Chronic Low Back PainE-lombactifsNCT04264949
E-lombactifs: Evaluation of the Impact a Smartphone Application on Adherence an Exercise Program in Chronic Low Back Pain
A study testing Education in the use of smartphone app (Mon coach dos) and conventional care in people with Chronic Low Back Pain, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
The main objective is to assess the impact of smartphone application on adherence to a physical exercise program in chronic low back pain patients. Adherence to a physical exercise program will be assessed at the start of the protocol, at three weeks and six months. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Low Back Pain
- What is being tested?
- Education in the use of smartphone app (Mon coach dos) and conventional care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- 9 Mar 2020to 18 Dec 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult People
- With nonspecific chronic low back pain (according to the definition of the HAS)
- Covered under the national health insurance
- Giving informed written consent to participate in the study
Who cannot join
- Patient who do not meet the diagnostic criteria according to the definition of HAS
- Behavioral disorders or comprehension difficulties making assessment impossible
- Patient with a contraindication to physical exercise for medical reasons
- Patient under guardianship, curatorship or safeguard of justice
Trial locations and contacts
1 site in 1 country.
About this study
The main objective is to assess the impact of smartphone application on adherence to a physical exercise program in chronic low back pain patients.
Adherence to a physical exercise program will be assessed at the start of the protocol, at three weeks and six months.
Read more
A control group will benefit from conventional care in a rehabilitation center and an intervention group will benefit from a conventional care in a rehabilitation center accompanied by education in the use of a smartphone application including physical exercises and information about low back pain.
The hypothesis of the search is that adherence is better in intervention group than control group at 6 months due to education in the use of smartphone application.
- Conditions
- Chronic Low Back Pain
- Being tested
- Education in the use of smartphone app (Mon coach dos), conventional care
- Keywords
- Chronic Low Back Pain, Physical activity, Adherence
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education in the use of smartphone app (Mon coach dos)Other
In addition to conventional care and the therapeutic education program, GA will benefit from three education sessions (one per week) on the use of the smartphone app mon coach dos
conventional careOther
conventional care and the therapeutic education program
| Study group | Role | What they receive |
|---|---|---|
| group application (GA) | Experimental | benefit from conventional care in a rehabilitation center, therapeutic education program and education in the use of the smartphone application "mon coach dos" Receives: Other: Education in the use of smartphone app (Mon coach dos); Other: conventional care |
| Groupe conventional care (GCC) | Active comparator | benefit from conventional care in a rehabilitation center and therapeutic education program Receives: Other: conventional care |
What is being measured
The primary outcome is the main question the study is designed to answer.
EARS : exercise adherence rating scale
EARS assess the adherence in physical activity program.
Measured: day1
EARS : exercise adherence rating scale
EARS assess the adherence in physical activity program.
Measured: day 15
EARS : exercise adherence rating scale
EARS assess the adherence in physical activity program.
Measured: day 180
Secondary outcomes (11)
OSWESTRY questionnaire
Disability is measured by OSWESTRY
Measured: day1, day 15, day 180
EPAP questionnaire
The perceived barriers to and facilitators of physical activity are measured by EPAP
Measured: day1, day 15, day 180
Pain measurment: numeric scale
The pain is measured by numeric scale
Measured: day1, day 15, day 180
6 minutes' walk test (6MWT)
Aerobic and functional capacities are measured by 6 minutes' walk test (6MWT)
Measured: day1, day 15, day 180
aerobic capacities
aerobic capacities are measured by sub maximal ergocycle test
Measured: day1, day 15, day 180
muscular endurance
the muscular endurance of the erector muscles of the spine is measured by Sorensen test
Measured: day1, day 15, day 180
muscular endurance of the flexor muscles of the spine
the muscular endurance of the flexor muscles of the spine is measured by ITO test
Measured: day1, day 15, day 180
muscular endurance of the extensor of the knee
the muscular endurance of the extensor of the knee is measured by Killy test
Measured: day1, day 15, day 180
Core measurment
Core is measured by plank test
Measured: day1, day 15, day 180
Flexibility on posterior chain
Flexibility on posterior chain is measured by DDS test
Measured: day1, day 15, day 180
Mobility on posterior chain
Mobility on posterior chain is measured by Schober test
Measured: day1, day 15, day 180
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2020
- Study start9 Mar 2020
- Primary completion18 Dec 2023
- Study completion18 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Low Back PainStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Baptiste Lechauve, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04264949
- Sponsor's protocol ID
- RBHP 2019 LECHAUVE
- Other IDs
- 2019-A02191-56
- Acronym
- E-lombactifs
- Status last verified
- Aug 2026
- First submitted
- 7 Feb 2020
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lechauve JB, Dobija L, Pereira B, Grolier M, Pelletier-Visa M, Lanhers C, Coudeyre E. Evaluation of the Impact of a Smartphone App on Adherence to an Exercise Program in People With Chronic Low Back Pain: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2026 Jun 15;14:e77736. doi: 10.2196/77736.
