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

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-21

Study Completion Date

2027-11-25

Brief Summary

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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

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Conditions

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Low Back Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomised, controlled, cluster trial. the project is multicentered.
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

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.

Group Type NO_INTERVENTION

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.

Group Type EXPERIMENTAL

Coordinated care

Intervention Type OTHER

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)

Intervention Type OTHER

Eligibility Criteria

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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


* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Angers

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status RECRUITING

Cluster Vaunoise

Breteil, , France

Site Status RECRUITING

Cluster BRULON

Brûlon, , France

Site Status RECRUITING

Cluster Château Gontier

Château-Gontier, , France

Site Status RECRUITING

Cluster Châteauneuf sur Sarthe / Morannes

Châteauneuf-sur-Sarthe, , France

Site Status RECRUITING

Cluster Clisson

Clisson, , France

Site Status RECRUITING

Cluster Conlie

Conlie, , France

Site Status RECRUITING

Cluster Craon Renaze Cosse

Craon, , France

Site Status RECRUITING

Cluster Entrammes Laval

Entrammes, , France

Site Status RECRUITING

Cluster Roche sur Yon

La Roche-sur-Yon, , France

Site Status RECRUITING

Cluster Chantenay

Nantes, , France

Site Status RECRUITING

Cluster Dinan / Quévert / Plouasne

Quévert, , France

Site Status RECRUITING

Cluster Rennes Beauregard

Rennes, , France

Site Status RECRUITING

Cluster Rennes Villejean

Rennes, , France

Site Status RECRUITING

Cluster Les Collines

Roquefort-les-Pins, , France

Site Status ACTIVE_NOT_RECRUITING

Cluster St Florent, Mauges, Possonnière

Saint-Florent-le-Vieil, , France

Site Status RECRUITING

Cluster Savenay

Savenay, , France

Site Status RECRUITING

Cluster SEGRE

Segré, , France

Site Status RECRUITING

Cluster Angers- Trélazé

Trélazé, , France

Site Status RECRUITING

Cluster Vence

Vence, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Aline RAMOND ROQUIN, MD-PHD

Role: CONTACT

0241735867 ext. +33

Anthea LOIEZ

Role: CONTACT

0241735867 ext. +33

Facility Contacts

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Ghislaine JUDALET, MD

Role: primary

0243903280 ext. +33

Laure FIQUET

Role: primary

0299615926 ext. +33

ANGOULVANT Cécile, MD

Role: primary

0243956299 ext. +33

Héloïse ROGER, MD

Role: primary

024370151506 ext. +33

Christine RENIER TISNE, MD

Role: primary

0478080400 ext. +33

Gilles BARNABE, MG

Role: primary

0240540939 ext. +33

Jessica GUELFF, MD

Role: primary

0243209520 ext. +33

Aline RAMOND ROQUIN, MD-PHD

Role: primary

0253945252 ext. +33

Matthieu PEUROIS, MD

Role: primary

0688895476 ext. +33

Sandrine Sandrine, MD

Role: primary

0251361547 ext. +33

Jean Pascal FOURNIER, MD

Role: primary

0240730602 ext. +33

CHAPRON ANTHONY, MD

Role: primary

0296870076 ext. +33

Sidonie CHHOR, MD

Role: primary

0299676733 ext. +33

Emmanuel ALLORY, MD

Role: primary

0664910897 ext. +33

Gwenaël BEAUVINEAU, MD

Role: primary

0241725422 ext. +33

Jérôme MICHENAUD, MD

Role: primary

0272005555 ext. +33

Stéphane FREZE, MD

Role: primary

0241947540 ext. +33

Catherine DE CASABIANCA, MD

Role: primary

0241473344 ext. +33

POUILLON MAUD, MD

Role: primary

0695882985 ext. +33

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.

Reference Type DERIVED
PMID: 37409270 (View on PubMed)

Other Identifiers

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2020-A01039-30

Identifier Type: -

Identifier Source: org_study_id

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