A Multilevel Intervention for Low Back Pain Management in Primary Care

Sponsor
Guillaume Christe
Study ID
NCT07137065
Status
Recruiting
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Conditions

  • Low Back Pain

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • PRImary care MultilEvel intervention for low back pain (PRIME) — BEHAVIORAL
    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.
  • Usual Care — OTHER
    In this arm, general practitioners will treat their patients as usual. They can prescribed any treatment or diagnostic tests to their patients.

Study Details

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.

Key Dates

First listed
Aug 22, 2025
Start date
Feb 5, 2026
Status verified
Feb 2026
Primary completion
Dec 31, 2027
Completion
Jun 30, 2028

Study Design

Enrollment
500 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: PRImary care MultilEvel intervention for low back pain (PRIME)
    For general practitioners in this arm, they will receive 2 x 1 hour of training, will have access to trained physiotherapists and will use a dedicated clinical pathway based on risk of chronicity.
  • Active Comparator: Usual Care
    General practitioners in this arm will continue to practice as usual.

Primary Outcome Measure

Mean incremental cost per quality-adjusted life-year (QALY) calculated using the EQ-5D-5L questionnaire [ Time Frame: 0-12 months period after enrolment ]

Central Contacts

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