Low Back PainNCT03612089
From Structural to Functional Characteristics of the Lumbar Multifidus in Low Back Pain
An observational study of Low Back Pain and Chronic Low Back Pain, run by KU Leuven at 1 site in Belgium.
Trial summary
To delineate the underlying mechanisms that contribute to chronic low back pain, by extending our knowledge on structural characteristics of the lumbar multifidus muscle using ultrasound muscle imaging, and by examining the association of structural features with functional performance, more precisely proprioceptive… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain, Chronic Low Back Pain
- How many people
- 60 participants
- Where
- 1 siteBelgium
- Study dates
- 27 Jul 2020to May 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Leuven and surroudings
Who may be able to join
- Non-specific low back pain, during 3 or more months, without radicular leg pain
- Modified Low Back Pain Disability Questionnaire > 20%
- Indication for MRI of the lumbar spine
- No contra-indications for MRI
- Informed consent to participate
- No history of low back pain needing medical treatment or resulting in limited activity level
- Any low back pain in the previous 3 months
- Informed consent to participate
Who cannot join
- Pregnancy
- Previous trauma or surgery to spine, abdomen or pelvis
- Structural deformity (e.g. scoliosis)
- Neurological/neuromuscular/systemic disease
- Inability to lie prone for 20 minutes
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
University Hospitals Leuven
Leuven, 3000
Sofie Rummens, MD, sofie.rummens@uzleuven.be
About this study
To delineate the underlying mechanisms that contribute to chronic low back pain, by extending our knowledge on structural characteristics of the lumbar multifidus muscle using ultrasound muscle imaging, and by examining the association of structural features with functional performance, more precisely proprioceptive control.
- Conditions
- Low Back Pain, Chronic Low Back Pain
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Low back pain group | Individuals with non-specific chronic low back pain | |
| Healthy control group | Healthy individuals without low back pain |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lumbar multifidus muscle volume measured by 3DfUS
in patients with chronic low back pain
Measured: immediately after inclusion in the study
Lumbar multifidus muscle volume measured by MRI
in patients with chronic low back pain
Measured: immediately after inclusion in the study
Cross-sectional area of the lumbar multifidus
measured by classic 2D-ultrasound in patients with chronic low back pain and healthy controls
Measured: immediately after inclusion in the study
Thickness of the lumbar multifidus
measured by classic 2D-ultrasound in patients with chronic low back pain and healthy controls
Measured: immediately after inclusion in the study
Proprioceptive postural control strategies in patients with low back pain with healthy controls
Mean center-of-pressure displacement in response to soleus muscle and/or multifidus muscle vibration (60 Hz, 0.5 mm) during upright standing on two support surfaces.
Measured: immediately after inclusion in the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2018
- Study start27 Jul 2020
- Primary completionMay 2021 (estimated)
- Study completionMay 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by KU LeuvenThe 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- Universitaire Ziekenhuizen KU Leuven
- Responsible party
- Principal investigator, Sofie Rummens, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03612089
- Sponsor's protocol ID
- s60404
- Status last verified
- Oct 2020
- First submitted
- 26 Jul 2018
- Last updated
- 19 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- From Structural to Functional Characteristics of the Lumbar Multifidus in Low Back Pain
- ClinicalTrials.gov ID
- NCT03612089
- Acronym / sponsor ID
- s60404
- Conditions
- Low Back Pain, Chronic Low Back Pain
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Collaborators
- Universitaire Ziekenhuizen KU Leuven
- Study start
- 27 Jul 2020 (actual)
- Primary completion
- May 2021 (estimated)
- Study completion
- May 2021 (estimated)
- First posted
- 2 Aug 2018 (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.
To delineate the underlying mechanisms that contribute to chronic low back pain, by extending our knowledge on structural characteristics of the lumbar multifidus muscle using ultrasound muscle imaging, and by examining the association of structural features with functional performance, more precisely proprioceptive control.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low back pain group | – | –Individuals with non-specific chronic low back pain |
| Healthy control group | – | –Healthy individuals without low back pain |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Leuven and surroudings
Key inclusion criteria (8 listed)
- Non-specific low back pain, during 3 or more months, without radicular leg pain
- Modified Low Back Pain Disability Questionnaire > 20%
- Indication for MRI of the lumbar spine
- No contra-indications for MRI
- Informed consent to participate
Key exclusion criteria (5 listed)
- Pregnancy
- Previous trauma or surgery to spine, abdomen or pelvis
- Structural deformity (e.g. scoliosis)
- Neurological/neuromuscular/systemic disease
- Inability to lie prone for 20 minutes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Lumbar multifidus muscle volume measured by 3DfUS
Time frame: immediately after inclusion in the study
in patients with chronic low back pain
Lumbar multifidus muscle volume measured by MRI
Time frame: immediately after inclusion in the study
in patients with chronic low back pain
Cross-sectional area of the lumbar multifidus
Time frame: immediately after inclusion in the study
measured by classic 2D-ultrasound in patients with chronic low back pain and healthy controls
Thickness of the lumbar multifidus
Time frame: immediately after inclusion in the study
measured by classic 2D-ultrasound in patients with chronic low back pain and healthy controls
Proprioceptive postural control strategies in patients with low back pain with healthy controls
Time frame: immediately after inclusion in the study
Mean center-of-pressure displacement in response to soleus muscle and/or multifidus muscle vibration (60 Hz, 0.5 mm) during upright standing on two support surfaces.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2020.
- Individual participant dataSharing planned: No
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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.
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 Low Back Pain and Chronic Low Back Pain, run by KU Leuven at 1 site in Belgium.
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 8 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 19 Oct 2020. 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 Belgium. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sofie Rummens, MD (+3216342180, sofie.rummens@uzleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lumbar multifidus muscle volume measured by 3DfUS (time frame: immediately after inclusion in the study). The study lists 5 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 19 Oct 2020.