Effectiveness of Coordinated Care to Reduce the Prolonged Disability Risk Among Patients Suffering From Low Back Pain in Primary Care
NCT ID: NCT04826757
Last Updated: 2025-09-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
500 participants
INTERVENTIONAL
2022-09-21
2027-11-25
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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standard care
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.
No interventions assigned to this group
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.
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)
Interventions
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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)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
60 Years
ALL
No
Sponsors
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University Hospital, Angers
OTHER_GOV
Responsible Party
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Principal Investigators
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Aline RAMOND ROQUIN, MD-PHD
Role: PRINCIPAL_INVESTIGATOR
Department of Family Medicine - University of Angers
Locations
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Cluster Bonchamp
Bonchamp-lès-Laval, , France
Cluster Vaunoise
Breteil, , France
Cluster BRULON
Brûlon, , 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, , France
Countries
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Central Contacts
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Facility Contacts
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References
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Ramond-Roquin A, Begue C, Vizzini J, Chhor S, Bouchez T, Parot-Schinkel E, Loiez A, Petit A, Ghali M, Peurois M, Bouton C. Effectiveness of coordinated care to reduce the risk of prolonged disability among patients suffering from subacute or recurrent acute low back pain in primary care: protocol of the CO.LOMB cluster-randomized, controlled study. Front Med (Lausanne). 2023 Jun 20;10:1156482. doi: 10.3389/fmed.2023.1156482. eCollection 2023.
Other Identifiers
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2020-A01039-30
Identifier Type: -
Identifier Source: org_study_id
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