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

NCT ID: NCT03387930

Last Updated: 2021-02-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

140 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-08-01

Study Completion Date

2022-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Low Back Pain

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Low back pain group

Participants will be followed up over 2 years to monitor the course of low back pain

No interventions assigned to this group

Asymptomatic group

Participants will be followed up over 2 years to monitor the incidence and course of low back pain

No interventions assigned to this group

Eligibility Criteria

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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'
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Oulu

OTHER

Sponsor Role collaborator

The University of Hong Kong

OTHER

Sponsor Role collaborator

Rush University

OTHER

Sponsor Role collaborator

Concordia University, Montreal

OTHER

Sponsor Role collaborator

Zurich University of Applied Sciences

OTHER

Sponsor Role collaborator

The Hong Kong Polytechnic University

OTHER

Sponsor Role lead

Responsible Party

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Dr Arnold Wong Yu Lok

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Arnold Wong, PhD

Role: PRINCIPAL_INVESTIGATOR

The Hong Kong Polytechnic University

Locations

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Queen Mary Hospital

Hong Kong, , Hong Kong

Site Status RECRUITING

Countries

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Hong Kong

Central Contacts

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Arnold Wong, PhD

Role: CONTACT

852-2766-6741

Facility Contacts

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Jason Cheung, MBBS

Role: primary

852-2255-4581

Other Identifiers

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HSEARS20151027007

Identifier Type: -

Identifier Source: org_study_id

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