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

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).

We will randomly allocate 64 participants with GT to physiotherapistadministered 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.

Amendments from Version 1
This version has addressed the points raised by the reviewers.
Clarifications have been added around a number of points as outlined in the author response to reviewers and more detail added to the ''Interventions'' and ''Usual care'' sections.Additionally, further details were provided on the comparison between the EDX intervention in the Australian LEAP trial and LEAP-Ireland feasibility trial, as well as the differences between the 'wait-and-see' comparator in the LEAP trial and 'usual care' in LEAP-Ireland.References have been updated, where older references have been replaced by newer references and some incorrect references has been replaced with more appropriate references.

Background
Gluteal Tendinopathy (GT) is a degenerative condition of the gluteus medius and minimus tendons characterised by lateral hip pain at or around the greater trochanter of the hip, with marked palpation tenderness (Fearon et al., 2014).It is also known as Greater Trochanteric Pain Syndrome (GTPS).GTPS is an umbrella term used to describe pain over the greater trochanter of the lateral hip, primarily due to gluteus medius and/or minimus tendinopathy, with symptoms also potentially arising from the trochanteric bursa (Long et al., 2013).However, the terminology of gluteal tendinopathy is used when gluteus medius and/or minimus tendon changes are detected on Ultrasound (US) or Magnetic Resonance Imaging (MRI) (Bird et al., 2001;Connell et al., 2003).Trochanteric bursitis has been shown to be present in less than 20% of those with lateral hip pain (Long et al., 2013).
GT is the most common lower limb tendinopathy with a reported prevalence of 4.22 per 1000 person years and incidence of 3.29 per 1000 person years, and is three times more prevalent in women than men, (Albers et al., 2016;Segal et al., 2007).GT can result in very high levels of hip dysfunction, with consequent negative impact on general health and well-being, quality of life and employment status, similar to end-stage hip osteoarthritis (Fearon et al., 2014;Plinsinga et al., 2018).
Along with structural changes in the gluteus medius and minimus tendons (Connell et al., 2003), individuals with GT have reduced hip abductor strength (Allison et al., 2016b) and higher external hip adduction moments during loading activities such as walking and stair-climbing (Allison et al., 2018;Allison et al., 2016a).
Abnormal hip biomechanics may predispose the development of GT.Specifically, it has been hypothesised that gluteal tendinopathy occurs due to compressive impingement of the gluteal tendons and bursa onto the greater trochanter by the iliotibial band (ITB) as the hip moves into adduction.Compressive forces are increased due to potential hip abductor muscle weakness, resulting in lateral pelvic tilt or ipsilateral shift in single leg stance, and relative hip adduction (Grimaldi & Fearon, 2015).
Although this evidence highlights the rationale for strengthening as a key intervention, traditionally, corticosteroid injections have been used to achieve pain relief.The lack of evidence for the long-term benefits of steroid injection (Mellor et al., 2018;Nissen et al., 2019;Rompe et al., 2009) highlights that interventions that result in long-term benefits are required.Additionally, steroid injections can, make tendons more vulnerable to tears (Abate et al., 2017).
There is general consensus, in line with management of other tendinopathies, that interventions should aim to reduce compressive and tensile loads through education on how to minimise or adapt compressive activities and positions such as singleleg stance (walking, running and stair climbing), adductionrelated activities such as sitting with legs crossed, certain hip stretches and sleeping positions (Grimaldi & Fearon, 2015).
Although a range of conservative management approaches are generally recommended, best practice in the management of GTPS/gluteal tendinopathy remains unclear.A three-arm Randomised Controlled Trial (RCT) in Australia (LEAP trial) compared 14 sessions of EDucation on load management plus eXercise (EDX) over 8 weeks to a single corticosteroid injection (CSI), and a 'wait and see' comparison group on pain and global improvement in 204 individuals with GT. Results showed that at 8 weeks (completion of treatment), 77% of the EDX group were at least 'moderately better', compared with 58% in the injection group, and 29% in the 'wait and see' group, with improvements maintained at one year and less pain was reported by the EDX group than the corticosteroid injection and 'wait and see' groups.Additionally, at 8 weeks a significant difference in hip abductor strength was found between the EDX and the 'wait and see' group (Mellor et al., 2018).
However, the 14 physiotherapy treatment sessions provided in the LEAP Trial (Mellor et al., 2018) may not be feasible in physiotherapy practice.For example, although exercise and education are the most common interventions for GT delivered by physiotherapists in Ireland, the number of physiotherapy sessions is usually limited to five or six (French et al., 2019).This treatment dosage is consistent across various musculoskeletal pathologies in the UK (Bury & Littlewood, 2018).Thus, whilst the LEAP trial in Australia demonstrated positive effects for EDX, delivery of this intervention over 14 sessions may not be practical to implement into physiotherapy practice, and evaluation of a lower dose of face-to-face sessions with a healthcare practitioner, which could be implemented into clinical practice is warranted.
Although current best evidence indicates, based on the LEAP trial findings, that a combination of physiotherapist-delivered exercise and education is clinically and cost-effective for management of GT (Mellor et al., 2018;Wilson et al., 2023), there are currently no clinical guidelines to guide practice.Indeed, usual care of gluteal tendinopathy by medical practitioners, to whom patients may initially present, is currently unknown.
This feasibility RCT will contribute to the following gaps in the literature: 1) to examine the feasibility of conducting a future definitive RCT to compare effectiveness of six sessions of physiotherapy-led Education on load management plus eXercise (EDX-Ireland) EDX to usual care and 2) to quantify usual care in GT management in Ireland.
Completion of a daily Home Exercise Programme (HEP) is an integral part of the EDX-Ireland intervention.Traditionally, paper-based diaries are used to record adherence, but adherence can be over-reported compared with electronic diaries (Stone et al., 2003).An RCT demonstrated improved exercise adherence using an app in people with musculoskeletal conditions, compared to paper handouts (Lambert et al., 2017), with high satisfaction rates reported by those who used the app.Given that >90% of phone users in Ireland have smartphones (Deloitte, 2023), the use of app-based technology may be potentially more feasible to monitor and enhance treatment adherence.
We therefore aim to evaluate the feasibility of conducting a future definitive RCT, using a reduced dose (6 sessions) of a proven-effective physiotherapy treatment (14 sessions) consisting of EDucation plus eXercise for GT in an Irish context.A Study Within A Trial (SWAT) will compare smartphone application versus paper-based diary for exercise adherence measurement.A SWAT is a type of research study that has been embedded within a host larger trial to evaluate alternative ways of delivering or organising a particular trial process (Treweek et al., 2018).

