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

August 2, 2024 updated by: University Hospital, Brest

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

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

19

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Brest, France, 29200
        • Cabinet de kinésithérapie Natanaël AUDREN
      • Brest, France, 29200
        • Cabinet de kinésithérapie Pierre VAL
      • Brest, France, 29200
        • Cabinet de kinésithérapie Pol KEROUANTON
      • Brest, France, 29200
        • Cabinet de kinésithérapie Vincent LUCAS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from functional impairment with Roland-Morris questionnaire at 6 weeks.
Time Frame: 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).
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
Time Frame: 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.
Day 0 (patient inclusion) and Day 42 (end of patient monitoring)
Difference of worse pain during the seven last days with VAS pain
Time Frame: 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.
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
Time Frame: 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).
Day 42 (end of patient monitoring)
Assessment of satisfaction with Likert scale
Time Frame: 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).
Day 42 (end of patient monitoring)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Brest

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 26, 2021

Primary Completion (Actual)

May 9, 2023

Study Completion (Actual)

May 9, 2023

Study Registration Dates

First Submitted

January 4, 2021

First Submitted That Met QC Criteria

January 25, 2021

First Posted (Actual)

January 26, 2021

Study Record Updates

Last Update Posted (Actual)

August 5, 2024

Last Update Submitted That Met QC Criteria

August 2, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 29BRC20.0294

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All collected data that underlie results in a publication

IPD Sharing Time Frame

Data will be available after the publication of result and ending fifteen years following the last visit of the last patient

IPD Sharing Access Criteria

Data access requests will be reviewed by the internal committee of Brest University Hospital. Requestors will be required to sign and complete a data access agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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