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

Not Applicable

Recruiting

• Conditions: Low Back Pain

• Registration Number: NCT05531201
• Lead Sponsor: CNGE Conseil

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-08-22
• Study First Submitted QC: 2022-09-05
• Study First Posted: 2022-09-07
• Study Start: 2023-02-15
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-26
• Last Update Posted: 2024-11-27
• Primary Completion: 2026-02-14
• Study Completion: 2026-11-13

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Disability at 3 months	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 Outcome Measures

Name	Time	Method
Health-related quality of life at 3 months	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
Evaluation of the course of care: number of consultations	12 months	total number of consultations with GPs and physiotherapists (PTs)
Evaluation of effective collaborative practices	12 months	qualitative analysis of GP/PT collaboration using semi-structured interviews with professionals
Disability at 12 months	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).
Health-related quality of life at 12 months	12 months	Absolute change of health-related quality of life by the EuroQol 5 Dimensions scale (EQ-5D) between 0 and 12 months
Evaluation of the course of care: compliance	12 months	number (%) of patients having followed the entire course of care
Evaluation of the course of care: medical imaging	12 months	total number of medical imaging related to low back during the follow up
Evaluation of the course of care: total cost	12 months	total cost (in euros €) of healthcare pathway in the two groups

Trial Locations

Locations (1)

Maison de Santé Pluriprofessionnelle Universitaire; 🇫🇷 Fontainebleau, France