Low Back PainNA-PLU-MALODOSNCT07915128
Evaluation of a Program to Prevent Recurrences of Episodes of Acute Low Back Pain, Assisted by the Axomove Application
A study testing 2 exercises program supervised by a physical therapist via a digital application and Care as usual in people with Low Back Pain, run by University Hospital, Bordeaux.
Trial summary
The purpose of this study is to demonstrate that the prescription of specific exercises, supervised by a numerical application, reduces the rate of recurrence of episodes of acute low back pain Read more about this study
- Who is it for?
- Ages 18 to 49 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- 2 exercises program supervised by a physical therapist via a digital application and Care as usual
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 194 participants
- Where
- No sites listed yet
- Study dates
- 31 Jan 2027to 31 Jan 2030
- 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 18 to 49 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Working adult patients,
- Between 18 and 49 years,
- Had an episode of acute common low-back pain in the month prior to inclusion and resolved at the time of inclusion attended to by one of the participating general practitioners
- With a smartphone and able to use it or with an internet connection,
- Agreeing with consulting a physical therapist participating in the study,
- Affiliated to the french public welfare system,
- With a signed consent
Who cannot join
- Persistence of work stoppage on day of inclusion,
- Work stoppage due to low back pain lasting more than one month in the year preceding inclusion,
- Suspicion of symptomatic low back pain based on the doctor's clinical examination,
- Presence of another chronic pathology likely to result in non-participation in the procedure (depression, cardio-respiratory insufficiency, obesity with BMI ≥ 30),
- Presence of a neoplasm or serious infection and any other condition that could lead to prolonged general deterioration of the patient's health,
- Patient under guardianship
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Evaluation of a Program to Prevent Recurrences of Episodes of Acute Low Back Pain, Assisted by the Axomove Application: Randomized Superiority Study With 2-year Follow-up, Including Analysis on SNDS Data
The purpose of this study is to demonstrate that the prescription of specific exercises, supervised by a numerical application, reduces the rate of recurrence of episodes of acute low back pain
Read the detailed description
The prevention of chronic low-back pain is a public health issue, particularly in view of the cost of work stoppages. The spontaneous incidence of recurrence after an initial episode of acute low-back pain is over 80% within three years. These recurrences form the basis for the transition to chronicity. Studies have shown the preventive potential of a specific exercise program, with a reduction in the recurrence rate from 80% over one year to 35% over 3 years. The development of telehealth tools opens up the possibility of implementing and evaluating such a preventive program in outpatient clinics. Confirmation, in a primary care context, of the preventive effects described will enable us to envisage recommendations based on a high level of scientific evidence.
This study will compare a group following French health insurance recommendations for the management of acute low back pain with a group following 2 recommended exercises supervised by a physical therapist via a digital application.
After checking eligibility criteria and signing a consent form, the patient will be randomized into one of the 2 groups. In the control group, the doctor will provide the patient with the health insurance recommendations. In the intervention group, the doctor will provide the patient with the health insurance recommendations and refer them to a physiotherapist who will train them in the 2 recommended exercises. The patient will be contacted every 3 months for 2 years to fill in questionnaires and ask about his absence from work.
- Conditions
- Low Back Pain
- Being tested
- 2 exercises program supervised by a physical therapist via a digital application, Care as usual
- Keywords
- low back pain, physical therapists, digital application
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2 exercises program supervised by a physical therapist via a digital applicationOther
The physical therapist will ask patients to carry out self-rehabilitation sessions, consisting of 5 to 6 sets of 20 to 25 repetitions for each of the two recommended movements. Patients will be encouraged to perform these exercises at least every other day-or daily, if possible-for a minimum duration of 12 weeks.
The intervention will consist of 2 initial sessions with a physiotherapist, who will introduce specific exercises and-depending on the patient's adherence (monitored via the Axomove app)-may subsequently offer between 1 and 8 follow-up sessions.
Care as usualOther
The French national health insurance system (Assurance Maladie) provides recommendations for preventing the recurrence of lower back pain. These are outlined on the website https://www.ameli.fr/assure/sante/themes/lombalgie-aigue/traitement-prevention and via the "Activ'Dos" mobile application. In general, the approach involves encouraging patients to engage in physical activity, providing them with appropriate and reassuring information, and advising them to visit the website to select exercises-from among some sixty options-to perform.
