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

Обзор

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.

Первичные конечные точки

• 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 [Срок оценки: Baseline]

Вторичные конечные точки (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. [Срок оценки: 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 [Срок оценки: 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. [Срок оценки: 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). [Срок оценки: Baseline]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Франция · 1 центр

• Service de neurologie CH de Valenciennes — Valenciennes

Идентификаторы

NCT: NCT05540548 · 2021_0522 · 2022-A00253-40

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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