Principal Investigator Margreth Grotle

PhD Student Daniel Major

Collaborators Yngve Røe (Oslo Metropolitan University), Chris Littlewood (Edge Hill University, UK), Jens Ivar Brox (University of Oslo & Oslo University Hospital), Dagfinn Matre (STAMI – The National Institute of Occupational Health in Norway), Heidi Gallet (Diakonhjemmet Hospital)

The overall objective of this pilot 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).