Chronic Low-back PainEMOTIVNCT05780021
Motivational Support Program in Chronic Low Back Pain After Multidisciplinary Functional Rehabilitation
A study testing Motivational Support Program Emotiv in people with Chronic Low-back Pain, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Chronic low back pain (CLBP) is a major public health problem. Multidisciplinary functional rehabilitation program (FRP), which give patients the skills to better manage pain and return to physical activity, are effective in the short term. 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?
- Motivational Support Program Emotiv
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- 26 Sep 2023to 26 Sep 2026
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 18 or over
- Disabling chronic low back pain: chronic painful patient, that is to say suffering from pain for more than 3 months, having interrupted all physical activity because of low back pain and have an indication for a FRP for low back pain.
- Having reached the end of an FRP program
- Possession of a smartphone
- Fluency in French (writing, reading)
- Health insurance coverage (beneficiary or beneficiary) except State Medical Aid.
- Patient Informed Consent Signature
Who cannot join
- Pregnant woman
- Patient refusal
- Patient deprived of liberty and patient under legal protection measure (guardianship, guardianship)
- Patient participating to another interventional search
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
Hôpital Pitié Salpêtrière
Paris, 75013
Violaine FOLTZ, Dr, 01 42 17 79 58, violaine.foltz@aphp.fr
About this study
Official title: Evaluation of the Effectiveness of a MOTIVational Support Program After Multidisciplinary Functional Rehabilitation in Chronic Low Back Pain
Chronic low back pain (CLBP) is a major public health problem. Multidisciplinary functional rehabilitation program (FRP), which give patients the skills to better manage pain and return to physical activity, are effective in the short term. In the medium and long term, due to lack of motivation, two thirds of patients stop their physical activity again, causing them to fall back into the vicious circle of pain. Investigators hypothesise that a remote assessment and motivational support program (MSP) based on an application, piloted by a care coordinator, could allow the continued improvement of symptoms and activities observed after the FRP programs, and thus limit the consequences of CLBP for the patient and society. The main objective of this study is to evaluate the effect of the motivational support program EMOTIV, on disability and pain at one year, in chronic low back pain patients who have benefited from a FRP program.
Read the detailed description
Multidisciplinary functional rehabilitation program (FRP) have shown their efficacy in disabilitie patient suffering from Chronic low back pain (CLBP). Unfortunately, at medium and long term two thirds of patients stop their physical activity due to lack of motivation. These patients then fall back into their painful vicious circle. Investigators hypothesis that motivational support program (MSP) based on an application, piloted by a care coordinator could increase the motivation to continue physical activity and thus limit the consequences of CLBP for the patient and society. The main objective is to evaluate the impact of a MSP (EMOTIV) on pain and functional abilities assessed according to the COMI scale (Core Outcome Measure Index), 12 months after a FRP in patients with LPBC. This program is compared to usual care as currently done. The secondary criteria concern: physical, neuropsychological and medico-economical criteria. This is a multicentre, cluster randomized trial. All adult patient suffering from low back pain, having finished a FRP and possessing a smartphone, will be included. Investigators plan to include 150 patients in 6 centres. The duration of the inclusion period is 12 months; The duration of participation of each subject is 24 months. Inclusion will be on the last day of the FRP program. The Follow-up in consultation is scheduled at 3, 12 and 24 months with evaluation of usual criteria (physical, self-questionnaires, and advice on the practice of physical activities depending on what is achieved). In Pitie salpetriere center only, patients will have in addition: lumbar MRI at 3 and 12 months; central pain awareness assessment. The activity of patients in the MSP group will be recorded continuously par EMOTIV App; pain, mental health and days off every week and self-questionnaires at 1, 2 and 6 months. The primary analysis of all endpoints will be performed in the intent-to-treat population, i.e. all patients randomized to the study. The COMI score will be compared between the 2 randomized groups by a linear mixed model.
- Conditions
- Chronic Low-back Pain
- Being tested
- Motivational Support Program Emotiv
- Keywords
- Chronic Low-back Pain, Multidisciplinary function rehabilitation, Motivational Support Program Emotiv
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational Support Program EmotivBehavioural
A motivational support program including a motivational and self-assessment remote application in the form of a Smartphone application for chronic low back pain patients after multidisciplinary functional rehabilitation.
| Study group | Role | What they receive |
|---|---|---|
| Standard arm | No intervention | The patients will have the usual care |
| Motivational Support Program Emotiv | Experimental | The patients will have the motivational support program Receives: Behavioral: Motivational Support Program Emotiv |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in disability and pain between the experimental (SHP) and control (usual care) groups, measured with the Core Outcome Measure Index (COMI) scale at 12 months.
