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

Official title

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.

Overview

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.

Interventions

• Other 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
• Other Physiotherapy management alone associated with mobile application Doado
  monodisciplinary physiotherapy rehabilitation program consisting of active treatment with a physiotherapist associated with Doado mobile application

Primary outcome measures

• Functional disability [Time frame: baseline, 3 months]

Secondary outcome measures (12)

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

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

France · 1 center

• Hôpital Privé Saint Martin — Pessac

Identifiers

NCT: NCT07061405 · REEDUCALGIE

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