Ignite Creation Date:
2024-07-17 @ 11:43 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06498271
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-12
First Post:
2024-06-20
Brief Title:
Personalized and Automated Digital Coaching in People With Non-specific Chronic Low Back Pain
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BACK-4P
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2020-A00100-39 | OTHER | None | None |