As in the experimental group, this procedure will be supplemented by the provision of a back-care guide, which reinforces the reassuring information delivered orally.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | The control group will apply French health insurance recommendations Receives: Other: Care as usual |
| Experimental group | Experimental | The experimental group will apply French health insurance recommendations and the 2 recommended exercises supervised by a physical therapist via the Axomove application Receives: Other: 2 exercises program supervised by a physical therapist via a digital application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of recurrent patients
Proportion of recurrent patients, i.e. declaring a new episode of acute low-back pain likely to result in work stoppage during the two-year follow-up period, with data collected every three months
Measured: From enrollment to the end of intervention at 24 months
Secondary outcomes (18)
Average quality of life measured between baseline and 24 months
Quality of life will be assessed using EQ-5D-5L scale every three months (Day 0, Month (M)3, M6, M9, M12, M15, M18, M21, M24).
Mean score of quality of life will be assessed.
Measured: From enrollment to 24 months
Average pain measured between baseline and 24 months
Changes in pain levels will be measured every 3 months using a numerical pain scale. This is a standard measure in clinical practice, which will allow for the assessment-throughout the study-of the intervention's effectiveness regarding changes in pain, based on the following question: "Rate the intensity of your pain over the last two days on a scale from 0 to 10 (where 0 = no pain, and 10 = the worst pain you can imagine)." Mean score of pain will be assessed.
Measured: From enrollment to 24 months
Change from baseline in functional disability at 24 months
Changes in functional disability related to low back pain will be measured using a validated scale-the Oswestry Disability Index, which consists of 10 items-at the beginning and end of the study (day 0 and month 24).
Measured: At 24 months
Number of Participants with chronic low-back pain
Occurrence of chronic low-back pain defined by permanent work cessation every three months (M3, M6, M9, M12, M15, M18, M21, M24)
Measured: From enrollment to 24 months
Change from baseline in Pain Anxiety Symptoms at 24 months
The Pain Anxiety Symptoms Scale, which consists of 20 items, is used to assess pain-related anxiety across four factors: fear/catastrophizing, cognitive anxiety, physiological symptoms, and escape or avoidance reactions.
Changes in Pain Anxiety Symptoms from baseline at 24 months will be assessed.
Measured: At 24 months
Change from baseline in Chronic Pain Self Efficacy at 24 months
The French-Canadian Chronic Pain Self Efficacy Scale -which, in its short version, consists of 6 items-is used to assess one's sense of self-efficacy in managing chronic pain.
Changes in Chronic Pain Self Efficacy from baseline at 24 months will be assessed.
Measured: At 24 months
Change from baseline in Kinesophobia at 24 months
The French-Canadian version of the Tampa Scale of Kinesophobia, which consists of 17 items, is used to assess the fear of movement.
Changes in Kinesophobia from baseline at 24 months will be assessed.
Measured: At 24 months
Change from baseline in Depression symptoms at 24 months
The Center for Epidemiologic Studies Depression Scale, which consists of 20 items, is used to assess depressive symptomatology.
Changes in Depression symptoms from baseline at 24 months will be assessed.
Measured: At 24 months
Change from baseline in occupational stress at 24 months
The Job Content Questionnaire, which consists of 31 items, is used to assess occupational stress across four factors: the degree of autonomy, psychological job demands, the seeking of support at work, and physical demands. It will be administered at the beginning and end of the study (at baseline and at 24 months).
Changes in occupational stress from baseline at 24 months will be assessed.
Measured: At 24 months
Pain-Related Coping Strategies and Beliefs before intervention
Pain-related coping strategies and beliefs about pain will be explored through semi-structured interviews with a subsample of 15 patients per study group. Interviews will investigate participants' experiences of pain, the coping strategies they use, and their beliefs about pain before the intervention.
Measured: Before the intervention (Day 0 to Day 8)
Pain-Related Coping Strategies and Beliefs after intervention
Pain-related coping strategies and beliefs about pain will be explored through semi-structured interviews with a subsample of 15 patients per study group. Interviews will investigate participants' experiences of pain, the coping strategies they use, and their beliefs about pain after the intervention.
Measured: at 24 months
Acceptability of the Intervention: Patient Expectations and Concerns
The acceptability of the intervention will be explored through semi-structured interviews with a subsample of 15 patients per study group. Interviews conducted before the intervention will explore participants' expectations, anticipated benefits, and concerns regarding the proposed intervention.
Measured: Before the intervention (Day 0 to Day 8)
Patient Experiences and Perceived Effectiveness of the Intervention
Patient experiences of the intervention will be explored through semi-structured interviews with a subsample of 15 patients per study group. Interviews will investigate participants' experiences, perceived effectiveness, difficulties encountered during implementation, and suggestions for improving the program
Measured: at 24 months
Physiotherapist Expectations and Concerns Regarding the Intervention
The acceptability of the intervention will be explored through semi-structured interviews with a subsample of 10 physiotherapists in the intervention group. Pre-intervention interviews will explore physiotherapists' expectations, anticipated benefits, and concerns regarding implementation of the intervention.
