Personalized and Automated Digital Coaching in People With Non-specific Chronic Low Back Pain
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Personalized and automated digital coaching using a mobile application.
- Who it may be relevant to
- Registry conditions: Chronic Low Back Pain. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Interventions
- Device 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
Primary outcome measures
- Mean change in activity limitations [Time frame: 4 months]
Secondary outcome measures (5)
- Mean change in activity limitations at 12 months after consent [Time frame: 12 months]
- Mean change in the intensity of low back pain at 4 months after consent [Time frame: 4 months]
- Mean change in the intensity of low back pain at 12 months after consent [Time frame: 12 months]
- Work absenteeism at 4 months after consent [Time frame: 4 months]
- Work absenteeism at 12 months after consent [Time frame: 12 months]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
France · 1 center
- Service de Rééducation et de Réadaptation de l'Appareil Locomoteur et des Pathologies du R — Paris
Identifiers
NCT: NCT06498271 · APHP200223 · 2020-A00100-39