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OpenTrials
Completed

NCT Number: NCT06669767

Behavioral Indicators of Pain Representation

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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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Université de Picardie Jules Verne

Amiens, 80025, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age between 18 and 55
  • Non-specific chronic low back pain for the concerned group

Exclusion criteria

  • Low back pain for 0 to 3 months
  • Unable to stand 1 minute without technical aid
  • Neurological, motor or cognitive know impairment
  • BMI > 30

Treatment and study plan

Primary outcomes

  1. Standard deviation of the position of the center of pressure on the anteroposterior axis (SD-COP-AP)

    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.

Secondary outcomes

  1. Mean position of the center of pressure on the anteroposterior axis (COP-AP)

    Time frame: Baseline

  2. Mean position of the center of pressure on the mediolateral axis (COP-ML)

    Time frame: Baseline

  3. Standard deviation of the position of the center of pressure on the mediolateral axis (SD-COP-ML)

    Time frame: Baseline

  4. Sway length of the center of pressure on the anteroposterior axis (L-COP-AP)

    Time frame: Baseline

  5. Sway length of the center of pressure on the mediolateral axis (L-COP-ML)

    Time frame: Baseline

  6. Tibialis anterior muscle activity

    Time frame: Baseline

    Measured by electromyography, RMS normalized to maximum voluntary contraction.

  7. Soleus muscle activity

    Time frame: Baseline

    Measured by electromyography, RMS normalized to maximum voluntary contraction.

  8. Longissimus dorsi muscle activity

    Time frame: Baseline

    Measured by electromyography, RMS normalized to maximum voluntary contraction.

  9. Co-activation (Soleus/Tibialis anterior)

    Time frame: Baseline

  10. Coefficient of variation for muscle activity of tibialis anterior

    Time frame: Baseline

  11. Coefficient of variation for muscle activity of soleus

    Time frame: Baseline

  12. Coefficient of variation for muscle activity of longissimus dorsi

    Time frame: Baseline

  13. Mean heart rate

    Time frame: Baseline

  14. Mean RR interval

    Time frame: Baseline

  15. Standard deviation of normal RR intervals (SDNN)

    Time frame: Baseline

  16. Root mean square of successive R-R intervals (RMSSD)

    Time frame: Baseline

  17. Power of very low frequency from frequency analysis (VLF)

    Time frame: Baseline

  18. Power of low frequency from frequency analysis (LF)

    Time frame: Baseline

  19. Power of high frequency from frequency analysis (HF)

    Time frame: Baseline

  20. Ratio of LF/HF (post-frequency analysis)

    Time frame: Baseline

  21. Tampa scale for kinesiophobia (TSK) score

    Time frame: 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.

  22. Brief pain inventory (BPI) score

    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.

  23. EQ-5D-5L questionnaire score

    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.

  24. Fear-Avoidance Component Scale (FACS) score

    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.

  25. Pain catastrophizing scale (PCS) score

    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.

  26. Hospital Anxiety and Depression scale (HAD) score

    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.

Sponsors and collaborators

Lead sponsor

Universite de Picardie Jules Verne

Other

Registry information

Acronym: ICOR

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 1, 2024
Registry last updated
Sep 2, 2025

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.

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