Measured: Before the intervention
Physiotherapist Experiences and Perceived Effectiveness of the Intervention
Acceptance and adoption of the intervention will be explored through semi-structured interviews with a subsample of 10 physiotherapists in the intervention group. Interviews will investigate their experiences implementing the program, perceived effectiveness, difficulties encountered, and suggestions for improvement.
Measured: at 24 months
Incremental Cost-Effectiveness Ratio per Quality-Adjusted Life-Year Gained
The incremental cost-effectiveness ratio will be calculated as the difference in costs between the intervention and control groups divided by the difference in quality-adjusted life-years (QALYs) gained over 2 years. Healthcare costs will be estimated using data from the French National Health Data System (Système National des Données de Santé, SNDS), and QALYs will be estimated using responses to the EQ-5D-5L questionnaire
Measured: From enrollment to 24 months
Costs to the French National Health Insurance System Associated With Low Back Pain-Related Sick Leave
Costs associated with low back pain-related sick leave will be estimated in euros using data from the French National Health Data System (SNDS) and study-specific data. Costs will be estimated from the perspective of the French National Health Insurance system
Measured: From enrollment to 24 months
Estimated 5-Year Net Financial Benefit of Nationwide Implementation of the Intervention
The net financial benefit to the French National Health Insurance system of nationwide implementation of the intervention will be estimated over a 5-year horizon. The analysis will extrapolate cost estimates derived from SNDS data and published literature to estimate the financial impact of implementing the intervention across France.
Measured: 5-years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2026
- Study start31 Jan 2027 (estimated)
- Primary completion31 Jan 2030 (estimated)
- Study completion31 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- 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
- Model description
- open-label, two-arms randomized clinical trial
- Masking
- None (open label)
- Enrolment
- 194 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07915128
- Sponsor's protocol ID
- CHUBX 2024/63
- Other IDs
- 2025-A01831-48
- Acronym
- NA-PLU-MALODOS
- Status last verified
- Oct 2026
- First submitted
- 28 Oct 2026
- Last updated
- 4 Nov 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 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Program to Prevent Recurrences of Episodes of Acute Low Back Pain, Assisted by the Axomove Application: Randomized Superiority Study With 2-year Follow-up, Including Analysis on SNDS Data
- ClinicalTrials.gov ID
- NCT07915128
- Acronym / sponsor ID
- NA-PLU-MALODOS / CHUBX 2024/63
- Conditions
- Low Back Pain
- Keywords
- low back pain, physical therapists, digital application
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 194 participants (estimated)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 31 Jan 2027 (estimated)
- Primary completion
- 31 Jan 2030 (estimated)
- Study completion
- 31 Jan 2030 (estimated)
- First posted
- 4 Nov 2026 (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.
The purpose of this study is to demonstrate that the prescription of specific exercises, supervised by a numerical application, reduces the rate of recurrence of episodes of acute low back pain
Detailed description
The prevention of chronic low-back pain is a public health issue, particularly in view of the cost of work stoppages. The spontaneous incidence of recurrence after an initial episode of acute low-back pain is over 80% within three years. These recurrences form the basis for the transition to chronicity. Studies have shown the preventive potential of a specific exercise program, with a reduction in the recurrence rate from 80% over one year to 35% over 3 years. The development of telehealth tools opens up the possibility of implementing and evaluating such a preventive program in outpatient clinics. Confirmation, in a primary care context, of the preventive effects described will enable us to envisage recommendations based on a high level of scientific evidence.
This study will compare a group following French health insurance recommendations for the management of acute low back pain with a group following 2 recommended exercises supervised by a physical therapist via a digital application.