The Core Outcome Measure Index (COMI) was developed from requirements of international back pain experts. According to European experts, the COMI should currently be recommended in assessment of chronic low back pain. This questionnaire assesses pain and disability in low back pain. It includes 9 items and its score is between 0 and 10. Higher scores is the worse outcome.
Measured: 12 months after completion of the multidisciplinary functional rehabilitation program
Secondary outcomes (21)
Evolution of pain
Pain will be measured by a Visual Analogic Scale (VAS) with a question about lumbar pain over the last 7 days. Minimum and maximum values are 0 and 100.
Measured: At 3 months, 12 months and 24 months
Evolution of flexibility
Flexibility will be evaluated by measuring the hand-to-ground distance
Measured: At 3 months, 12 months and 24 months
Evolution of muscular endurance
Muscular endurance will be assessed by measuring Shirado (abdominal endurance). Its score is between 0 and no limit. 0 is the worse outcome.
Measured: At 3 months, 12 months and 24 months
Evolution of muscular endurance
Muscular endurance will be assessed by measuring Sorensen (spinal extensor endurance). Its score is between 0 and no limit. 0 is the worse outcome.
Measured: At 3 months, 12 months and 24 months
Evolution of disability and pain
Disability and pain will be assessed by the Core Outcome Measure Index (COMI) questionnaire. Its score is between 0 and 10. Higher scores is the worse outcome.
Measured: At 3 months, 12 months and 24 months
Evolution of endurance and sports performance (VO2 max)
Endurance and sports performance will be assessed on the treadmill
Measured: At 3 months, 12 months and 24 months
Evolution of the intensity of physical activity
Intensity of physical activity will be assessed by the IPAQ (International Physical Activity Questionnaire). Scoring a high level of physical activity on the IPAQ means the physical activity levels equate to approximately one hour of activity per day or more at least a moderate intensity activity level.
Measured: At 3 months, 12 months and 24 months
Evolution of muscular trophicity in the 2 groups
Muscular trophicity will be done by the measurement of the cross-sectional area (CSA) of the extensor muscles at the level of the upper and lower plateaus of L4 at the lumbar spine
Measured: At 3 months and 12 months
Evolution of the level of anxiety and depression
Level of anxiety and depression will be assessed by the HAD (Hospital Anxiety and Depression) scale.
14 items rated from 0 to 3. Seven questions relate to anxiety (total A) and seven others to the depressive dimension (total D), thus allowing two scores (maximum and worse of each score equal 21)
Measured: At 3 months, 12 months and 24 months
Evolution of the level of central pain awareness
Two parameters will be used, in accordance with international recommendations on Quantitative Sensory Testings : the pain pressure threshold using an algometer, at a distance from the painful area (forearm), and the temporal summation by repeating a painful stimulus with a calibrated needle (PinPrick)
Measured: At inclusion, 3 months, 12 months and 24 months
Medico-economic analysis
The elements for the medico-economic analysis will be collected on the basis of a questionnaire validated in French. The data collected are : - consultations in general medicine and rheumatology as part of the usual follow-up of patients, - biological or imaging examinations carried out for the spinal problem, - medicinal treatments (drugs, infiltrative procedures) and non-medicinal treatments (physiotherapy, others) carried out for the spinal problem, - any hospitalizations related to the spinal problem
Measured: At 3 months, 12 months and 24 months
Cost of care (i.e, health resource use and related costs or direct costs)
Health resource use will be quantified by the number of consultations, biologic and imaging workups, hospitalisations with their motives, and the list of treatments taken by the patients. It will be valued on the basis of the tariffs of the National Health Insurance Fund (CNAM). Health resource use related costs will be expressed in Euros
Measured: At 3 months, 12 months and 24 months
Cost of care (i.e, health resource use and related costs or direct costs)
Health resource use will be quantified by the number of consultations, biologic and imaging workups, hospitalisations with their motives, and the list of treatments taken by the patients. It will be valued using data from the Common Classification of Medical Acts (CCAM). Health resource use related costs will be expressed in Euros
Measured: At 3 months, 12 months and 24 months
Cost of care (i.e, health resource use and related costs or direct costs)
Health resource use will be quantified by the number of consultations, biologic and imaging workups, hospitalisations with their motives, and the list of treatments taken by the patients. It will be valued using data from the Nomenclature of Medical Biology Acts (NABM). Health resource use related costs will be expressed in Euros
Measured: At 3 months, 12 months and 24 months
Cost of care (i.e, health resource use and related costs or direct costs)
Health resource use will be quantified by the number of consultations, biologic and imaging workups, hospitalisations with their motives, and the list of treatments taken by the patients. It will be valued using data from the national scale of costs (ENC) for hospitalisations. Health resource use related costs will be expressed in Euros
Measured: At 3 months, 12 months and 24 months
Sick leave days
The number of working days off work will be elicited
Measured: At 3 months, 12 months and 24 months
Productivity loss (i.e, sick leave-related costs or indirect costs)
Sick leave days will be valued on the basis of the average daily salaries published each year by the French National Institute of Statistics (INSEE, www.insee.fr). It will be expressed in Euros.
