Evaluation of a Program to Prevent Recurrences of Episodes of Acute Low Back Pain, Assisted by the Axomove Application
NCT07915128, Not applicable, Not yet recruiting, University Hospital, Bordeaux
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Evaluation of a Program to Prevent Recurrences of Episodes of Acute Low Back Pain, Assisted by the Axomove Application | ClinicalTrials.gov |
| NCT number | NCT07915128 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 194 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | University Hospital, Bordeaux | ClinicalTrials.gov |
| Conditions | Low Back Pain | ClinicalTrials.gov |
| Interventions | 2 exercises program supervised by a physical therapist via a digital application, Care as usual | ClinicalTrials.gov |
| First posted | 2026-11-04 | ClinicalTrials.gov |
| Last updated | 2026-11-04 | ClinicalTrials.gov |
Registered outcomes 19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Proportion of recurrent patients | 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 | ClinicalTrials.gov |
| Secondary | Average quality of life measured between baseline and 24 months | From enrollment to 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. | ClinicalTrials.gov |
| Secondary | Average pain measured between baseline and 24 months | From enrollment to 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. | ClinicalTrials.gov |
| Secondary | Change from baseline in functional disability at 24 months | 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). | ClinicalTrials.gov |
| Secondary | Number of Participants with chronic low-back pain | From enrollment to 24 months | Occurrence of chronic low-back pain defined by permanent work cessation every three months (M3, M6, M9, M12, M15, M18, M21, M24) | ClinicalTrials.gov |
| Secondary | Change from baseline in Pain Anxiety Symptoms at 24 months | 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. | ClinicalTrials.gov |
| Secondary | Change from baseline in Chronic Pain Self Efficacy at 24 months | 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. | ClinicalTrials.gov |
| Secondary | Change from baseline in Kinesophobia at 24 months | 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. | ClinicalTrials.gov |
| Secondary | Change from baseline in Depression symptoms at 24 months | 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. | ClinicalTrials.gov |
| Secondary | Change from baseline in occupational stress at 24 months | 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. | ClinicalTrials.gov |
| Secondary | Pain-Related Coping Strategies and Beliefs before intervention | Before the intervention (Day 0 to Day 8) | 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. | ClinicalTrials.gov |
| Secondary | Pain-Related Coping Strategies and Beliefs after intervention | at 24 months | 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. | ClinicalTrials.gov |
| Secondary | Acceptability of the Intervention: Patient Expectations and Concerns | Before the intervention (Day 0 to Day 8) | 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. | ClinicalTrials.gov |
| Secondary | Patient Experiences and Perceived Effectiveness of the Intervention | at 24 months | 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 | ClinicalTrials.gov |
| Secondary | Physiotherapist Expectations and Concerns Regarding the Intervention | Before 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. | ClinicalTrials.gov |
| Secondary | Physiotherapist Experiences and Perceived Effectiveness of the Intervention | at 24 months | 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. | ClinicalTrials.gov |
| Secondary | Incremental Cost-Effectiveness Ratio per Quality-Adjusted Life-Year Gained | From enrollment to 24 months | 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 | ClinicalTrials.gov |
| Secondary | Costs to the French National Health Insurance System Associated With Low Back Pain-Related Sick Leave | From enrollment to 24 months | 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 | ClinicalTrials.gov |
| Secondary | Estimated 5-Year Net Financial Benefit of Nationwide Implementation of the Intervention | 5-years | 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. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)