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.

NCT06644053 | Completed

• 1 other identifier: 2023-A00870-45
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 1

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

Keywords

Chronic Low back Pain; Crossing task paradigm; ecological paradigm; Assessment; Walking; Affordance

Outcome Measures

Primary Outcomes (1)

• Critical threshold for motion adaptation

  The critical threshold corresponds to the goal position at which individuals change their mode of action, i.e. the goal at which participants will cross the narrow aperture.

  Clinical assessment at base line

Secondary Outcomes (4)

• Walking speed

  Clinical assessment at base line

• Clearance distance

  Clinical assessment at base line

• Shoulder rotation

  Clinical assessment at base line

• Phase shift between the scapular and pelvic angles

  Clinical assessment at base line

Other Outcomes (8)

• Pain intensity

  Clinical assessment at base line

• Levels of anxiety and depression

  Clinical assessment at base line

• Pain Catastrophizing

  Clinical assessment at base line

Study Arms (2)

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).

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

Control group

Participant with no current or past chronic pain

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

Interventions

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

Functional test that reproduce a task of daily living

Chronic Non-Specific Low Back Pain participants; Control group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with chronic non-specific low back pain are recruited as part of their medical follow-up in a medical centre 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
• 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.)

Sponsors & Collaborators

• University of Rennes 2: lead

Study Sites (1)

University of Rennes 2

Rennes, 35000, France

Location

Study Design

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

Study Record Dates

• First Submitted: October 14, 2024
• First Posted: October 16, 2024
• Study Start: July 14, 2023
• Primary Completion: February 8, 2024
• Study Completion: February 8, 2024
• Last Updated: October 16, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)