Comparing an Adherence to self-managed exercises strategy to usual follow-up care for patients with Subacromial Pain: the Ad-Shoulder Trial
Leader: Associate Professor Ynge Røe
PhD Student: Daniel Major
The overall objective of this randomized controlled trial is to establish the effectiveness of an Adherence to self-managed exercises strategy (the Ad-Shoulder intervention) compared to usual follow-up care in terms of long-term improvement in pain-related disability and cost-effectiveness in participants with subacromial pain. We hypothesize that for people who have received conservative treatment for subacromial pain, the Ad-Shoulder strategy will result in significantly less pain-related disability (assessed by Shoulder Pain and Disability Index – SPADI) compared to usual follow-up care at 3, 6, 12, 18 and 24 months follow-up. We also hypothesize that the improved long-term function will be mediated by two key mediators – adherence to exercises and pain self-efficacy. Pain self-efficacy will be regularly collected using single items during the follow-up. Adherence will be objectively measured using actigraphs.
Secondary objectives include comparing the Ad-Shoulder strategy to usual care by a range of clinical outcomes and health economic outcomes at 3, 6, 12, 18 and 24 months. Clinical outcomes include Quick-Dash, Patient-Specific Function Scale, pain interference with work, and daily routine and health-related quality-of-life (EQ5D). Finally, we will explore whether sociodemographic and/or clinical characteristics predict long-term function. This study will be carried out in three phases; first, a feasibility study of the Ad-Shoulder intervention using a single-subject design will be carried out. Second, a randomized controlled pilot study will be carried out in order to explore the potential mean difference between the groups. Finally, a full-scale trial will be performed including approximately 115 patients (might be adjusted after the pilot study).