Clinical trial NCT06669767: Behavioral Indicators of Pain Representation
Official title: Behavioral Indicators of Pain Representation
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Non-specific Chronic Low Back Pain
Healthy Volunteer
Keywords: Kinesiophobia
Low back pain
Posturography
Lead sponsor: Universite de Picardie Jules Verne
Sponsor class: OTHER
First posted: 2024-11-01
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: General population

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.


Eligibility criteria: 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

Primary outcomes:
measure: Standard deviation of the position of the center of pressure on the anteroposterior axis (SD-COP-AP)
timeFrame: Baseline
Secondary outcomes:
measure: Mean position of the center of pressure on the anteroposterior axis (COP-AP)
timeFrame: Baseline
measure: Mean position of the center of pressure on the mediolateral axis (COP-ML)
timeFrame: Baseline
measure: Standard deviation of the position of the center of pressure on the mediolateral axis (SD-COP-ML)
timeFrame: Baseline
measure: Sway length of the center of pressure on the anteroposterior axis (L-COP-AP)
timeFrame: Baseline
measure: Sway length of the center of pressure on the mediolateral axis (L-COP-ML)
timeFrame: Baseline
measure: Tibialis anterior muscle activity
timeFrame: Baseline
measure: Soleus muscle activity
timeFrame: Baseline
measure: Longissimus dorsi muscle activity
timeFrame: Baseline
measure: Co-activation (Soleus/Tibialis anterior)
timeFrame: Baseline
measure: Coefficient of variation for muscle activity of tibialis anterior
timeFrame: Baseline
measure: Coefficient of variation for muscle activity of soleus
timeFrame: Baseline
measure: Coefficient of variation for muscle activity of longissimus dorsi
timeFrame: Baseline
measure: Mean heart rate
timeFrame: Baseline
measure: Mean RR interval
timeFrame: Baseline
measure: Standard deviation of normal RR intervals (SDNN)
timeFrame: Baseline
measure: Root mean square of successive R-R intervals (RMSSD)
timeFrame: Baseline
measure: Power of very low frequency from frequency analysis (VLF)
timeFrame: Baseline
measure: Power of low frequency from frequency analysis (LF)
timeFrame: Baseline
measure: Power of high frequency from frequency analysis (HF)
timeFrame: Baseline
measure: Ratio of LF/HF (post-frequency analysis)
timeFrame: Baseline
measure: Tampa scale for kinesiophobia (TSK) score
timeFrame: Baseline
measure: Brief pain inventory (BPI) score
timeFrame: Baseline
measure: EQ-5D-5L questionnaire score
timeFrame: Baseline
measure: Fear-Avoidance Component Scale (FACS) score
timeFrame: Baseline
measure: Pain catastrophizing scale (PCS) score
timeFrame: Baseline
measure: Hospital Anxiety and Depression scale (HAD) score
timeFrame: Baseline
Other outcomes:
Locations:
city: Amiens
country: France
facility: Université de Picardie Jules Verne
Study officials:
affiliation: Universite de Picardie Jules Verne
name: Thierry LELARD, PhD
role: STUDY_DIRECTOR
References: