after decompression surgery for patients with sLSS
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 2025.
- Derived from this study: PubMed 40472708Koch D, Nuesch C, Ignasiak D, Scharen S, Ferguson SJ, Mundermann A, Netzer C. Age and activity but not lumbar spinal stenosis and muscle fatigue affect sagittal spinal alignment: A pilot study. Clin Biomech (Bristol). 2025 Jul;127:106577. doi: 10.1016/j.clinbiomech.2025.106577. Epub 2025 Jun 1.
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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.
Cordula Netzer, PD Dr. med. principal investigator
Spine Center, 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 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 12 inclusion and 16 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 2025. 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?
Global spinal imbalance assessed using motion capture (time frame: approximate duration: 30 minutes at baseline and at 1 year after decompression surgery for patients with sLSS). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05309447, which also lists 1 linked publication.
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 2025.