Exploring Locomotion Behavior of Chronic Non-Specific Low Back Pain (cNSLBP) Patients While Walking Through Apertures in Different Configurations: Influence of Environmental and Social Factors.

NCT ID: NCT06644053

Last Updated: 2024-10-16

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 36 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-07-14
• Study Completion Date: 2024-02-08

Brief Summary

The biomechanical parameters studied in chronic non-specific low back pain (cNSLBP) 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. This study focuses on a crossing task through different horizontal openings, varying the environmental context (two opening widths: one narrow and one wide) and the social context by placing an experimenter in the center of the two openings for some trials. The primary objective was to determine whether the cNSLBP affects the participant's decision to cross one of the two apertures as a function of the width of the aperture and the presence or absence of an experimenter. The secondary aim was twofold, firstly to study the kinematic variables of walking and secondly to assess the influence of pain perception variables on the choice of aperture crossed.

Conditions

Chronic Low Back Pain (non-specific, Uncomplicated); Walking

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Chronic Non-Specific Low Back Pain participants

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).

Quantified analysis of walking during a crossing task through different horizontal openings

Intervention Type: BEHAVIORAL

Functional test that reproduce a task of daily living

Control group

Participant with no current or past chronic pain

Quantified analysis of walking during a crossing task through different horizontal openings

Intervention Type: BEHAVIORAL

Functional test that reproduce a task of daily living

Interventions

Quantified analysis of walking during a crossing task through different horizontal openings

Functional test that reproduce a task of daily living

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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 not be on any treatment or have been on stable analgesic treatment for at least 2 weeks prior to inclusion
• 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

Exclusion Criteria

• 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
• 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.)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Rennes 2

OTHER

Sponsor Role: lead

Responsible Party

Agathe Bilhaut

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Rennes 2

Rennes, , France

Countries

France

Other Identifiers

2023-A00870-45

Identifier Type: -

Identifier Source: org_study_id