Chronic Low-back PainE-lombaqualNCT06517342
Motivations, Obstacles and Opportunities for Using a Health Application to Encourage Physical Activity in People With Chronic Low Back Pain
An observational study of Chronic Low-back Pain, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
In industrialized countries, low back pain can be considered a priority health issue. Some studies define it as one of the leading causes of disability in people under 45, or the leading cause of musculoskeletal disorders, with a prevalence of 26.9%. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Low-back Pain
- How many people
- 25 participants
- Where
- 1 siteFrance
- Study dates
- 19 Sep 2024to 30 Sep 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients will be contacted in the Physical Medicine and Rehabilitation department of Clermont-Ferrand University Hospital for a presentation of the study. They will be given an information leaflet and time to reflect on their participation. If the patient agrees to take part, the EAPA will schedule an appointment to complete the non-objection form. A semi-structured interview will be scheduled in an office on the PRM ward, in order to meet the study objectives. Again, the objectives of the study will be stated, as well as the instructions for this structured interview. Questionnaires will be submitted and completed only after the interview. Data will be collected on a dictaphone and then manually transcribed into text format (verbatims) during the interview by a second operator. An a posteriori analysis will be carried out using the qualitative method. The interview guide is likely to be adapted according to the first individual interviews, as required by the qualitative method.
Who may be able to join
- Major patients
- Chronic non-specific low-back pain.
- Diagnosis confirmed according to HAS definition (i.e. pain located between the thoraco-lumbar hinge and the lower gluteal fold. It may be associated with radiculalgia corresponding to pain in one or both lower limbs at the level of one or more dermatomes). Patients included in the study must have given written informed consent.
Who cannot join
- Patients not meeting HAS diagnostic criteria
- Patients with comprehension difficulties (making it impossible to fill in questionnaires)
- Patients with medical contraindications to physical exercise
- Patients under guardianship, curatorship or safeguard of justice.
- Patients without a smartphone
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU Clermont-Ferrand
Clermont-Ferrand
Lise Laclautre, 0473751195, promo_interne_drci@chu-clermontferrand.fr
Jean-Baptiste LECHAUVE
About this study
Official title: E-lombaqual: Motivations, Obstacles and Opportunities for Using a Health Application to Encourage Physical Activity in People With Chronic Low Back Pain
In industrialized countries, low back pain can be considered a priority health issue. Some studies define it as one of the leading causes of disability in people under 45, or the leading cause of musculoskeletal disorders, with a prevalence of 26.9%. Chronic forms account for less than 10% of acute episodes, but represent around 85% of costs. It has been recognized that rest and physical inactivity are not beneficial in the treatment of low back pain, and worse, increase the risk of chronicity. Functional Restoration of the Spine (FRS) programs have been introduced in rehabilitation centers, and have proved to be effective both physically and psycho-socially. Patients generally adhere well to this type of program during in-center treatment. The effects obtained tend to fade rapidly on discharge, due to a lack of adherence to what can be offered conventionally (exercise sheets, oral advice). The development of connected tools (smartphones, tablets, etc.) could be a lever in this respect, as it would enable better patient support. In 2022, 84% of the population will own a smartphone. The content offered would be of higher quality, and would enable regular remote monitoring of the patient. The effects of the initial intensive treatment would be maintained by this new interactive, fun tool.
- Conditions
- Chronic Low-back Pain
- Keywords
- chronic low back pain, m-health, smartphone, qualitative study
What is being measured
The primary outcome is the main question the study is designed to answer.
Phenomenological analysis of semi-structured interviews with patients.