After checking eligibility criteria and signing a consent form, the patient will be randomized into one of the 2 groups. In the control group, the doctor will provide the patient with the health insurance recommendations. In the intervention group, the doctor will provide the patient with the health insurance recommendations and refer them to a physiotherapist who will train them in the 2 recommended exercises. The patient will be contacted every 3 months for 2 years to fill in questionnaires and ask about his absence from work.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- open-label, two-arms randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Other: Care as usualThe control group will apply French health insurance recommendations |
| Experimental group | Experimental | Other: 2 exercises program supervised by a physical therapist via a digital applicationThe experimental group will apply French health insurance recommendations and the 2 recommended exercises supervised by a physical therapist via the Axomove application |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Working adult patients,
- Between 18 and 49 years,
- Had an episode of acute common low-back pain in the month prior to inclusion and resolved at the time of inclusion attended to by one of the participating general practitioners
- With a smartphone and able to use it or with an internet connection,
- Agreeing with consulting a physical therapist participating in the study,
Key exclusion criteria (6 listed)
- Persistence of work stoppage on day of inclusion,
- Work stoppage due to low back pain lasting more than one month in the year preceding inclusion,
- Suspicion of symptomatic low back pain based on the doctor's clinical examination,
- Presence of another chronic pathology likely to result in non-participation in the procedure (depression, cardio-respiratory insufficiency, obesity with BMI ≥ 30),
- Presence of a neoplasm or serious infection and any other condition that could lead to prolonged general deterioration of the patient's health,
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 |
|---|---|---|
| 2 exercises program supervised by a physical therapist via a digital applicationThe physical therapist will ask patients to carry out self-rehabilitation sessions, consisting of 5 to 6 sets of 20 to 25 repetitions for each of the two recommended movements. Patients will be encouraged to perform these exercises at least every other day-or daily, if possible-for a minimum duration of 12 weeks. The intervention will consist of 2 initial sessions with a physiotherapist, who will introduce specific exercises and-depending on the patient's adherence (monitored via the Axomove app)-may subsequently offer between 1 and 8 follow-up sessions. | Other | Experimental group |
| Care as usualThe French national health insurance system (Assurance Maladie) provides recommendations for preventing the recurrence of lower back pain. These are outlined on the website https://www.ameli.fr/assure/sante/themes/lombalgie-aigue/traitement-prevention and via the "Activ'Dos" mobile application. In general, the approach involves encouraging patients to engage in physical activity, providing them with appropriate and reassuring information, and advising them to visit the website to select exercises-from among some sixty options-to perform. As in the experimental group, this procedure will be supplemented by the provision of a back-care guide, which reinforces the reassuring information delivered orally. | Other | Control group |
Primary outcome
Proportion of recurrent patients
Time frame: From enrollment to the end of intervention at 24 months
Proportion of recurrent patients, i.e. declaring a new episode of acute low-back pain likely to result in work stoppage during the two-year follow-up period, with data collected every three months
18 secondary outcomes
Average quality of life measured between baseline and 24 months
Time frame: From enrollment to 24 months
Average pain measured between baseline and 24 months
Time frame: From enrollment to 24 months
Change from baseline in functional disability at 24 months
Time frame: At 24 months
Number of Participants with chronic low-back pain
Time frame: From enrollment to 24 months
Change from baseline in Pain Anxiety Symptoms at 24 months
Time frame: At 24 months
Change from baseline in Chronic Pain Self Efficacy at 24 months
Time frame: At 24 months
Change from baseline in Kinesophobia at 24 months
Time frame: At 24 months
Change from baseline in Depression symptoms at 24 months
Time frame: At 24 months
Change from baseline in occupational stress at 24 months
Time frame: At 24 months
Pain-Related Coping Strategies and Beliefs before intervention
Time frame: Before the intervention (Day 0 to Day 8)
Pain-Related Coping Strategies and Beliefs after intervention
Time frame: at 24 months
Acceptability of the Intervention: Patient Expectations and Concerns
Time frame: Before the intervention (Day 0 to Day 8)
Patient Experiences and Perceived Effectiveness of the Intervention
Time frame: at 24 months
Physiotherapist Expectations and Concerns Regarding the Intervention
Time frame: Before the intervention
Physiotherapist Experiences and Perceived Effectiveness of the Intervention
Time frame: at 24 months
Incremental Cost-Effectiveness Ratio per Quality-Adjusted Life-Year Gained
Time frame: From enrollment to 24 months
Costs to the French National Health Insurance System Associated With Low Back Pain-Related Sick Leave
Time frame: From enrollment to 24 months
Estimated 5-Year Net Financial Benefit of Nationwide Implementation of the Intervention
Time frame: 5-years
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 4 Nov 2026.
- Individual participant dataSharing planned: No
Related trials for Low Back Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effects of Whole-Body Vibration and Cervical Stabilization With Core Stabilization in Young Adults With Non-Specific Low Back Pain
Nonspecific Low Back Pain
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)
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.
Questions about this trial
What is this clinical trial studying?
A study testing 2 exercises program supervised by a physical therapist via a digital application and Care as usual in people with Low Back Pain, run by University Hospital, Bordeaux.
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 7 inclusion and 6 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 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Mathieu DE SEZE, MD, PhD (+33 5 56 79 55 16, mathieu.de-seze@chu-bordeaux.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of recurrent patients (time frame: From enrollment to the end of intervention at 24 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 4 Nov 2026.