Chronic Non-specific Low Back PainLOMBATEXTNCT06903091
Efficacy of Text-messaging on Activity Limitation in People With Chronic Low Back
A study testing SMS in people with Chronic Non-specific Low Back Pain, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The main aim of this study was to evaluate the medium-term efficacy of an intervention involving personalized, automated text messaging (SMS), following face-to-face rehabilitation sessions, on activity limitation in people with chronic low back pain. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chronic Non-specific Low Back Pain
- What is being tested?
- SMS
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jun 2026to 1 Aug 2028
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- People with chronic low back pain (common low back pain, duration of low back pain > 3 months)
- People who own a cell phone and have mastered the basics of using it (consulting and sending sms).
- Person with a moderate to high self-efficacy for exercise score (SEE score ≥ 31/90).
- Patient having signed the study participation consent form. Patient affiliated to a social security scheme or entitled beneficiary
Who cannot join
- Any other pathology affecting postural stability or voluntary active mobility
- Contraindication to exercise
- Lumbar spine surgery in the 12 months prior to inclusion in the study
- Inability to write, speak or read French
- Psychiatric and/or behavioral disorders
- Current pregnancy (declarative) No inclusion of persons covered by articles L. 1121-5 to L. 1121-8 and L. 1122-1-2 of the French Public Health Code (e.g. minors, protected adults, etc.).
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
Assistance Publique - Hôpitaux de Paris, Service de Rééducation et de Réadaptation de l'Appareil Locomoteur et des Pathologies du Rachis, Hôpital Cochin
Paris, Île-de-France Region, 75014
Camille THERY, MK, 07 77 31 10 55 ext. +33, camille.thery@aphp.fr
Alexandra ROREN, PhD, alexandra.roren@aphp.fr
About this study
Official title: Efficacy of Automated Text-messaging on Activity Limitation in Participants With Chronic Low Back Pain: a Randomized Controlled Trial
The main aim of this study was to evaluate the medium-term efficacy of an intervention involving personalized, automated text messaging (SMS), following face-to-face rehabilitation sessions, on activity limitation in people with chronic low back pain. We hypothesize that personalized SMS follow-up, following face-to-face rehabilitation sessions, could reduce activity limitation in people with chronic low back pain. Prospective multicenter randomized controlled trial.
Participants in both groups, experimental and comparator will have 4 face-to-face multidisciplinary rehabilitation sessions.
Read more
Participants in the 2 groups will have a face-to-face medical-kinesthetic clinical consultation at M3.
Participants in the experimental group will be monitored by personalized SMS messages over 6 months.
Read the detailed description
Non-specific low-back pain is one of the leading causes of activity limitation worldwide. Physical exercise is the treatment that has the best proven its efficacy on pain and activity limitation. Adherence to treatment is an essential factor in its effectiveness. Adherence decreases over time and is low in the medium and long term. Lack of patient follow-up is incriminated in poor adherence. Improving the follow-up of chronic low back pain patients appears to be an important lever for improving their function in the medium and long term.
The Memoquest digital solution (Calmedica) solution is based on a conversational robot that generates SMS messages. It integrates an alert and relay system by the therapist.
Participants will be recruited from patients seen in consultation in the physical medicine and rehabilitation (PMR) departments and in the networks of physicians and town-based MKs at the three centers. Randomization will be centralized.
Patients in the 2 groups will have 4 face-to-face multidisciplinary rehabilitation sessions, lasting 1h30 each, over approximately 15 days (2/week over 2 weeks). During these sessions, participants will learn a personalized exercise self-program (APE).
Participants in the 2 groups will have a face-to-face medico-kinesitherapy clinical consultation at M3: the doctor will question the patient about the evolution of his pain, check for the absence of warning signs and assess the tolerance and efficacy of pharmacological treatments, where appropriate. The physiotherapist will question the patient on the completion of the exercises in the self-program, and will provide additional information if necessary. The physiotherapist may also suggest modifications to the exercises to support the participant's progress.
Participants in the experimental group will be monitored by personalized SMS messages, over 6 months: from the end of the face-to-face rehabilitation sessions, they will receive 2 types of messages on their cell phones:
- Messages type A (received weekly for the first two weeks, then every 15 days): exercise reminders and encouragement
- Messages type B (received monthly): assessment of APE practice over the past week: "how many times did you do your exercise program last week?". Depending on the response: <3 or ≥ 3 times: participants will receive messages of encouragement or will be asked about the main obstacle encountered (keyword); levers adapted to the obstacle will be delivered to them. If participants wish to receive further information, they will be directed by a link to the Cochin PRM department website.
