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

NCT ID: NCT05531201

Last Updated: 2025-07-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-15
• Study Completion Date: 2026-11-13

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.

Conditions

Low Back Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Interventional

Trainig of GP and physiotherapist at collaborative coordinated care pathway

Group Type: EXPERIMENTAL

collaboration general practitioner and physiotherapist

Intervention Type: PROCEDURE

training general practitioner and physiotherapist

Control

without modification of the usual follow-up

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

collaboration general practitioner and physiotherapist

training general practitioner and physiotherapist

Intervention Type: PROCEDURE

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 3.
• 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
• Patients not affiliated to the general social security system
• Patients with difficulties in understanding the French language
• Patients with an inability to give express consent

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CNGE Conseil

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tan-Trung PHAN

Role: STUDY_CHAIR

Département Universitaire d'Enseignement et de Recherche en Médecine Générale - Université Paris-Est Créteil, 8 rue du Général Sarrail 94010 Créteil Cedex

Locations

Maison de Santé Pluriprofessionnelle Universitaire

Fontainebleau, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Tan-Trung PHAN

Role: CONTACT

tan-trung.phan@u-pec.fr

01 85 48 12 34/06 63 48 53 81

Julien LE BRETON

Role: CONTACT

julien.le.breton@u-pec.fr

06 64 00 91 07

Facility Contacts

Tan-Trung PHAN, Dr

Role: primary

tantrungphan1@gmail.com

01 85 48 12 34

Other Identifiers

2021-A02432-39

Identifier Type: REGISTRY

Identifier Source: secondary_id

CNGE-2021/01

Identifier Type: -

Identifier Source: org_study_id