NCT05337995

Brief Summary

The biomechanical parameters studied in non-specific chronic low back pain patients in a locomotion task have so far focused on straight line walking. Although locomotion is primarily an automated action composed of repetitive patterns allowing movement from one place to another, walkers must respond to the environmental demands.These modifications show a flexible and adaptive approach to the constraints of the environment. In this study, we are particularly interested in a task of passage through a horizontal opening, similar to a doorway, which is a standardized task that has shown its interest in the study of perceptual-motor co-ordinations. In particular, it allows to consider anthropometric and functional abilities of individuals, reflecting their action capacities.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

March 1, 2022

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

March 30, 2022

Completed
21 days until next milestone

First Posted

Study publicly available on registry

April 20, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2022

Completed
Last Updated

May 1, 2023

Status Verified

April 1, 2023

Enrollment Period

6 months

First QC Date

March 30, 2022

Last Update Submit

April 28, 2023

Conditions

Chronic Low-back PainWalking

Keywords

Low Back PainPsychomotor Performance / physiologyWalking / physiology*AdultHumansMotion Perception / physiology*

Outcome Measures

Primary Outcomes (1)

  • Critical threshold

    Defined as the width of opening making the transition between openings that it is possible or not to cross while walking without modification of the movement. We will then identify the trials, i.e. the door widths, where the participants have turned their shoulders. To do this, we will compare the shoulder angle observed during the doorway crossing with the average angle observed in the control conditions, corresponding to a straight line walk without any opening to cross.

    Clinical assessment at base line

Secondary Outcomes (4)

  • Phase shift between shoulder and pelvic angles in the transverse plane

    Clinical assessment at base line

  • Stability of the trunk

    Clinical assessment at base line

  • Step length

    Clinical assessment at base line

  • Walking speed

    Clinical assessment at base line

Other Outcomes (9)

  • Pain intensity

    Clinical assessment at base line

  • Temporal aspects of pain

    Clinical assessment at base line

  • Levels of anxiety and depression

    Clinical assessment at base line

  • +6 more other outcomes

Study Arms (2)

Non-Specific Low Back Pain patients

Participants must have pain located between the thoracolumbar hinge and the lower gluteal fold, with or without pain in either leg, present for more than 12 weeks, on a daily or almost daily basis (at least 4 days out of 7).

Other: Quantified analysis of walking during a task of passage through a horizontal opening

Control group

Participant with no current or past chronic pain

Other: Quantified analysis of walking during a task of passage through a horizontal opening

Interventions

Quantified analysis of walking during a task of passage through a horizontal openingOTHER

Functional test that reproduce a task of daily living, similar to a doorway

Control groupNon-Specific Low Back Pain patients

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

NSCLBP patients who do their medical follow-up in medical center in France

You may qualify if:

  • Participants must have pain located between the thoracolumbar hinge and the lower gluteal fold, with or without pain in either leg.
  • This pain must have been present for more than 12 weeks, on a daily or almost daily basis (at least 4 days out of 7)
  • Participants must speak, read and understand French
  • Participants must be between 18 and 65 years of age
  • Participants must be able to understand simple commands and experimental instructions
  • Participants must have normal or corrected vision
  • Participants must have given informed consent to participate in the study
  • Participants must be enrolled in or receiving social security benefits

You may not qualify if:

  • Participants must not be pregnant or nursing mothers.
  • Participants must not have cognitive or psychological impairments that are incompatible with compliance and/or understanding of the protocol (MMSE \> 28)
  • Participants must not be unable to understand informed consent, or be under guardianship or conservatorship
  • Subjects must not already be participating in another research protocol involving the human subject or in parallel
  • Participants must not be persons deprived of liberty by judicial or administrative decision
  • Participants must not be under psychiatric care
  • The participants must not present neurological signs evoking a neurodegenerative disease responsible for walking disorders (parkinsonian syndrome, ...)
  • The participants must not present warning signs (red flags) pointing to an underlying pathology requiring specific and/or urgent care such as
  • Ongoing litigation following a work-related accident
  • Pain related to a cancer diagnosis
  • Associated spinal cord symptoms (pyramidal signs, coordination disorders, motor or sensory deficits, sphincter disorders, etc.)
  • Pain following an infection (night sweats, fever, chills, intravenous drug abuse, immunodeficiency, recent surgery, urinary or skin infection, etc.)
  • Recent or pathological fractures (traffic accidents, history of osteoporosis, chronic use of corticosteroids, advanced age, unexplained weight loss, fatigue, history of cancer, etc. )
  • Vascular problems (cold feet, decreased peripheral arterial pulse, etc.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Rennes 2

Rennes, 35000, France

Location

Related Publications (1)

  • Bilhaut A, Menard M, Roze O, Cretual A, Olivier AH. Locomotion behavior of chronic Non-Specific Low Back Pain (cNSLBP) participants while walking through apertures. Gait Posture. 2023 Jul;104:140-146. doi: 10.1016/j.gaitpost.2023.06.015. Epub 2023 Jun 22.

    PMID: 37419055DERIVED

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Olivier Roze, MD

    clinique de la Sagesse

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

March 30, 2022

First Posted

April 20, 2022

Study Start

March 1, 2022

Primary Completion

August 15, 2022

Study Completion

August 15, 2022

Last Updated

May 1, 2023

Record last verified: 2023-04

Locations

FR(1)