Clinical trial NCT04826757: Effectiveness of Coordinated Care to Reduce the Prolonged Disability Risk Among Patients Suffering from Low Back Pain in Primary Care
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Low Back Pain
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2021-04-01
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomised, controlled, cluster trial. the project is multicentered.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


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

Primary outcomes:
measure: Perceived inability at 1 year
timeFrame: Enrollment to 12 months follow up
Secondary outcomes:
measure: Perceived inability
timeFrame: Enrollment to 3 months follow up, Enrollment to 6 months follow up
measure: Roland Morris Disability score over time
timeFrame: Enrollment, 3 months, 6 months, 12 months
measure: Pain perceived
timeFrame: Enrollment - 3 months , Enrollment - 6 months and Enrollment -12 months
measure: Numerical pain scale over time
timeFrame: Enrollment, 3 months, 6 months, 12 months
measure: Occupational status
timeFrame: at 3 months, 6 months and 12 months
measure: Employment rate
timeFrame: Enrollment, 3 months, 6 months, 12 months
measure: Sick leave
timeFrame: during 12 months after inclusion
measure: Improved patients
timeFrame: at 3 months, 6 months and 12 months
measure: Evolution of improved patients ratio
timeFrame: Enrollment, 3 months, 6 months, 12 months
measure: Mental component score of Short Form -12
timeFrame: Enrollment, 3 months, 6 months, 12 months
measure: Physical component score of Short Form -12
timeFrame: Enrollment, 3 months, 6 months, 12 months
measure: Occupational component score of Fear Avoidance Beliefs Questionnaire
timeFrame: Enrollment, 3 months, 12 months
measure: Physical activity component score of Fear Avoidance Beliefs Questionnaire
timeFrame: Enrollment, 3 months, 12 months
measure: Anxiety component score of Hospital Anxiety and Depression Scale
timeFrame: Enrollment 3 months, 12 months
measure: Depression component score of Hospital Anxiety and Depression Scale
timeFrame: Enrollment, 3 months, 12 months
measure: Coordination care score of Patient Centered Coordination by a Care Team questionnaire
timeFrame: Enrollment, 3 months, 12 months
measure: GP satisfaction related to patient care
timeFrame: 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)
measure: Physiotherapist satisfaction related to patient care
timeFrame: 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)
measure: Professionals trained for intervention
timeFrame: Baseline intervention formations
measure: Biomechanical component score of Pain Attitudes and Beliefs score - for intervention physiotherapists
timeFrame: 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)
measure: Biopsychosocial component score of Pain Attitudes and Beliefs score - for intervention physiotherapists
timeFrame: 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)
measure: Biopsychosocial component score of Pain Attitudes and Beliefs score - for GPs
timeFrame: 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)
measure: Biomechanical component score of Pain Attitudes and Beliefs score - for GPs
timeFrame: 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)
measure: Professional dialogues
timeFrame: during the 12 months of follow up
measure: Number of consultations or sessions
timeFrame: during the 12 months of follow up
Other outcomes:
Locations:
city: Bonchamp-lès-Laval
country: France
facility: Cluster Bonchamp
city: Breteil
country: France
facility: Cluster Vaunoise
city: Brulon
country: France
facility: Cluster BRULON
city: Château-Gontier
country: France
facility: Cluster Château Gontier
city: Châteauneuf-sur-Sarthe
country: France
facility: Cluster Châteauneuf sur Sarthe / Morannes
city: Clisson
country: France
facility: Cluster Clisson
city: Conlie
country: France
facility: Cluster Conlie
city: Craon
country: France
facility: Cluster Craon Renaze Cosse
city: Entrammes
country: France
facility: Cluster Entrammes Laval
city: La Roche-sur-Yon
country: France
facility: Cluster Roche sur Yon
city: Nantes
country: France
facility: Cluster Chantenay
city: Quévert
country: France
facility: Cluster Dinan / Quévert / Plouasne
city: Rennes
country: France
facility: Cluster Rennes Beauregard
city: Rennes
country: France
facility: Cluster Rennes Villejean
city: Roquefort les pins
country: France
facility: Cluster Les Collines
city: Saint-Florent-le-Vieil
country: France
facility: Cluster St Florent, Mauges, Possonnière
city: Savenay
country: France
facility: Cluster Savenay
city: Segré
country: France
facility: Cluster SEGRE
city: Trélazé
country: France
facility: Cluster Angers- Trélazé
city: Vence
country: France
facility: Cluster Vence
Study officials:
affiliation: Department of Family Medicine - University of Angers
name: Aline RAMOND ROQUIN, MD-PHD
role: PRINCIPAL_INVESTIGATOR
References: