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Clinical Trials/NCT05531201
NCT05531201
Active, not recruiting
Not Applicable

Evaluation of the Efficacy of a Coordinated Interprofessional Care Pathway on Disability in Patients With Chronic Low Back Pain and Patients at Risk of Chronic Low Back Pain in Primary Care: a Cluster Randomized Controlled Trial

CNGE Conseil1 site in 1 country123 target enrollmentFebruary 15, 2023

Overview

Phase
Not Applicable
Intervention
Control
Conditions
Low Back Pain
Sponsor
CNGE Conseil
Enrollment
123
Locations
1
Primary Endpoint
Disability at 3 months
Status
Active, not recruiting
Last Updated
2 months ago

Overview

Brief Summary

Low back pain is a public health problem with major individual and socio-economic repercussions. In primary care, strong disparities are observed in the management of low back pain patients. While general practitioners (GPs) and physiotherapists appear as two essential first-line caregivers, collaboration between these professionals remains underdeveloped, most often characterized by a lack of consultation or coordination. Systematic increased interprofessional collaboration is likely to improve the results of the care pathway, by optimizing the existing care offer.

Registry
clinicaltrials.gov
Start Date
February 15, 2023
End Date
November 13, 2026
Last Updated
2 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
CNGE Conseil
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Adult patients between the ages of 18 and 65
  • Patients consulting their GP for a first or new eisode of acute low back pain (more than 12 months from the previous one) with a STarT Back screening tool score greater than
  • OR low back pain at risk of chronicity (presence of yellow flags, according to the recommendation of the High Health Authority (HAS) of 2019
  • OR recurrent low back pain: in the event of recurrence of low back pain within 12 months after the previous episode, then considered to be at risk of chronicity
  • OR having chronic low back pain (low back pain for more than 3 months)
  • Patients benefiting from the general social security system
  • Patients who understand and speak French fluently
  • Patients who have given their consent after having received complete information on the protocol

Exclusion Criteria

  • Minor patients
  • Pregnant women (declared pregnancy) or immediately postpartum (up to 3 months)
  • Patients with "red flags" (serious neurological impairment, cancer, infection, fracture or inflammatory disease), according to the 2019 HAS recommendation
  • Patients referred immediately for imaging or specialist advice during the first consultation with the GP (suspicion of underlying pathology)
  • Patients with no history of acute low back pain, at low risk of chronicity (STarT Back screening tool score less than or equal to 3)
  • Patients with a contraindication to rehabilitation by physiotherapy
  • Patients who have already undergone spine surgery
  • Patients with cognitive impairment
  • Patients whose life expectancy is less than 12 months
  • Patients under guardianship or curatorship, under judicial protection or safeguard of justice

Arms & Interventions

Control

without modification of the usual follow-up

Interventional

Trainig of GP and physiotherapist at collaborative coordinated care pathway

Intervention: collaboration general practitioner and physiotherapist

Outcomes

Primary Outcomes

Disability at 3 months

Time Frame: 3 months

Absolute change in overall Oswestry Disability Index (ODI) scale score between 0 and 3 months. Total score ranging from 0 (no functional disability) to 100 (severe functional disability).

Secondary Outcomes

  • Health-related quality of life at 3 months(3 months)
  • Evaluation of the course of care: number of consultations(12 months)
  • Evaluation of effective collaborative practices(12 months)
  • Disability at 12 months(12 months)
  • Health-related quality of life at 12 months(12 months)
  • Evaluation of the course of care: compliance(12 months)
  • Evaluation of the course of care: medical imaging(12 months)
  • Evaluation of the course of care: total cost(12 months)

Study Sites (1)

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