Impact of a Multidisciplinary Rehabilitation Program Associated With the Doado Application in Lowback Pain Management

Официальное название

Impact of a Multidisciplinary Rehabilitation Program and Doado Application on the Functional Disability of Patients With Low Back Pain at Risk of Chronicization, Compared With a Monodisciplinary Rehabilitation Program and Doado Application.

Обзор

This study is aimed at patients consulting a physiotherapist for acute low-back pain at risk of becoming chronic. The goal of this study is to compare two types of rehabilitation programs for these patients, on their functional disability at 3 months: * A multidisciplinary program lasting two weeks, including physiotherapists, rheumatologists, physical medicine and rehabilitation specialists, occupational physicians, psychologists, etc. * A monodisciplinary physiotherapy rehabilitation program consisting of active treatment with a physiotherapist, with 2 to 3 sessions per week for 4 to 5 weeks, based on muscle-strengthening exercises for the trunk and lower limbs and stretching exercises for the back and lower limbs. Patients will be evaluated before treatment (baseline), and at 1, 3, 6 and 12 months to evaluate the following secondary outcomes: pain, absence of chronicity, evolution of functional disability, muscle endurance, flexibility, level of fear, apprehension and avoidance associated with low back pain over the time, return to work and to physical activities, painful relapses and analgesic treatment consumption.

Вмешательства

• Другое Multidisciplinary management associated with mobile application Doado
  multidisciplinary program including physiotherapists, rheumatologists, physical medicine and rehabilitation specialists, occupational physicians, psychologists, etc., associated with Doado mobile application
• Другое Physiotherapy management alone associated with mobile application Doado
  monodisciplinary physiotherapy rehabilitation program consisting of active treatment with a physiotherapist associated with Doado mobile application

Первичные конечные точки

• Functional disability [Срок оценки: baseline, 3 months]

Вторичные конечные точки (12)

• Lumbar pain [Срок оценки: baseline, one month, 3 months, 6 months, 12 months]
• Lumbar pain chronicity [Срок оценки: over 12 months of follow-up]
• Functional disability [Срок оценки: Baseline, one month, 3 months, 6 months, 12 months]
• Muscular endurance (Shirado-Ito test) [Срок оценки: baseline, one month, 3 months]
• Muscular endurance (hip bridge endurance) [Срок оценки: baseline, one month, 3 months]
• Muscular endurance (Biering-Sorensen) [Срок оценки: baseline, one month, 3 months]
• Muscular endurance (Killy test) [Срок оценки: baseline, one month, 3 months]
• Flexibility (finger-ground distance test) [Срок оценки: baseline, one month, 3 months]
• Flexibility (knee extension angle test) [Срок оценки: expressed in degrees of amplitude Time Frame : baseline, one month, 3 months]
• Flexibility (hill-ischin procubitus measurement test) [Срок оценки: baseline, one month, 3 months]
• Fear, apprehension and avoidance related to low back pain (SBST questionnaire) [Срок оценки: baseline, one month, 3 months, 6 months, 12 months]
• Fear, apprehension and avoidance related to low back pain (FABQ questionnaire) [Срок оценки: baseline, one month, 3 months, 6 months, 12 months]

Критерии участия

Критерии включения

Patient:

• Suffering from acute common low back pain for less than 3 months at the time of the initial consultation
• With a prescription for physiotherapy
• Available for both programs
• Aged between 20 and 55
• Equipped with a smartphone compatible with the Doado application
• Having been informed and having signed the free and informed consent form prior to any specific study procedure
• Affiliated to a health insurance scheme

Критерии исключения

Patient:

• suffering from a first episode of acute common low back pain for less than one month at the time of the initial consultation
• With a history of spinal surgery:

• For lumbar arthrodesis in the 12 months prior to inclusion
• For lumbar arthroplasty in the 6 months prior to inclusion
• For lumbar recalibration or lumbar disc herniation within 3 months of inclusion.
• With suspected specific low-back pain
• Suffering from radiculalgia of the lower limbs
• Suffering from sensory-motor disorders of the lower limbs
• Suffering from continuous low-back pain for at least 3 months
• Have severely impaired physical and/or psychological health, which in the investigator's opinion may affect the participant's compliance with the study.
• Participating in other interventional research
• In a period of exclusion from other research still in progress at the time of inclusion.
• Protected: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision.
• Pregnant, breast-feeding or parturient.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Франция · 1 центр

• Hôpital Privé Saint Martin — Pessac

Идентификаторы

NCT: NCT07061405 · REEDUCALGIE

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