APLOMB: Contribution of the Podiatrist-Posturologist in the Evaluation of the Link Between the Stabilometric Parameters and the Pain Felt in Patients With Chronic Low Back Pain

Sponsor
University Hospital, Lille (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05540548
Collaborator
(none)
139
12

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    139 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Contribution of the Podiatrist-Posturologist in the Evaluation of the Link Between the Stabilometric Parameters and the Pain Felt in Patients With Chronic Low Back Pain
    Anticipated Study Start Date :
    Jan 1, 2023
    Anticipated Primary Completion Date :
    Jan 1, 2024
    Anticipated Study Completion Date :
    Jan 1, 2024

    Outcome Measures

    Primary Outcome Measures

    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 Outcome Measures

    1. 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]

    2. 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]

    3. 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]

    4. 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

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • 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

    Exclusion Criteria:
    • 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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • University Hospital, Lille

    Investigators

    • Principal Investigator: Frédéric VISEUX, University Hospital, Lille

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Lille
    ClinicalTrials.gov Identifier:
    NCT05540548
    Other Study ID Numbers:
    • 2021_0522
    • 2022-A00253-40
    First Posted:
    Sep 14, 2022
    Last Update Posted:
    Sep 14, 2022
    Last Verified:
    Sep 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University Hospital, Lille
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Sep 14, 2022