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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

330 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-30

Study Completion Date

2026-03-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Chronic Low Back Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Experimental group

Personalized and automated digital coaching smartphone application

Group Type EXPERIMENTAL

Personalized and automated digital coaching using a mobile application

Intervention Type 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

Comparator group

Usual care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No