NCT03750474

Brief Summary

Chronic low back pain remains a major public health issue. Low back pain is frequently associated with stiffness changes of the lumbar back muscles. The techniques which assess the stiffness of the back muscles are poorly reliable and do not allow the quantification of stiffness changes. Elastography (magnetic resonance imaging and ultrasound) can be used to objectively and non-invasively quantify in vivo tissue elasticity. The aim of the investigator's study is to compare the stiffness in the main lumbar back muscles (i.e. the erector spinae and the multifidus) by using magnetic resonance elastography and shear wave elastography.

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
52

participants targeted

Target at P25-P50 for not_applicable low-back-pain

Timeline
Completed

Started Dec 2018

Typical duration for not_applicable low-back-pain

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 20, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 23, 2018

Completed
8 days until next milestone

Study Start

First participant enrolled

December 1, 2018

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2020

Completed
Last Updated

November 23, 2018

Status Verified

November 1, 2018

Enrollment Period

1.4 years

First QC Date

November 20, 2018

Last Update Submit

November 21, 2018

Conditions

Low Back Pain

Keywords

elastography; magnetic resonance imaging

Outcome Measures

Primary Outcomes (1)

  • Stiffness mapping and measurement of the shear modulus (m/s) in the multifidus and the erector spinae (1) with magnetic resonance elastography (Aera; 1,5T)

    First, the subjects undergoes a magnetic resonance elastography in decubitus in two postures: at rest and with stretching of back muscles (hip flexion). Then, stiffness will be measurement with sonography in several postures: prone position, upright, bending forward, bending backward.

    18 months

Study Arms (2)

patient with chronic low back pain

EXPERIMENTAL

magnetic resonance elastography and shear wave elastography of the back muscles

Diagnostic Test: magnetic resonance elastography and shear wave elastography

healthy controls

OTHER

magnetic resonance elastography and shear wave elastography of the back muscles

Diagnostic Test: magnetic resonance elastography and shear wave elastography

Interventions

magnetic resonance elastography and shear wave elastographyDIAGNOSTIC_TEST

magnetic resonance elastography and shear wave elastography of the back muscles

healthy controlspatient with chronic low back pain

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Chronic low back pain (defined as low back pain for more than 3 months)
  • Lumbar MRI without planned injection in chronic low back pain assessment
  • Age between 18 and 80 years
  • Ability to keep still in an MRI machine
  • No contraindication to MRI
  • No major sporting activity within 48 hours prior to the exam
  • Informed and written consent"
  • No lumbar pain symptomatology, no lumbar static disorder, known neuromuscular pathology
  • Age between 18 and 80 years
  • Ability to keep still in an MRI machine
  • No contraindication to MRI
  • Informed and written consent

You may not qualify if:

  • Inability to keep still in an MRI machine
  • Intercurrent illness that may interfere with exam results
  • Concomitant use of medications that may alter muscle metabolism
  • Need to inject contrast during MRI
  • Non-affiliation to a social security
  • Minors, protected adults, persons unable to consent, persons under the protection of justice

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital Bicêtre - Radiology Department

Le Kremlin-Bicêtre, 94270, France

Location

MeSH Terms

Conditions

Low Back Pain

Interventions

Elasticity Imaging Techniques

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

UltrasonographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Maud CREZE, PHU

    APHP

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Maud CREZE

CONTACT

0145213377maud.creze@aphp.fr

Maud CREZE, PHU

CONTACT

0145213377maud.creze@aphp.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 20, 2018

First Posted

November 23, 2018

Study Start

December 1, 2018

Primary Completion

May 1, 2020

Study Completion

May 1, 2020

Last Updated

November 23, 2018

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)