NCT Number: NCT04826757
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.
This study is active but is not currently recruiting participants.
Notify Me18 year–60 year
All sexes
Interventional
Not applicable
Cluster Bonchamp, Bonchamp-lès-Laval, France
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Non-inclusion Criteria:
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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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 )
Time frame: Enrollment, 3 months, 6 months, 12 months
Evolution of employment rate over time
Time frame: during 12 months after inclusion
number of sick leave days
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
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)
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)
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: Baseline intervention formations
number of professionals trained for intervention
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)
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)
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)
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)
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: during the 12 months of follow up
Existence and types of dialogues between GP and other professionals
Time frame: during the 12 months of follow up
Number of consultations or sessions
University Hospital, Angers
Other Gov
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
Acronym: COLOMB
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