NCT06669767

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 28, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 1, 2024

Completed
13 days until next milestone

Study Start

First participant enrolled

November 14, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 6, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 6, 2025

Completed
Last Updated

September 2, 2025

Status Verified

August 1, 2025

Enrollment Period

7 months

First QC Date

October 28, 2024

Last Update Submit

August 25, 2025

Conditions

Keywords

KinesiophobiaLow back painPosturography

Outcome Measures

Primary Outcomes (1)

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

    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.

    Baseline

Secondary Outcomes (26)

  • 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

  • +21 more secondary outcomes

Study Arms (2)

Non-specific chronic low back pain

Participants with non-specific chronic low back pain (\>3 months).

Control group

Healthy volunteers, without any low back pain.

Eligibility Criteria

Age18 Years - 55 Years
Sexall(Gender-based eligibility)
Gender Eligibility DetailsMale/Female
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

General population

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Université de Picardie Jules Verne

Amiens, 80025, France

Location

MeSH Terms

Conditions

KinesiophobiaLow Back Pain

Condition Hierarchy (Ancestors)

Phobic DisordersAnxiety DisordersMental DisordersBack PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Thierry LELARD, PhD

    Universite de Picardie Jules Verne

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research engineer

Study Record Dates

First Submitted

October 28, 2024

First Posted

November 1, 2024

Study Start

November 14, 2024

Primary Completion

June 6, 2025

Study Completion

June 6, 2025

Last Updated

September 2, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations