Health TrialsbyHealthPanel

Personalized and Automated Digital Coaching in People With Non-specific Chronic Low Back Pain

ConditionChronic Low Back Pain
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAssistance Publique - Hôpitaux de Paris

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

No exclusion criteria

Trial design

Design model

Parallel

Treatments tested in this trial

  • Personalized and automated digital coaching using a mobile application

    Device

    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

Treatment groups

330 Participants
are divided into 2 treatment groups
Group A: Experimental groupExperimental treatment 1 intervention
Group B: Comparator groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Mean change in activity limitations

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

Time frame
4 months

Secondary outcomes

1

Mean change in activity limitations at 12 months after consent

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

Time frame
12 months
2

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

Self-administered numerical scale with 11 classes incremented by 10 points (0, no pain and 100, maximum pain)

Time frame
4 months
3

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

Self-administered numerical scale with 11 classes incremented by 10 points (0, no pain and 100, maximum pain)

Time frame
12 months
4

Work absenteeism at 4 months after consent

Number of self-reported days off work

Time frame
4 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Assistance Publique - Hôpitaux de Paris

Lead sponsor

Arthritis Foundation

Collaborator

Societe Francaise de Rhumatologie

Collaborator

Association Malakoff Médéric Innovation Santé

Collaborator

URC-CIC Paris Descartes Necker Cochin

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: