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Behavioral Indicators of Pain Representation

Behavioral Indicators of Pain Representation

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06669767
Acronym
ICOR
Enrollment
34
Registered
2024-11-01
Start date
2024-11-14
Completion date
2025-06-06
Last updated
2025-09-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteer, Non-specific Chronic Low Back Pain

Keywords

Kinesiophobia, Low back pain, Posturography

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.

Interventions

None listed

Sponsors

Universite de Picardie Jules Verne
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Standard deviation of the position of the center of pressure on the anteroposterior axis (SD-COP-AP)BaselineMovements 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

MeasureTime frameDescription
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 activityBaselineMeasured by electromyography, RMS normalized to maximum voluntary contraction.
Soleus muscle activityBaselineMeasured by electromyography, RMS normalized to maximum voluntary contraction.
Longissimus dorsi muscle activityBaselineMeasured by electromyography, RMS normalized to maximum voluntary contraction.
Co-activation (Soleus/Tibialis anterior)Baseline
Coefficient of variation for muscle activity of tibialis anteriorBaseline
Coefficient of variation for muscle activity of soleusBaseline
Coefficient of variation for muscle activity of longissimus dorsiBaseline
EQ-5D-5L questionnaire scoreBaselineThe 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.
Mean RR intervalBaseline
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) scoreBaselineKinesiophobia 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) scoreBaselinePain 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.
Fear-Avoidance Component Scale (FACS) scoreBaselineThe 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) scoreBaselineCatastrophism 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) scoreBaselineThe 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.
Mean heart rateBaseline

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026