Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID07137065

A Multilevel Intervention for Low Back Pain Management in Primary Care: An Effectiveness-implementation Hybrid Study

Led by Guillaume Christe · Updated on 2026-02-12

500

Participants Needed

2

Research Sites

26 weeks

Total Duration

On this page

Sponsors

G

Guillaume Christe

Lead Sponsor

H

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

Collaborating Sponsor

AI-Summary

What this Trial Is About

Low back pain is a leading cause of disability worldwide and a common reason for primary care visits. This research aims to improve how low back pain is managed in primary care by testing a multilevel intervention developed with general practitioners, physiotherapists, and occupational therapists. The study evaluates the effectiveness of this new care approach compared to usual care, focusing on cost-effectiveness, imaging rates, and patient disability over time. The intervention includes training general practitioners, sending reminders, providing patient education, and using a clinical pathway based on risk of chronicity. Patients may receive education and self-management support, individual physiotherapy sessions after a specialized two-day workshop, and multidisciplinary group management if needed. Care pathways involve screening, follow-up questionnaires assessing risk and work ability, and tailored treatment steps over several weeks, with coordination among healthcare providers encouraged. Participants will be monitored for 12 months through questionnaires at multiple time points and administrative data. Outcomes measured include back-related disability, imaging referrals, opioid and sick leave prescriptions, pain intensity, quality of life, work participation, and beliefs about back pain. Healthcare professionals' confidence and beliefs will also be assessed. Implementation outcomes such as acceptability and feasibility will be explored via interviews and focus groups with patients and practitioners to understand integration into routine care.

CONDITIONS

Brief Title

A Multilevel Intervention for Low Back Pain Management in Primary Care

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients consulting their participating general practitioner for a primary concern of low back pain, with or without leg pain
  • Age 18 years or older
Not Eligible

You will not qualify if you...

  • Consulted their general practitioner for low back pain in the past 3 months
  • Unable to give consent, such as due to cognitive impairment
  • Unable to comfortably access an electronic device for questionnaires
  • Unable to answer questionnaires in French
  • Known pregnancy
  • Back surgery in the last 6 months
  • Specific causes of low back pain like inflammatory arthritis, malignancy, infection, fracture, or cauda equina syndrome
  • Major strength deficit due to radiculopathy requiring emergency or specialist referral
  • Patients with confirmed specific low back pain may be excluded after randomization by an independent doctor

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Up to 12 months

Participants receive either the PRIME multilevel intervention including GP training, patient education, and a clinical pathway involving physiotherapy and possibly multidisciplinary group management, or usual care from their general practitioners. The clinical pathway includes education, self-management, physiotherapy sessions, and multidisciplinary care based on risk factors for chronicity and work ability.

Questionnaires completed online at baseline, 10 days, 6 weeks, 3 months, 6 months, 9 months, and 12 months

Trial Site Locations

Total: 2 locations

1

Geneva

Geneva, Canton of Geneva, Switzerland, 1200

Actively Recruiting

2

Vaud

Lausanne, Canton of Vaud, Switzerland, 1011

Actively Recruiting

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Research Team

G

Guillaume Christe, PhD

M

Mathilde Rosa, MSc

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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