Measured: At 3 months, 12 months and 24 months
Satisfaction with the program
Satisfaction with the program will be measured by a Visual Analogic Scale (VAS). Minimum and maximum values are 0 and 100. The better score is 100.
Measured: At 3 months, 12 months and 24 months
Adherence to the program
Adherence to the program will be evaluated on the number of connection (minimum value 0 and no maximum)
Measured: At 3 months, 12 months and 24 months
Adherence to the program
Adherence to the program will be evaluated on the time of connection (minimum value 0 and no maximum)
Measured: At 3 months, 12 months and 24 months
Adherence to the program
Adherence to the program will be evaluated on number of reminders necessary by the coordinator in case of non connection and/or non attendance at the follow-up (minimum value 0 and non maximum)
Measured: At 3 months, 12 months and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2023
- Study start26 Sep 2023
- Primary completion26 Sep 2025 (estimated)
- Study completion26 Sep 2026 (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 Assistance Publique - Hôpitaux de ParisThe 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
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Violaine FOLTZ, Dr, Principal investigator, Hôpital Pitié Salpêtrière - Assistance Publique Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05780021
- Sponsor's protocol ID
- APHP210077
- Other IDs
- 2022-A00828-35
- Acronym
- EMOTIV
- Status last verified
- Aug 2025
- First submitted
- 23 Jan 2023
- Last updated
- 22 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients. Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of a MOTIVational Support Program After Multidisciplinary Functional Rehabilitation in Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT05780021
- Acronym / sponsor ID
- EMOTIV / APHP210077
- Conditions
- Chronic Low-back Pain
- Keywords
- Chronic Low-back Pain, Multidisciplinary function rehabilitation, Motivational Support Program Emotiv
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 26 Sep 2023 (actual)
- Primary completion
- 26 Sep 2025 (estimated)
- Study completion
- 26 Sep 2026 (estimated)
- First posted
- 22 Mar 2023 (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.
Chronic low back pain (CLBP) is a major public health problem. Multidisciplinary functional rehabilitation program (FRP), which give patients the skills to better manage pain and return to physical activity, are effective in the short term. In the medium and long term, due to lack of motivation, two thirds of patients stop their physical activity again, causing them to fall back into the vicious circle of pain. Investigators hypothesise that a remote assessment and motivational support program (MSP) based on an application, piloted by a care coordinator, could allow the continued improvement of symptoms and activities observed after the FRP programs, and thus limit the consequences of CLBP for the patient and society. The main objective of this study is to evaluate the effect of the motivational support program EMOTIV, on disability and pain at one year, in chronic low back pain patients who have benefited from a FRP program.
Detailed description
Multidisciplinary functional rehabilitation program (FRP) have shown their efficacy in disabilitie patient suffering from Chronic low back pain (CLBP). Unfortunately, at medium and long term two thirds of patients stop their physical activity due to lack of motivation. These patients then fall back into their painful vicious circle. Investigators hypothesis that motivational support program (MSP) based on an application, piloted by a care coordinator could increase the motivation to continue physical activity and thus limit the consequences of CLBP for the patient and society. The main objective is to evaluate the impact of a MSP (EMOTIV) on pain and functional abilities assessed according to the COMI scale (Core Outcome Measure Index), 12 months after a FRP in patients with LPBC. This program is compared to usual care as currently done. The secondary criteria concern: physical, neuropsychological and medico-economical criteria. This is a multicentre, cluster randomized trial. All adult patient suffering from low back pain, having finished a FRP and possessing a smartphone, will be included. Investigators plan to include 150 patients in 6 centres. The duration of the inclusion period is 12 months; The duration of participation of each subject is 24 months. Inclusion will be on the last day of the FRP program. The Follow-up in consultation is scheduled at 3, 12 and 24 months with evaluation of usual criteria (physical, self-questionnaires, and advice on the practice of physical activities depending on what is achieved). In Pitie salpetriere center only, patients will have in addition: lumbar MRI at 3 and 12 months; central pain awareness assessment. The activity of patients in the MSP group will be recorded continuously par EMOTIV App; pain, mental health and days off every week and self-questionnaires at 1, 2 and 6 months. The primary analysis of all endpoints will be performed in the intent-to-treat population, i.e. all patients randomized to the study. The COMI score will be compared between the 2 randomized groups by a linear mixed model.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard arm | No intervention | –The patients will have the usual care |
| Motivational Support Program Emotiv | Experimental | Behavioral: Motivational Support Program EmotivThe patients will have the motivational support program |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- age 18 or over
- Disabling chronic low back pain: chronic painful patient, that is to say suffering from pain for more than 3 months, having interrupted all physical activity because of low back pain and have an indication for a FRP for low back pain.
