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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
500
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)
Cluster Bonchamp
Bonchamp-lès-Laval, France
RECRUITINGCluster Vaunoise
Breteil, France
RECRUITINGCluster BRULON
Brûlon, France
RECRUITINGCluster Château Gontier
Château-Gontier, France
RECRUITINGCluster Châteauneuf sur Sarthe / Morannes
Châteauneuf-sur-Sarthe, France
RECRUITINGCluster Clisson
Clisson, France
RECRUITINGCluster Conlie
Conlie, France
RECRUITINGCluster Craon Renaze Cosse
Craon, France
RECRUITINGCluster Entrammes Laval
Entrammes, France
RECRUITINGCluster Roche sur Yon
La Roche-sur-Yon, France
RECRUITING...and 10 more locations
Perceived inability at 1 year
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
Time frame: Enrollment to 12 months follow up
Perceived inability
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
Time frame: Enrollment to 3 months follow up, Enrollment to 6 months follow up
Roland Morris Disability score over time
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
Time frame: Enrollment, 3 months, 6 months, 12 months
Pain perceived
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
Time frame: Enrollment - 3 months , Enrollment - 6 months and Enrollment -12 months
Numerical pain scale over time
Evolution of numerical pain scale over time. The minimum value is 0 and the maximun value is 10. A higher score mean worse outcome
Time frame: Enrollment, 3 months, 6 months, 12 months
Occupational status
Ratio of patients having an active occupation (defined by have an employment and be present at work )
Time frame: at 3 months, 6 months and 12 months
Employment rate
Evolution of employment rate over time
Time frame: Enrollment, 3 months, 6 months, 12 months
Sick leave
number of sick leave days
Time frame: during 12 months after inclusion
Improved patients
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
Time frame: at 3 months, 6 months and 12 months
Evolution of improved patients ratio
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
Time frame: Enrollment, 3 months, 6 months, 12 months
Mental component score of Short Form -12
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
Time frame: Enrollment, 3 months, 6 months, 12 months
Physical component score of Short Form -12
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
Time frame: Enrollment, 3 months, 6 months, 12 months
Occupational component score of Fear Avoidance Beliefs Questionnaire
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
Time frame: Enrollment, 3 months, 12 months
Physical activity component score of Fear Avoidance Beliefs Questionnaire
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
Time frame: Enrollment, 3 months, 12 months
Anxiety component score of Hospital Anxiety and Depression Scale
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
Time frame: Enrollment 3 months, 12 months
Depression component score of Hospital Anxiety and Depression Scale
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
Time frame: Enrollment, 3 months, 12 months
Coordination care score of Patient Centered Coordination by a Care Team questionnaire
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
Time frame: Enrollment, 3 months, 12 months
GP satisfaction related to patient care
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
Time frame: 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)
Physiotherapist satisfaction related to patient care
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
Time frame: 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)
Professionals trained for intervention
number of professionals trained for intervention
Time frame: Baseline intervention formations
Biomechanical component score of Pain Attitudes and Beliefs score - for intervention physiotherapists
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
Time frame: 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)
Biopsychosocial component score of Pain Attitudes and Beliefs score - for intervention physiotherapists
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
Time frame: 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)
Biopsychosocial component score of Pain Attitudes and Beliefs score - for GPs
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
Time frame: 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)
Biomechanical component score of Pain Attitudes and Beliefs score - for GPs
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
Time frame: 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)
Professional dialogues
Existence and types of dialogues between GP and other professionals
Time frame: during the 12 months of follow up
Number of consultations or sessions
Number of consultations or sessions
Time frame: during the 12 months of follow up
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