An EDucation and eXercise intervention for gluteal tendinopathy in an Irish setting: a protocol for a feasibility randomised clinical trial (LEAP-Ireland RCT).
Autor: | Almousa S; School of Physiotherapy, Royal College of Surgeons in Ireland, Dublin, Ireland., Vicenzino B; School of Health and Rehabilitation Sciences, The University of Queensland, Saint Lucia, Queensland, Australia., Mellor R; School of Health and Rehabilitation Sciences, The University of Queensland, Saint Lucia, Queensland, Australia., Grimaldi A; School of Health and Rehabilitation Sciences, The University of Queensland, Saint Lucia, Queensland, Australia., Bennett K; Division of Population Health Sciences, Royal College of Surgeons in Ireland, Dublin, Ireland., Doyle F; Department of Health Psychology, Royal College of Surgeons in Ireland, Dublin, Ireland., McCarthy GM; Department of Rheumatology, Mater Misericordiae University Hospital, Dublin, Ireland., McDonough SM; School of Physiotherapy, Royal College of Surgeons in Ireland, Dublin, Ireland., Ryan JM; School of Physiotherapy, Royal College of Surgeons in Ireland, Dublin, Ireland., Lynch K; Patient Representative, Dublin, Ireland., Sorensen J; Health Outcomes Research Centre, Royal College of Surgeons in Ireland, Dublin, Ireland., French HP; School of Physiotherapy, Royal College of Surgeons in Ireland, Dublin, Ireland. |
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Jazyk: | angličtina |
Zdroj: | HRB open research [HRB Open Res] 2024 Jun 28; Vol. 6, pp. 76. Date of Electronic Publication: 2024 Jun 28 (Print Publication: 2023). |
DOI: | 10.12688/hrbopenres.13796.2 |
Abstrakt: | 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). Competing Interests: No competing interests were disclosed. (Copyright: © 2024 Almousa S et al.) |
Databáze: | MEDLINE |
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