Effectiveness of Coordinated Care to Reduce the Prolonged Disability Risk Among Patients Suffering From Low Back Pain in Primary Care
COLOMB
1 other identifier
interventional
500
1 country
20
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable low-back-pain
Started Sep 2022
Longer than P75 for not_applicable low-back-pain
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 3, 2021
CompletedFirst Posted
Study publicly available on registry
April 1, 2021
CompletedStudy Start
First participant enrolled
September 21, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 25, 2027
September 19, 2025
September 1, 2025
4.1 years
March 3, 2021
September 15, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (25)
Perceived inability
Enrollment to 3 months follow up, Enrollment to 6 months follow up
Roland Morris Disability score over time
Enrollment, 3 months, 6 months, 12 months
Pain perceived
Enrollment - 3 months , Enrollment - 6 months and Enrollment -12 months
Numerical pain scale over time
Enrollment, 3 months, 6 months, 12 months
Occupational status
at 3 months, 6 months and 12 months
- +20 more secondary outcomes
Study Arms (2)
standard care
NO INTERVENTIONstandard 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.
coordinated care
EXPERIMENTALCoordinated 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.
Interventions
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
You may qualify if:
- 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
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (20)
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
Related Publications (1)
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.
PMID: 37409270DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Aline RAMOND ROQUIN, MD-PHD
Department of Family Medicine - University of Angers
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 3, 2021
First Posted
April 1, 2021
Study Start
September 21, 2022
Primary Completion (Estimated)
October 31, 2026
Study Completion (Estimated)
November 25, 2027
Last Updated
September 19, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- The data will be shared after signing a negotiated data transfer agreement ( data access agreement), for the duration specified in the agreement.
- Access Criteria
- The data will be made available via secure transfer (sharing platform approved by the university hospital: BlueFiles or Oodrive).
Data will be shared upon reasonable request. Only de-identified data will be shared. Any data collected during the study may be shared. The protocol will be shared initially. Other documents may be shared at a later date upon request (e.g., the CRF to allow a collaborator to select the data they wish to access). The recipients of the data will be researchers. The data will be available for any purpose deemed relevant by the study investigator, based on a protocol provided by the requester, after verification of the obtaining of regulatory approvals, including the favorable opinion of an ethics committee.