A Multilevel Intervention for Low Back Pain Management in Primary Care

NCT07137065 | Recruiting DMC

• 2 other identifiers: PRIME_2025_08_08PT0043_222873
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Primary care; Guidelines implementation

Outcome Measures

Primary Outcomes (3)

• Mean incremental cost per quality-adjusted life-year (QALY) calculated using the EQ-5D-5L questionnaire

  Primary system-level outcome measures will be the mean incremental cost per quality-adjusted life-year (QALY) calculated using the EQ-5D-5L questionnaire from a healthcare payer and a societal perspective

  0-12 months period after enrolment

• Back-related imaging rate (%) among patients with low back pain

  The primary practitioner-level outcome measure will be the back-related imaging rate (%) among patients with LBP during 6 months after the primary consultation.

  0-6 months period after enrolment

• Self-reported back-related disability measured with the Roland Morris Disability Questionnaire

  The primary patient-level outcome will be self-reported back-related disability measured with the Roland Morris Disability Questionnaire (RMDQ) six months after the initial general practitioner consultation

  6 months after enrolment

Secondary Outcomes (18)

• Pain intensity with the Numerical Rating Scale

  10 days, 6 weeks, 3 months, 6 months, 9 months, 12 months after enrolment

• Health-related quality of life (HRQL) with the EQ-5D-5L questionnaire

  3, 6, 12 months after enrolment

• Work participation with the Work Productivity and Activity Impairment Questionnaire (WPAI)

  10 days, 6 weeks, 3 months, 6 months, 9 months, 12 months after enrolment

• Pain Self-Efficacy with the Pain Self Efficacy Questionnaire short form (PSEQ-2)

  6 weeks and 6 months after enrolment

• Fear of movement

  6 weeks and 6 months after enrolment

Study Arms (2)

PRImary care MultilEvel intervention for low back pain (PRIME)

EXPERIMENTAL

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.

Behavioral: PRImary care MultilEvel intervention for low back pain (PRIME)

Usual Care

ACTIVE COMPARATOR

General practitioners in this arm will continue to practice as usual.

Other: Usual Care

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.

Also known as: Healthcare professional training, Reminders, Patient education, Stratified care

PRImary care MultilEvel intervention for low back pain (PRIME)

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.

Usual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients consulting their participating general practitioner for a primary concern of LBP (with or without leg pain)
• Above 18 years old

You may not qualify if:

• 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.

Sponsors & Collaborators

• Guillaume Christe: lead
• Haute Ecole de Santé Vaud (HESAV), Lausanne, Switzerland: collaborator
• University of Geneva, Switzerland: collaborator

Study Sites (2)

Geneva

Geneva, Canton of Geneva, 1200, Switzerland

RECRUITING

Vaud

Lausanne, Canton of Vaud, 1011, Switzerland

RECRUITING

MeSH Terms

Conditions

Low Back Pain

Interventions

Patient Education as Topic

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Health Education; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Guillaume Christe, PhD

  Haute Ecole de Santé Vaud

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Guillaume Christe, PhD

CONTACT

+41 21 556 62 67; guillaume.christe@hesav.ch

Mathilde Rosa, MSc

CONTACT

+41 21 556 65 17; mathilde.rosa@hesav.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: All outcome measures will be directly recorded in Redcap by the participants (no outcome assessor).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Model Details: This study uses an effectiveness-implementation hybrid design (type 1), which prioritizes the evaluation of clinical effectiveness while collecting detailed information on the implementation process. The study is a cluster randomized controlled trial, with the unit of randomization being quality circles of general practitioners (GPs) affiliated with a care network in the French-speaking part of Switzerland. A total of 20 quality circles will be randomized into intervention and control arms. Each quality circle includes multiple GP practices, and approximately 100 GPs will participate in total.

Study Record Dates

• First Submitted: August 8, 2025
• First Posted: August 22, 2025
• Study Start: February 5, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): June 30, 2028
• Last Updated: February 12, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the study completion

Locations

CH (2)