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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
19

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 26, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 9, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 9, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 4, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 25, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 26, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 5, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 2, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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