Specific objectives are as follows:
1. To assess recruitment and retention rates to inform a future definitive RCT 2. To estimate the effect size for an appropriate primary study outcome in a future definitive RCT 3. To determine the success of different patient recruitment methods (community recruitment, primary care and secondary care) 4. To identify the constituents of 'usual care' for gluteal tendinopathy in an Irish context and to determine if inclusion of a usual care arm in a future definitive RCT is feasible and appropriate without the potential for co-intervention bias 5. To assess outcome measure completion 6.To assess the feasibility of collecting healthcare utilisation and cost data for cost-effectiveness analysis 7.  (Mellor et al., 2018).

Recruitment
Participants will be recruited from various sources, including rheumatology, orthopaedic and musculoskeletal triage clinics in three acute hospitals in Dublin, General Practitioners (GPs), social media and community recruitment throughout Dublin via advertisements in sports and leisure clubs and community organisations.

Procedure
Eligibility will be assessed through a 3-phase process of phone screening, physical screening and MRI.Initial screening for eligibility will be done via telephone by the Trial Manager (SA).If the phone interview indicates possible eligibility, potential participants will attend RCSI for a physical examination against specific selection criteria, undertaken by the Trial Manager.A battery of clinical tests will be used at the physical screening stage to clinically diagnose GT (Grimaldi et al., 2017).To be eligible, participants must experience pain on direct palpation of the gluteal tendon insertion on the greater trochanter, with reproduction of lateral hip pain on at least one of the following clinical tests: Hip Flexion, Adduction, External Rotation (FADER), resisted internal rotation in the FADER position (FADER-R), Flexion, Abduction, External Rotation (FABER), passive hip adduction in side lying (ADD), resisted isometric abduction in the ADD test position ADD-R), and a Single Leg Stance on the affected leg for 30 seconds (Mellor et al., 2016).If participants meet the physical screening eligibility criteria, an MRI will be arranged to confirm the tendinopathic changes on MRI.Criteria for tendon pathology on MRI as used by Mellor et 2).Written consent will be obtained at the time of physical screening for pragmatic purposes, but full eligibility will be confirmed on the basis of the MRI results.Once participants complete the baseline assessment, they will be randomly allocated into one of two groups: (1) education and exercise programme (EDX-Ireland), or (2) usual care.Participants will complete the patient-reported outcomes (PROs) and abductor muscle strength assessment at baseline, 8 weeks, and 3 months.
Participants will be asked to refrain from other treatments during the trial period, but analgesia and anti-inflammatory drugs will be permitted.All medication use and co-interventions will be recorded via the healthcare utilisation questionnaire.

Blinding
The trial manager (SA) assessing outcome measures at baseline, 8 weeks and 3 months follow-up will be blinded to group • Any systemic diseases affecting the muscular or nervous system, or uncontrolled diabetes • Fibromyalgia • Use of walking aid • Malignant tumour (current or in the past 6 months) • Systemic inflammatory disease • Any factors that preclude the participant from having an MRI (e.g., pacemaker, metal implants, pregnancy, or trying to become pregnant, claustrophobia) • If the participant is involved in any injury claim • If the participant is unable to commit to an 8-week programme of up to 6 sessions of exercise allocation and will not be involved in randomisation or intervention delivery.

