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NCT Number: NCT07061405

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

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.

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Key information

Age range

20 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

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

Primary outcomes

  1. Functional disability

    Time frame: baseline, 3 months

    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%.

Secondary outcomes

  1. Lumbar pain

    Time frame: baseline, one month, 3 months, 6 months, 12 months

    Mean patient lumbar pain on the last 7 days measured on a visual analog scale. It takes the form of a horizontal line with a qualifier at each end - "no pain (0)" on the left, "maximum imaginable pain (10)" on the right - onto which the patient draws a line (or positions a cursor on the online version), corresponding to the level of intensity of their pain.

    The result is the distance in mm between 0 and the line.

  2. Lumbar pain chronicity

    Time frame: over 12 months of follow-up

    Presence of lumbar pain chronicity, defined by daily continuous pain during at least 12 weeks. This data will be collected from the start and end dates of each recurrence entered by the patient in the patient logbook.

  3. Functional disability

    Time frame: Baseline, one month, 3 months, 6 months, 12 months

    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%.

  4. Muscular endurance (Shirado-Ito test)

    Time frame: baseline, one month, 3 months

    The patient must remain as long as possible with the hips and knees bent at 90°, shoulder blades lifted, arms crossed over torso and hands resting on shoulders. The test result is the time, in seconds, that the patient remains in this position (for a maximum of 5 minutes), measured by the physiotherapist using a stopwatch.

  5. Muscular endurance (hip bridge endurance)

    Time frame: baseline, one month, 3 months

    The patient lies on his or her back on a flat surface, knees bent and feet flat on the floor, positioned hip-width apart. Arms are crossed over the chest. The patient lifts his hips toward the ceiling, lifting his pelvis off the floor. When his shoulders are in line with his pelvis and knees, he stretches out his left leg, taking off the heel of the same leg so that there is alignment between shoulders, pelvis, knees and lifted foot. The stopwatch is then started.

    The patient holds this position for as long as possible, without letting the hips collapse or releasing the leg in the air. The result is timed in seconds, measured by the physiotherapist.

    The timer is stopped as soon as a change of at least 10 degrees in the alignment of the transverse or sagittal plane is visually detected by the physiotherapist.

    The test is done on both sides (left and right). The result is expressed in seconds.

  6. Muscular endurance (Biering-Sorensen)

    Time frame: baseline, one month, 3 months

    The patient is positioned on a Roman lumbar extension chair, prone with trunk in the air, arms crossed over the chest. The pelvis rests on the support up to the level of the anterior superior iliac spines. The lower limbs and pelvis are supported by the wedges. The patient must keep the trunk horizontal for as long as possible (within 4 minutes). The result is measured in seconds by the physiotherapist.

  7. Muscular endurance (Killy test)

    Time frame: baseline, one month, 3 months

    The patient simulates sitting on a chair, back and head pressed against the wall, hips and knees bent at 90° but not touching, hands touching the wall but not resting against it. The patient must hold the position for as long as possible. The result is timed in seconds, measured by the physiotherapist. The stopwatch is stopped as soon as : shoulders lift off the wall, the patient's pelvis moves up the wall, so that the thighs are no longer parallel to the floor, the hands rest on the thighs or on the wall (as this facilitates positioning).

  8. Flexibility (finger-ground distance test)

    Time frame: baseline, one month, 3 months

    Standing with feet together, the patient slowly tilts the chest forward, uncoiling the back with arms outstretched, in an attempt to touch the ground with the fingers, without bending the knees. The result of the test is the distance between the fingertips and the ground, measured with a ruler (cm). If the patient manages to touch the ground with the fingers and could go beyond this distance, the value will be scored at 0.

  9. Flexibility (knee extension angle test)

    Time frame: expressed in degrees of amplitude Time Frame : baseline, one month, 3 months

    The patient lies supine, while the physiotherapist flexes the hip and extends the knee. An inclinometer is placed on the patient's tibia to quantify amplitude. Alternatively, a goniometer can be used. The test is repeated on the opposite side. By comparing the right and left amplitudes, if the practitioner notes an angular amplitude deficit, this may reflect a hamstring amplitude deficit. The test result is expressed in degrees of amplitude.

  10. Flexibility (hill-ischin procubitus measurement test)

    Time frame: baseline, one month, 3 months

    The patient lies prone (procubitus) on a flat, comfortable surface. Legs should be fully extended and parallel. A tape measure is placed so that one end is aligned with the heel of the foot (posterior part of the heel) and the other end is directed towards the ischium (pelvic bone). The patient bends the knee of one leg as far as it will go, while keeping the other leg fully extended.

    The test result is the distance between the heel of the extended leg and the ischium on the same side, measured in cm.

  11. Fear, apprehension and avoidance related to low back pain (SBST questionnaire)

    Time frame: baseline, one month, 3 months, 6 months, 12 months

    Start Back Screening Tool (SBST) is a 9 items questionnaire which identifies the presence of potentially modifiable physical and psychological indicators, persistent and disabling symptoms among patients suffering from low back pain. The result is a score between 0 and 9.

  12. Fear, apprehension and avoidance related to low back pain (FABQ questionnaire)

    Time frame: baseline, one month, 3 months, 6 months, 12 months

    Fear Avoidance Belief Questionnaire (FABQ) is an assessment tool used in low back pain patients to measure patients' beliefs and attitudes about pain and physical activity, particularly in the context of musculoskeletal pain. It assesses how fear of pain may influence physical activity avoidance behavior. There are two subscales in the FABQ: the work subscale (FABQw) with 7 questions (maximum score of 42) and the physical activity subscale (FABQpa) with 4 questions (maximum score of 24).

  13. Return to work

    Time frame: between the end of the 2 weeks of initial treatment and 1 year of follow-up

    Number of days off work

  14. Return to sport activities

    Time frame: between baseline and 1 year of follow-up

    Number of days off sports activities

  15. Painful relapses

    Time frame: between baseline and 1 year of follow-up

    Number of new episodes of low back pain during follow-up. The patient indicates the start and end dates of each painful episode.

  16. Analgesics consumption

    Time frame: over 12 months of follow-up

    The name of the treatment taken, the start and end dates and the doses of analgesics will be noted by the patient in the patient's diary.

  17. Patient satisfaction regarding each program

    Time frame: one month of follow-up

    5-modality Likert scale developed specifically for the study from very dissatisfied to very satisfied

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Elsan

Other

Registry information

Official study 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.

Acronym: REEDUCALGIE

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jul 11, 2025
Registry last updated
Apr 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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