The Role of Lumbar Multifidus Characteristics in the Development of Low Back Pain

Low back pain (LBP) is a severe epidemic in the world. Despite its high prevalence, 90% of the cases have no identifiable cause. Approximately 44% of them experience recurrent LBP within one year and 10% of them develop chronic LBP that lasts for three months or more.

Mechanically, the lumbar spine is unstable and requires spinal muscle to maintain spinal stability and to prevent injuries. Lumbar multifidus (LM) muscle is thought to be the major spinal stabilizer responsible for spinal stability and spinal proprioception. Prior studies have revealed that increased fat infiltration, atrophy or activation deficits of LM in patients with LBP as compared to asymptomatic individuals. Unfortunately, inconsistent findings have also been reported.

Although prior research attempted to determine if abnormal LM characteristics can inform clinical decision-making, their results are limited because they only investigated a single LM characteristic at a time, which might not reflect the actual LM condition. Further, many studies adopted cross-sectional design that could not reveal the casual relations between abnormal LM characteristics and LBP. As such, the current study aims to identify specific LM characteristics that can predict new episode of LBP in asymptomatic individuals, and recurrent/chronic LBP in individuals with LBP at baseline.

Study Overview

• Status: Recruiting
• Conditions: Low Back Pain

Detailed Description

Low back pain (LBP) is a severe epidemic in the world. Despite its high prevalence, 90% of the cases have no identifiable cause. While most people with LBP recover shortly after onset, approximately 44% of them experience recurrent LBP within one year and 10% of them develop chronic LBP that lasts for three months or more.

Mechanically, the lumbar spine is unstable and requires spinal muscle to maintain spinal stability and to prevent injuries. Lumbar multifidus (LM) muscle is thought to be the major spinal stabilizer responsible for spinal stability and spinal proprioception. Different cross-sectional studies have revealed that increased fat infiltration, atrophy or activation deficits of LM in patients with LBP as compared to asymptomatic individuals. Research has shown that abnormal morphology or activation of LM is associated with LBP intensity/location, or LBP-related disability. Unfortunately, inconsistent findings have also been reported.

Although prior research attempted to determine if abnormal LM characteristics can inform clinical decision-making, their results are limited because they only investigated a single LM characteristic at a time, which might not reflect the actual LM condition. Further, many studies adopted cross-sectional design that could not reveal the casual relations between abnormal LM characteristics and LBP.

Given the above, the current study aims to identify specific LM characteristics that can predict new episode of LBP in asymptomatic individuals, and recurrent/chronic LBP in individuals with LBP at baseline.

• Study Type: Observational
• Enrollment (Anticipated): 140

Contacts and Locations

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Recruiting
    • Queen Mary Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Symptomatic participants should have LBP that requires medical consultation(s) in the last three months, and have LBP intensity of at least 5 on the 11-point numeric pain rating scale at baseline.

Asymptomatic participants should be pain free at baseline, and should not have LBP in the last year nor LBP lasting more than a week in the last 3 years.

Description

Inclusion Criteria:

• aged 18 to 65 years
• Symptomatic participants should have LBP that requires medical consultation(s) in the last three months
• LBP intensity of at least 5 on the 11-point numeric pain rating scale at baseline (for symptomatic participants)
• Asymptomatic participants should be pain free at baseline, and should not have LBP in the last year nor LBP lasting more than a week in the last 3 years

Exclusion Criteria:

• a history of neurological disease or vestibular impairment
• systemic inflammatory disease
• prior spinal surgery
• acute/chronic neuropathy or radiculopathy
• spinal infections/fractures/tumors, metabolic disorders,
• medical 'red flags'

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Low back pain group; Participants will be followed up over 2 years to monitor the course of low back pain
Asymptomatic group; Participants will be followed up over 2 years to monitor the incidence and course of low back pain

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
11-point numeric pain rating scale (NPRS) for low back pain	The current pain intensity of each participant will be quantified by an 11-point NPRS, where 0 means no pain and 10 means the worst imaginable pain.	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Morphometry of lumbar multifidus	B-mode ultrasound imaging will be used to quantify morphometry of multifidus	2 years
Proprioception of lumbar multifidus	An established protocol to measure proprioception of lumbar multifidus	2 years
Stiffness of lumbar multifidus	Elastography will be used to measure lumbar multifidus stiffness	2 years
Fatty infiltration of lumbar multifidus	Magnetic resonance imaging will be used to quantify the fatty infiltration of multifidus	2 years

Collaborators and Investigators

• Sponsor: The Hong Kong Polytechnic University
• Collaborators: The University of Hong Kong; University of Oulu; Rush University; Zurich University of Applied Sciences; Concordia University, Montreal

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2017
• Primary Completion (Anticipated): March 31, 2022
• Study Completion (Anticipated): June 30, 2022

Study Registration Dates

• First Submitted: December 23, 2017
• First Submitted That Met QC Criteria: December 23, 2017
• First Posted (Actual): January 2, 2018

Study Record Updates

• Last Update Posted (Actual): February 10, 2021
• Last Update Submitted That Met QC Criteria: February 8, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Low back pain; Magnetic resonance imaging; Elastography; Proprioception; lumbar multifidus
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: HSEARS20151027007

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