Feasibility and acceptability of design and conduct of a registry-based randomised clinical trial evaluating eVIS as a digital support for physical activity in interdisciplinary pain rehabilitation programs: A randomised pilot study

Abstract

Background Patients with chronic pain often struggle to engage in physical activity despite its health benefits. The eVISualisation of physical activity and pain intervention (eVIS) was developed to support adherence to physical activity plans in Interdisciplinary Pain Rehabilitation Programs (IPRPs) by visualising activity, pain levels, pain interference, and pharmacological use. This pilot study assesses the feasibility and acceptability of trial design and trial conduct of a registry-based randomised clinical trial (R-RCT). Method This randomised clinical pilot study included the first 10% (n = 39, mean age 43.5, 74.4% females) of the R-RCT sample (n≈400). Participants with non-cancer chronic pain from six IPRP units were randomly assigned to either the intervention group (IPRP + eVIS, n = 19) or the control group (IPRP, n = 20). Feasibility and acceptability were evaluated using pre-defined criteria on recruitment- and data collection procedures (e.g., inclusion rates, representativeness, adverse events), physiotherapists’ ratings of trial design and conduct (e.g., acceptability, feasibility), and outcome data characteristics and completeness (e.g., adherence, data accessibility). Results Recruitment was largely feasible, though attrition differences and the need for refined eligibility screening were noted. Physiotherapists cited time and implementation challenges. Both groups had satisfactory data completeness, but the control group showed lower adherence to daily reporting in the final third of the study. The intervention group had greater improvements in physical health, with 19.5% more participants achieving the minimum clinically important difference (≥3) on the physical component summary scale (PCS). No adverse events occurred. Conclusion With minor adjustments, the R-RCT design is mostly feasible, though some challenges to feasibility were identified and addressed.