Effectiveness of Coordinated Care to Reduce the Prolonged Disability Risk Among Patients Suffering From Low Back Pain in Primary Care

Study Overview
=================
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.

Official Title
-----------------
Effectiveness of Coordinated Care to Reduce the Risk of Prolonged Disability Among Patients Suffer From Subacute or Recurrent Acute Low Back Pain in Primary Care

Conditions
-----------------
Low Back Pain

Intervention / Treatment
-----------------
* Other: Coordinated care


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomised, controlled, cluster trial. the project is multicentered.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: standard care<br>standard care for low back pain management by general practioners (GPs). the physiotherapist and occupational health services can be solicited independently by the patient or GP. | |
| Experimental: coordinated care<br>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. | Other: Coordinated care<br>* 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)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Enrollment to 12 months follow up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | 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 | 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 ) | at 3 months, 6 months and 12 months | 
| Employment rate | Evolution of employment rate over time | Enrollment, 3 months, 6 months, 12 months | 
| Sick leave | number of sick leave days | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | during the 12 months of follow up | 
| Number of consultations or sessions | Number of consultations or sessions | during the 12 months of follow up |