Efficacy of Text-messaging on Activity Limitation in People With Chronic Low Back (LOMBATEXT)

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.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Non-specific Low Back Pain
• Intervention / Treatment: Procedure: SMS

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 Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Valérie PLENCE, Msc; Phone Number: +33 01 58 41 11 78; Email: valerie.plence-fauroux@aphp.fr
• Study Contact Backup: Name: Camille THERY, MD; Phone Number: +33 07 77 31 10 55; Email: camille.thery@aphp.fr

Study Locations

• France
  • Île-de-France Region
    • Paris, Île-de-France Region, France, 75014
      • Assistance Publique - Hôpitaux de Paris, Service de Rééducation et de Réadaptation de l'Appareil Locomoteur et des Pathologies du Rachis, Hôpital Cochin
      • Contact: Camille THERY, MK; Phone Number: +33 07 77 31 10 55; Email: camille.thery@aphp.fr
      • Contact: Alexandra ROREN, PhD; Email: alexandra.roren@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ARM A : 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.	Procedure: SMS; Usual follow-up
Active Comparator: ARM B : Usual follow-up; Face-to-face multidisciplinary rehabilitation sessions,; Face-to-face medical and physiotherapy clinical consultation at M3.	Procedure: SMS; Usual follow-up

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Activity limitation	Change in score on the Roland Morris Disability questionnaire (RMDQ, 0 no activity limitation; 24, maximum limitation)	Month 6 (M6)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Activity limitation	Change in RMDQ score	M3
Physical activity	Change in overall physical activity measured by pedometer: measurement of average daily activity in the 7 days preceding assessments	M3 and M6
Pain intensity	Change in pain score measured by numerical scale (at the end of face-to-face supervised PEC	M3 and M6
Quality of life	Change in quality of life measured by the Medical Outcome Study Short Form-12	M6
Adherence	Change in adherence score: Exercise Adherence Rating Scale (EARS)	M3 and M6
Exercice burden	Change in exercise burden score : Exercice Therapy Burden questionnaire (ETBQ)	M3 and M6
Self-efficacy	Change in self-efficacy for exercise	M3 and M6
Level of physical activity (IPAQ)		D0 and M6
Perception of change		M6

Other Outcome Measures

Outcome Measure	Time Frame
Anxiety and depression (HAD), fears and false beliefs (FABQ), level of physical activity (IPAQ) at D0 and M6	Day 0 and Month 6 (D0 and M6)
Perception of change	Month 6 (M6)
Protocol acceptability and overall satisfaction with protocol	Month 6 (M6)
Investigator time spent explaining how automated SMS works and making phone calls (in the event of no response or repeated response to SMS messages)	Month 6 (M6)
Use of the automated SMS tool by participants in the experimental group	Month 6 (M6)
Experience of SMS a sample of participants from the experimental group using semi-structured interviews.	Month 6 (M6)

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: URC-CIC Paris Descartes Necker Cochin
• Investigators: Principal Investigator: Camille Camille, MK, Université Paris Cité, Faculté de Santé | UFR de Médecine

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): August 1, 2028

Study Registration Dates

• First Submitted: March 14, 2025
• First Submitted That Met QC Criteria: March 24, 2025
• First Posted (Actual): March 30, 2025

Study Record Updates

• Last Update Posted (Actual): May 6, 2026
• Last Update Submitted That Met QC Criteria: April 30, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: adherence; Chronic low back pain; SMS; therapeutic exercises
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: APHP241558

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No