Effectiveness of Coordinated Care to Reduce the Prolonged Disability Risk Among Patients Suffering from Low Back Pain in Primary Care
- Conditions
- Low Back Pain
- Interventions
- Other: Coordinated care
- Registration Number
- NCT04826757
- Lead Sponsor
- University Hospital, Angers
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 500
- 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
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description coordinated care Coordinated care Coordinated care between general practioners, physiotherapist and occupational health services. An intervention training will be performed before the start of the study for any care professional's to elaborate coordination tools and have an active communication.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
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 )
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
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
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
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
Number of consultations or sessions during the 12 months of follow up Number of consultations or sessions
Sick leave during 12 months after inclusion number of sick leave days
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
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
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 outcomeGP 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
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
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
Employment rate Enrollment, 3 months, 6 months, 12 months Evolution of employment rate over time
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
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 outcomeAnxiety 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
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 outcomeMental 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
Trial Locations
- Locations (20)
Cluster Bonchamp
🇫🇷Bonchamp-lès-Laval, France
Cluster Vaunoise
🇫🇷Breteil, France
Cluster BRULON
🇫🇷Brulon, France
Cluster Château Gontier
🇫🇷Château-Gontier, France
Cluster Châteauneuf sur Sarthe / Morannes
🇫🇷Châteauneuf-sur-Sarthe, France
Cluster Clisson
🇫🇷Clisson, France
Cluster Conlie
🇫🇷Conlie, France
Cluster Craon Renaze Cosse
🇫🇷Craon, France
Cluster Entrammes Laval
🇫🇷Entrammes, France
Cluster Roche sur Yon
🇫🇷La Roche-sur-Yon, France
Cluster Chantenay
🇫🇷Nantes, France
Cluster Dinan / Quévert / Plouasne
🇫🇷Quévert, France
Cluster Rennes Beauregard
🇫🇷Rennes, France
Cluster Rennes Villejean
🇫🇷Rennes, France
Cluster Les Collines
🇫🇷Roquefort les pins, France
Cluster St Florent, Mauges, Possonnière
🇫🇷Saint-Florent-le-Vieil, France
Cluster Savenay
🇫🇷Savenay, France
Cluster SEGRE
🇫🇷Segré, France
Cluster Vence
🇫🇷Vence, France
Cluster Angers- Trélazé
🇫🇷Trélazé, France