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

Low Back Pain Clinical Trial

— EFFIBACK  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05531201
• Other study ID #: CNGE-2021/01
• Secondary ID: 2021-A02432-39
• Status: Recruiting
• Phase: N/A
• Start date: February 15, 2023
• Est. completion date: November 13, 2025

Study information

• Verified date: June 2024
• Source: CNGE Conseil
• Contact: Tan-Trung PHAN
• Phone: 01 85 48 12 34/06 63 48 53 81
• Email: tan-trung.phan[@]u-pec.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: November 13, 2025
• Est. primary completion date: February 14, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Procedure:
• collaboration general practitioner and physiotherapist
training general practitioner and physiotherapist

Locations

Country	Name	City	State
France	Maison de Santé Pluriprofessionnelle Universitaire	Fontainebleau

Sponsors (1)

Lead Sponsor	Collaborator
CNGE Conseil

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Evaluation of the course of care: compliance	number (%) of patients having followed the entire course of care	12 months
Secondary	Evaluation of the course of care: number of consultations	total number of consultations with GPs and physiotherapists (PTs)	12 months
Secondary	Evaluation of the course of care: medical imaging	total number of medical imaging related to low back during the follow up	12 months
Secondary	Evaluation of the course of care: total cost	total cost (in euros €) of healthcare pathway in the two groups	12 months
Secondary	Evaluation of effective collaborative practices	qualitative analysis of GP/PT collaboration using semi-structured interviews with professionals	12 months