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

NCT ID: NCT07061405

Last Updated: 2025-07-11

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-30
• Study Completion Date: 2028-03-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Multidisciplinary management associated with mobile application Doado

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.

Group Type: EXPERIMENTAL

Multidisciplinary management associated with mobile application Doado

Intervention Type: OTHER

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

Physiotherapy management alone associated with mobile application Doado

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.

Group Type: ACTIVE_COMPARATOR

Physiotherapy management alone associated with mobile application Doado

Intervention Type: OTHER

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

Interventions

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

Intervention Type: 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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

Patient:

1. Suffering from acute common low back pain for less than 3 months at the time of the initial consultation

2. With a prescription for physiotherapy

3. Available for both programs

4. Aged between 20 and 55

5. Equipped with a smartphone compatible with the Doado application

6. Having been informed and having signed the free and informed consent form prior to any specific study procedure

7. Affiliated to a health insurance scheme

Exclusion Criteria

Patient:

1. suffering from a first episode of acute common low back pain for less than one month at the time of the initial consultation

2. With a history of spinal surgery:

1. For lumbar arthrodesis in the 12 months prior to inclusion

2. For lumbar arthroplasty in the 6 months prior to inclusion

3. For lumbar recalibration or lumbar disc herniation within 3 months of inclusion.

3. With suspected specific low-back pain

4. Suffering from radiculalgia of the lower limbs

5. Suffering from sensory-motor disorders of the lower limbs

6. Suffering from continuous low-back pain for at least 3 months

7. Have severely impaired physical and/or psychological health, which in the investigator's opinion may affect the participant's compliance with the study.

8. Participating in other interventional research

9. In a period of exclusion from other research still in progress at the time of inclusion.

10. Protected: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision.

11. Pregnant, breast-feeding or parturient.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Elsan

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hôpital Privé Saint Martin

Pessac, , France

Countries

France

Central Contacts

Marin GUY

Role: CONTACT

recherche.na@elsan.care

+335 40 13 02 67

Charlène PY

Role: CONTACT

charlene.py@elsan.care

+335 56 00 30 48

Facility Contacts

Marin GUY

Role: primary

recherche.na@elsan.care

+335 40 13 02 67

Other Identifiers

REEDUCALGIE

Identifier Type: -

Identifier Source: org_study_id