Randomisation and concealed allocation
The randomisation schedule will be generated using a computer-generated random sequence in advance of trial commencement by the trial statistician (KB), who will not be involved in recruitment or outcome assessment.Randomisation will be stratified by recruitment method (GP, secondary care or community/social media).Participants will be randomly allocated (1:1 ratio) using random blocks of size 2, 4, 6, or 8 within each stratum.Within the intervention arm (n=32) a further 1:1 blocked randomisation (block size 2, 4 or 6) will be developed for random allocation of the EDX-Ireland group, within the SWAT, to either the smartphone application (n=16) or paper-based diaries (n=16).Randomisation and allocation will be done by the PI (HPF), who will not be involved in screening or baseline assessment of trial participants, thus maintaining concealed allocation.

Interventions
The EDX intervention is described based on the Template for Intervention Description and Replication (TIDieR) (Hoffmann et al., 2014).
The EDX-Ireland intervention will be delivered in four physiotherapy clinics located in different geographical areas in Dublin.Physiotherapists will have attended a training session outlining study objectives and requirements, demonstrating the detailed education material, the theoretical and practical part of the exercise protocol and progressions.Additionally, a detailed study manual will be provided for reference (Mellor et al., 2016).
The EDX-Ireland intervention will involve six face-to-face sessions with a physiotherapist, delivered over eight weeks (60 mins for the initial session and 30 mins thereafter).The sessions will be scheduled as weekly appointments for the first four weeks and the final two sessions will be delivered at fortnightly intervals.Participants will receive education on tendon care and gradual progression of tendon loading.This will be delivered via an 18-minute video, which was used in the LEAP trial (provided via DVD), which will be provided to study participants via the online Physiapp patient-facing companion application, used alongside the Physitrack online exercise prescription platform (https://www.physitrack.com/).The education video explains relevant basic anatomy, terminology related to tendinopathy and bursitis, risk factors, and advice related to sitting, lying positions walking and load modification.Participants will be asked to watch the education video prior to their first appointment with the physiotherapist.Education will also be reinforced by the physiotherapist over the 8-week intervention period.The treating physiotherapist will also provide graduated exercise with 4-6 exercises performed six days a week, with alternate low and high load days, and one rest day.The exercise programme includes three key streams: 1. Isometric abduction: low load isometric abduction training in supine and standing, to improve muscle coordination and control, and to potentially assist with pain relief.
2. Functional loading: bridging (double-leg, offset and single-leg exercises) and squatting (double-leg, offset, single-leg stance and squat, step-ups) progressions with an emphasis on gluteal muscle recruitment and femoropelvic control.3. Abductor loading: targeted frontal plane abductor muscle and tendon loading to improve load tolerance by applying progressively higher loads across the abductor muscles, as tolerated.This includes sidestepping tasks and standing band-resisted hip abduction.
Week 1 will focus on familiarisation with the basic program and load management strategies.Week 2 will involve early loading and optimisation of movement patterns in the base exercises.Weeks 3-8 focus on graduated loading, where participants will perform exercises, six days a week, with three of those days including exercises performed at a 'hard' to 'very hard' level.These hard days will alternate with three 'light' days' and one rest day.The physiotherapist will monitor exercise difficulty level, exercise technique and pain response to exercise.Level of exercise difficulty will be monitored with the Borg Scale of Perceived Exertion (6-20 scale), where isometric abduction will be performed at a 'light' level (Borg 11-12), functional loading at a 'somewhat hard' to 'hard' level (13-15), and targeted abductor loading from 'somewhat hard' towards 'hard' to 'very hard' level (14)(15)(16)(17), depending on response to loading.A maximum of 5/10 on a pain NRS will be allowed as long as it does not result in increased pain that night or the next day.Other everyday activity loading that participants are undertaking, along with the exercise programme and technique, will be reviewed and modified accordingly to reduce loading levels.Key differences between the exercise programme used in the LEAP and LEAP-Ireland trial include the number of in-clinic days per week and number of weeks of treatment.Additionally, the LEAP-Ireland trial will not entail use of a sliding platform with spring resistance during weeks 3-8; resistive exercise bands will be used to provide resistance.Details of the exercise programme with images, used in the LEAP trial are available in Supplemental Table 2 of the LEAP trial (Mellor et al., 2018).

Study Within A trial (SWAT)
To test objective 7, the 32 participants randomly allocated to the EDX-Ireland intervention will also be randomly allocated to either a 'PhysiApp' or 'Diary' group for recording of home exercises, using a second computer-generated random sequence, prepared by the trial statistician.Participants will be informed at the time of group allocation by the randomiser (HPF).Treating therapists will be provided with access to Physitrack (Physitrack Ltd, London, UK), an online exercise management system used by physiotherapists for exercise prescription for the duration of the recruitment and intervention period.Both groups ('PhysiApp' and 'Diary') will use the patient-facing companion app, PhysiApp (Physitrack Ltd, London, UK), for home exercises, but only the 'PhysiApp' group will record exercise adherence on the app.Those assigned to the 'Diary' group will be provided with a paper-based diary to record exercise completion and the exercise recording function in PhysiApp will be deactivated.Physiotherapists will check adherence at each appointment and assist with any barriers to exercise completion.

