Subacromial impingement syndrome and pain: protocol for a randomised controlled trial of exercise and corticosteroid injection (the SUPPORT trial)

Abstract

BackgroundSubacromial impingement syndrome is the most frequent cause of shoulder problems which themselves affect 1 in 3 adults. Management commonly includes exercise and corticosteroid injection. However, the few existing trials of exercise or corticosteroid injection for subacromial impingement syndrome are mostly small, of poor quality, and focus only on short-term results. Exercise packages tend to be standardised rather than individualised and progressed. There has been much recent interest in improving outcome from corticosteroid injections by using musculoskeletal ultrasound to guide injections. However, there are no high-quality trials comparing ultrasound-guided and blind corticosteroid injection in subacromial impingement syndrome. This trial will investigate how to optimise the outcome of subacromial impingement syndrome from exercise (standardised advice and information leaflet versus physiotherapist-led exercise) and from subacromial corticosteroid injection (blind versus ultrasound-guided), and provide long-term follow-up data on clinical and cost-effectiveness.Methods/DesignThe study design is a 2x2 factorial randomised controlled trial. 252 adults with subacromial impingement syndrome will be recruited from two musculoskeletal Clinical Assessment and Treatment Services at the primary-secondary care interface in Staffordshire, UK. Participants will be randomised on a 1:1:1:1 basis to one of four treatment groups: (1) ultrasound-guided subacromial corticosteroid injection and a physiotherapist-led exercise programme, (2) ultrasound-guided subacromial corticosteroid injection and an advice and exercise leaflet, (3) blind subacromial corticosteroid injection and a physiotherapist-led exercise programme, or (4) blind subacromial corticosteroid injection and an advice and exercise leaflet. The primary intention-to-treat analysis will be the mean differences in Shoulder Pain and Disability Index (SPADI) scores at 6 weeks for the comparison between injection interventions and at 6 months for the comparison between exercise interventions. Although independence of treatment effects is assumed, the magnitude of any interaction effect will be examined (but is not intended for the main analyses). Secondary outcomes will include comparison of long-term outcomes (12 months) and cost-effectiveness. A secondary per protocol analysis will also be performed.DiscussionThis protocol paper presents detail of the rationale, design, methods and operational aspects of the SUPPORT trial.Trial registrationCurrent controlled trials ISRCTN42399123.

A comparison of the effectiveness of lateral versus posterior approach to shoulder injection in patients with subacromial impingement syndrome: A pragmatic randomized controlled trial

“…The present study used SPADI for both baseline and follow-up measures. This is consistent with recent RCTs that used SPADI as the primary outcome to compare corticosteroid injection with manual physical therapy in the management of patients with shoulder impingement syndrome (Rhon, Boyles, & Cleland, 2014;Roddy et al, 2015).…”

Structured Wii protocol for rehabilitation of shoulder impingement syndrome: A pilot study

“…Second, imbalances between the rotator cuff muscles must be corrected. Typically the internal rotators are stronger than the external rotators, which must be addressed by strengthening the external rotators to create net neutral forces [30,31]. Third, after the rotator cuff muscles have been strengthened, coordination in compound shoulder movements, involving movements in multiple planes, must be improved [32,33].…”

Can the efficacy of subacromial corticosteroid injection be improved using a single-session mobilization treatment in subacromial impingement syndrome? A randomized single-blind controlled trial

“…Adhesive capsulitis was diagnosed if there was range of motion (ROM) limitation of the shoulder to all directions both active and passive with external rotation reduced by at least 50% and elevation <100° compared with the normal side in the absence of bone pathology. Patients with a history of inflammatory arthritis, fracture, infection, malignancy, ipsilateral shoulder surgery, shoulder injection, or shoulder-focused exercise program history within 6 months were excluded from the study, as were those for whom SACS injections were contradicted and patients on a surgery waiting list [9]. G Power 3.1 software was used to calculate the required sample size.…”