Title: Improving outcomes for patients with shoulder impingement: a randomised trial
Funder: Department of Health (England)

Abstract: Background Shoulder pain affects 1 in 3 adults at some point in their lives. More than half report pain and activity restriction after a year. Subacromial impingement syndrome (SIS) is the most frequently diagnosed shoulder disorder. Primary care treatment, to minimise pain and optimise function, includes mostly advice to exercise and corticosteroid injection. Evidence from other musculoskeletal conditions supports individualised exercise over standard exercise advice but to date there is no evidence of this for SIS. In addition, patients’ outcomes from injection may be improved through the addition of ultrasound guidance, but no previous studies are sufficiently powered or conducted within the UK. A new trial is needed to test ways to improve outcomes from these two common treatment approaches. Aims Based within musculoskeletal interface clinics, our trial will test the clinical and cost-effectiveness of approaches to improve outcomes from exercise and injection for adults with SIS: Primary research questions: · Does an individualised exercise programme provide better improvements in pain and function than a standardised advice and exercise leaflet? · Does ultrasound-guided injection provide better improvements in pain and function than usual (blind) injection? Secondary research questions: · Does combining the interventions lead to better outcomes? · Is an individualised exercise programme more cost-effective than a standardised advice & exercise leaflet? · Is ultrasound-guided injection more cost-effective than blind injection? Plan of Investigation A 2x2 randomised factorial trial will test the clinical and cost-effectiveness of individualised exercise, ultrasound-guided shoulder injection or both. The comparisons will be those patients who receive a standardised advice and exercise leaflet and usual (blind) injection. We will recruit 250 adults with SIS from musculoskeletal shoulder pain interface clinics in North Staffordshire. Participants will be individually randomised, using Keele's Clinical Trials Unit, to 1 of 4 treatment groups to ensure that patients from each interface clinic have an equal chance of receiving any of the interventions. Outcomes, including pain and function will be assessed at baseline, 6 weeks, 6 and 12 months using postal questionnaires and medical record review. The trial will take 36 months to complete. Potential Impact The trial will benefit patients and practitioners in addressing important clinical questions about the effectiveness of commonly used treatments for shoulder pain: Does the addition of ultrasound guidance improve the outcomes from corticosteroid injection, does providing physiotherapy-led individualised and supervised exercise improve the outcomes from exercise and what is the additional benefit of combining these two approaches? Patients and clinicians have been involved in the design and planned processes of the trial, which aims to provide evidence about the clinical and cost-effectiveness of approaches to improve patients’ outcomes from the most common treatments for shoulder impingement syndrome. NHS impact will be assessed by further consultations and NHS resource use.


Research activity codes: 6.7 PHYSICAL;6.1 PHARMACEUTICALS
Health categories: MUSCULOSKELETAL