Exercise type, dose and progression will be individualised, supervised and progressed in 6 to 8 sessions over a 12 to 16 weeks.
Therefore the protocol for Individually Tailored Exercise was developed to ensure the prescription of an individualised, supervised and progressed lower limb exercise programme.
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.
The APEX trial [ 18, 19], which incorporated a more intensive exercise intervention that was supervised and progressed over six treatment sessions, resulted in greater improvements in pain than the exercise programme in the TOPIK trial [ 15].
Our previous trial results [ 15, 19] suggested that a lower limb exercise programme that was supervised and progressed over six treatment sessions resulted in greater improvements in pain than one provided over an average of four sessions.
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).
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.
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].
