A Multilevel Intervention for Low Back Pain Management in Primary Care

NCT07137065 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 500

Last updated 2026-02-12

No results posted yet for this study

Summary

Low back pain is the leading cause of disability worldwide and one of the main reasons for consulting in primary care. This project aims to improve the management of people with low back pain in primary care through an innovative intervention developed in collaboration with general practitioners, physiotherapists, and occupational therapists.

The main objective is to test the effectiveness of a multilevel intervention designed to improve the care pathway for individuals with low back pain consulting their general practitioner. The intervention supports healthcare professionals in adopting practices based on current guidelines, promotes patient education, and offers an interprofessional care pathway tailored to each person's needs and profile.

The study will include over 100 general practitioners in French-speaking Switzerland, randomly assigned to either the intervention group or the control group (usual care). Around 500 patients will be followed according to their doctor's approach. Their progress will be monitored over 12 months using questionnaires and administrative data.

This project addresses an urgent need to improve the care pathway in primary care. It will rigorously assess the effectiveness of this new care approach and explore the barriers and facilitators to its integration into daily practice, taking into account the experiences of both healthcare professionals and the people concerned.

Conditions

  • Low Back Pain

Interventions

BEHAVIORAL

PRImary care MultilEvel intervention for low back pain (PRIME)

The multilevel intervention includes four main components: 1\. GP training. GPs will receive training to improve their confidence in LBP guidelines, diagnostic triage and best practice. Furthermore, they will be trained to provide both general and cognitive reassurance to patients, use a stratified care strategy and improve interprofessional communication. 2. Reminders. GPs will receive regular reminders by email to reinforce the integration of high-value care into practice. 3. Patient education. GPs will reassure patients, help them understand their LBP in the initial consultation and target unhelpful beliefs about LBP. 4. Clinical pathway. The clinical pathway includes a gradual stratified care pathway based on risk factors for chronicity. The core interventions of this 3-step clinical pathway are education and self-management, individual sessions with a trained physiotherapist, and multidisciplinary group management. GPs remain free to make all clinical decisions.

OTHER

Usual Care

In this arm, general practitioners will treat their patients as usual. They can prescribed any treatment or diagnostic tests to their patients.

Sponsors & Collaborators

  • Haute Ecole de Santé Vaud (HESAV), Lausanne, Switzerland

    collaborator UNKNOWN
  • University of Geneva, Switzerland

    collaborator OTHER
  • Guillaume Christe

    lead OTHER

Principal Investigators

  • Guillaume Christe, PhD · Haute Ecole de Santé Vaud

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-05
Primary Completion
2027-12-31
Completion
2028-06-30

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07137065 on ClinicalTrials.gov