Usual care
In the LEAP trial ''wait and see'' arm, participants attended one 30-minute session with a trial physiotherapist, where they received reassurance that the condition is likely to resolve over time, as well as advice regarding general tendon care and self-management (Mellor et al., 2016).However, usual care in the LEAP-Ireland trial was chosen as the comparator for this study to determine if it is an appropriate comparator, and to identify the exact constituents of usual care, in advance of conducting a full-scale RCT.Usual care for this trial is defined as the treatment that a participant has followed so far or has been prescribed by their referrer into the trial (i.e., GP, orthopaedic consultant, rheumatologist or musculoskeletal triage physiotherapist).For those not referred from a healthcare practitioner (e.g., community recruitment/social media), usual care may not be relevant, but any healthcare utilisation will be recorded on a pre-standardised form.Participants randomised to the Usual Care group will receive an information leaflet only with general advice to remain active within limits of pain, and reassurance that the condition will improve with time.The information leaflet is identical to that used in the LEAP Trial, however, no one-off education physiotherapy session will be provided for the Usual Care group.

Intervention acceptability
To further explore trial feasibility and acceptability (objectives 8 and 9), semi-structured interviews will be conducted with approximately 18 participants (nine from both groups) to explore their experiences of the trial, intervention content, face-to-face clinic interaction, HEP completion, and acceptability of the smartphone app or paper diaries for HEP recording.The topic guides will be developed using the Theoretical Framework of Acceptability (Sekhon et al., 2017).Semi-structured interviews will also be conducted with treating therapists (n=7) to ascertain their perspectives of the acceptability of the EDX-Ireland intervention.Interviews will also be undertaken with approximately 8-10 healthcare professionals (doctors or musculoskeletal triage physiotherapists) who referred participants into the trial and were allocated to usual care, to explore their knowledge of management options for gluteal tendinopathy, their rationale for choice of usual care, as well as any barriers or facilitators to providing optimal care for gluteal tendinopathy.Interviews will be audio recorded and transcribed verbatim for thematic analysis.

Outcomes measures
Primary outcome measures.Primary outcomes focus on feasibility issues including success of recruitment and retention to the 3-month time point.Details of feasibility outcomes and methods used to collect these outcomes are outlined in Table 3.

Objective Data collection method
To assess recruitment rates and determine the success of different patient recruitment methods community recruitment, primary care and secondary care) To assess short (8-week) and medium-term (3-month) retention rates To identify the constituents of 'usual care' and to determine if inclusion of a usual care arm is feasible and appropriate without the potential for cointervention bias Referral sources will be asked to complete a checklist of usual care options (including medications, referral for physiotherapy/other healthcare services).This will be cross-referenced against the participant-completed health and cost questionnaire.Participants will also complete details on current and past treatment for gluteal tendinopathy at baseline assessment.
To estimate the effect size for a likely primary study outcome in a future definitive trial Semi-structured interviews of study participants to explore acceptability of the paper diaries and smartphone app for exercise provision and adherence recording be evaluated using two measures.

Adverse events
Adverse events related to the EDX intervention are considered low risk in this trial.Treating physiotherapists will record and report adverse effects to the Principal Investigator.All adverse events will also be reported to the Trial Management Group (TMG) and the Trial Steering Committee (TSC).Serious adverse events will be reported to the trial sponsor and may result in trial withdrawal.

Participant confidentiality and data management
Participants will be identified by a study-specific unique identifier number (UIN) during the study.Processing of any personal data will comply with national and EU General Data Protection Regulations (GDPR), and compliance with GDPR will be maintained throughout the trial (European Commission, 2018).

Statistical analysis
Descriptive analysis will include proportions and 95% confidence intervals (CI), means and standard deviations (SD) or medians and inter-quartile ranges (IQR) where appropriate.Feasibility outcomes of recruitment and retention rates will be descriptively reported overall across both arms of the trial (percentages and 95% CIs) and by method of recruitment.Outcome measure completion will be described both by participant and by outcome measure using percentages.Recruitment rates will be calculated as the number of participants who consent to participate divided by the number of eligible participants approached.Trial retention rates will be calculated from the number of participants who complete all outcome measures divided by the number who record baseline outcome measures.Adherence rate of exercises within the SWAT for the EDX group, and types of usual care for the control group will be reported as percentages.
Results of secondary clinical outcomes including NPRS, hip abduction strength and measures of psychological distress will be reported using means and SD or medians and IQR, where appropriate for baseline, 8-and 3-month follow-up.Statistical analysis will be performed using Stata v18 (StataCorp, College Station, Texas, USA).
Sensitivity analysis will be conducted as a secondary analysis to impute any missing data using multiple imputation.The resource use data captured by the OCC-Q will be valued using unit costs derived from local and national sources and will be analysed in a manner consistent with the clinical outcome data.
Qualitative data from interviews will be transcribed verbatim.A two-stage analysis will be undertaken, initially through inductive line-by-line coding of the extracted results to identify emergent themes, followed by deductive mapping of pre-identified codes to the Theoretical Framework of Acceptability (Sekhon et al., 2017).
Trustworthiness will be attained through procedures such as member checking, maintaining a reflexive journal of the research procedures and a clear audit trail of the process (Braun & Clarke, 2014).

