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

University Hospital, Angers20 sites in 1 country500 target enrollmentSeptember 21, 2022

ConditionsLow Back Pain

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Low Back Pain
Sponsor: University Hospital, Angers
Enrollment: 500
Locations: 20
Primary Endpoint: Perceived inability at 1 year
Status: Recruiting
Last Updated: 7 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

September 21, 2022

End Date

November 25, 2027

Last Updated

7 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University Hospital, Angers

Responsible Party

Sponsor

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

Exclusion Criteria

Not provided

Outcomes

Primary Outcomes

Perceived inability at 1 year

Time Frame: Enrollment to 12 months follow up

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

Secondary Outcomes

Occupational status(at 3 months, 6 months and 12 months)
Roland Morris Disability score over time(Enrollment, 3 months, 6 months, 12 months)
Improved patients(at 3 months, 6 months and 12 months)
Numerical pain scale over time(Enrollment, 3 months, 6 months, 12 months)
Depression component score of Hospital Anxiety and Depression Scale(Enrollment, 3 months, 12 months)
Physiotherapist satisfaction related to patient care(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(Baseline intervention formations)
Number of consultations or sessions(during the 12 months of follow up)
Sick leave(during 12 months after inclusion)
Biopsychosocial component score of Pain Attitudes and Beliefs score - for intervention physiotherapists(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(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(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(during the 12 months of follow up)
Perceived inability(Enrollment to 3 months follow up, Enrollment to 6 months follow up)
Occupational component score of Fear Avoidance Beliefs Questionnaire(Enrollment, 3 months, 12 months)
GP satisfaction related to patient care(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 intervention physiotherapists(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))
Pain perceived(Enrollment - 3 months , Enrollment - 6 months and Enrollment -12 months)
Employment rate(Enrollment, 3 months, 6 months, 12 months)
Evolution of improved patients ratio(Enrollment, 3 months, 6 months, 12 months)
Physical activity component score of Fear Avoidance Beliefs Questionnaire(Enrollment, 3 months, 12 months)
Anxiety component score of Hospital Anxiety and Depression Scale(Enrollment 3 months, 12 months)
Coordination care score of Patient Centered Coordination by a Care Team questionnaire(Enrollment, 3 months, 12 months)
Mental component score of Short Form -12(Enrollment, 3 months, 6 months, 12 months)
Physical component score of Short Form -12(Enrollment, 3 months, 6 months, 12 months)