CClinicalTrials.gg
Active, not recruitingNCT04826757COLOMBUpdated Jul 13, 2026

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

An interventional study of Coordinated care in Low Back Pain, sponsored by University Hospital, Angers. Active, not recruiting at 20 sites in France. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-07-13.

Sponsored by University Hospital, Angers · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
220
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Low Back Pain

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03

In context

Low Back Pain

2,818 studies on the registry are indexed under Low Back Pain; 482 are open to participants now.

This study's enrollment of 220 is above the median of 60 across 2,268 interventional studies indexed under Low Back Pain.

Browse Low Back Pain studies →

Lead sponsor

University Hospital, Angers is the lead sponsor of 464 studies on the registry; 116 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

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
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Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
220 participants (actual)

Study arms

  • 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

Interventions

  • OtherCoordinated 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)

06

What researchers measure

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

    Time frame: Enrollment to 12 months follow up

Secondary outcomes

  1. 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

    Time frame: Enrollment to 3 months follow up, Enrollment to 6 months follow up

  2. 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

    Time frame: Enrollment, 3 months, 6 months, 12 months

  3. 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

    Time frame: Enrollment - 3 months , Enrollment - 6 months and Enrollment -12 months

  4. 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

    Time frame: Enrollment, 3 months, 6 months, 12 months

  5. Occupational status

    Ratio of patients having an active occupation (defined by have an employment and be present at work )

    Time frame: at 3 months, 6 months and 12 months

  6. Employment rate

    Evolution of employment rate over time

    Time frame: Enrollment, 3 months, 6 months, 12 months

  7. Sick leave

    number of sick leave days

    Time frame: during 12 months after inclusion

  8. 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

    Time frame: at 3 months, 6 months and 12 months

  9. 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

    Time frame: Enrollment, 3 months, 6 months, 12 months

  10. 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

    Time frame: Enrollment, 3 months, 6 months, 12 months

  11. 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

    Time frame: Enrollment, 3 months, 6 months, 12 months

  12. 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

    Time frame: Enrollment, 3 months, 12 months

  13. 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

    Time frame: Enrollment, 3 months, 12 months

  14. 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

    Time frame: Enrollment 3 months, 12 months

  15. 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

    Time frame: Enrollment, 3 months, 12 months

  16. 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

    Time frame: Enrollment, 3 months, 12 months

  17. 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

    Time frame: 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)

  18. 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

    Time frame: 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)

  19. Professionals trained for intervention

    number of professionals trained for intervention

    Time frame: Baseline intervention formations

  20. 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

    Time frame: 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)

  21. 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

    Time frame: 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)

  22. 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

    Time frame: 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)

  23. 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

    Time frame: 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)

  24. Professional dialogues

    Existence and types of dialogues between GP and other professionals

    Time frame: during the 12 months of follow up

  25. Number of consultations or sessions

    Number of consultations or sessions

    Time frame: during the 12 months of follow up

07

Study locations

20 sites
  • 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
08

References and documents

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. PubMed 37409270 ↗

Individual participant data

Plan to share: Yes — 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.

Supporting information: Study protocol

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 13, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04826757
Lead sponsor
University Hospital, Angers
Responsible party
Sponsor
First posted
Apr 1, 2021
Start date
Sep 21, 2022
Primary completion
Jan 22, 2026
Completion
Feb 22, 2027 (estimated)
Last update
Jul 13, 2026

Study contacts

Aline RAMOND ROQUIN, MD-PHD
principal investigator · Department of Family Medicine - University of Angers

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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