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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Low Back Pain
• Intervention / Treatment: Other: Coordinated care

• Study Type: Interventional
• Enrollment (Actual): 220
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Bonchamp-lès-Laval, France
    • Cluster Bonchamp
  • Breteil, France
    • Cluster Vaunoise
  • Brûlon, France
    • Cluster BRULON
  • Château-Gontier, France
    • Cluster Château Gontier
  • Châteauneuf-sur-Sarthe, France
    • Cluster Châteauneuf sur Sarthe / Morannes
  • Clisson, France
    • Cluster Clisson
  • Conlie, France
    • Cluster Conlie
  • Craon, France
    • Cluster Craon Renaze Cosse
  • Entrammes, France
    • Cluster Entrammes Laval
  • La Roche-sur-Yon, France
    • Cluster Roche sur Yon
  • Nantes, France
    • Cluster Chantenay
  • Quévert, France
    • Cluster Dinan / Quévert / Plouasne
  • Rennes, France
    • Cluster Rennes Beauregard
  • Rennes, France
    • Cluster Rennes Villejean
  • Roquefort-les-Pins, France
    • Cluster Les Collines
  • Saint-Florent-le-Vieil, France
    • Cluster St Florent, Mauges, Possonnière
  • Savenay, France
    • Cluster Savenay
  • Segré, France
    • Cluster SEGRE
  • Trélazé, France
    • Cluster Angers- Trélazé
  • Vence, France
    • Cluster Vence

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 56 years (Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: 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.
Experimental: 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.	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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Hospital, Angers
• Investigators: Principal Investigator: Aline RAMOND ROQUIN, MD-PHD, Department of Family Medicine - University of Angers

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 21, 2022
• Primary Completion (Actual): January 22, 2026
• Study Completion (Estimated): February 22, 2027

Study Registration Dates

• First Submitted: March 3, 2021
• First Submitted That Met QC Criteria: March 29, 2021
• First Posted (Actual): April 1, 2021

Study Record Updates

• Last Update Posted (Actual): July 13, 2026
• Last Update Submitted That Met QC Criteria: July 9, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Low Back Pain
• Other Study ID Numbers: 2020-A01039-30

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: The data will be shared after signing a negotiated data transfer agreement ( data access agreement), for the duration specified in the agreement.
• IPD Sharing Access Criteria: The data will be made available via secure transfer (sharing platform approved by the university hospital: BlueFiles or Oodrive).
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No