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

Sponsor

University Hospital, Brest (Other)

Overall Status

Recruiting

CT.gov ID

NCT04725344

Collaborator

(none)

Enrollment

Location

Arms

10.2

Anticipated Duration (Months)

4.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Disease Lumbago	Other: ACTIV'DOS group Other: Usual practise	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

46 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

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.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)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Jul 26, 2021

Anticipated Primary Completion Date :

Jun 1, 2022

Anticipated Study Completion Date :

Jun 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ACTIV'DOS group 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 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.
Experimental: Control group 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 Control group uses a standard sheet of paper to do the self-rehabilitation (15 minutes per day) during 6 weeks. There are 7 exercises.

Arm

Intervention/Treatment

Experimental: ACTIV'DOS group

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

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.

Experimental: Control group

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

Control group uses a standard sheet of paper to do the self-rehabilitation (15 minutes per day) during 6 weeks. There are 7 exercises.

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 99 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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