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

Not Applicable

Not yet recruiting

• Conditions: Chronic Low Back Pain
• Interventions: Device: Personalized and automated digital coaching using a mobile application

• Registration Number: NCT06498271
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Study Timeline

• Status Verified: 2024-06
• Study First Submitted: 2024-06-20
• Study First Submitted QC: 2024-07-04
• Last Update Submitted: 2024-07-04
• Study First Posted: 2024-07-12
• Last Update Posted: 2024-07-12
• Study Start: 2024-09
• Primary Completion: 2026-03
• Study Completion: 2026-03

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 330

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

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Exclusion Criteria

• No exclusion criteria

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental group	Personalized and automated digital coaching using a mobile application	Personalized and automated digital coaching smartphone application

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Work absenteeism at 12 months after consent	12 months	Number of self-reported days off work
Mean change in the intensity of low back pain at 12 months after consent	12 months	Self-administered numerical scale with 11 classes incremented by 10 points (0, no pain and 100, maximum pain)
Mean change in activity limitations at 12 months after consent	12 months	French version of the self-administered Roland Morris Disability Questionnaires (RMDQ). Higher scores indicate worse function
Mean change in the intensity of low back pain at 4 months after consent	4 months	Self-administered numerical scale with 11 classes incremented by 10 points (0, no pain and 100, maximum pain)
Work absenteeism at 4 months after consent	4 months	Number of self-reported days off work

Trial Locations

Locations (1)

Service de Rééducation et de Réadaptation de l'Appareil Locomoteur et des Pathologies du Rachis - hôpital Cochin; 🇫🇷 Paris, France