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

NCT05531201 | Active Not Recruiting

• 2 other identifiers: CNGE-2021/012021-A02432-39
• Study Type: interventional
• Target: 123
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Disability at 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).

  3 months

Secondary Outcomes (8)

• Disability at 12 months

  12 months

• Health-related quality of life at 3 months

  3 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: number of consultations

  12 months

Study Arms (2)

Interventional

EXPERIMENTAL

Trainig of GP and physiotherapist at collaborative coordinated care pathway

Procedure: collaboration general practitioner and physiotherapist

Control

NO INTERVENTION

without modification of the usual follow-up

Interventions

collaboration general practitioner and physiotherapist PROCEDURE

training general practitioner and physiotherapist

Interventional

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• CNGE Conseil: lead

Study Sites (1)

Maison de Santé Pluriprofessionnelle Universitaire

Fontainebleau, 77300, France

Location

MeSH Terms

Conditions

Low Back Pain

Interventions

Physical Therapists

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Health Personnel; Health Care Facilities Workforce and Services

Study Officials

• Tan-Trung PHAN

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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2022
• First Posted: September 7, 2022
• Study Start: February 15, 2023
• Primary Completion: January 20, 2026
• Study Completion (Estimated): November 13, 2026
• Last Updated: February 11, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)