Lumbar Pain SyndromeREEDUCALGIENCT07061405
Impact of a Multidisciplinary Rehabilitation Program Associated With the Doado Application in Lowback Pain Management
A study testing Multidisciplinary management associated with mobile application Doado and Physiotherapy management alone associated with mobile application Doado in people with Lumbar Pain Syndrome, run by Elsan at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 55 years
- Conditions the study is for
- Lumbar Pain Syndrome
- What is being tested?
- Multidisciplinary management associated with mobile application Doado and Physiotherapy management alone associated with mobile application Doado
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteFrance
- Study dates
- May 2026to Nov 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 15Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Hôpital Privé Saint Martin
Pessac
Marin GUY, +335 40 13 02 67, recherche.na@elsan.care
About this study
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.
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:
Read more
- 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
- Being tested
- Multidisciplinary management associated with mobile application Doado, Physiotherapy management alone associated with mobile application Doado
- Keywords
- rehabilitation, functional disability, multidisciplinary program, physiotherapy
- Medical subject headings
- Somatoform Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multidisciplinary management associated with mobile application DoadoOther
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 DoadoOther
monodisciplinary physiotherapy rehabilitation program consisting of active treatment with a physiotherapist associated with Doado mobile application
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Physiotherapy management alone associated with mobile application Doado |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%.
Measured: baseline, 3 months
Secondary outcomes (17)
Lumbar pain
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.
Measured: baseline, one month, 3 months, 6 months, 12 months
Lumbar pain chronicity
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.
Measured: over 12 months of follow-up
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%.
Measured: Baseline, one month, 3 months, 6 months, 12 months
Muscular endurance (Shirado-Ito test)
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.
Measured: baseline, one month, 3 months
Muscular endurance (hip bridge endurance)
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.
Measured: baseline, one month, 3 months
Muscular endurance (Biering-Sorensen)
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.
Measured: baseline, one month, 3 months
Muscular endurance (Killy test)
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).
Measured: baseline, one month, 3 months
Flexibility (finger-ground distance test)
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.
Measured: baseline, one month, 3 months
Flexibility (knee extension angle test)
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.
Measured: expressed in degrees of amplitude Time Frame : baseline, one month, 3 months
Flexibility (hill-ischin procubitus measurement test)
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.
Measured: baseline, one month, 3 months
Fear, apprehension and avoidance related to low back pain (SBST questionnaire)
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.
Measured: baseline, one month, 3 months, 6 months, 12 months
Fear, apprehension and avoidance related to low back pain (FABQ questionnaire)
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).
Measured: baseline, one month, 3 months, 6 months, 12 months
Return to work
Number of days off work
Measured: between the end of the 2 weeks of initial treatment and 1 year of follow-up
Return to sport activities
Number of days off sports activities
Measured: between baseline and 1 year of follow-up
Painful relapses
Number of new episodes of low back pain during follow-up. The patient indicates the start and end dates of each painful episode.
Measured: between baseline and 1 year of follow-up
Analgesics consumption
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.
Measured: over 12 months of follow-up
Patient satisfaction regarding each program
5-modality Likert scale developed specifically for the study from very dissatisfied to very satisfied
Measured: one month of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2025
- Study startMay 2026 (estimated)
- Primary completionFeb 2028 (estimated)
- Study completionNov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Pain SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Elsan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07061405
- Sponsor's protocol ID
- REEDUCALGIE
- Acronym
- REEDUCALGIE
- Status last verified
- Jul 2025
- First submitted
- 2 Jul 2025
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT07061405
- Acronym / sponsor ID
- REEDUCALGIE / REEDUCALGIE
- Conditions
- Lumbar Pain Syndrome
- Keywords
- rehabilitation, functional disability, multidisciplinary program, physiotherapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- ElsanUniversity, hospital or other
- Study start
- May 2026 (estimated)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Nov 2028 (estimated)
- First posted
- 11 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multidisciplinary management associated with mobile application Doado | Experimental | Other: Multidisciplinary management associated with mobile application Doado10 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. |
| Physiotherapy management alone associated with mobile application Doado | Active comparator | Other: Physiotherapy management alone associated with mobile application Doado10 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. |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multidisciplinary management associated with mobile application Doadomultidisciplinary program including physiotherapists, rheumatologists, physical medicine and rehabilitation specialists, occupational physicians, psychologists, etc., associated with Doado mobile application | Other | Multidisciplinary management associated with mobile application Doado |
| Physiotherapy management alone associated with mobile application Doadomonodisciplinary physiotherapy rehabilitation program consisting of active treatment with a physiotherapist associated with Doado mobile application | Other | Physiotherapy management alone associated with mobile application Doado |
Primary outcome
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%.
17 secondary outcomes
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
Return to work
Time frame: between the end of the 2 weeks of initial treatment and 1 year of follow-up
Return to sport activities
Time frame: between baseline and 1 year of follow-up
Painful relapses
Time frame: between baseline and 1 year of follow-up
Analgesics consumption
Time frame: over 12 months of follow-up
Patient satisfaction regarding each program
Time frame: one month of follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multidisciplinary management associated with mobile application Doado and Physiotherapy management alone associated with mobile application Doado in people with Lumbar Pain Syndrome, run by Elsan at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marin GUY (+335 40 13 02 67, recherche.na@elsan.care), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional disability (time frame: baseline, 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2026.