Chronic DiseaseACTIV'DOSNCT04725344
Relevance of the Activ'Dos App for Chronic Low Back Pain Patients
A study testing ACTIV'DOS group and Usual practise in people with Chronic Disease and Lumbago, run by University Hospital, Brest at 4 sites in France.
Trial summary
The purpose of this study is to compare a self rehabilitation program using ACTIV'DOS app versus using a standard sheet of paper. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Chronic Disease, Lumbago
- What is being tested?
- ACTIV'DOS group and Usual practise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 4 sitesFrance
- Study dates
- 26 Jul 2021to 9 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
France4 sites
Cabinet de kinésithérapie Natanaël AUDREN
Brest, 29200
Cabinet de kinésithérapie Pierre VAL
Brest, 29200
Cabinet de kinésithérapie Pol KEROUANTON
Brest, 29200
Cabinet de kinésithérapie Vincent LUCAS
Brest, 29200
About this study
Official title: 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.
Read the 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.
- Conditions
- Chronic Disease, Lumbago
- Being tested
- ACTIV'DOS group, Usual practise
- Keywords
- Exercise, Self-rehabilitation, Chronic low back pain, Mobile app, mHealth, eHealth, Physiotherapy, Disability, Pain
- Medical subject headings
- Chronic Disease, Low Back Pain, Motor Activity, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACTIV'DOS groupOther
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.
Usual practiseOther
Control group uses a standard sheet of paper to do the self-rehabilitation (15 minutes per day) during 6 weeks. There are 7 exercises.
| Study group | Role | What they receive |
|---|---|---|
| ACTIV'DOS group | Experimental | 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. Receives: Other: ACTIV'DOS group |
| Control group | Experimental | 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. Receives: Other: Usual practise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Day 0 (patient inclusion) and Day 42 (end of patient monitoring)
Secondary outcomes (4)
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.
Measured: Day 0 (patient inclusion) and Day 42 (end of patient monitoring)
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.
Measured: 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
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).
Measured: Day 42 (end of patient monitoring)
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).
Measured: Day 42 (end of patient monitoring)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2021
- Study start26 Jul 2021
- Primary completion9 May 2023
- Study completion9 May 2023
Why it stopped: Recruitement difficulties
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04725344
- Sponsor's protocol ID
- 29BRC20.0294
- Acronym
- ACTIV'DOS
- Status last verified
- Jul 2024
- First submitted
- 4 Jan 2021
- Last updated
- 5 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected data that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relevance of the Activ'Dos App for Chronic Low Back Pain Patients - Randomized Trial
- ClinicalTrials.gov ID
- NCT04725344
- Acronym / sponsor ID
- ACTIV'DOS / 29BRC20.0294
- Conditions
- Chronic Disease, Lumbago
- Keywords
- Exercise, Self-rehabilitation, Chronic low back pain, Mobile app, mHealth, eHealth, Physiotherapy, Disability
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitement difficulties
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 26 Jul 2021 (actual)
- Primary completion
- 9 May 2023 (actual)
- Study completion
- 9 May 2023 (actual)
- First posted
- 26 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| ACTIV'DOS group | Experimental | Other: ACTIV'DOS groupACTIV'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. |
| Control group | Experimental | Other: Usual practiseThis 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. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ACTIV'DOS groupACTIV'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. | Other | ACTIV'DOS group |
| Usual practiseControl group uses a standard sheet of paper to do the self-rehabilitation (15 minutes per day) during 6 weeks. There are 7 exercises. | Other | Control group |
Primary outcome
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).
4 secondary outcomes
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)
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)
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)
Assessment of satisfaction with Likert scale
Time frame: Day 42 (end of patient monitoring)
Results and safety
The study was stopped early (reason given: Recruitement difficulties). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2024.
- Individual participant dataSharing planned: Yes. All collected data that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ACTIV'DOS group and Usual practise in people with Chronic Disease and Lumbago, run by University Hospital, Brest at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Recruitement difficulties). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from functional impairment with Roland-Morris questionnaire at 6 weeks. (time frame: Day 0 (patient inclusion) and Day 42 (end of patient monitoring)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2024.