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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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05531201
Acronym
EFFIBACK
Enrollment
123
Registered
2022-09-07
Start date
2023-02-15
Completion date
2026-11-13
Last updated
2026-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Low Back Pain

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.

Interventions

PROCEDUREcollaboration general practitioner and physiotherapist

training general practitioner and physiotherapist

Sponsors

CNGE Conseil
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Disability at 3 months3 monthsAbsolute 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

MeasureTime frameDescription
Health-related quality of life at 3 months3 monthsAbsolute 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
Health-related quality of life at 12 months12 monthsAbsolute 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: compliance12 monthsnumber (%) of patients having followed the entire course of care
Evaluation of the course of care: number of consultations12 monthstotal number of consultations with GPs and physiotherapists (PTs)
Evaluation of the course of care: medical imaging12 monthstotal number of medical imaging related to low back during the follow up
Evaluation of the course of care: total cost12 monthstotal cost (in euros €) of healthcare pathway in the two groups
Disability at 12 months12 monthsAbsolute change in overall ODI scale score between 0 and 12 months. Total score ranging from 0 (no functional disability) to 100 (severe functional disability).
Evaluation of effective collaborative practices12 monthsqualitative analysis of GP/PT collaboration using semi-structured interviews with professionals

Countries

France

Contacts

STUDY_CHAIRTan-Trung PHAN

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026