Clinical trial NCT06644053: 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.
Official title: 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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Low Back Pain (non-specific, Uncomplicated)
Walking
Keywords: Chronic Low back Pain
Crossing task paradigm
ecological paradigm
Assessment
Walking
Affordance
Lead sponsor: University of Rennes 2
Sponsor class: OTHER
First posted: 2024-10-16
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: Inclusion Criteria Non Specific Chronic 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.
* 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 Non Specific Chronic Low Back Pain patients:

* 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.)

Inclusion and Exclusion Criteria of control group :

Participants strictly meet the same inclusion and non-inclusion criteria as NSCLBP patients, but must not have ongoing chronic pain or a history of significant chronic pain (≥ 4/10 for at least 6 months). They are matched for age and gender. They must not have any pathologies that affect walking or posture. These individuals must be able to perform the studied movements without the appearance of discomfort or exaggerated fatigue.

Primary outcomes:
measure: Critical threshold for motion adaptation
timeFrame: Clinical assessment at base line
Secondary outcomes:
measure: Walking speed
timeFrame: Clinical assessment at base line
measure: Clearance distance
timeFrame: Clinical assessment at base line
measure: Shoulder rotation
timeFrame: Clinical assessment at base line
measure: Phase shift between the scapular and pelvic angles
timeFrame: Clinical assessment at base line
Other outcomes:
measure: Pain intensity
timeFrame: Clinical assessment at base line
measure: Levels of anxiety and depression
timeFrame: Clinical assessment at base line
measure: Pain Catastrophizing
timeFrame: Clinical assessment at base line
measure: Kinesiophobia
timeFrame: Clinical assessment at base line
measure: Psychological Inflexibility in Pain
timeFrame: Clinical assessment at base line
measure: Fear Avoidance Beliefs
timeFrame: Clinical assessment at base line
measure: Physical functioning
timeFrame: Clinical assessment at base line
measure: Quality of life assessment
timeFrame: Clinical assessment at base line
Locations:
city: Rennes
country: France
facility: University of Rennes 2
Study officials:
References: