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NCT03612089 Clinical Trial

From Structural to Functional Characteristics of the Lumbar Multifidus in Low Back Pain

Low Back Pain Clinical Trial

Official title:
From Structural to Functional Characteristics of the Lumbar Multifidus in Low Back Pain

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03612089
Other study ID # s60404
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date July 27, 2020
Est. completion date May 2021

Study information
Verified date October 2020
Source KU Leuven
Contact Sofie Rummens, MD
Phone +3216342180
Email sofie.rummens@uzleuven.be
Is FDA regulated No
Health authority
Study type Observational

Clinical 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 control.

Recruitment information / eligibility
Status Recruiting
Enrollment 60
Est. completion date May 2021
Est. primary completion date May 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 60 Years
Eligibility Inclusion criteria for chronic low back pain group: - 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 Inclusion criteria for healthy control group: - 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 Exclusion criteria for all subjects: - 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Belgium University Hospitals Leuven Leuven

Sponsors (2)
Lead Sponsor Collaborator
KU Leuven Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

Outcome
Type Measure Description Time frame Safety issue
Primary Lumbar multifidus muscle volume measured by 3DfUS in patients with chronic low back pain immediately after inclusion in the study
Primary Lumbar multifidus muscle volume measured by MRI in patients with chronic low back pain immediately after inclusion in the study
Primary 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
Primary 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
Primary 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
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