Clinical trial NCT03387930: The Role of Lumbar Multifidus Characteristics in the Development of Low Back Pain
Official title: The Role of Lumbar Multifidus Characteristics in the Development of Low Back Pain
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Low Back Pain
Keywords: Low back pain
lumbar multifidus
Proprioception
Elastography
Magnetic resonance imaging
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
Collaborators: name: University of Oulu
name: The University of Hong Kong
name: Rush University
name: Concordia University, Montreal
name: Zurich University of Applied Sciences
First posted: 2018-01-02
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

Brief 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.

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.

Eligibility criteria: 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'

Primary outcomes:
measure: 11-point numeric pain rating scale (NPRS) for low back pain
timeFrame: 2 years
Secondary outcomes:
measure: Morphometry of lumbar multifidus
timeFrame: 2 years
measure: Proprioception of lumbar multifidus
timeFrame: 2 years
measure: Stiffness of lumbar multifidus
timeFrame: 2 years
measure: Fatty infiltration of lumbar multifidus
timeFrame: 2 years
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital
Study officials:
affiliation: The Hong Kong Polytechnic University
name: Arnold Wong, PhD
role: PRINCIPAL_INVESTIGATOR
References: