Back to results

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

Primary Purpose

Chronic Disease, Lumbago

Status

Recruiting

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

ACTIV'DOS group

Usual practise

About this trial

This is an interventional supportive care trial for Chronic Disease focused on measuring Exercise, Self-rehabilitation, Chronic low back pain, Mobile app, mHealth, eHealth, Physiotherapy, Disability, Pain

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

CHRU de BrestRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

ACTIV'DOS group

Control group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.

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.

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).

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).

Full Information

NCT ID

NCT04725344

First Posted

January 4, 2021

Last Updated

July 11, 2023

Sponsor

University Hospital, Brest

1. Study Identification

Unique Protocol Identification Number

NCT04725344

Brief Title

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

Acronym

ACTIV'DOS

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Recruiting

Study Start Date

July 26, 2021 (Actual)

Primary Completion Date

June 1, 2024 (Anticipated)

Study Completion Date

June 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Brest

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Disease, Lumbago

Keywords

Exercise, Self-rehabilitation, Chronic low back pain, Mobile app, mHealth, eHealth, Physiotherapy, Disability, Pain

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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)

Allocation

Randomized

Enrollment

46 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

ACTIV'DOS group

Arm Type

Experimental

Arm Description

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.

Arm Title

Control group

Arm Type

Experimental

Arm Description

Intervention Type

Other

Intervention Name(s)

ACTIV'DOS group

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Usual practise

Intervention Description

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

Primary Outcome Measure Information:

Title

Change from functional impairment with Roland-Morris questionnaire at 6 weeks.

Description

Time Frame

Day 0 (patient inclusion) and Day 42 (end of patient monitoring)

Secondary Outcome Measure Information:

Title

Difference of average pain during the seven last days with VAS pain

Description

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.

Time Frame

Day 0 (patient inclusion) and Day 42 (end of patient monitoring)

Title

Difference of worse pain during the seven last days with VAS pain

Description

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.

Time Frame

Day 0 (patient inclusion) and Day 42 (end of patient monitoring)

Title

Compliance (number of sessions done over the number of recommanded sessions) of self-rehabilitation program at 6 weeks

Description

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).

Time Frame

Day 42 (end of patient monitoring)

Title

Assessment of satisfaction with Likert scale

Description

Likert scale is a scale with 10 questions. For each question, the scale ranges from 3 (strongly agree) to -3 (strongly disagree).

Time Frame

Day 42 (end of patient monitoring)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

99 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Marc Beaumont

Phone

+33 (0)2 98 62 61 60

mbeaumont@ch-morlaix.fr

First Name & Middle Initial & Last Name or Official Title & Degree

Antoine COBIGO

Phone

+33 (0) 6 47 71 40 20

cobigo.an@gmail.com

Facility Information:

Facility Name

CHRU de Brest

City

Brest

State/Province

Finistère

ZIP/Postal Code

29609

Country

France

Individual Site Status

Recruiting

Facility Contact: