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

Assistance Publique - Hôpitaux de Paris

Status: Not yet enrolling

Conditions: Chronic Low Back Pain

Treatments: Device: Personalized and automated digital coaching using a mobile application

Study type: Interventional

Funder types: Other

Identifiers

NCT06498271

APHP200223

2020-A00100-39 (Other Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment: 330 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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330 participants in 2 patient groups

Experimental group

Experimental group

Description:

Personalized and automated digital coaching smartphone application

Treatment:

Device: Personalized and automated digital coaching using a mobile application

Comparator group

No Intervention group

Description:

Usual care