Sample size
We will aim to recruit 64 participants.A sample of 60 participants (n=30 per arm of the trial) would provide an estimate of the recruitment rate of ≥50% (95% confidence interval (95% CI) 37.3% to 62.7%), and an estimated retention rate of ≥80% (95% CI of 69.8% to 90.2%).To ensure balance within each stratum, sample size will be increased to 64 with 32 allocated to each arm.This sample size will also allow for the potential effect of the primary outcome (GROC) between the two groups to be determined for powering a larger definitive trial.
Study status : is currently ongoing.The expected end date for the study is January 2025.

Patient and Public Involvement
This study embeds Patient and Public Involvement (PPI) in its overall approach and processes.To date, PPI actions have included contribution to outcome measures, study logo, recruitment strategies and participant-facing information regarding study recruitment materials.

Trial governance and data management
This study will be conducted in accordance with international standards of Good Clinical Practice in trials.A Trial Management Committee (TMC) and a Trial Steering Committee (TSC) will be established to ensure adequate trial management, governance and safety monitoring for the trial.The Trial Management Group will be responsible for data management and stewardship, under the leadership of the lead applicant.
All data will be handled in accordance with RCSI research policies and ethical principles.The FAIR principles will be adhered to, to ensure Findability, Accessibility, Interoperability and Reusability.Research data will be stored on a unique Share-Point site at RCSI, managed, processed, and stored in a secure environment, and regularly and securely backed up by the RCSI IT department.Any data will be encrypted at source and transferred using secure methods that comply with RCSI data management policies and data protection policies for storage on the RCSI SharePoint site.Access to research files will be restricted to the research team.Data will be stored for a minimum of five years in line with HRB and RCSI guidelines on good research practice and general audit requirements.

Dissemination of findings
We will disseminate study findings to scientific, lay and clinical audiences at local, national and international level through conferences, peer-reviewed journals and social media.
Trial sponsor RCSI University of Medicine and Health Sciences (sponsorship@rcsi.ie).

Discussion
Gluteal tendinopathy is the most common lower limb tendinopathy, which can negatively impact everyday function and quality of life (Albers et al., 2016).We aim to evaluate the feasibility of a future definitive RCT to test the delivery of a lower dose (6 sessions) of a 14-session education and exercise programme, which demonstrated short and long-term improvement compared with corticosteroid injection and 'wait and see' (Mellor et al., 2018).Current evidence suggests that GT management needs targeted interventions, which improve the ability of the gluteus medius and minimus tendons to tolerate load required for everyday activities, and to strengthen the associated muscles, as well as minimising compressive load. Exercise

Lyndsay A. Alexander
School of Health Sciences, Robert Gordon University, Aberdeen, UK Thank you for the invitation to review this protocol for a feasibility RCT adapting the LEAP trial to an Irish setting.The study rationale, objectives and study design are appropriate, and clearly described.The authors have addressed previous reviewer comments so i have only one main thought in relation to this paper: Within the methods there is a lack of clarity regarding inclusion of participants that may or may not own/have access to a smart phone.This is not stated in the inc/exc criteria nor does the text clarify if provision of a smart phone will be provided for the duration of the study.This may potentially impact inclusion for some and overall recruitment perhaps.

Are the datasets clearly presented in a useable and accessible format? Not applicable
Competing Interests: No competing interests were disclosed.

Chris Clifford
Glasgow Caledonian University, Glasgow, UK Katie Monnington Royal National Orthopaedic Hospital NHS Trust, London, UK

No further comments
Is the rationale for, and objectives of, the study clearly described?Not applicable

Are the datasets clearly presented in a useable and accessible format? Not applicable
Competing Interests: No competing interests were disclosed.

Reviewer Expertise: Tendinopathy
We confirm that we have read this submission and believe that we have an appropriate level of expertise to confirm that it is of an acceptable scientific standard.

Version 1
Reviewer Report 11 April 2024 https://doi.org/10.21956/hrbopenres.15095.r38734© 2024 Fearon A. This is an open access peer review report distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

University of Canberra, Canberra, Australia
The authors plan to test the feasibility of conduction an RCT into the effectiveness of an amended LEAP protocol, 6 sessions over 8 weeks, compared to the original of 14 session.This is a very worthwhile project.I do have some relatively minor concerns about the written protocol.
Paragraph 1. 1. Cook and Purdam (2009).Defining GT is difficult, and I don't under-estimate the complexity of being clear with this definition.However, Cook and Purdams' 2009 paper does not provide a definition of GT.It provides a model to understand the clinical presentation and the underlying pathology -so as to guide treatment.Cook and Purdam make no reference to GT or even palpation.I suggest you consider.

2.Kong et al 2006 (cited x2
), is a descriptive paper.There is no statement about how many participants were included, how they were chosen, what their clinical features were, or any information about the people who did the reports.It is not an incidence/prevalence paper.The papers above and [5], plus others you should look for, should help.

3.
Stephens 2019 is a study on how physios treat people with GTPS.This also is not an appropriate reference for this statement.

