NCT06498271

Brief Summary

The investigators hypothesize that a personalized and automated digital coaching could reduce activity limitations in people with chronic low back pain as compared to usual care

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
330

participants targeted

Target at P75+ for not_applicable

Timeline
18mo left

Started Sep 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 20, 2024

Completed
22 days until next milestone

First Posted

Study publicly available on registry

July 12, 2024

Completed
2.1 years until next milestone

Study Start

First participant enrolled

September 1, 2026

Expected
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2028

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2028

Last Updated

May 6, 2026

Status Verified

April 1, 2026

Enrollment Period

1.5 years

First QC Date

June 20, 2024

Last Update Submit

April 30, 2026

Conditions

Chronic Low Back Pain

Keywords

Chronic low back painDigital coaching

Outcome Measures

Primary Outcomes (1)

  • Mean change in activity limitations

    French version of the self-administered Roland Morris Disability Questionnaires (RMDQ). Higher scores indicate worse function

    4 months

Secondary Outcomes (5)

  • Mean change in activity limitations at 12 months after consent

    12 months

  • Mean change in the intensity of low back pain at 4 months after consent

    4 months

  • Mean change in the intensity of low back pain at 12 months after consent

    12 months

  • Work absenteeism at 4 months after consent

    4 months

  • Work absenteeism at 12 months after consent

    12 months

Study Arms (2)

Experimental group

EXPERIMENTAL

Personalized and automated digital coaching smartphone application

Device: Personalized and automated digital coaching using a mobile application

Comparator group

NO INTERVENTION

Usual care

Interventions

Personalized and automated digital coaching using a mobile applicationDEVICE

Participants allocated to the experimental group will be invited to download a smartphone application which will appraise their motivation and automatically propose: 1) exercises to be performed at home and adapted to their pain levels; 2) audio recordings for pain management; and 3) educational and coaching content adapted to their motivation. In addition, the smartphone application enables users to plan their home exercises

Experimental group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults aged 18 or over
  • Having non-specific chronic LBP
  • Participating in the "ComPaRe" e-cohort
  • Having provided consent for their data to be used to assess trial eligibility
  • And to be randomized if eligible
  • And to, allow their data to be used to evaluate intervention effectiveness without being notified that they are in the control group, if randomized to usual the control group
  • Having a valid email address
  • Able to read and write French Having a smartphone functioning with Android acquired after 2020

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service de Rééducation et de Réadaptation de l'Appareil Locomoteur et des Pathologies du Rachis - hôpital Cochin

Paris, 75014, France

Location

Related Links

Study Officials

  • Christelle NGUYEN

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

  • François RANNOU, MD,PhD

    Assistance Publique - Hôpitaux de Paris

    STUDY DIRECTOR

Central Study Contacts

Christelle NGUYEN, MD, PhD

CONTACT

+33 1 58 41 29 45christelle.nguyen2@aphp.fr

Laetitia PEAUDECERF, PhD

CONTACT

+33 1 58 41 12 13laetitia.peaudecerf@aphp.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 20, 2024

First Posted

July 12, 2024

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

March 1, 2028

Study Completion (Estimated)

March 1, 2028

Last Updated

May 6, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)