If the patient raises the same obstacle during 2 successive exchanges, or if the patient does not respond to the reminder message (48 hours after the initial message), or if the response is not appropriate, the participant will be called on the telephone by an MK taking part in the study.
The participant may withdraw from the study at any time by mentioning
- Conditions
- Chronic Non-specific Low Back Pain
- Being tested
- SMS
- Keywords
- Chronic low back pain, SMS, adherence, therapeutic exercises
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SMSProcedure or surgery
Usual follow-up
| Study group | Role | What they receive |
|---|---|---|
| ARM A : SMS | Experimental | * Face-to-face multidisciplinary rehabilitation sessions,
* Face-to-face medical and physiotherapy clinical consultation at M3
* Follow-up:
* Messages type A (received weekly for the first two weeks, then every 15 days): evaluation of self-program exercise practice and encouragement or reminder of the importance of exercise in the treatment of chronic low-back pain.
* Messages type B (received monthly): evaluation of APE practice over the past week: "how many times did you do your exercise program last week?". Depending on the response: <3 or ≥ 3 times: participants will receive messages of encouragement or will be asked about the main obstacle encountered (key word); levers adapted to the obstacle will be delivered to them. Receives: Procedure: SMS |
| ARM B : Usual follow-up | Active comparator | * Face-to-face multidisciplinary rehabilitation sessions,
* Face-to-face medical and physiotherapy clinical consultation at M3. Receives: Procedure: SMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Activity limitation
Change in score on the Roland Morris Disability questionnaire (RMDQ, 0 no activity limitation; 24, maximum limitation)
Measured: Month 6 (M6)
Secondary outcomes (9)
Activity limitation
Change in RMDQ score
Measured: M3
Physical activity
Change in overall physical activity measured by pedometer: measurement of average daily activity in the 7 days preceding assessments
Measured: M3 and M6
Pain intensity
Change in pain score measured by numerical scale (at the end of face-to-face supervised PEC
Measured: M3 and M6
Quality of life
Change in quality of life measured by the Medical Outcome Study Short Form-12
Measured: M6
Adherence
Change in adherence score: Exercise Adherence Rating Scale (EARS)
Measured: M3 and M6
Exercice burden
Change in exercise burden score : Exercice Therapy Burden questionnaire (ETBQ)
Measured: M3 and M6
Self-efficacy
Change in self-efficacy for exercise
Measured: M3 and M6
Level of physical activity (IPAQ)
Measured: D0 and M6
Perception of change
Measured: M6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2025
- Study start1 Jun 2026 (estimated)
- Primary completion1 Feb 2028 (estimated)
- Study completion1 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Non-specific 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
- Single blind
- Who is masked
- Care provider
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Camille Camille, MK, Principal investigator, Université Paris Cité, Faculté de Santé | UFR de Médecine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06903091
- Sponsor's protocol ID
- APHP241558
- Acronym
- LOMBATEXT
- Status last verified
- Apr 2026
- First submitted
- 14 Mar 2025
- Last updated
- 6 May 2026
- 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 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Automated Text-messaging on Activity Limitation in Participants With Chronic Low Back Pain: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06903091
- Acronym / sponsor ID
- LOMBATEXT / APHP241558
- Conditions
- Chronic Non-specific Low Back Pain
- Keywords
- Chronic low back pain, SMS, adherence, therapeutic exercises
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 1 Feb 2028 (estimated)
- Study completion
- 1 Aug 2028 (estimated)
- First posted
- 30 Mar 2025 (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 aim of this study was to evaluate the medium-term efficacy of an intervention involving personalized, automated text messaging (SMS), following face-to-face rehabilitation sessions, on activity limitation in people with chronic low back pain. We hypothesize that personalized SMS follow-up, following face-to-face rehabilitation sessions, could reduce activity limitation in people with chronic low back pain. Prospective multicenter randomized controlled trial.
Participants in both groups, experimental and comparator will have 4 face-to-face multidisciplinary rehabilitation sessions.
Participants in the 2 groups will have a face-to-face medical-kinesthetic clinical consultation at M3.
Participants in the experimental group will be monitored by personalized SMS messages over 6 months.
Detailed description
Non-specific low-back pain is one of the leading causes of activity limitation worldwide. Physical exercise is the treatment that has the best proven its efficacy on pain and activity limitation. Adherence to treatment is an essential factor in its effectiveness. Adherence decreases over time and is low in the medium and long term. Lack of patient follow-up is incriminated in poor adherence. Improving the follow-up of chronic low back pain patients appears to be an important lever for improving their function in the medium and long term.
