Low Back Pain
Conditions
Brief summary
Common low back pain affects about 23% of general population and can be associated with psychosocial difficulties and prolonged inability to work. Its management in France mainly depends on general practioners, and sometime on physiotherapists. A coordinated care between general practioners, physiotherapists and occupational health services would help to improve the care pathway for patients and health professionals. The main objective is to assess the impact of coordinated primary care and deployed at the territories' level, in subacute or acute recurrent low back pain patients in comparison with the standard care.
Interventions
OTHERCoordinated care
Coordinated care between general practioners; physiotherapists and occupational health services. Early contact with occupational health service by the general practioner and use of occupational retention tool Active physiotherapy (Individual active, intensive and regular rehabilitation program with 15 sessions of 1 hour, at a rate of 2 or 3 sessions per week)
Sponsors
University Hospital, Angers
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
Randomised, controlled, cluster trial. the project is multicentered.
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Patient consulting an investigator GP for subacute low back pain or acute recurrent low back pain * Patient with occupational activity (including sick leave) * Patient depending of occupational health service * Obtaining the signature of the consent to participate in this trial * Patient Registered with social security scheme Non-inclusion Criteria: * Specific low back pain (fracture, infection, osteoporosis, inflammatory disease, tumor) * Low back pain with sciatic, cruralgia * Contraindication to active reeducation * Impossibility to follow up during 12 months * Patient planning to retire within the 12 months following the enrollment * Disability to write or read french * Adult patient protected under the law (guardianship), * Pregnant, breastfeeding or parturient women * Persons deprived of their liberty by judicial or administrative decision * Persons subject to legal protection measures * Persons unable to consent * Persons on coercion psychiatric care * Physiotherapy by a physiotherapist who don't participate in this trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Perceived inability at 1 year | Enrollment to 12 months follow up | Ratio of patient presenting improvement equal or above 4 points of Roland Morris Disability Questionnaire. The minimum value of Roland Morris Disability Questionnaire is 0 and the maximun value is 24. A higher score mean worse outcome |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Perceived inability | Enrollment to 3 months follow up, Enrollment to 6 months follow up | Ratio of patient presenting improvement equal or above 4 points of Roland Morris Disability Questionnaire. The minimum value of Roland Morris Disability Questionnaire is 0 and the maximun value is 24. A higher score mean worse outcome |
| Roland Morris Disability score over time | Enrollment, 3 months, 6 months, 12 months | Evolution of Roland Morris Disability Questionnaire over time. The minimum value is 0 and the maximun value is 24. A higher score mean worse outcome |
| Pain perceived | Enrollment - 3 months , Enrollment - 6 months and Enrollment -12 months | Ratio of patients presenting improvement equal or above 2 points of numerical pain scale The minimum value is 0 and the maximun value is 10. A higher score mean worse outcome |
| Numerical pain scale over time | Enrollment, 3 months, 6 months, 12 months | Evolution of numerical pain scale over time. The minimum value is 0 and the maximun value is 10. A higher score mean worse outcome |
| Occupational status | at 3 months, 6 months and 12 months | Ratio of patients having an active occupation (defined by have an employment and be present at work ) |
| Employment rate | Enrollment, 3 months, 6 months, 12 months | Evolution of employment rate over time |
| Sick leave | during 12 months after inclusion | number of sick leave days |
| Improved patients | at 3 months, 6 months and 12 months | Ratio of improved patients. Improved patients is defined by patient presenting improvement equal or above 4 points of Roland Morris Disability Questionnaire and improvement equal or above 2 points of numerical pain scale and having a active occupational |
| Evolution of improved patients ratio | Enrollment, 3 months, 6 months, 12 months | Evolution of improved patients ratio over time Improved patients is defined by patient presenting improvement equal or above 4 points of Roland Morris Disability Questionnaire and improvement equal or above 2 points of numerical pain scale and having a active occupational |
| Mental component score of Short Form -12 | Enrollment, 3 months, 6 months, 12 months | Evolution of mental scores over time The mental component score is determined by 4 categories of Short Form -12. The minimum value of each category is 0 and the maximun value is 100. A higher score mean better outcome |
| Physical component score of Short Form -12 | Enrollment, 3 months, 6 months, 12 months | Evolution of physical scores over time. The physical component score is determined by 4 categories of Short Form -12. The minimum value of each category is 0 and the maximun value is 100. A higher score mean better outcome |
