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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-A00100-39 | Other Identifier | ID-RCB |
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| Name | Class |
|---|---|
| Arthritis Foundation | OTHER |
| Societe Francaise de Rhumatologie | OTHER |
| Association Malakoff Médéric Innovation Santé | UNKNOWN |
| URC-CIC Paris Descartes Necker Cochin |
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The investigators hypothesize that a personalized and automated digital coaching could reduce activity limitations in people with chronic low back pain as compared to usual care
Non-specific low back pain (LBP) is the leading cause of years of life lived with disability worldwide and its burden is growing alongside the increasing and ageing population.
LBP is usually treated according to symptoms duration, presence of concomitant radicular pain and of consistent anatomical abnormalities and is defined according to symptoms duration: acute (< 6 weeks), subacute (6 to 12 weeks) and chronic (> 12 weeks). The prognosis of acute LBP is excellent, but in 5 to 15% of individuals, LBP becomes chronic. At 6 months, about 10% of individuals with chronic LBP are on sick leave, and at 12 months, 20% report persistent disability.
Unfavourable evolution of chronic LBP is characterized by onset and persistence of spine-specific disability in all individuals and work absenteeism in working age individuals. The probability of returning to work is only 20% after 1 year of sick leave and 0% after 2 years. Multidisciplinary rehabilitation that combines education, physical therapy, cognitive behavioural therapy and rehabilitation is usually offered. However, lack of personalization of these programs could affect their efficacy and systematic evaluation suggests their low cost-effectiveness).
Current management of non-specific chronic low back pain involves a multidisciplinary approach that typically includes non-opioid analgesics, physical exercise and strength training, education, and cognitive behavioural therapies. Therapeutic interventions such as massage, acupuncture, or spinal manipulation may also be beneficial.
The investigators hypothesize that a personalized and automated digital coaching could reduce activity limitations in people with chronic LBP, as compared to usual care.
Participants allocated to the experimental group will be invited to download a smartphone application which will appraise their motivation and automatically propose 1) exercises to be performed at home and adapted to their pain levels; 2) audio recordings for pain management; and 3) educational and coaching content adapted to their motivation. In addition, the smartphone application enables users to plan their home exercises.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Experimental | Personalized and automated digital coaching smartphone application |
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| Comparator group | No Intervention | Usual care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Personalized and automated digital coaching using a mobile application | Device | Participants allocated to the experimental group will be invited to download a smartphone application which will appraise their motivation and automatically propose: 1) exercises to be performed at home and adapted to their pain levels; 2) audio recordings for pain management; and 3) educational and coaching content adapted to their motivation. In addition, the smartphone application enables users to plan their home exercises |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change in activity limitations | French version of the self-administered Roland Morris Disability Questionnaires (RMDQ). Higher scores indicate worse function | 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change in activity limitations at 12 months after consent | French version of the self-administered Roland Morris Disability Questionnaires (RMDQ). Higher scores indicate worse function | 12 months |
| Mean change in the intensity of low back pain at 4 months after consent |
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Inclusion Criteria:
Adults aged 18 or over
Having non-specific chronic LBP
Participating in the "ComPaRe" e-cohort
Having provided consent for their data to be used to assess trial eligibility
Having a valid email address
Able to read and write French Having a smartphone functioning with Android acquired after 2020
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Christelle NGUYEN, MD, PhD | Contact | +33 1 58 41 29 45 | christelle.nguyen2@aphp.fr | |
| Laetitia PEAUDECERF, PhD | Contact | +33 1 58 41 12 13 | laetitia.peaudecerf@aphp.fr |
| Name | Affiliation | Role |
|---|---|---|
| Christelle NGUYEN | Assistance Publique - Hôpitaux de Paris | Principal Investigator |
| François RANNOU, MD,PhD | Assistance Publique - Hôpitaux de Paris | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Service de Rééducation et de Réadaptation de l'Appareil Locomoteur et des Pathologies du Rachis - hôpital Cochin | Paris | 75014 | France |
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| Label | URL |
|---|---|
| ComPaRe ("Communauté de Patients pour la Recherche") is a collaborative open e-cohort of patients with chronic conditions. Within the ComPaRe platform, a cohort specific to non-specific low back pain was launched | View source |
| click here for more information about this study Back-4P | View source |
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| OTHER |
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|
Self-administered numerical scale with 11 classes incremented by 10 points (0, no pain and 100, maximum pain) |
| 4 months |
| Mean change in the intensity of low back pain at 12 months after consent | Self-administered numerical scale with 11 classes incremented by 10 points (0, no pain and 100, maximum pain) | 12 months |
| Work absenteeism at 4 months after consent | Number of self-reported days off work | 4 months |
| Work absenteeism at 12 months after consent | Number of self-reported days off work | 12 months |