Physiotherapists as first-contact practitioners for patients with low back pain in French primary care: a pragmatic cluster randomised controlled trial.

Background: A new model of care enables French physiotherapists (PT) working in collaboration with family physicians (FP) to expand their usual scope of practice for patients with acute low back pain (LBP). The aim of our study is to evaluate the impact of this new first-contact physiotherapy (FCP) advanced practice model compared to usual FP care.

Methods: A multicentre pragmatic non-inferiority cluster randomised controlled trial (RCT) has been conducted in six multidisciplinary primary healthcare centres in France. Patients from 20 to 55 years old with acute LBP consulted either the PT or the FP. PT independently assessed and managed patients including medication prescription. The primary outcome measure was disability at six weeks (Roland Morris Disability Questionnaire, range 0-24). Secondary outcomes include pain, risk disability prognosis, satisfaction with care, healthcare resources use and wait times. Data were collected at baseline, six and twelve weeks. Outcomes across arms were compared using mixed models regression analysis. Except for non-inferiority analysis of the primary outcome measure, other analyses were performed with a two-sided significance level of 0.05.

Results: Sixty patients were recruited (PT: 32, FP: 28). The adjusted mean difference between groups for disability at 6 weeks was 0.39 in favour of the FP group (95%CI: -2.03; 2.81, p = 0.753). Considering a 5 points minimal clinically important difference, the FCP-led model of care was not inferior to usual FP care for the primary outcome. There was no statistically significant difference between groups in disability at 3 months and pain at 6 weeks and 3 months. PTs prescribed significantly less medications than FPs (p < 0.001). No statistically significant difference was found for other healthcare resource use outcomes, patients' satisfaction and wait times.

Conclusion: This is the first RCT to evaluate the impact of a FCP advanced practice model of care including medical delegated acts in a primary care setting. Our results suggest that the FCP-led model of care is not inferior to usual FP care regarding disability at 6 weeks. The FCP model could result in possible benefits in terms of healthcare resources use. Further adequate powered studies with larger sample size are needed to draw stronger conclusions.

Trial Registration: The study has been registered in ClinicalTrials.gov (NCT05200533) on the 20th of January 2022.