I think you can find a better paper than Dodour et al 2021 for this statement.
Please check all your references from here forward.You should plan to use high quality primary references were possible to support your statements.
Paragraph 2 "GT is (arguably) the most common lower limb tendinopathy..." reference please (Abler 2016) ...in women at risk of knee oa (the 25% statistic is a common error if based on Segal aloneyou need another citation for this statement -there are plenty out there.Park 2013 is about muscles and fat.Kleinman and Gross is about ruptures -there are other papers that you will find that would be better references for this.
Paragraph staring "However, the number..." Make it clear you are referring back to the LEAP trial -and reference it.
14 treatments is not likely to be practical in the Australian setting as well.Please don't assume that Australians will have 14 treatments.The French paper demonstrates this is.Thus, please revise.
Paragraph starting "Although...:" It would be generous to include other studies that have had a positive result from exercise and education in this statement.
Completion of a (don't forget to check you have the best references here) define HEP Please provide a citation for "...is essential to optimise..." We therefore aim to evaluate..You can't have a feasibility study and conduct a "definitive RCT" -please rephrase.
Objectives 2 -What is the likely primary outcome?Interventions "The EDX-Ireland intervention will be delivered in four physiotherapy clinics located in northside and southside Dublin locations."Is this eight in total?(I don't think so, but it reads that way) Week 1 will focus on... What will the physios do if the pain is exacerbated?Is there an escape clause?Are there any guidelines around the advice the physios provide regarding barriers to completion?Leaflet -is that included in the protocol?(there is no reference here and I can't see it in an appendix) Acceptability Will you recruit equal numbers from both patient groups?How many health care professionals are you planning on interviewing?I ask b/c a) you should have a plan, and b) if you interview all the referring health care providers, you may end up with an unmanageable number.Thus, you need to plan how many, and how you'll decide who to interview.
Health costs -will you be modifying this? and if so, what will the modifications be?Please provide some guidance around this, or include the modified version in an appendix.
Adverse events Do you need to report these to your local ethics committee?Confidentiality Please provide a citation for the GDPR Sample size I'm sorry, but I am unclear how you estimate the recruitment rate, without an estimate of how many people you think will be referred.

Discussion
Reference first paragraph appropriately Additionally...note this is in Ireland.
Please provide in appendices information that would allow this trial to be repeated.e.g.leaflets, noting if participants will get DVDs (as in the LEAP trial).I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above.8.This has been reworded as follows ''Although this evidence highlights the rationale for strengthening as a key intervention, traditionally, corticosteroid injections have been used to achieve pain relief.The lack of evidence for the long-term benefits of steroid injection (Mellor et al., 2018;Nissen et al., 2019;Rompe et al., 2009) highlights that interventions that result in long-term benefits are required.Additionally, steroid injections can make tendons more vulnerable to tears (Abate, Salini, Schiavone, & Andia, 2017).''9.The Rompe paper was chosen as it demonstrated that corticosteroid was less effective long-term than other conservative therapies.We have moved the citation in the sentence so that it is after part of the sentence which refers to the lack of evidence for long-term effects of steroid injection and the Nissen citation has also been added.A change has been made in this paragraph in the Background section: ''However, the 14 physiotherapy treatment sessions provided in the LEAP trial (Mellor et al., 2018) may not be feasible in physiotherapy practice.''12.We have revised the wording to read as follows: ''However, the 14 physiotherapy treatment sessions provided in the LEAP trial (Mellor et al., 2018) may not be feasible in physiotherapy practice.For example, although exercise and education are the most common interventions for GT delivered by physiotherapists in Ireland, the number of physiotherapy sessions is usually limited to five or six (French, Grimaldi, Woodley, O'Connor, & Fearon, 2019).This treatment dosage is consistent across various musculoskeletal pathologies in the UK (Bury & Littlewood, 2018).Thus, whilst the LEAP trial in Australia demonstrated positive effects for EDX, delivery of this intervention over 14 sessions may not be practical to implement into physiotherapy practice, and evaluation of a lower dose of face-to-face sessions with a healthcare practitioner, which could be implemented into clinical practice is warranted.''

Citations have been added:
Processing of any personal data will comply with national and EU General Data Protection Regulations (GDPR), and compliance with GDPR will be maintained throughout the trial (European Commission, 2018).''27.Thank you for that comment.Recruitment rate refers to how many study participants are recruited per month to reach target sample size.This will inform planning of a future fully-powered trial in relation to the number of months required to recruit to target sample size.

The following change has been made:
''Additionally, this study will quantify current usual care for this condition in Ireland.''30.The written information leaflet provided to the 'Usual Care' group has been added to the Extended data with a DOI link.
The education component in the 2018 LEAP trial entailed specific and detailed advice and education on tendon care.This information was delivered in hard copy handouts, verbal explanation and a DVD, which included an 18-minute education video.
In the LEAP-Ireland trial, the exact same 18-minute video is being used and available for study participants in the PhysiApp software application, rather than by DVD, as well as verbal explanation.This education video is narrated by one of the LEAP investigators (Dr Grimaldi).

Please see previous response in relation to the education component of the EDX intervention.
Competing Interests: No competing interests were disclosed.Could the written information leaflet be added as an Appendix?

