Background: Patient education, advice on returning to normal activities and (home-based) exercise therapy are
established treatment options for patients with non-specific low back pain (LBP). However, the effectiveness of
physiotherapy interventions on physical functioning and prevention of recurrent events largely depends on patient
self-management, adherence to prescribed (home-based) exercises and recommended physical activity behaviour.
Therefore we have developed e-Exercise LBP, a blended intervention in which a smartphone application is
integrated within face-to-face care. E-Exercise LBP aims to improve patient self-management skills and adherence to
exercise and physical activity recommendations and consequently improve the effectiveness of physiotherapy on
patients’ physical functioning. The aim of this study is to investigate the short- (3 months) and long-term (12 and
24 months) effectiveness on physical functioning and cost-effectiveness of e-Exercise LBP in comparison to usual
primary care physiotherapy in patients with LBP.
Methods: This paper presents the protocol of a prospective, multicentre cluster randomized controlled trial. In total 208
patients with LBP pain were treated with either e-Exercise LBP or usual care physiotherapy. E-Exercise LBP is stratified
based on the risk for developing persistent LBP. Physiotherapists are able to monitor and evaluate treatment progress
between face-to-face sessions using patient input from the smartphone application in order to optimize physiotherapy
care. The smartphone application contains video-supported self-management information, video-supported exercises and
a goal-oriented physical activity module. The primary outcome is physical functioning at 12-months follow-up. Secondary
outcomes include pain intensity, physical activity, adherence to prescribed (home-based) exercises and recommended
physical activity behaviour, self-efficacy, patient activation and health-related quality of life. All measurements will be
performed at baseline, 3, 12 and 24months after inclusion. An economic evaluation will be performed from the societal
and the healthcare perspective and will assess cost-effectiveness of e-Exercise LBP compared to usual physiotherapy at 12
and 24months.
Discussion: A multi-phase development and implementation process using the Center for eHealth Research Roadmap
for the participatory development of eHealth was used for development and evaluation. The findings will provide
evidence on the effectiveness of blended care for patients with LBP and help to enhance future implementation of
blended physiotherapy.