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

Low Back Pain Clinical Trial

— COLOMB  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04826757
• Other study ID #: 2020-A01039-30
• Status: Recruiting
• Phase: N/A
• Start date: September 21, 2022
• Est. completion date: September 2026

Study information

• Verified date: April 2024
• Source: University Hospital, Angers
• Contact: Aline RAMOND ROQUIN, MD-PHD
• Phone: 0241735867
• Email: aline.ramond[@]univ-angers.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: September 2026
• Est. primary completion date: September 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Other:
• Coordinated 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)

Locations

Country	Name	City	State
France	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 Angers- Trélazé	Trélazé
France	Cluster Vence	Vence

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Angers

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Employment rate	Evolution of employment rate over time	Enrollment, 3 months, 6 months, 12 months
Secondary	Sick leave	number of sick leave days	during 12 months after inclusion
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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)
Secondary	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)
Secondary	Professionals trained for intervention	number of professionals trained for intervention	Baseline intervention formations
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	Professional dialogues	Existence and types of dialogues between GP and other professionals	during the 12 months of follow up
Secondary	Number of consultations or sessions	Number of consultations or sessions	during the 12 months of follow up