Feasibility of conducting a cohort randomized controlled trial assessing the effectiveness of a nurse-led package of care for knee pain

Abstract

Abstract Objective To evaluate the feasibility of conducting a cohort randomized controlled trial (RCT) of a nurse-led package of care for knee pain and determining a treatment sequence for use in a future trial. Methods This study was an open-label, three-arm, single-centre, mixed-methods, feasibility cohort RCT. Adults aged ≥40 years with moderate-to-severe knee pain for ≥3 months were eligible. Participants were randomized into group A (non-pharmacological treatment first), group B (pharmacological treatment first), or group C (usual care). The intervention was delivered over 26 weeks. Outcomes were dropout rate, recruitment rate, intervention fidelity, ability to collect outcome data, and treatment acceptability. Results Seventeen participants were randomized and enrolled into each of groups A and B (5.2% recruitment rate), and 174 participants were randomized to group C. The participant characteristics at randomization were comparable across the three arms. Coronavirus disease (COVID-19) paused the study from March–November 2020. Participants enrolled in groups A and B before March 2020 were withdrawn at the restart. Of the 20 participants enrolled after the restart, 18 completed the study (10% dropout). The nurse reported delivering most aspects of the intervention with high fidelity. The participants viewed the package of care as structured, supportive and holistic, they learnt about self-managing knee pain, and they could engage with and follow the non-pharmacological treatment. Most found the non-pharmacological treatment more useful than the pharmacological treatment, preferring to receive it before or alongside analgesia. Many self-report questionnaires were not fully completed. Conclusion The nurse-led package of care for knee pain was acceptable, with low dropout, although the cohort RCT design may not be feasible for a definitive trial. Trial registration ClinicalTrials.gov, https://clinicaltrials.gov, NCT03670706.