Actively Recruiting
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
Eligibility Criteria
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
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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
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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