Team-based program to improve primary care for adults with low back pain
A Multilevel Intervention for Low Back Pain Management in Primary Care: An Effectiveness-implementation Hybrid Study
This project will test a multilevel program that helps GPs, physiotherapists, and occupational therapists follow guidelines, educate patients, and coordinate care for adults with low back pain.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Haute Ecole de Santé Vaud Academic / other |
| Locations | 2 sites (Geneva, Canton of Geneva and 1 other locations) |
| Trial ID | NCT07137065 on ClinicalTrials.gov |
What this trial studies
Using a cluster randomized design, over 100 general practitioners in French-speaking Switzerland will be assigned to either the multilevel PRIME program or usual care, and roughly 500 patients will be followed. The intervention supports clinicians in adopting guideline-based practices, delivers patient education, and creates an interprofessional care pathway tailored to each patient's needs. Primary outcomes include cost-effectiveness, imaging prescription rates, and patient-reported back-related disability, with secondary measures of opioid prescribing, sick leave, pain, function, and clinician beliefs. As a hybrid type 1 effectiveness-implementation study, the trial will also measure implementation outcomes such as acceptability, feasibility, fidelity, and adoption among clinicians.
Who should consider this trial
Good fit: Adults (18+) consulting a participating general practitioner in French-speaking Switzerland for a primary complaint of low back pain who can give consent, use an electronic device, and complete questionnaires in French are eligible.
Not a fit: Patients with recent back surgery, a known specific cause of low back pain (e.g., infection, malignancy, fracture), major neurologic deficit requiring specialist or emergency referral, pregnancy, inability to consent or complete French electronic questionnaires, or who saw their GP for the same low back pain issue in the prior 3 months may not benefit from the intervention.
Why it matters
Potential benefit: If successful, patients could receive more coordinated, guideline-based care that reduces unnecessary imaging and improves pain-related function and recovery.
How similar studies have performed: Previous guideline-based and multidisciplinary implementation efforts have shown modest success in reducing unnecessary imaging and improving clinician adherence, though impacts on long-term disability have been mixed.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients consulting their participating general practitioner for a primary concern of LBP (with or without leg pain) * Above 18 years old Exclusion Criteria: * If they had consulted their general practitioner for a primary concern of LBP in the past 3 months, as care was already started prior to the study. * Unable to give consent (eg. cognitive impairment) * Unable to access comfortably an electronic device to answer the questionnaires (smartphone, computer) * Unable to answer questionnaires in French * Known pregnancy * Have had back surgery in the last 6 months * Any specific cause of LBP (e.g. inflammatory arthritis, malignancy, infection, fracture, cauda equina syndrome). * a major strength deficit (M3 and below) due to radiculopathy or have to be referred directly to emergency or a specialist because of that. As specific causes of LBP may be unknown at the first consultation in primary care, patients with a confirmed diagnosis of specific LBP could be excluded post-allocation by an independent doctor that is part of the Data Monitoring Committee.
Where this trial is running
Geneva, Canton of Geneva and 1 other locations
- Geneva — Geneva, Canton of Geneva, Switzerland (Recruiting)
- Vaud — Lausanne, Canton of Vaud, Switzerland (Recruiting)
Study contacts
- Principal investigator: Guillaume Christe, PhD — Haute Ecole de Santé Vaud
- Study coordinator: Guillaume Christe, PhD
- Email: guillaume.christe@hesav.ch
- Phone: +41 21 556 62 67
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.