| Occupational component score of Fear Avoidance Beliefs Questionnaire | Enrollment, 3 months, 12 months | Evolution of occupational component score over time. Occupational component is assessed using the Fear Avoidance Beliefs Questionnaire. The minimum value is 0 and the maximun value is 42. A higher score mean worse outcome |
| Physical activity component score of Fear Avoidance Beliefs Questionnaire | Enrollment, 3 months, 12 months | Evolution of physical activity component score over time. Physical activity component is assessed using the Fear Avoidance Beliefs Questionnaire. The minimum value is 0 and the maximun value is 24. A higher score mean worse outcome |
| Anxiety component score of Hospital Anxiety and Depression Scale | Enrollment 3 months, 12 months | Evolution of Anxiety score over time Anxiety Component is assessed using the Hospital Anxiety and Depression Scale The minimum value is 0 and the maximun value is 21. A higher score mean worse outcome |
| Depression component score of Hospital Anxiety and Depression Scale | Enrollment, 3 months, 12 months | Evolution of Depression score over time Depression component is assessed using the Hospital Anxiety and Depression Scale The minimum value is 0 and the maximun value is 21. A higher score mean worse outcome |
| Coordination care score of Patient Centered Coordination by a Care Team questionnaire | Enrollment, 3 months, 12 months | Evolution of coordination care score over time This score is assessed by using Patient Centered Coordination by a Care Team questionnaire. The minimum value is 0 and the maximun value is 42. A higher score mean better outcome |
| GP satisfaction related to patient care | T0 = baseline (cluster initiation); T1 = 1 year (6 months after inclusion of the 5th cluster patient); T2 = through study completion, an average of 3 years (12 months after the last cluster patient inclusion) | Evolution of GP satisfaction using an numerical scale The minimum value is 0 and the maximun value is 10. A higher score mean worse outcome |
| Physiotherapist satisfaction related to patient care | T0 = baseline (cluster initiation); T1 = 1 year (6 months after inclusion of the 5th cluster patient); T2 = through study completion, an average of 3 years (12 months after the last cluster patient inclusion) | Evolution of physiotherapist satisfaction using an numerical scale The minimum value is 0 and the maximun value is 10. A higher score mean worse outcome |
| Professionals trained for intervention | Baseline intervention formations | number of professionals trained for intervention |
| Biomechanical component score of Pain Attitudes and Beliefs score - for intervention physiotherapists | T0 = baseline (cluster initiation); T1 = 1 year (6 months after inclusion of the 5th cluster patient); T2 = through study completion, an average of 3 years (12 months after the last cluster patient inclusion) | Evolution of Biomechanical component score for intervention physiotherapists. Biomechanical component is assessed using the Pain Attitudes and Beliefs Score. The minimum value is 10 and the maximun value is 60. A higher score mean worse outcome |
| Biopsychosocial component score of Pain Attitudes and Beliefs score - for intervention physiotherapists | T0 = baseline (cluster initiation); T1 = 1 year (6 months after inclusion of the 5th cluster patient); T2 = through study completion, an average of 3 years (12 months after the last cluster patient inclusion) | Evolution of Biopsychosocial component score for intervention physiotherapists. Biopsychosocial component is assessed using the Pain Attitudes and Beliefs Score.The minimum value is 9 and the maximun value is 54. A higher score mean better outcome |
| Biopsychosocial component score of Pain Attitudes and Beliefs score - for GPs | T0 = baseline (cluster initiation); T1 = 1 year (6 months after inclusion of the 5th cluster patient); T2 = through study completion, an average of 3 years (12 months after the last cluster patient inclusion) | Evolution of Biopsychosocial component score for GPs. Biopsychosocial component is assessed using the Pain Attitudes and Beliefs Score.The minimum value is 9 and the maximun value is 54. A higher score mean better outcome |
| Biomechanical component score of Pain Attitudes and Beliefs score - for GPs | T0 = baseline (cluster initiation); T1 = 1 year (6 months after inclusion of the 5th cluster patient); T2 = through study completion, an average of 3 years (12 months after the last cluster patient inclusion) | Evolution of Biomechanical component score for GPs. Biomechanical component is assessed using the Pain Attitudes and Beliefs Score. The minimum value is 10 and the maximun value is 60. A higher score mean worse outcome |
| Professional dialogues | during the 12 months of follow up | Existence and types of dialogues between GP and other professionals |
| Number of consultations or sessions | during the 12 months of follow up | Number of consultations or sessions |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORAline RAMOND ROQUIN, MD-PHD
Department of Family Medicine - University of Angers
Outcome results
None listed