From Structural to Functional Characteristics of the Lumbar Multifidus in Low Back Pain
1 other identifier
observational
60
1 country
1
Brief 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 control.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jul 2020
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 26, 2018
CompletedFirst Posted
Study publicly available on registry
August 2, 2018
CompletedStudy Start
First participant enrolled
July 27, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2021
CompletedOctober 19, 2020
October 1, 2020
9 months
July 26, 2018
October 16, 2020
Conditions
Outcome Measures
Primary Outcomes (5)
Lumbar multifidus muscle volume measured by 3DfUS
in patients with chronic low back pain
immediately after inclusion in the study
Lumbar multifidus muscle volume measured by MRI
in patients with chronic low back pain
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
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
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.
immediately after inclusion in the study
Study Arms (2)
Low back pain group
Individuals with non-specific chronic low back pain
Healthy control group
Healthy individuals without low back pain
Eligibility Criteria
Leuven and surroudings
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- KU Leuvenlead
- Universitaire Ziekenhuizen KU Leuvencollaborator
Study Sites (1)
University Hospitals Leuven
Leuven, 3000, Belgium
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
July 26, 2018
First Posted
August 2, 2018
Study Start
July 27, 2020
Primary Completion
May 1, 2021
Study Completion
May 1, 2021
Last Updated
October 19, 2020
Record last verified: 2020-10
Data Sharing
- IPD Sharing
- Will not share