Chronic Disease, Lumbago
Conditions
Keywords
Exercise, Self-rehabilitation, Chronic low back pain, Mobile app, mHealth, eHealth, Physiotherapy, Disability, Pain
Brief summary
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
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.
Interventions
OTHERACTIV'DOS group
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.
OTHERUsual practise
Control group uses a standard sheet of paper to do the self-rehabilitation (15 minutes per day) during 6 weeks. There are 7 exercises.
Sponsors
University Hospital, Brest
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from functional impairment with Roland-Morris questionnaire at 6 weeks. | Day 0 (patient inclusion) and Day 42 (end of patient monitoring) | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Difference of average pain during the seven last days with VAS pain | Day 0 (patient inclusion) and Day 42 (end of patient monitoring) | 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. |
| Difference of worse pain during the seven last days with VAS pain | Day 0 (patient inclusion) and Day 42 (end of patient monitoring) | 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. |
| Compliance (number of sessions done over the number of recommanded sessions) of self-rehabilitation program at 6 weeks | Day 42 (end of patient monitoring) | 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). |
| Assessment of satisfaction with Likert scale | Day 42 (end of patient monitoring) | Likert scale is a scale with 10 questions. For each question, the scale ranges from 3 (strongly agree) to -3 (strongly disagree). |
Countries
France
Outcome results
None listed