Table 1 UK FROST trial objectives

1

The primary objective is to determine the effectiveness of ESP versus MUA versus ACR for patients referred to secondary care for treatment of primary frozen shoulder. This will be achieved using as a parallel-group RCT and, as our primary outcome, the Oxford Shoulder Score (OSS) which is a patient-reported outcome measure at 3, 6 and 12 months. The primary time point is 12 months after randomisation

2

To compare the cost-effectiveness of the three management policies, to identify the most efficient provision of future care, and to describe the resource impact that various policies for frozen shoulder management will have on the NHS

3

To qualitatively explore the acceptability of the different treatments to patients and health care professionals and to provide important patient-centred insight to further guide clinical decision-making

4

To update the HTA-funded systematic review of management of the frozen shoulder for RCT evidence of the effectiveness of these interventions in secondary care. This will allow our findings to be considered in the context of existing evidence on all treatments of interest for this condition

5

To use networks of health care professionals, patients, health service managers and commissioning groups to widely disseminate the findings of this study. This will be in addition to publishing the results of the study in key journals and publishing the HTA report