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

NCT06903091 | Not Yet Recruiting

• 1 other identifier: APHP241558
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Chronic Non-specific Low Back Pain

Keywords

Chronic low back pain; SMS; adherence; therapeutic exercises

Outcome Measures

Primary Outcomes (1)

• Activity limitation

  Change in score on the Roland Morris Disability questionnaire (RMDQ, 0 no activity limitation; 24, maximum limitation)

  Month 6 (M6)

Secondary Outcomes (9)

• Activity limitation

  M3

• Physical activity

  M3 and M6

• Pain intensity

  M3 and M6

• Quality of life

  M6

• Adherence

  M3 and M6

Study Arms (2)

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.

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.

Procedure: SMS

Interventions

SMS PROCEDURE

Usual follow-up

ARM A : SMS; ARM B : Usual follow-up

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Any other pathology affecting postural stability or voluntary active mobility
• Contraindication to exercise
• Inability to write, speak or read French
• Psychiatric and/or behavioral disorders

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• URC-CIC Paris Descartes Necker Cochin: collaborator

Study Sites (1)

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, France

Location

Study Officials

• Camille Camille, MK

  Université Paris Cité, Faculté de Santé | UFR de Médecine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Camille THERY, MD

CONTACT

07 77 31 10 55; camille.thery@aphp.fr

Valérie PLENCE, Msc

CONTACT

01 58 41 11 78; valerie.plence-fauroux@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: statisticians will be masked
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2025
• First Posted: March 30, 2025
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): August 1, 2028
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)