Predictive Factors for the Success of Rehabilitation Programs in Chronic Low Back Pain

Обзор

Chronic low back pain is the leading cause of years lived with disability in the world among 19-49 year olds. The usual progression leads to 15% of acute episodes of persistent pain and more than 50% of persistent activity limitations. Persistent pain lasting between 5 and 7 years causes relatively stable patterns, probably linked to well-known predictive factors of activity limitations such as psychosocial factors (catastrophizing, fears and maladaptive beliefs), physical (deconditioning), professional (fear of returning to work, stress, burden) or personal (financial, insecurity). The effectiveness of treatments is often difficult to predict. Current evidence does not support the use of pharmacological treatments given their low effectiveness and the risks associated with the prescription of non-steroidal anti-inflammatories or opioids, particularly in the chronic phase where the risk of dependence is highest. Thus, international recommendations strongly suggest the use of non-pharmacological therapies, including, physical exercises, rehabilitation, physical and sports activities and spinal manipulations. Most meta-analyses conclude that there is a cumulative effect of the different strategies, without the specific effect of each one being able to be isolated, justifying multidisciplinary protocols. A cornerstone of the management of chronic disabling low back pain therefore relies programs combining physical, cognitive-behavioral, psychological and professional care, most often in dedicated centers. The objective is to empower the patient and promote a change in behavior with regard to the consequences of their pain in the long-term. However, there are very few predictive criteria for the success or failure of these programs, probably because many multiple biological, psychological, and social factors interact over time. Certain models resulting from expert consensus seek to conceptualize these interactions and propose a categorization of these different factors. It is now crucial to validate these categorizations and their relative weight in the progression of patients to best guide their recovery. The aim of this work is to identify the biomarkers predictive of the success of multidisciplinary programs in the short-, medium- and long-term.

Вмешательства

• Другое mobility skills testing session
  A mobility skills testing session using the Qualisys system (Trinoma), when carrying out specific tasks plus 7-day recording of activity using an accelerometer.

Первичные конечные точки

• Level of disability [Срок оценки: Baseline]
• Level of disability [Срок оценки: Month 6]
• Patient age [Срок оценки: Baseline]
• Patient sex [Срок оценки: Baseline]
• Patient Body Mass Index [Срок оценки: Baseline]
• Comorbidities [Срок оценки: Baseline]
• Pain duration [Срок оценки: Baseline]
• Professional situation [Срок оценки: Baseline]
• Work stoppage [Срок оценки: Baseline]
• Work accident [Срок оценки: Baseline]

Вторичные конечные точки (12)

• Level of disability [Срок оценки: Month 1]
• Level of disability [Срок оценки: Month 3]
• Level of disability [Срок оценки: Month 12]
• Level of pain [Срок оценки: Month 1]
• Level of pain [Срок оценки: Month 3]
• Level of pain [Срок оценки: Month 6]
• Level of pain [Срок оценки: Month 12]
• Patient-reported health-related quality of life [Срок оценки: Baseline]
• Patient-reported health-related quality of life [Срок оценки: Month 1]
• Patient-reported health-related quality of life [Срок оценки: Month 3]
• Patient-reported health-related quality of life [Срок оценки: Month 6]
• Patient-reported health-related quality of life [Срок оценки: Month 12]

Критерии участия

Критерии включения

• Patient with chronic low back pain ≥ three months
• The patient must have given their free and informed consent and signed the consent form
• The patient must be a member or beneficiary of a health insurance plan

Критерии исключения

• The patient is participating in a category 1 interventional study, or a study on a medication or medical device without prior approval of the primary investigator
• The patient is in a period of exclusion determined by a previous study
• It is impossible to give the subject informed information
• The patient is under safeguard of justice or state guardianship
• Patient followed or treated for a psychiatric, cancerous or orthopedic pathology that risks modifying their course of care
• Pregnant, parturient or breastfeeding patient.

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

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Франция · 6 центров

• CHU de Clermont Ferrand — Clermont-Ferrand
• Centre Hospitalier Universitaire de Nîmes — Nîmes
• CHU de Montpellier — Montpellier
• CHU de Nîmes — Nîmes
• CHU de Clermont-Ferrand — Clermont-Ferrand
• CHU de Montpellier — Montpellier

Идентификаторы

NCT: NCT07051772 · NIMAO/2023-1/AD-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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