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| Name | Class |
|---|---|
| URC-CIC Paris Descartes Necker Cochin | OTHER |
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The main aim of this study was to evaluate the medium-term efficacy of an intervention involving personalized, automated text messaging (SMS), following face-to-face rehabilitation sessions, on activity limitation in people with chronic low back pain. We hypothesize that personalized SMS follow-up, following face-to-face rehabilitation sessions, could reduce activity limitation in people with chronic low back pain. Prospective multicenter randomized controlled trial.
Participants in both groups, experimental and comparator will have 4 face-to-face multidisciplinary rehabilitation sessions.
Participants in the 2 groups will have a face-to-face medical-kinesthetic clinical consultation at M3.
Participants in the experimental group will be monitored by personalized SMS messages over 6 months.
Non-specific low-back pain is one of the leading causes of activity limitation worldwide. Physical exercise is the treatment that has the best proven its efficacy on pain and activity limitation. Adherence to treatment is an essential factor in its effectiveness. Adherence decreases over time and is low in the medium and long term. Lack of patient follow-up is incriminated in poor adherence. Improving the follow-up of chronic low back pain patients appears to be an important lever for improving their function in the medium and long term.
The Memoquest digital solution (Calmedica) solution is based on a conversational robot that generates SMS messages. It integrates an alert and relay system by the therapist.
Participants will be recruited from patients seen in consultation in the physical medicine and rehabilitation (PMR) departments and in the networks of physicians and town-based MKs at the three centers. Randomization will be centralized.
Patients in the 2 groups will have 4 face-to-face multidisciplinary rehabilitation sessions, lasting 1h30 each, over approximately 15 days (2/week over 2 weeks). During these sessions, participants will learn a personalized exercise self-program (APE).
Participants in the 2 groups will have a face-to-face medico-kinesitherapy clinical consultation at M3: the doctor will question the patient about the evolution of his pain, check for the absence of warning signs and assess the tolerance and efficacy of pharmacological treatments, where appropriate. The physiotherapist will question the patient on the completion of the exercises in the self-program, and will provide additional information if necessary. The physiotherapist may also suggest modifications to the exercises to support the participant's progress.
Participants in the experimental group will be monitored by personalized SMS messages, over 6 months: from the end of the face-to-face rehabilitation sessions, they will receive 2 types of messages on their cell phones:
If the patient raises the same obstacle during 2 successive exchanges, or if the patient does not respond to the reminder message (48 hours after the initial message), or if the response is not appropriate, the participant will be called on the telephone by an MK taking part in the study.
The participant may withdraw from the study at any time by mentioning
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ARM A : SMS | Experimental |
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| ARM B : Usual follow-up | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SMS | Procedure | Usual follow-up |
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| Measure | Description | Time Frame |
|---|---|---|
| Activity limitation | Change in score on the Roland Morris Disability questionnaire (RMDQ, 0 no activity limitation; 24, maximum limitation) | Month 6 (M6) |
| Measure | Description | Time Frame |
|---|---|---|
| Activity limitation | Change in RMDQ score | M3 |
| Physical activity | Change in overall physical activity measured by pedometer: measurement of average daily activity in the 7 days preceding assessments |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Camille THERY, MD | Contact | 07 77 31 10 55 | +33 | camille.thery@aphp.fr |
| Valérie PLENCE, Msc | Contact | 01 58 41 11 78 | +33 | valerie.plence-fauroux@aphp.fr |
| Name | Affiliation | Role |
|---|---|---|
| Camille Camille, MK | Université Paris Cité, Faculté de Santé | UFR de Médecine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Assistance Publique - Hôpitaux de Paris, Service de Rééducation et de Réadaptation de l'Appareil Locomoteur et des Pathologies du Rachis, Hôpital Cochin | Paris | Île-de-France Region | 75014 | France |
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statisticians will be masked
| M3 and M6 |
| Pain intensity | Change in pain score measured by numerical scale (at the end of face-to-face supervised PEC | M3 and M6 |
| Quality of life | Change in quality of life measured by the Medical Outcome Study Short Form-12 | M6 |
| Adherence | Change in adherence score: Exercise Adherence Rating Scale (EARS) | M3 and M6 |
| Exercice burden | Change in exercise burden score : Exercice Therapy Burden questionnaire (ETBQ) | M3 and M6 |
| Self-efficacy | Change in self-efficacy for exercise | M3 and M6 |
| Level of physical activity (IPAQ) | D0 and M6 |
| Perception of change | M6 |
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