Back2Action: Effectiveness of physiotherapy blended with ehealth consisting pain education and behavioral activation-protocol for a pragmatic randomized clinical trial.

Introduction: Psychosocial factors predict recovery in patients with spinal pain. Several of these factors are modifiable. However, physiotherapists indicate that they do not feel sufficiently equipped to address these factors. We developed an eHealth intervention to support physiotherapists in managing psychosocial factors in patients with spinal pain. This paper describes the protocol for a pragmatic randomised clinical trial which evaluates the effectiveness of this eHealth intervention blended with physiotherapy compared to physiotherapy alone. Methods: Participants with non-specific low back pain and/or neck pain for at least six weeks who also experience psychosocial symptoms will be recruited in a pragmatic multi-centre cluster randomised clinical trial. The experimental intervention consists of physiotherapy blended with six online modules of pain education and behavioural activation. The control intervention consists of usual care physiotherapy. The primary outcomes are disability and perceived effect. Outcomes will be assessed at baseline, and at 2, 6 and 12 months after baseline. The results will be analysed using linear mixed models. Results: At this moment, 357 patients were assessed for eligibility and 140 patients are included. Our hypothesis is that the blended intervention is more effective than usual physiotherapy at 12 month follow-up. Process evaluation: Inclusion of participants has proven challenging, we have extended the inclusion phase with 1.5 years and recruited more physiotherapy practices. [ABSTRACT FROM AUTHOR]

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