An EDucation and eXercise intervention for gluteal tendinopathy in an Irish setting: a protocol for a feasibility randomised clinical trial (LEAP-Ireland RCT)

Abstract

Background Gluteal tendinopathy (GT) is a degenerative tendon condition characterised by pain over the greater trochanter of the hip. A randomised controlled trial (RCT) in Australia found that 14 sessions of EDucation on load management plus eXercise (EDX) delivered over 8 weeks resulted in greater improvements in global rating of change and pain outcomes at 8 and 52 weeks, compared with corticosteroid injection or ‘wait and see’. Typically, 5-6 physiotherapy sessions are provided in public and private physiotherapy settings in Ireland, therefore, the aim of this study is to examine the feasibility of conducting an RCT to investigate effectiveness of 6 sessions of the EDX programme compared to usual care. Methods We will randomly allocate 64 participants with GT to physiotherapist-administered EDX or usual care. The EDX intervention (EDX-Ireland) will be delivered in 6 sessions over 8 weeks. To determine feasibility of an RCT, we will assess recruitment and retention and outcome measure completion. The health status outcomes to be assessed at baseline, 8 weeks and 3 months include: Global Rating of Change, pain severity, the Victorian Institute of Sport Assessment-Gluteal Questionnaire (VISA-G), the Patient-Specific Functional Scale, the Pain Catastrophizing Scale, Patient Health Questionnaire (PHQ), Pain Self-Efficacy Questionnaire, the EQ-5D-5L, the Central Sensitisation Inventory and hip abductor muscle strength. We will explore acceptability of the EDX-Ireland intervention from the perspective of patients and treatment providers, and the perspective of referrers to the trial. A Study Within A Trial will be also applied to compare recording of exercise adherence using app-based technology to paper-based diary. Discussion There is a need to establish effective treatments for GT that potentially can be implemented into existing health systems. The findings of this feasibility trial will inform development of a future definitive RCT. Registration The trial is registered prospectively on ClinicalTrials.gov (NCT05516563, 27/10/2022).