NCT03387930

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
140

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2017

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 23, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 2, 2018

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
Last Updated

February 10, 2021

Status Verified

February 1, 2021

Enrollment Period

4.7 years

First QC Date

December 23, 2017

Last Update Submit

February 8, 2021

Conditions

Low Back Pain

Keywords

Low back painlumbar multifidusProprioceptionElastographyMagnetic resonance imaging

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Morphometry of lumbar multifidus

    2 years

  • Proprioception of lumbar multifidus

    2 years

  • Stiffness of lumbar multifidus

    2 years

  • Fatty infiltration of lumbar multifidus

    2 years

Study Arms (2)

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

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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

You may not qualify if:

  • 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'

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Queen Mary Hospital

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Arnold Wong, PhD

    The Hong Kong Polytechnic University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Arnold Wong, PhD

CONTACT

852-2766-6741arnold.wong@polyu.edu.hk

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

December 23, 2017

First Posted

January 2, 2018

Study Start

August 1, 2017

Primary Completion

March 31, 2022

Study Completion

June 30, 2022

Last Updated

February 10, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations

HK(1)