45-minute semi-structured interview
Measured: Up to 1 day
Secondary outcomes (15)
Identification of patient expectations via a semi-structured interview
45-minute semi-structured interview
Measured: Up to 1 day
Characterization of patients' profiles using a socio-demographic
Responses to the socio-demographic questionnaire : sex in ration Male and femalle
Measured: Up to 1 day
Characterization of patients' profiles using a socio-demographic
Responses to the socio-demographic questionnaire : age in year
Measured: Up to 1 day
Characterization of patients' profiles using a socio-demographic
Responses to the socio-demographic questionnaire : height in cm
Measured: Up to 1 day
Characterization of patients' profiles using a socio-demographic
Responses to the socio-demographic questionnaire : family situation as a couple or single
Measured: Up to 1 day
Characterization of patients' profiles using a socio-demographic
Responses to the socio-demographic questionnaire : weight in Kg
Measured: Up to 1 day
Characterization of patients' profiles using a socio-demographic
Responses to the socio-demographic questionnaire : level of education (no diploma, less than baccalaureate, baccalaureate or more than baccalaureate)
Measured: Up to 1 day
Characterization of patients' profiles using a socio-demographic
Responses to the socio-demographic questionnaire : lifestyle (active, retired, disabled)
Measured: Up to 1 day
Characterization of patients' profiles using a socio-demographic
Responses to the socio-demographic questionnaire : living environment (urban, rural)
Measured: Up to 1 day
Characterization of patients' profiles using a socio-demographic
Responses to the socio-demographic questionnaire : regular physical activity (frequency, type of activity)
Measured: Up to 1 day
Characterization of patients' profiles using a socio-demographic
Responses to the socio-demographic questionnaire : leisure activities (frequency, type)
Measured: Up to 1 day
Physical Activity Perception Scale
Self-questionnaire score: Physical Activity Perception Scale (EPAP). Identification of barriers and levers to regular physical activity using the EPAP questionnaire. This questionnaire contains 26 items on the facilities and obstacles encountered when engaging in physical activity. The maximum score for this questionnaire is 100 points thanks to an equation. Responses range from "Strongly disagree" (0 points) to "Strongly agree" (4 points). The total score ranges from 0 - "Poor perception of physical activity" to 100 - "Excellent perception of physical activity".
Measured: Up to 1 day
Visual Analogue Pain Scale
Visual Analogue Pain Scale (VAS Pain). A value of 10 indicates very intense pain. On the contrary, a pain value of 0 means that no pain is felt.
Measured: Up to 1 day
Functional disability
Self-questionnaire score: OSWESTRY Disabitity Index (ODI). Questionnaire on disability rated by a Likert scale ranging from 0 "no restriction" to 5 "severe restriction". scores can range from 0 to 50 points. a score of 0 to 4 indicates no disability. A score of 5 to 14 indicates a mild disability, 15 to 24 a moderate disability, and 25 to 34 a severe disability. A higher score indicates complete disability.
Measured: Up to 1 day
Fears and beliefs
Self-questionnaire score : Fear Avoidance Belief Questionnaire (FABQ). The FABQ consists of 2 subscales, corresponding to two distinct subsections. The first subscale (items 1-5) is the physical activity subscale (FABQPA; PA - Physical activity), and the second subscale (items 6-16) is the work subscale (FABQW; W-Work). Each subscale is ranked separately by summing the item responses of the respective scale (0-6 for each item). For scoring purposes, only 4 of the physical items on the activity scale are rated (24 possible points) and only 7 of the work items (42 possible points). A higher score indicates higher levels of fear-avoidance beliefs.
Measured: Up to 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2024
- Study start19 Sep 2024
- Primary completion30 Sep 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06517342
- Sponsor's protocol ID
- RNI 2024 LECHAUVE
- Acronym
- E-lombaqual
- Status last verified
- Sep 2025
- First submitted
- 12 Jul 2024
- Last updated
- 22 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- E-lombaqual: Motivations, Obstacles and Opportunities for Using a Health Application to Encourage Physical Activity in People With Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT06517342
- Acronym / sponsor ID
- E-lombaqual / RNI 2024 LECHAUVE
- Conditions
- Chronic Low-back Pain
- Keywords
- chronic low back pain, m-health, smartphone, qualitative study
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 19 Sep 2024 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 24 Jul 2024 (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.