○
Could the exercise programme be added as an Appendix with images?
○ Do the authors plan to provide more detail on 'pain on activity/loading'?While I understand it to be one of the ICON core domains, does this relate to walking, stairs, running?○ Reviewer 2:

General Comments
Thank you for the submission of your research protocol for a feasibility randomised controlled trial (RCT) exploring whether education plus exercise (EDX) compared to usual care in gluteal tendinopathy, is effective at a lower dose of 6 sessions.The aim of this study will determine whether a further trial should be conducted to explore the effect of EDX at a lower dose to accommodate other health care systems.In addition a Study Within A Trial (SWAT) is planned to compare the recording of exercise adherence using app-based technology to a paper-based diary.

Specific Comments:
Could there be further clarity on the rationale for the choice of 6 sessions in this study as difficulty gathering this information from the referenced article [3] ○ Could the content of the training and education provided to the treating physiotherapists be included as an appendix?
○ Terminology used for the exercises could be easily understood and in a common language.Are images of the exercises also planned to be included?The education component in the 2018 LEAP trial entailed specific and detailed advice and education on tendon care.This information was delivered in hard copy handouts, verbal explanation and a DVD, which included an education 18-minute video.
In the LEAP-Ireland trial, the exact same 18-minute video is being used and available for study participants in the PhysiApp software application, rather than by DVD, as well as verbal explanation.This education video is narrated by one of the LEAP investigators (Dr Grimaldi).
The following text has been added into the section on EDX in the Methods ''This will be delivered via an 18-minute video, which was used in the LEAP trial (provided via DVD), which will be provided to study participants via the online Physiapp patient-facing companion application, used alongside the Physitrack online exercise prescription platform ( https://www.physitrack.com/).The education video explains relevant basic anatomy, terminology related to tendinopathy and bursitis, risk factors, and advice related to sitting, lying positions walking and load modification.Participants will be asked to watch the education video prior to their first appointment with the physiotherapist.Education will also be reinforced by the physiotherapist over the 8-week intervention period.'' It is not possible to add this an appendix.
Competing Interests: No competing interests were disclosed.
Number of individuals who contact the research team about the trial (community recruitment) • Recruitment source of each person who undergoes screening process • Number who do/do not consent to telephone screening • Number who are eligible/ineligible to proceed to physical screening • Number who are eligible/ineligible to proceed to MRI • Number who are eligible/ineligible based on MRI findings • Number who are eligible based on MRI findings but decline to participate • Number who consent to participate in the study • Number randomised to participate in the study • Number who attend for 8-week and 3-monthfollow-up • Number who cannot be contacted • Number who do not attend • Number who cannot attend/cancel follow-up (reasons) Based on clinical outcomes collected at 8 weeks and 3 monthsTo determine outcome measure completion Completion rate of clinical outcomes collected at baseline, 8 weeks and 3 monthsTo assess the feasibility of collecting healthcare utilisation and cost data for future cost-effectiveness analysis in a definitive trial Participants will complete questionnaires on use of pain medications, visits to GP and other medical specialties, investigations, attendance at physiotherapy or other healthcare practitioners or, hospital attendance for their hip pain until the 3-month follow-upTo assess if adherence to the home exercise programme of those allocated to EDX-Ireland differs when recorded on a smartphone application compared with paper diaries Adherence to the home exercise programme will be recorded by the study participant using the smartphone app or paper-based diaryTo assess participants' and therapists' acceptability of a smartphone-based application (app) for recording home exercise Adherence in the EDX armTo assess the acceptability of the EDX intervention and usual care from the perspective of study participants and service providers (treating therapists and providers of usual care)

Reviewer Report 10
July 2024 https://doi.org/10.21956/hrbopenres.15234.r41034© 2024 Clifford C et al.This is an open access peer review report distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
Mellor et al 2016 -is the protocol for Mellor et al 2018 -only cite the latter.Further -this is the wrong paper (the Allison papers at the ones to look at).Paragraph 3 "Although this evidence highlights the rationale for strengthening as a key intervention," Except that Mellor et al 2018 didn't demonstrate that a group difference in strength was associated with reduced pain.Consider rephrasing this in light of what Mellor et al 2018 actually report about the strengthening.I'm not sure why you solely reference Rompe here -as the Mellor paper (and the Ganderton paper, and the Nissen paper) are more robust RCTs to reference.

