Ad-Shoulder Trial

Principal Investigator Yngve Røe and Margreth Grotle

PhD Student Daniel Major

Collaborators 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) and Heidi Gallet (Diakonhjemmet Hospital)

Shoulder pain is the third most common musculoskeletal disorder, with significant disability and societal costs. Subacromial pain accounts for up to 70% of cases. Clinical guidelines recommend exercise interventions as the primary treatment, with recent research suggesting self-managed exercises provide similar clinical outcomes and superior cost-effectiveness compared to supervised interventions. However, key components for effective self-managed exercises remain unclear. This project aimed to assess critical aspects of self-managed exercise interventions for shoulder pain and inform a future randomized controlled trial. The specific objectives were to: 1) evaluate the completeness of exercise intervention reporting in randomized controlled trials using the Consensus and Exercise Reporting Template (CERT), 2) examine the relationship between fear of movement, emotional distress, and self-reported disability over one year, and 3) assess the feasibility of an individualized self-managed exercise intervention (Ad-Shoulder) for future clinical trials.

Methods: Five reviewer pairs applied the CERT tool to 34 trials from a 2016 Cochrane review on manual therapy and exercise for shoulder pain (Paper I). Inter-rater reliability was measured using percentage agreement and the Prevalence and Bias Adjusted Kappa (PABAK) coefficient. In a prospective cohort study (Paper II), patients with shoulder pain referred to a secondary outpatient clinic were included. Associations between fear of movement, emotional distress, and QuickDASH-measured disability over one year were analyzed using linear mixed-effects models, adjusting for prognostic factors. A feasibility study (Paper III) recruited adults (>18 years) with subacromial pain who had received conservative treatment for six months. The Ad-Shoulder intervention included 1-5 individualized sessions over three months, emphasizing self-efficacy and adherence to self-managed exercises. Feasibility outcomes included recruitment rate, follow-up rate, physical activity (accelerometer data), exercise adherence, intervention fidelity, and adverse events.

Results: The median CERT score was 5 (range 0-16), with high inter-rater agreement for 15 items and moderate to excellent reliability across all items. In the cohort study, 138 patients were recruited, with 117 and 110 providing follow-up data at 3 and 12 months, respectively. Increased baseline fear of movement correlated with a 1.10-point worsening in QuickDASH scores (95% CI 0.2-2.0), while emotional distress was associated with a 19.9-point increase (95% CI 13.9-25.9) over one year. In the feasibility study, 11 participants were recruited over 16 weeks, with 10 completing follow-up. Physiotherapists adhered to the intervention protocol, and accelerometer data were successfully collected. However, recruitment and exercise adherence rates were suboptimal.

Conclusions: The findings highlight key considerations for a future trial on self-managed exercise interventions for shoulder pain. Poor reporting quality of exercise interventions in published trials underscores the need for standardized reporting tools like CERT. Psychological factors significantly impact disability and should be addressed in interventions. While the Ad-Shoulder intervention met feasibility criteria for data collection and fidelity, recruitment and adherence require further optimization. These insights will inform the design of a future trial evaluating the effectiveness of the Ad-Shoulder intervention.

The results were published in a thesis and the following three papers: Major, D. H., et al. (2022). «Fear of movement and emotional distress as prognostic factors for disability in patients with shoulder pain: a prospective cohort study.» BMC Musculoskeletal Disorders 23(1): 183; Major, D. H., et al. (2019) Content reporting of exercise interventions in rotator cuff disease trials: results from application of the Consensus on Exercise Reporting Template (CERT). BMJ Open Sport & Exercise Medicine 5, e000656 DOI: 10.1136/bmjsem-2019-000656; Major, D. H., et al. (2021). «Adherence to self-managed exercises for patients with persistent subacromial pain: the Ad-Shoulder feasibility study.» Pilot and Feasibility Studies 7(1): 31.