In industrialized countries, low back pain can be considered a priority health issue. Some studies define it as one of the leading causes of disability in people under 45, or the leading cause of musculoskeletal disorders, with a prevalence of 26.9%. Chronic forms account for less than 10% of acute episodes, but represent around 85% of costs. It has been recognized that rest and physical inactivity are not beneficial in the treatment of low back pain, and worse, increase the risk of chronicity. Functional Restoration of the Spine (FRS) programs have been introduced in rehabilitation centers, and have proved to be effective both physically and psycho-socially. Patients generally adhere well to this type of program during in-center treatment. The effects obtained tend to fade rapidly on discharge, due to a lack of adherence to what can be offered conventionally (exercise sheets, oral advice). The development of connected tools (smartphones, tablets, etc.) could be a lever in this respect, as it would enable better patient support. In 2022, 84% of the population will own a smartphone. The content offered would be of higher quality, and would enable regular remote monitoring of the patient. The effects of the initial intensive treatment would be maintained by this new interactive, fun tool.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be contacted in the Physical Medicine and Rehabilitation department of Clermont-Ferrand University Hospital for a presentation of the study. They will be given an information leaflet and time to reflect on their participation. If the patient agrees to take part, the EAPA will schedule an appointment to complete the non-objection form. A semi-structured interview will be scheduled in an office on the PRM ward, in order to meet the study objectives. Again, the objectives of the study will be stated, as well as the instructions for this structured interview. Questionnaires will be submitted and completed only after the interview. Data will be collected on a dictaphone and then manually transcribed into text format (verbatims) during the interview by a second operator. An a posteriori analysis will be carried out using the qualitative method. The interview guide is likely to be adapted according to the first individual interviews, as required by the qualitative method.
Key inclusion criteria (3 listed)
- Major patients
- Chronic non-specific low-back pain.
- Diagnosis confirmed according to HAS definition (i.e. pain located between the thoraco-lumbar hinge and the lower gluteal fold. It may be associated with radiculalgia corresponding to pain in one or both lower limbs at the level of one or more dermatomes). Patients included in the study must have given written informed consent.
Key exclusion criteria (5 listed)
- Patients not meeting HAS diagnostic criteria
- Patients with comprehension difficulties (making it impossible to fill in questionnaires)
- Patients with medical contraindications to physical exercise
- Patients under guardianship, curatorship or safeguard of justice.
- Patients without a smartphone
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Phenomenological analysis of semi-structured interviews with patients.
Time frame: Up to 1 day
45-minute semi-structured interview
15 secondary outcomes
Identification of patient expectations via a semi-structured interview
Time frame: Up to 1 day
Characterization of patients' profiles using a socio-demographic
Time frame: Up to 1 day
Characterization of patients' profiles using a socio-demographic
Time frame: Up to 1 day
Characterization of patients' profiles using a socio-demographic
Time frame: Up to 1 day
Characterization of patients' profiles using a socio-demographic
Time frame: Up to 1 day
Characterization of patients' profiles using a socio-demographic
Time frame: Up to 1 day
Characterization of patients' profiles using a socio-demographic
Time frame: Up to 1 day
Characterization of patients' profiles using a socio-demographic
Time frame: Up to 1 day
Characterization of patients' profiles using a socio-demographic
Time frame: Up to 1 day
Characterization of patients' profiles using a socio-demographic
Time frame: Up to 1 day
Characterization of patients' profiles using a socio-demographic
Time frame: Up to 1 day
Physical Activity Perception Scale
Time frame: Up to 1 day
Visual Analogue Pain Scale
Time frame: Up to 1 day
Functional disability
Time frame: Up to 1 day
Fears and beliefs
Time frame: Up to 1 day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2025.
- Individual participant dataSharing planned: No
Related trials for Chronic Low-back Pain
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Effects of 3-dimensional Versus Dynamic Myofascial Release Techniques With Lumbar Mobilization and Exercise Therapy Program in Chronic Non-specific Low Back Pain.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of 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 3 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 22 Sep 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lise Laclautre (04 73 75 11 95, promo_interne_drci@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phenomenological analysis of semi-structured interviews with patients. (time frame: Up to 1 day). 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 22 Sep 2025.