Clinical trial NCT05531201: 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
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Low Back Pain
Lead sponsor: CNGE Conseil
Sponsor class: OTHER
First posted: 2022-09-07
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Disability at 3 months
timeFrame: 3 months
Secondary outcomes:
measure: Disability at 12 months
timeFrame: 12 months
measure: Health-related quality of life at 3 months
timeFrame: 3 months
measure: Health-related quality of life at 12 months
timeFrame: 12 months
measure: Evaluation of the course of care: compliance
timeFrame: 12 months
measure: Evaluation of the course of care: number of consultations
timeFrame: 12 months
measure: Evaluation of the course of care: medical imaging
timeFrame: 12 months
measure: Evaluation of the course of care: total cost
timeFrame: 12 months
measure: Evaluation of effective collaborative practices
timeFrame: 12 months
Other outcomes:
Locations:
city: Fontainebleau
country: France
facility: Maison de Santé Pluriprofessionnelle Universitaire
Study officials:
affiliation: Département Universitaire d'Enseignement et de Recherche en Médecine Générale - Université Paris-Est Créteil, 8 rue du Général Sarrail 94010 Créteil Cedex
name: Tan-Trung PHAN
role: STUDY_CHAIR
References: