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

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 Overview

• Status: Unknown
• Conditions: Low Back Pain; Chronic Low Back Pain

• Study Type: Observational
• Enrollment (Anticipated): 60

Contacts and Locations

Study Locations

• Belgium
  • Leuven, Belgium, 3000
    • Recruiting
    • University Hospitals Leuven
    • Contact: Sofie Rummens, MD; Email: sofie.rummens@uzleuven.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Leuven and surroudings

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Low back pain group; Individuals with non-specific chronic low back pain
Healthy control group; Healthy individuals without low back pain

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: KU Leuven
• Collaborators: Universitaire Ziekenhuizen KU Leuven

Study record dates

Study Major Dates

• Study Start (Actual): July 27, 2020
• Primary Completion (Anticipated): May 1, 2021
• Study Completion (Anticipated): May 1, 2021

Study Registration Dates

• First Submitted: July 26, 2018
• First Submitted That Met QC Criteria: July 26, 2018
• First Posted (Actual): August 2, 2018

Study Record Updates

• Last Update Posted (Actual): October 19, 2020
• Last Update Submitted That Met QC Criteria: October 16, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: s60404

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No