Personalized and Automated Digital Coaching in People With Non-specific Chronic Low Back Pain (BACK-4P)

Personalized and Automated Digital Coaching in People With Non-specific Chronic Low Back Pain: a Randomized Controlled Trial Nested in the "ComPaRe" E-cohort

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

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Low Back Pain
• Intervention / Treatment: Device: Personalized and automated digital coaching using a mobile application

Detailed Description

Non-specific low back pain (LBP) is the leading cause of years of life lived with disability worldwide and its burden is growing alongside the increasing and ageing population.

LBP is usually treated according to symptoms duration, presence of concomitant radicular pain and of consistent anatomical abnormalities and is defined according to symptoms duration: acute (< 6 weeks), subacute (6 to 12 weeks) and chronic (> 12 weeks). The prognosis of acute LBP is excellent, but in 5 to 15% of individuals, LBP becomes chronic. At 6 months, about 10% of individuals with chronic LBP are on sick leave, and at 12 months, 20% report persistent disability.

Unfavourable evolution of chronic LBP is characterized by onset and persistence of spine-specific disability in all individuals and work absenteeism in working age individuals. The probability of returning to work is only 20% after 1 year of sick leave and 0% after 2 years. Multidisciplinary rehabilitation that combines education, physical therapy, cognitive behavioural therapy and rehabilitation is usually offered. However, lack of personalization of these programs could affect their efficacy and systematic evaluation suggests their low cost-effectiveness).

Current management of non-specific chronic low back pain involves a multidisciplinary approach that typically includes non-opioid analgesics, physical exercise and strength training, education, and cognitive behavioural therapies. Therapeutic interventions such as massage, acupuncture, or spinal manipulation may also be beneficial.

The investigators hypothesize that a personalized and automated digital coaching could reduce activity limitations in people with chronic LBP, as compared to usual care.

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.

• Study Type: Interventional
• Enrollment (Estimated): 330
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Christelle NGUYEN, MD, PhD; Phone Number: +33 1 58 41 29 45; Email: christelle.nguyen2@aphp.fr
• Study Contact Backup: Name: Laetitia PEAUDECERF, PhD; Phone Number: +33 1 58 41 12 13; Email: laetitia.peaudecerf@aphp.fr

Study Locations

• France
  • Paris, France, 75014
    • Service de Rééducation et de Réadaptation de l'Appareil Locomoteur et des Pathologies du Rachis - hôpital Cochin
    • Contact: Christelle NGUYEN, MD, PhD; Phone Number: +33 1 58 41 29 45; Email: christelle.nguyen2@aphp.fr

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• No exclusion criteria

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group; Personalized and automated digital coaching smartphone application	Device: Personalized and automated digital coaching using a mobile application; 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
No Intervention: Comparator group; Usual care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean change in activity limitations	French version of the self-administered Roland Morris Disability Questionnaires (RMDQ). Higher scores indicate worse function	4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	12 months
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)	4 months
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)	12 months
Work absenteeism at 4 months after consent	Number of self-reported days off work	4 months
Work absenteeism at 12 months after consent	Number of self-reported days off work	12 months

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: Societe Francaise de Rhumatologie; URC-CIC Paris Descartes Necker Cochin; Arthritis Foundation; Association Malakoff Médéric Innovation Santé
• Investigators: Principal Investigator: Christelle NGUYEN, Assistance Publique - Hopitaux de Paris; Study Director: François RANNOU, MD,PhD, Assistance Publique - Hopitaux de Paris

Publications and helpful links

Helpful Links

• ComPaRe ("Communauté de Patients pour la Recherche") is a collaborative open e-cohort of patients with chronic conditions. Within the ComPaRe platform, a cohort specific to non-specific low back pain was launched
• click here for more information about this study Back-4P

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028

Study Registration Dates

• First Submitted: June 20, 2024
• First Submitted That Met QC Criteria: July 4, 2024
• First Posted (Actual): July 12, 2024

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: Digital coaching; Chronic low back pain
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: APHP200223; 2020-A00100-39 (Other Identifier: ID-RCB)

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