Relevance of the Activ'Dos App for Chronic Low Back Pain Patients

Study Overview
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Brief Summary
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The purpose of this study is to compare a self rehabilitation program using ACTIV'DOS app versus using a standard sheet of paper.

Detailed Description
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This study involves patients with chronic low back pain. The purpose of this study is to compare a self-rehabilitation program using ACTIV'DOS app versus a standard sheet of paper. Disabilities are measured with a Roland-Morris questionnaire.

Official Title
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Relevance of the Activ'Dos App for Chronic Low Back Pain Patients - Randomized Trial

Conditions
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Chronic Disease, Lumbago

Intervention / Treatment
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* Other: ACTIV'DOS group
* Other: Usual practise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: chronic low back pain for more than 3 months Aged to 18 or more Possibility to use Activ'dos application with smartphone or tablet Initial score of Roland Morris questionnaire >= 4 Fit to consent Who has signed consent form Exclusion Criteria: Any signs of severe illness underlying to radicular and lumbar pain like red flags Guardianship or protection of vulnerable adult Pregnant or nursing Refuse to participate

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: There are 2 groups : an interventional group with ACTIV'DOS app ; and a control group with a standard procedure using a sheet of paper.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ACTIV'DOS group<br>ACTIV'DOS is a smartphone application of self rehabilitation. There are 7 muscular exercices. Patients going to exercices during 15 minutes per day, during 6 weeks. | Other: ACTIV'DOS group<br>* ACTIV'DOS group use ACTIV'DOS application (with smartphone) to do the self rehabilitation each day (15 minutes per day) during 6 weeks. There are 7 exercices.<br>|
| Experimental: Control group<br>This group uses a sheet of paper for self-rehabilitation exercise. The self-rehabilitation program is the same as the ACTIV'DOS group. Patients have to exercise during 15 minutes per day, during 6 weeks. | Other: Usual practise<br>* Control group uses a standard sheet of paper to do the self-rehabilitation (15 minutes per day) during 6 weeks. There are 7 exercises.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from functional impairment with Roland-Morris questionnaire at 6 weeks. | Disabilities are measured with Roland-Morris questionnaire, from Day 0 to Day 42. This questionnaire includes 24 items with 1 point per item. The score ranges from 0 (no disability) to 24 (max. disability). | Day 0 (patient inclusion) and Day 42 (end of patient monitoring) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference of average pain during the seven last days with VAS pain | VAS pain is a scale measuring pain intensity from 0 (no pain) to 10 (extreme pain). For this outcome, the average pain during the seven last days is evaluated. | Day 0 (patient inclusion) and Day 42 (end of patient monitoring) | 
| Difference of worse pain during the seven last days with VAS pain | VAS pain is a scale measuring pain intensity from 0 (no pain) to 10 (extreme pain). For this outcome, the worse pain during the seven last days is evaluated. | Day 0 (patient inclusion) and Day 42 (end of patient monitoring) | 
| Compliance (number of sessions done over the number of recommanded sessions) of self-rehabilitation program at 6 weeks | Compliance is evaluated with a compliance table. Patients have to complete this table after each session. Investigators will report the compliance table at the end of the patient monitoring (Week 6). | Day 42 (end of patient monitoring) | 
| Assessment of satisfaction with Likert scale | Likert scale is a scale with 10 questions. For each question, the scale ranges from 3 (strongly agree) to -3 (strongly disagree). | Day 42 (end of patient monitoring) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Exercise, Self-rehabilitation, Chronic low back pain, Mobile app, mHealth, eHealth, Physiotherapy, Disability, Pain