Background: Neck and shoulder complaints are common in primary care physiotherapy. These patients experience
pain and disability, resulting in high societal costs due to, for example, healthcare use and work absence. Content
and intensity of physiotherapy care can be matched to a patient’s risk of persistent disabling pain. Mode of care
delivery can be matched to the patient’s suitability for blended care (integrating eHealth with physiotherapy
sessions). It is hypothesized that combining these two approaches to stratified care (referred to from this point as
Stratified Blended Approach) will improve the effectiveness and cost-effectiveness of physiotherapy for patients
with neck and/or shoulder complaints compared to usual physiotherapy.
Methods: This paper presents the protocol of a multicenter, pragmatic, two-arm, parallel-group, cluster randomized
controlled trial. A total of 92 physiotherapists will be recruited from Dutch primary care physiotherapy practices.
Physiotherapy practices will be randomized to the Stratified Blended Approach arm or usual physiotherapy arm by
a computer-generated random sequence table using SPSS (1:1 allocation). Number of physiotherapists (1 or > 1) will
be used as a stratification variable. A total of 238 adults consulting with neck and/or shoulder complaints will be
recruited to the trial by the physiotherapy practices. In the Stratified Blended Approach arm, physiotherapists will
match I) the content and intensity of physiotherapy care to the patient’s risk of persistent disabling pain,
categorized as low, medium or high (using the Keele STarT MSK Tool) and II) the mode of care delivery to the
patient’s suitability and willingness to receive blended care. The control arm will receive physiotherapy as usual.
Neither physiotherapists nor patients in the control arm will be informed about the Stratified Blended Approach
arm. The primary outcome is region-specific pain and disability (combined score of Shoulder Pain and Disability
Index & Neck Pain and Disability Scale) over 9 months. Effectiveness will be compared using linear mixed models.
An economic evaluation will be performed from the societal and healthcare perspective.
Discussion: The trial will be the first to provide evidence on the effectiveness and cost-effectiveness of the
Stratified Blended Approach compared with usual physiotherapy in patients with neck and/or shoulder complaints.