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

U

University Hospital, Angers

Status

Enrolling

Conditions

Low Back Pain

Treatments

Other: Coordinated care

Study type

Interventional

Funder types

Other

Identifiers

NCT04826757
2020-A01039-30

Details and patient eligibility

About

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.

Enrollment

500 estimated patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

500 participants in 2 patient groups

standard care
No Intervention group
Description:
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.
coordinated care
Experimental group
Description:
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.
Treatment:
Other: Coordinated care

Trial contacts and locations

20

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Central trial contact

Aline RAMOND ROQUIN, MD-PHD; Anthea LOIEZ

Data sourced from clinicaltrials.gov

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