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
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Back Pain
• Chronic Low Back Pain
• Low Back Pain

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