Service de Rééducation et de Réadaptation de l'Appareil Locomoteur et des Pathologies du Rachis - hôpital Cochin
Paris, 75014, France
NCT Number: NCT06498271
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
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
Paris, 75014, France
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: 4 months
French version of the self-administered Roland Morris Disability Questionnaires (RMDQ). Higher scores indicate worse function
Time frame: 12 months
French version of the self-administered Roland Morris Disability Questionnaires (RMDQ). Higher scores indicate worse function
Time frame: 4 months
Self-administered numerical scale with 11 classes incremented by 10 points (0, no pain and 100, maximum pain)
Time frame: 12 months
Self-administered numerical scale with 11 classes incremented by 10 points (0, no pain and 100, maximum pain)
Time frame: 4 months
Number of self-reported days off work
Time frame: 12 months
Number of self-reported days off work
Contact information is provided by the study sponsor or research team.
Christelle NGUYEN, MD, PhD
CONTACT
Laetitia PEAUDECERF, PhD
CONTACT
Assistance Publique - Hôpitaux de Paris
Other
Personalized and Automated Digital Coaching in People With Non-specific Chronic Low Back Pain: a Randomized Controlled Trial Nested in the "ComPaRe" E-cohort
Acronym: BACK-4P
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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