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 (EFFIBACK)

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Low Back Pain
• Intervention / Treatment: Procedure: collaboration general practitioner and physiotherapist

• Study Type: Interventional
• Enrollment (Actual): 123
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Fontainebleau, France, 77300
    • Maison de Santé Pluriprofessionnelle Universitaire

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Interventional; Trainig of GP and physiotherapist at collaborative coordinated care pathway	Procedure: collaboration general practitioner and physiotherapist; training general practitioner and physiotherapist
No Intervention: Control; without modification of the usual follow-up

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disability at 12 months	Absolute change in overall ODI scale score between 0 and 12 months. Total score ranging from 0 (no functional disability) to 100 (severe functional disability).	12 months
Health-related quality of life at 3 months	Absolute change of health-related quality of life by the EuroQol 5 Dimensions scale (EQ-5D) between 0 and 3 months and between 0 and 12 months	3 months
Health-related quality of life at 12 months	Absolute change of health-related quality of life by the EuroQol 5 Dimensions scale (EQ-5D) between 0 and 12 months	12 months
Evaluation of the course of care: compliance	number (%) of patients having followed the entire course of care	12 months
Evaluation of the course of care: number of consultations	total number of consultations with GPs and physiotherapists (PTs)	12 months
Evaluation of the course of care: medical imaging	total number of medical imaging related to low back during the follow up	12 months
Evaluation of the course of care: total cost	total cost (in euros €) of healthcare pathway in the two groups	12 months
Evaluation of effective collaborative practices	qualitative analysis of GP/PT collaboration using semi-structured interviews with professionals	12 months

Collaborators and Investigators

• Sponsor: CNGE Conseil
• Investigators: Study Chair: 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 record dates

Study Major Dates

• Study Start (Actual): February 15, 2023
• Primary Completion (Actual): January 20, 2026
• Study Completion (Estimated): November 13, 2026

Study Registration Dates

• First Submitted: August 22, 2022
• First Submitted That Met QC Criteria: September 5, 2022
• First Posted (Actual): September 7, 2022

Study Record Updates

• Last Update Posted (Actual): February 11, 2026
• Last Update Submitted That Met QC Criteria: February 9, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Low Back Pain; Health Care Facilities Workforce and Services; Health Personnel; Physical Therapists
• Other Study ID Numbers: CNGE-2021/01; 2021-A02432-39 (Registry Identifier: IDRCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No