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NCT Number: NCT06498271

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Paris, 75014, France

Location contact

Christelle NGUYEN, MD, PhD

CONTACT

[email protected]

+33 1 58 41 29 45

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Mean change in activity limitations

    Time frame: 4 months

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

Secondary outcomes

  1. Mean change in activity limitations at 12 months after consent

    Time frame: 12 months

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

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

    Time frame: 4 months

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

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

    Time frame: 12 months

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

  4. Work absenteeism at 4 months after consent

    Time frame: 4 months

    Number of self-reported days off work

  5. Work absenteeism at 12 months after consent

    Time frame: 12 months

    Number of self-reported days off work

Study contacts

Contact information is provided by the study sponsor or research team.

Christelle NGUYEN, MD, PhD

CONTACT

[email protected]

+33 1 58 41 29 45

Laetitia PEAUDECERF, PhD

CONTACT

[email protected]

+33 1 58 41 12 13

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • Arthritis Foundation
  • Association Malakoff Médéric Innovation Santé
  • Societe Francaise de Rhumatologie
  • URC-CIC Paris Descartes Necker Cochin

Registry information

Official study title

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

Acronym: BACK-4P

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jul 12, 2024
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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