PubMed 42296544Lechauve JB, Dobija L, Pereira B, Grolier M, Goldstein A, Lanhers C, Coudeyre E. Evaluation of the impact of a smartphone application on adherence to home exercise program for people with chronic low back pain: research protocol for a pilot randomised controlled trial. BMJ Open. 2023 Mar 24;13(3):e062290. doi: 10.1136/bmjopen-2022-062290.
PubMed 36963800
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- E-lombactifs: Evaluation of the Impact a Smartphone Application on Adherence an Exercise Program in Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT04264949
- Acronym / sponsor ID
- E-lombactifs / RBHP 2019 LECHAUVE
- Conditions
- Chronic Low Back Pain
- Keywords
- Chronic Low Back Pain, Physical activity, Adherence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 9 Mar 2020 (actual)
- Primary completion
- 18 Dec 2023 (actual)
- Study completion
- 18 Dec 2023 (actual)
- First posted
- 11 Feb 2020 (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 main objective is to assess the impact of smartphone application on adherence to a physical exercise program in chronic low back pain patients.
Adherence to a physical exercise program will be assessed at the start of the protocol, at three weeks and six months.
A control group will benefit from conventional care in a rehabilitation center and an intervention group will benefit from a conventional care in a rehabilitation center accompanied by education in the use of a smartphone application including physical exercises and information about low back pain.
The hypothesis of the search is that adherence is better in intervention group than control group at 6 months due to education in the use of smartphone application.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group application (GA) | Experimental | Other: Education in the use of smartphone app (Mon coach dos), Other: conventional carebenefit from conventional care in a rehabilitation center, therapeutic education program and education in the use of the smartphone application "mon coach dos" |
| Groupe conventional care (GCC) | Active comparator | Other: conventional carebenefit from conventional care in a rehabilitation center and therapeutic education program |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult People
- With nonspecific chronic low back pain (according to the definition of the HAS)
- Covered under the national health insurance
- Giving informed written consent to participate in the study
Key exclusion criteria (4 listed)
- Patient who do not meet the diagnostic criteria according to the definition of HAS
- Behavioral disorders or comprehension difficulties making assessment impossible
- Patient with a contraindication to physical exercise for medical reasons
- Patient under guardianship, curatorship or safeguard of justice
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 |
|---|---|---|
| Education in the use of smartphone app (Mon coach dos)In addition to conventional care and the therapeutic education program, GA will benefit from three education sessions (one per week) on the use of the smartphone app mon coach dos | Other | group application (GA) |
| conventional careconventional care and the therapeutic education program | Other | Groupe conventional care (GCC), group application (GA) |
Primary outcome
EARS : exercise adherence rating scale
Time frame: day1
EARS assess the adherence in physical activity program.
EARS : exercise adherence rating scale
Time frame: day 15
EARS assess the adherence in physical activity program.
EARS : exercise adherence rating scale
Time frame: day 180
EARS assess the adherence in physical activity program.
11 secondary outcomes
OSWESTRY questionnaire
Time frame: day1, day 15, day 180
EPAP questionnaire
Time frame: day1, day 15, day 180
Pain measurment: numeric scale
Time frame: day1, day 15, day 180
6 minutes' walk test (6MWT)
Time frame: day1, day 15, day 180
aerobic capacities
Time frame: day1, day 15, day 180
muscular endurance
Time frame: day1, day 15, day 180
muscular endurance of the flexor muscles of the spine
Time frame: day1, day 15, day 180
muscular endurance of the extensor of the knee
Time frame: day1, day 15, day 180
Core measurment
Time frame: day1, day 15, day 180
Flexibility on posterior chain
Time frame: day1, day 15, day 180
Mobility on posterior chain
Time frame: day1, day 15, day 180
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2026.
- Results publication: PubMed 42296544Lechauve JB, Dobija L, Pereira B, Grolier M, Pelletier-Visa M, Lanhers C, Coudeyre E. Evaluation of the Impact of a Smartphone App on Adherence to an Exercise Program in People With Chronic Low Back Pain: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2026 Jun 15;14:e77736. doi: 10.2196/77736.
- Derived from this study: PubMed 36963800Lechauve JB, Dobija L, Pereira B, Grolier M, Goldstein A, Lanhers C, Coudeyre E. Evaluation of the impact of a smartphone application on adherence to home exercise program for people with chronic low back pain: research protocol for a pilot randomised controlled trial. BMJ Open. 2023 Mar 24;13(3):e062290. doi: 10.1136/bmjopen-2022-062290.
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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.
Jean-Baptiste Lechauve principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education in the use of smartphone app (Mon coach dos) and conventional care in people with Chronic Low Back Pain, run by University Hospital, Clermont-Ferrand at 1 site 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 4 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: finished, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
EARS : exercise adherence rating scale (time frame: day1). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04264949, which also lists 2 linked publications.
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 2026.