University of Rennes 2
Rennes, 35000, France
NCT Number: NCT06644053
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.
Looking for future studies?
Notify Me18 year–65 year
All sexes
Observational
Rennes, 35000, France
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Non Specific Chronic Low Back Pain patients:
Exclusion criteria
Non Specific Chronic Low Back Pain patients:
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.
Functional test that reproduce a task of daily living
Time frame: Clinical assessment at base line
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.
Time frame: Clinical assessment at base line
Speed will calculate using the first derivative of the participant's position (location of the center of each participant at each point in time).
Time frame: Clinical assessment at base line
The clearance distance corresponds to the distance between the participant and the central obstacle forming the two apertures, i.e. a pole for the condition with modified environment and a human being for the conditions with modified social factors.
Time frame: Clinical assessment at base line
The shoulder rotation of each participant will be calculate from the horizontal coordinates of the two glenohumeral (GH) for the unobstructed straight lines and the experimental trials. The angle will be define in the horizontal plane between the GH line and the instantaneous walking direction at time where participants cross the aperture.
Time frame: Clinical assessment at base line
The difference between the angles of rotation of the shoulders and pelvis in the horizontal plane of each participant will be calculated from the horizontal coordinates of the displacement of the markers positioned on the two glenohumeral and on the anterior superior iliac spine for the straight-line trials with no obstacles in the path and for the experimental trials.
Time frame: Clinical assessment at base line
Pain intensity reflects the overall magnitude of the patient's perceived pain experience. The investigators will assess this variable using a visual analogue scale (VAS) in paper format. The VAS is represented by a 100 mm long horizontal line with descriptors at both ends: on the left "no pain" and on the right "worst pain imaginable". The patient must then draw a mark on the line corresponding to his or her pain experience. "0" corresponds to "no pain" and "10" corresponds to "worst pain imaginable".
Time frame: Clinical assessment at base line
Anxiety refers to fear, extreme worrying and hyperarousal symptoms. Depression refers to negative mood, loss of self-confidence, loss of motivation and pleasure. The investigators will use these measures using the Hospital Anxiety Depression Scale (HADS). This tool consists of 14 items scored from 0 to 3. Seven questions relate to anxiety (Total A) and 7 questions to the depressive dimension (Total D), resulting in two scores with a maximum total of 21 each. The higher the score, the more anxiety or depression the person has.
Time frame: Clinical assessment at base line
Catastrophizing refers to the cognitive process in which anxious patients dwell on the most negative consequences and refers here to the interpretation of pain as extremely threatening. The investigators will use the Pain Catastrophizing Scale (PCS) to assess three dimensions: rumination, amplification and helplessness. This scale consists of 13 items scored from 0 (not at all) to 4 (all the time) with a maximum score of 52. The higher the score, the greater the level of catastrophisation.
Time frame: Clinical assessment at base line
Fear of movement is characterized by pain-related fears and anxieties that often result in avoidance of movement that could cause or worsen an injury. The investigators will use the Tampa Scale Kinesiophobia (TSK). This scale consists of 17 items rated from 1 (strongly disagree) to 4 (strongly agree) with a maximum score of 68. The higher the score, the greater the level of kinesiophobia.
Time frame: Clinical assessment at base line
Psychological flexibility measures psychological functioning in phase (in fusion) with the pain or whether the patient has certain degrees of freedom from it. The investigators will use the Psychological Inflexibility in Pain Scale (PIPS) allowing to assess two factors: avoidance and cognitive fusion. This scale consists of 16 items with a scale of 1 (never true) to 7 (always true). The higher the score, the greater the level of psychological inflexibility.
Time frame: Clinical assessment at base line
Fear and avoidance beliefs reflect patients' pain avoidance behaviors. The investigators will use the Fear Avoidance Beliefs Questionnaire (FABQ) to assess two subscales: beliefs about work and beliefs about physical activity. The questionnaire consists of 16 items scored from 0 (absolutely disagree with the sentence) to 6 (completely agree with the sentence). The maximum score for beliefs about work is 42 and the maximum score for beliefs about physical activity is 24. The higher the score, the greater the level of beliefs.
Time frame: Clinical assessment at base line
Physical functioning refers to the impact on the patient's ability to perform daily physical activities necessary to meet basic needs, ranging from self-care to more complex activities that require a combination of skills. The investigators will use the Roland Morris Disability Questionnaire (RMDQ). This questionnaire has 24 items with a maximum score of 24. The higher the score, the more functional disabilities the person has.
Time frame: Clinical assessment at base line
Quality of life refers to the impact on the physical, psychological, and social domains of health, considered as distinct domains that are influenced by a person's experiences, beliefs, expectations, and perceptions. The investigators will use the EuroQol 5 Dimension questionnaire (EQ-5D) allowing for the assessment of five dimensions: mobility, ability to care for oneself, usual work, home, and leisure activities, pain/discomfort, anxiety, and depression. Five degrees of severity in ascending order are used to assess each dimension: "no problems" to "total disability" for items that assess ability, and "no problem" to "extreme" for the other items. The higher the score, the lower the level of quality of life.
University of Rennes 2
Other
Acronym: PERL3
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06874881
Chronic Low Back Pain (Non-specific, Uncomplicated)
Edinburgh, United Kingdom
View Trial DetailsNCT06961903
Anxiety Disorders, Chronic Low Back Pain (Non-specific, Uncomplicated)
Istanbul, Turkey (Türkiye)
View Trial DetailsNCT00371384
Back Pain, Chronic Low Back Pain (Non-specific, Uncomplicated)
Seattle, Washington, United States
View Trial DetailsNCT07675304
Chronic Low Back Pain (Non-specific, Uncomplicated)
Warsaw, Poland
View Trial Details