The BEEP trial protocol for Individually Tailored Exercise will consist of a supervised individually tailored and progressed exercise programme.
The individualised, supervised and progressed exercise programme will be delivered by community-based, musculoskeletal physiotherapists and commenced within 3 weeks of injection.
Attendance at the physiotherapy-led individualised, supervised and progressed exercise sessions will be monitored, and all non-attended sessions will be recorded on the appropriate case report form.
Studies in other musculoskeletal conditions support individualised, supervised and progressed exercise rather than a standard exercise approach [ 12] but, to date, there are few trials to guide exercise practice for patients with SIS [ 13- 15].
Secondary objectives are to determine whether there is an interaction effect of combining US-guided injection and an individualised, supervised and progressed exercise programme and to conduct two separate cost-effectiveness analyses for the comparisons outlined in (1) and (2).
The SUPPORT trial will compare the clinical and cost-effectiveness of (1) US-guided corticosteroid injection to unguided (blind) corticosteroid injection and (2) a physiotherapist-delivered individualised, supervised and progressed exercise programme to provision of a standardised advice and exercise leaflet, for treatment of patients with SIS.
For participants randomised to receive the physiotherapist-led individualised, supervised and progressed exercise programme, the trial administrator will arrange their first physiotherapy appointment within 3 weeks of the shoulder injection, thereby meeting recommendations that recommendations that resistance exercise should be avoided for 2 weeks following steroid injection [ 4].
To address whether the physiotherapy-led intervention consisting of individualised, supervised and progressed exercise provides better improvements in pain and function than a standardised advice and exercise leaflet, we will use the total SPADI score at the 6 month time-point, as the primary outcome measure.
In comparison to existing trials of injection and exercise interventions for SIS, the strengths of the SUPPORT trial are its size, long-term follow-up and inclusion of an individualised, supervised and progressed exercise programme which builds upon existing guidelines [ 4] to optimise treatment outcome [ 12- 15] and inclusion of a cost-effectiveness analysis.
The primary evaluations will be mean differences in total SPADI scores at 6 weeks between those randomised to receive US-guided injection versus unguided injection, and mean differences in total SPADI scores at 6 months between those randomised to physiotherapist-led individualised, supervised and progressed exercise versus advice and exercise leaflet.