The Memoquest digital solution (Calmedica) solution is based on a conversational robot that generates SMS messages. It integrates an alert and relay system by the therapist.
Participants will be recruited from patients seen in consultation in the physical medicine and rehabilitation (PMR) departments and in the networks of physicians and town-based MKs at the three centers. Randomization will be centralized.
Patients in the 2 groups will have 4 face-to-face multidisciplinary rehabilitation sessions, lasting 1h30 each, over approximately 15 days (2/week over 2 weeks). During these sessions, participants will learn a personalized exercise self-program (APE).
Participants in the 2 groups will have a face-to-face medico-kinesitherapy clinical consultation at M3: the doctor will question the patient about the evolution of his pain, check for the absence of warning signs and assess the tolerance and efficacy of pharmacological treatments, where appropriate. The physiotherapist will question the patient on the completion of the exercises in the self-program, and will provide additional information if necessary. The physiotherapist may also suggest modifications to the exercises to support the participant's progress.
Participants in the experimental group will be monitored by personalized SMS messages, over 6 months: from the end of the face-to-face rehabilitation sessions, they will receive 2 types of messages on their cell phones:
- Messages type A (received weekly for the first two weeks, then every 15 days): exercise reminders and encouragement
- Messages type B (received monthly): assessment of APE practice over the past week: "how many times did you do your exercise program last week?". Depending on the response: <3 or ≥ 3 times: participants will receive messages of encouragement or will be asked about the main obstacle encountered (keyword); levers adapted to the obstacle will be delivered to them. If participants wish to receive further information, they will be directed by a link to the Cochin PRM department website.
If the patient raises the same obstacle during 2 successive exchanges, or if the patient does not respond to the reminder message (48 hours after the initial message), or if the response is not appropriate, the participant will be called on the telephone by an MK taking part in the study.
The participant may withdraw from the study at any time by mentioning
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ARM A : SMS | Experimental | Procedure: SMS* Face-to-face multidisciplinary rehabilitation sessions, * Face-to-face medical and physiotherapy clinical consultation at M3 * Follow-up: * Messages type A (received weekly for the first two weeks, then every 15 days): evaluation of self-program exercise practice and encouragement or reminder of the importance of exercise in the treatment of chronic low-back pain. * Messages type B (received monthly): evaluation of APE practice over the past week: "how many times did you do your exercise program last week?". Depending on the response: <3 or ≥ 3 times: participants will receive messages of encouragement or will be asked about the main obstacle encountered (key word); levers adapted to the obstacle will be delivered to them. |
| ARM B : Usual follow-up | Active comparator | Procedure: SMS* Face-to-face multidisciplinary rehabilitation sessions, * Face-to-face medical and physiotherapy clinical consultation at M3. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- People with chronic low back pain (common low back pain, duration of low back pain > 3 months)
- People who own a cell phone and have mastered the basics of using it (consulting and sending sms).
- Person with a moderate to high self-efficacy for exercise score (SEE score ≥ 31/90).
- Patient having signed the study participation consent form. Patient affiliated to a social security scheme or entitled beneficiary
Key exclusion criteria (6 listed)
- Any other pathology affecting postural stability or voluntary active mobility
- Contraindication to exercise
- Lumbar spine surgery in the 12 months prior to inclusion in the study
- Inability to write, speak or read French
- Psychiatric and/or behavioral disorders
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 |
|---|---|---|
| SMSUsual follow-up | Procedure or surgery | ARM A : SMS, ARM B : Usual follow-up |
Primary outcome
Activity limitation
Time frame: Month 6 (M6)
Change in score on the Roland Morris Disability questionnaire (RMDQ, 0 no activity limitation; 24, maximum limitation)
9 secondary outcomes
Activity limitation
Time frame: M3
Physical activity
Time frame: M3 and M6
Pain intensity
Time frame: M3 and M6
Quality of life
Time frame: M6
Adherence
Time frame: M3 and M6
Exercice burden
Time frame: M3 and M6
Self-efficacy
Time frame: M3 and M6
Level of physical activity (IPAQ)
Time frame: D0 and M6
Perception of change
Time frame: M6
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 6 May 2026.
- Individual participant dataSharing planned: No
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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.
Camille Camille, MK principal investigator
Université Paris Cité, Faculté de Santé | UFR de Médecine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SMS in people with Chronic Non-specific 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 4 inclusion and 6 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: opening soon, as of the sponsor's last update on 6 May 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?
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 Camille THERY, MD (07 77 31 10 55 ext. +33, camille.thery@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Activity limitation (time frame: Month 6 (M6)). 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 6 May 2026.