Clinical trial NCT06498271: Personalized and Automated Digital Coaching in People With Non-specific Chronic Low Back Pain
Official 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Chronic Low Back Pain
Keywords: Chronic low back pain
Digital coaching
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Arthritis Foundation
name: Societe Francaise de Rhumatologie
name: Association Malakoff Médéric Innovation Santé
First posted: 2024-07-12
Enrollment: 330
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Mean change in activity limitations
timeFrame: 4 months
Secondary outcomes:
measure: Mean change in activity limitations at 12 months after consent
timeFrame: 12 months
measure: Mean change in the intensity of low back pain at 4 months after consent
timeFrame: 4 months
measure: Mean change in the intensity of low back pain at 12 months after consent
timeFrame: 12 months
measure: Work absenteeism at 4 months after consent
timeFrame: 4 months
measure: Work absenteeism at 12 months after consent
timeFrame: 12 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Service de Rééducation et de Réadaptation de l'Appareil Locomoteur et des Pathologies du Rachis - hôpital Cochin
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Christelle NGUYEN
role: PRINCIPAL_INVESTIGATOR
affiliation: Assistance Publique - Hôpitaux de Paris
name: François RANNOU, MD,PhD
role: STUDY_DIRECTOR
References: