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

Low Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03387930
• Other study ID #: HSEARS20151027007
• Status: Recruiting
• Start date: August 1, 2017
• Est. completion date: June 30, 2022

Study information

• Verified date: February 2021
• Source: The Hong Kong Polytechnic University
• Contact: Arnold Wong, PhD
• Phone: 852-2766-6741
• Email: arnold.wong[@]polyu.edu.hk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: June 30, 2022
• Est. primary completion date: March 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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'

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Locations

Country	Name	City	State
Hong Kong	Queen Mary Hospital	Hong Kong

Sponsors (6)

Lead Sponsor	Collaborator
The Hong Kong Polytechnic University	Concordia University, Montreal, Rush University, The University of Hong Kong, University of Oulu, Zurich University of Applied Sciences

Country where clinical trial is conducted

Hong Kong, 

Outcome

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