NCT05540548

Brief Summary

Chronic low back pain is one of the major causes of disability worldwide. Knowledge about the pathophysiology of low back pain is insufficient, and an accurate diagnosis can only be obtained in 10 to 15% of cases. The absence of a precise diagnosis leads to a therapeutic challenge due to the large number of treatments available, the overall efficacy of which is low to moderate. Therefore, the identification of subgroups of non-specific chronic low back pain patients is essential and will allow the optimization of therapeutic management. A detailed description of the stabilometric parameters associated with the evaluation of pain, kinematic disturbance and the degree of kinesiophobia would allow us to establish specific postural profiles, to propose a relevant clinical model and to improve the accuracy of the diagnosis of people with chronic low back pain. The objectives of this research project are to evaluate the relationship between stabilometric parameters and pain (main objective), lumbar kinematics, kinesiophobia, and quality of life (secondary objectives) in order to propose specific postural profiles in chronic low back pain patients.

Trial Health

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Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
139

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2024

Geographic Reach
1 country

1 active site

Status
recruiting

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

September 12, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 14, 2022

Completed
1.7 years until next milestone

Study Start

First participant enrolled

June 11, 2024

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 11, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 11, 2026

Completed
Last Updated

August 24, 2025

Status Verified

August 1, 2025

Enrollment Period

2 years

First QC Date

September 12, 2022

Last Update Submit

August 19, 2025

Conditions

Keywords

Chronic low back painKinesiophobiaPainPosturologyStabilometry

Outcome Measures

Primary Outcomes (1)

  • Correlation between the average speed of displacement of the center of pressure measured in the open-eyes position and the level of pain felt in patients suffering from chronic low back pain

    Baseline

Secondary Outcomes (4)

  • Correlation between the other stabilometric parameters (mean surface, mean frontal and sagittal position) of postural stability measured in the open-eyes position and the level of pain felt.

    Baseline

  • Correlation between the stabilometric parameters (mean speed, mean surface, mean frontal and sagittal position) of postural stability (measured in the open-eyes position and in the closed-eyes position) and neuropathic pain

    Baseline

  • Correlation of stabilometric parameters (mean speed, mean surface, mean frontal and sagittal position) of postural stability (measured in open-eyes and closed-eyes position) with the degree of kinesiophobia and quality of life.

    Baseline

  • Reproducibility of the stabilometric measurements (average speed, average surface, average frontal and sagittal position) in each of the conditions (in the open-eyes position and in the closed-eyes position).

    Baseline

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The patients will be recruited within the pain unit of the General Hospital of Valenciennes, within the framework of the multidisciplinary consultation of the optimized pain and dedicated to the low back pain patients, where intervene a neurosurgeon algologist and a podiatrist posturologist. The selection of patients enrolled in the multidisciplinary pain consultation dedicated to low back pain patients will be reviewed by the Clinical Study Technician (screening) and checked by the principal investigator before the newsletter is sent.

You may qualify if:

  • Suffering from low back pain, possibly associated with painful gluteal radiation in the form of mono or bilateral pygalgia (non-radicular) evolving for at least three months (chronic low back pain
  • Understanding and being able to express himself in French
  • Giving informed, dated and signed consent

You may not qualify if:

  • Neurosurgical criteria: (i) presence of clinical signs of compression and/or single or multi-root pain (Lumbosciatica with or without deficit signs, intermittent claudication of the cauda equina roots with possible sphincter signs), (ii) history inflammatory arthropathy (ankylosing spondylitis, rheumatoid arthritis), and (iii) history of lumbar spine surgery.
  • Radiographic criteria: (i) presence on the lumbar MRI of multi-level discopathy (more than 2 discopathy), (ii) spinal instability confirmed by CT or MRI (degenerative spondylolisthesis or by isthmic lysis).
  • Pregnant or breastfeeding women
  • Visually impaired patient
  • Patient suffering from neurological and/or orthopedic disorders that may affect balance.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service de neurologie CH de Valenciennes

Valenciennes, 59300, France

RECRUITING

MeSH Terms

Conditions

KinesiophobiaPain

Condition Hierarchy (Ancestors)

Phobic DisordersAnxiety DisordersMental DisordersNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Frédéric VISEUX

    University Hospital, Lille

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2022

First Posted

September 14, 2022

Study Start

June 11, 2024

Primary Completion

June 11, 2026

Study Completion

June 11, 2026

Last Updated

August 24, 2025

Record last verified: 2025-08

Locations