An EDucation and EXercise Intervention for Gluteal Tendinopathy in an Irish Setting: a Protocol for a Feasibility Randomised Clinical Trial (LEAP-Ireland RCT)

Overview

Journal HRB Open Res

Specialty Biomedical Engineering

Date 2024 Jul 24

PMID 39045032

Authors

Sania Almousa

Bill Vicenzino

Rebecca Mellor

Alison Grimaldi

Kathleen Bennett

Frank Doyle

Geraldine M McCarthy

Suzanne M McDonough

Jennifer M Ryan

Karen Lynch

Jan Sorensen

Helen P French

Affiliations

Soon will be listed here.

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 a future definitive 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 diaries.

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).

Citing Articles

Current and future advances in practice: tendinopathies of the hip.

Grimaldi A, Mellor R, Nasser A, Vicenzino B, Hunter D Rheumatol Adv Pract. 2024; 8(2):rkae022.

PMID: 38601140 PMC: 11003818. DOI: 10.1093/rap/rkae022.

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