Physiotherapist-led exercise versus usual care (waiting-list) control for patients awaiting rotator cuff repair surgery: A pilot randomised controlled trial (POWER).

BACKGROUND: Once a decision to undergo rotator cuff repair surgery is made, patients are placed on the waiting list. It can take weeks or months to receive surgery. There has been a call to move from waiting lists to 'preparation' lists to better prepare patients for surgery and to ensure it remains an appropriate treatment option for them. OBJECTIVE: To evaluate the feasibility, as measured by recruitment rates, treatment fidelity and follow-up rates, of a future multi-centre randomised controlled trial to compare the clinical and cost-effectiveness of undertaking a physiotherapist-led exercise programme while waiting for surgery versus usual care (waiting-list control). DESIGN: Two-arm, multi-centre pilot randomised controlled trial with feasibility objectives in six NHS hospitals in England. METHOD: Adults (n = 76) awaiting rotator cuff repair surgery were recruited and randomly allocated to a programme of physiotherapist-led exercise (n = 38) or usual care control (n = 38). RESULTS: Of 302 eligible patients, 76 (25%) were randomised. Of 38 participants randomised to physiotherapist-led exercise, 28 (74%) received the exercise programme as intended. 51/76 (67%) Shoulder Pain and Disability Index questionnaires were returned at 6-months. Of 76 participants, 32 had not received surgery after 6-months (42%). Of those 32, 20 were allocated to physiotherapist-led exercise; 12 to usual care control. CONCLUSIONS: A future multi-centre randomised controlled trial is feasible but would require planning for variable recruitment rates between sites, measures to improve treatment fidelity and opportunity for surgical exit, and optimisation of follow-up. A fully powered, randomised controlled trial is now needed to robustly inform clinical decision-making.

RAPID-2 study protocol: a cluster randomised feasibility trial of a midwife facilitated intervention for pregnant women with symptoms of mild to moderate anxiety.

INTRODUCTION: Many women experience symptoms during pregnancy. Elevated and prolonged anxiety can have negative effects on the woman and baby. The RAPID intervention aims to provide suitable, timely support for women with mild-moderate anxiety. The RAPID intervention is based on social support, relational continuity, psychological and relaxation response theory, and comprises midwife facilitated group discussions, one-to-one support and directed self-help materials. METHODS AND ANALYSIS: Four National Health Service Trusts in England that provide maternity care will be cluster randomised to the RAPID intervention plus usual care or usual care. At each intervention site, two midwives and two maternity support workers will facilitate the intervention over a 12-week period. Eligibility includes nulliparous women at 16-20 weeks of pregnancy (n=50) with self-report symptoms of mild-moderate anxiety. Community midwives will signpost women to the study. The aim of the study is to establish the feasibility of conducting a definitive trial to examine the effectiveness of the RAPID intervention in addition to usual care. The objectives are to assess recruitment and completion rates, and a qualitative assessment of women's and facilitators' experiences of participation. An estimation of change in the seven-item Generalised Anxiety Disorder scale will inform the sample size for a definitive cluster trial. ETHICS AND DISSEMINATION: Ethical approval was given by East Midlands-Derby Research Ethics Committee 14 March 2022 (REC Reference: 22/EM/0018). Findings will be made available through publication in peer-reviewed journals, conferences and to participants. A final report will be submitted to HEE/NIHR ICA awards committee for publication. TRIAL REGISTRATION NUMBER: ISRCTN12834758.