Université de Picardie Jules Verne
Amiens, 80025, France
NCT Number: NCT06669767
The goal of this observational study is to compare the postural response to the mental simulation of everyday situations identified as painful in participants with non-specific low back pain and healthy volunteers.
The main questions it aims to answer are :
Do participants with low-back pain show reduced variability in center of pressure displacements compared with non-painful participants when faced with mental simulation of everyday situations identified as painful? Is the postural response correlated with the level of kinesiophobia? Participants will be faced to pictures of everyday situations identified as painful while several physiological measurements (posturography, electromyography, heart rate) are being recorded.
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Notify Me18 year–55 year
All sexes
Observational
Amiens, 80025, France
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Baseline
Movements of the center of pressure (COP) are recorded using a force plate, and the SD-COP-AP is calculated after recording and is an indicator of the postural response.
Time frame: Baseline
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Measured by electromyography, RMS normalized to maximum voluntary contraction.
Time frame: Baseline
Measured by electromyography, RMS normalized to maximum voluntary contraction.
Time frame: Baseline
Measured by electromyography, RMS normalized to maximum voluntary contraction.
Time frame: Baseline
Time frame: Baseline
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Kinesiophobia was evaluated with the Tampa Scale for Kinesiophobia (TSK), a self-administered questionnaire validated in French. The TSK measures the fear of movement and is used in various painful conditions. It includes 17 items evaluated on a 4-point Likert scale. The total score range is 17-68 and a high score indicates a greater fear of movement.
Time frame: Baseline
Pain was assessed with the Brief Pain Inventory (BPI), a reliable self-administered questionnaire about pain severity (4 items) and interference with daily living (7 items) validated in French. Each item is evaluated on a numerical scale from 0 to 10. A high score indicates significant pain or significant interference in daily living.
Time frame: Baseline
The EQ-5D-5L is a standardized questionnaire used as a measure of health-related quality of life. The first part assesses 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression, on a five-level scale (no problem, slight problems, moderate problems, severe problems, unable to). The second part consist in a visual analogic scale about global health of the participant and provide a value from 0 to 100 with high value representing a good health.
Time frame: Baseline
The fear-avoidance component scale is used to measure the major fear-avoidance signs in painful conditions. It includes 20 items evaluated on a 5-point Likert scale. The total score is from 0 to 100 with 5 severity levels: 0-20 subclinical, 21-40 low, 41-60 moderate, 61-80 severe, and extreme 81-100.
Time frame: Baseline
Catastrophism was evaluated with the pain catastrophizing scale. It includes 13 items evaluated on a 4-point Likert scale and divided into 3 dimensions: magnification, rumination, and helplessness. A high score corresponds to a high level of catastrophism. The total score ranges from 0 to 52 with a cut-off score of 30 for a significant catastrophism level.
Time frame: Baseline
The Hospital Anxiety and Depression scale (HAD) includes 14 items, 7 for anxiety and 7 for depression validated in French. Each item is rated from 0 to 3 and the scores for each dimension range from 0 to 21. Cut-off scores were established with 8-10 being uncertain symptomatology and above 10 being definite symptomatology.
Universite de Picardie Jules Verne
Other
Acronym: ICOR
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