Behavioral Indicators of Pain Representation
- Conditions
- Non-specific Chronic Low Back PainHealthy Volunteer
- Registration Number
- NCT06669767
- Lead Sponsor
- Universite de Picardie Jules Verne
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 40
- Age between 18 and 55
- Non-specific chronic low back pain for the concerned group
- Low back pain for 0 to 3 months
- Unable to stand 1 minute without technical aid
- Neurological, motor or cognitive know impairment
- BMI > 30
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Standard deviation of the position of the center of pressure on the anteroposterior axis (SD-COP-AP) 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.
- Secondary Outcome Measures
Name Time Method Mean position of the center of pressure on the anteroposterior axis (COP-AP) Baseline Mean position of the center of pressure on the mediolateral axis (COP-ML) Baseline Standard deviation of the position of the center of pressure on the mediolateral axis (SD-COP-ML) Baseline Sway length of the center of pressure on the anteroposterior axis (L-COP-AP) Baseline Sway length of the center of pressure on the mediolateral axis (L-COP-ML) Baseline Tibialis anterior muscle activity Baseline Measured by electromyography, RMS normalized to maximum voluntary contraction.
Soleus muscle activity Baseline Measured by electromyography, RMS normalized to maximum voluntary contraction.
Longissimus dorsi muscle activity Baseline Measured by electromyography, RMS normalized to maximum voluntary contraction.
Co-activation (Soleus/Tibialis anterior) Baseline Coefficient of variation for muscle activity of tibialis anterior Baseline Coefficient of variation for muscle activity of soleus Baseline Coefficient of variation for muscle activity of longissimus dorsi Baseline Mean heart rate Baseline Mean RR interval Baseline Standard deviation of normal RR intervals (SDNN) Baseline Root mean square of successive R-R intervals (RMSSD) Baseline Power of very low frequency from frequency analysis (VLF) Baseline Power of low frequency from frequency analysis (LF) Baseline Power of high frequency from frequency analysis (HF) Baseline Ratio of LF/HF (post-frequency analysis) Baseline Tampa scale for kinesiophobia (TSK) score Baseline 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.
Brief pain inventory (BPI) score 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.
EQ-5D-5L questionnaire score 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.
Fear-Avoidance Component Scale (FACS) score 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.
Pain catastrophizing scale (PCS) score 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.
Hospital Anxiety and Depression scale (HAD) score 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.
Trial Locations
- Locations (1)
Université de Picardie Jules Verne
🇫🇷Amiens, France