- Having reached the end of an FRP program
- Possession of a smartphone
- Fluency in French (writing, reading)
Key exclusion criteria (4 listed)
- Pregnant woman
- Patient refusal
- Patient deprived of liberty and patient under legal protection measure (guardianship, guardianship)
- Patient participating to another interventional search
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 |
|---|---|---|
| Motivational Support Program EmotivA motivational support program including a motivational and self-assessment remote application in the form of a Smartphone application for chronic low back pain patients after multidisciplinary functional rehabilitation. | Behavioural | Motivational Support Program Emotiv |
Primary outcome
Difference in disability and pain between the experimental (SHP) and control (usual care) groups, measured with the Core Outcome Measure Index (COMI) scale at 12 months.
Time frame: 12 months after completion of the multidisciplinary functional rehabilitation program
The Core Outcome Measure Index (COMI) was developed from requirements of international back pain experts. According to European experts, the COMI should currently be recommended in assessment of chronic low back pain. This questionnaire assesses pain and disability in low back pain. It includes 9 items and its score is between 0 and 10. Higher scores is the worse outcome.
21 secondary outcomes
Evolution of pain
Time frame: At 3 months, 12 months and 24 months
Evolution of flexibility
Time frame: At 3 months, 12 months and 24 months
Evolution of muscular endurance
Time frame: At 3 months, 12 months and 24 months
Evolution of muscular endurance
Time frame: At 3 months, 12 months and 24 months
Evolution of disability and pain
Time frame: At 3 months, 12 months and 24 months
Evolution of endurance and sports performance (VO2 max)
Time frame: At 3 months, 12 months and 24 months
Evolution of the intensity of physical activity
Time frame: At 3 months, 12 months and 24 months
Evolution of muscular trophicity in the 2 groups
Time frame: At 3 months and 12 months
Evolution of the level of anxiety and depression
Time frame: At 3 months, 12 months and 24 months
Evolution of the level of central pain awareness
Time frame: At inclusion, 3 months, 12 months and 24 months
Medico-economic analysis
Time frame: At 3 months, 12 months and 24 months
Cost of care (i.e, health resource use and related costs or direct costs)
Time frame: At 3 months, 12 months and 24 months
Cost of care (i.e, health resource use and related costs or direct costs)
Time frame: At 3 months, 12 months and 24 months
Cost of care (i.e, health resource use and related costs or direct costs)
Time frame: At 3 months, 12 months and 24 months
Cost of care (i.e, health resource use and related costs or direct costs)
Time frame: At 3 months, 12 months and 24 months
Sick leave days
Time frame: At 3 months, 12 months and 24 months
Productivity loss (i.e, sick leave-related costs or indirect costs)
Time frame: At 3 months, 12 months and 24 months
Satisfaction with the program
Time frame: At 3 months, 12 months and 24 months
Adherence to the program
Time frame: At 3 months, 12 months and 24 months
Adherence to the program
Time frame: At 3 months, 12 months and 24 months
Adherence to the program
Time frame: At 3 months, 12 months and 24 months
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 Aug 2025.
- Individual participant dataSharing planned: Yes. The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients. Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.
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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.
Violaine FOLTZ, Dr principal investigator
Hôpital Pitié Salpêtrière - Assistance Publique Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motivational Support Program Emotiv in people with Chronic Low-back Pain, run by Assistance Publique - Hôpitaux de Paris 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 7 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: looking for participants now, as of the sponsor's last update on 22 Aug 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 Violaine FOLTZ, Dr (01 42 17 79 58, violaine.foltz@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in disability and pain between the experimental (SHP) and control (usual care) groups, measured with the Core Outcome Measure Index (COMI) scale at 12 months. (time frame: 12 months after completion of the multidisciplinary functional rehabilitation program). 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 Aug 2025; AzTrials last refreshed its copy on 30 Oct 2026.