An interventional study of 2 exercises program supervised by a physical therapist via a digital application and Care as usual in Low Back Pain, sponsored by University Hospital, Bordeaux. Not yet recruiting. Open to participants aged 18 Years to 49 Years. Per ClinicalTrials.gov, last updated 2026-11-04.
Sponsored by University Hospital, Bordeaux · Not applicable, Interventional, and Treatment
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
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.
2,884 studies on the registry are indexed under Low Back Pain; 483 are open to participants now.
This study's planned enrollment of 194 is above the median of 60 across 2,324 interventional studies indexed under Low Back Pain.
Browse Low Back Pain studies →University Hospital, Bordeaux is the lead sponsor of 805 studies on the registry; 196 are open to participants now.
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Exclusion Criteria:
The control group will apply French health insurance recommendations
Other: Care as usual
The experimental group will apply French health insurance recommendations and the 2 recommended exercises supervised by a physical therapist via the Axomove application
Other: 2 exercises program supervised by a physical therapist via a digital application
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.
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.
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
Time frame: From enrollment to the end of intervention at 24 months
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.
Time frame: 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.
Time frame: 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).
Time frame: 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)
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 5-years
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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