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

NCT07061405 | Not Yet Recruiting

• 1 other identifier: REEDUCALGIE
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lumbar Pain Syndrome

Keywords

rehabilitation; functional disability; multidisciplinary program; physiotherapy

Outcome Measures

Primary Outcomes (1)

• Functional disability

  Oswestry disability Index (ODI): 10 questions with 6 possible answers each, to assess the impact of the pain on several life habits and functionalities (walk, personal care, sitting position, etc.). The score is expressed as a percentage of handicap between 0 and 100%.

  baseline, 3 months

Secondary Outcomes (17)

• Lumbar pain

  baseline, one month, 3 months, 6 months, 12 months

• Lumbar pain chronicity

  over 12 months of follow-up

• Functional disability

  Baseline, one month, 3 months, 6 months, 12 months

• Muscular endurance (Shirado-Ito test)

  baseline, one month, 3 months

• Muscular endurance (hip bridge endurance)

  baseline, one month, 3 months

Study Arms (2)

Multidisciplinary management associated with mobile application Doado

EXPERIMENTAL

10 half-day sessions, in a day hospital, for 2 weeks, 5 times a week (Monday to Friday), each comprising 3 workshops, with the following contributors: physiotherapist, doctor, nurse, occupational therapist, psychologist, dietician, Adapted Physical Activity (APA) teacher. This program is associated with the Doado mobile application. The Doado mobile application includes rehabilitation exercises and educational content, to be used at home by the patients.

Other: Multidisciplinary management associated with mobile application Doado

Physiotherapy management alone associated with mobile application Doado

ACTIVE COMPARATOR

10 active functional re-education sessions (1 hour), 2 to 3 per week (sessions are therefore spread over approximately 4 to 5 weeks), based on muscle-strengthening exercises for the trunk and lower limbs, as well as stretching exercises for the back and lower limbs. This program is associated with the Doado mobile application.

Other: Physiotherapy management alone associated with mobile application Doado

Interventions

Multidisciplinary management associated with mobile application Doado OTHER

multidisciplinary program including physiotherapists, rheumatologists, physical medicine and rehabilitation specialists, occupational physicians, psychologists, etc., associated with Doado mobile application

Multidisciplinary management associated with mobile application Doado

Physiotherapy management alone associated with mobile application Doado OTHER

monodisciplinary physiotherapy rehabilitation program consisting of active treatment with a physiotherapist associated with Doado mobile application

Physiotherapy management alone associated with mobile application Doado

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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:
• 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
• Protected: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision.
• Pregnant, breast-feeding or parturient.

Sponsors & Collaborators

• Elsan: lead

Study Sites (1)

Hôpital Privé Saint Martin

Pessac, France

Location

MeSH Terms

Conditions

Somatoform Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Central Study Contacts

Marin GUY

CONTACT

+335 40 13 02 67; recherche.na@elsan.care

Charlène PY

CONTACT

+335 56 00 30 48; charlene.py@elsan.care

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2025
• First Posted: July 11, 2025
• Study Start: May 1, 2026
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): November 1, 2028
• Last Updated: April 23, 2026

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)