Figure 1 I
Figure 1 I am concerned that you have "+/-physical screening" in the box with the phone screening.I know

Table 1 . Inclusion and exclusion criteria. Inclusion Criteria Exclusion Criteria
Lumbar radiculopathy or pain in another body location greater than the hip pain • Known advanced knee pathology or restricted knee range of motion (must have minimum 90° flexion and full extension, bilaterally)

Table 2 . MRI classification of pathology for definition of gluteal tendinopathy (Blankenbaker et al., 2008). T2 Hyperintensity around Greater Trochanter (representing oedema/fluid
Partial thickness tearTendon irregular, thinned or focally Discontinuous Full thickness tear Discontinuity and/or retraction of the torn tendon from greater trochanter *Intratendinous high T2 signal considered as tendinopathy with a thickened tendon without any irregularity, tendon thinning, or focal tendon discontinuity.MRI, Magnetic Resonance Imaging. -point scale, related to pain and function and is reliable and valid(Fearon et al., 2015).
The Global Rating of Change (GROC) is a 15-point rating scale, completed by the patient based on their perceived overall change in their hip condition and ranges from -7 (a very great deal worse) to +7 (a very great deal better)(Kamper  et al., 2009)and allows patients to consider factors that they consider important for their clinical situation.Victorian Institute of Sport Assessment-Gluteal (VISA-G)is a self-reported questionnaire, which measures disability associated with gluteal tendinopathy.It contains eight items, rated on an 11Psychological distress, which is associated with gluteal tendinopathy (Plinsinga et al., 2018; Plinsinga et al., 2020) will

Table 3 . Feasibility outcomes.
The Pain Catastrophising Scale (PCS) is a valid and reliable 13-item self-report measure, which asks about thoughts and feelings associated with pain (Sullivan et al., 1995).The Patient Health Questionnaire (PHQ) is a valid and reliable self-reported questionnaire for measurement of depressive symptoms.It contains nine questions with a score range of 0-27.A score of ≥5 indicates mild depressive symptoms, ≥10 moderate, ≥15 moderately severe and ≥20 severe (Kroenke et al., 2001).
and load management are recommended as the cornerstone of an effective non-invasive management of tendinopathy(Cook et al., 2016).The exercise and load management programme to be used in this study is focused specifically on hip abductor muscle function, commencing at low load and gradually progressing over the course of the 8-week period, as well as avoiding compressive loads on the gluteal tendons, such as adopted/prescribed hip muscle stretching techniques(Mellor et al., 2016).
Additionally, this study will quantify current usual care for this condition in Ireland.Whilst numerous systematic reviews of interventions for GT/GTPS have been published, (Barratt et al., 2017; Gazendam et al., 2022; Koulischer et al., 2017) no clinical guidelines have been developed to provide guidance on what usual care for this condition should include.Usual care is a common comparator in intervention trials, and whilst it is a term used to describe current treatments used by clinicians, it is commonly unclear how it is defined and may be inconsistent, highly variable and non-evidence based (Angriman et al., 2019; Pascoe et al., 2022).Findings from this feasibility trial should elucidate what typical care entails across primary and secondary care settings and may be used to inform decisions for comparators for a future definitive RCT.

Table 2 -
consider using the primary research here, rather than referencing a reference.Mellor et al didn't do the research to support this diagnosis -reference who did.
RCT) protocol where the authors intend to compare the effect of education plus exercise (EDX) to usual care in patients with gluteal tendinopathy.The study design is similar to a previous RCT published in the British Medical Journal [1].Participants will be randomised to either i) 8 weeks of exercise and education or ii) 'usual care' which consists of a single session and exercise pamphlet.The aim of this study is to determine the feasibility of conducting an RCT before performing a larger definitive trial using a reduced dose (6 sessions of the EDX programme) that can potentially be implemented into existing health systems.Is the 'Usual Care' group identical to the 'Wait and See' group in the LEAP trial?Could a sentence be added to clarify as this will likely be of interest to readers, especially those familiar with the LEAP trial?
○Specific Comments○ What will the 'general advice' given to the 'Usual Care' group consist of and what will be the duration of this session?For the LEAP trial the wait and see group received a 90-minute session [2] ○ Is the written information leaflet provided to the 'Usual Care' group identical to what was previously provided to participant's in the LEAP trial?Has it been amended based on authors experience/participant feedback/new developments in the field?○

Is the rationale for, and objectives of, the study clearly described? Yes Is the study design appropriate for the research question? Yes Are sufficient details of the methods provided to allow replication by others? Yes Are the datasets clearly presented in a useable and accessible format? Not
content and reasoning for the education component would therefore be helpful.Could this be added as an appendix?References 1. Mellor R, Bennell K, Grimaldi A, Nicolson P, et al.: Education plus exercise versus corticosteroid injection use versus a wait and see approach on global outcome and pain from gluteal tendinopathy: prospective, single blinded, randomised clinical trial.BMJ.2018; 361: k1662 PubMed Abstract | Publisher Full Text 2. Plinsinga ML, Mellor R, Setchell J, Ford K, et al.: Perspectives and experiences of people who were randomly assigned to wait-and-see approach in a gluteal tendinopathy trial: a qualitative follow-up study.BMJ Open.2021; 11 (4): e044934 PubMed Abstract | Publisher Full Text 3. French HP, Woodley SJ, Fearon A, O'Connor L, et al.: Physiotherapy management of greater trochanteric pain syndrome (GTPS): an international survey of current physiotherapy practice.Physiotherapy.2020; 109: 111-120 PubMed Abstract | Publisher Full Text ○Is the education component of EDX identical to that of LEAP 2018 [1]?Further clarity on the○ applicableCompeting Interests: No competing interests were disclosed.

Reviewer Expertise: Tendinopathy We confirm that we have read this submission and believe that we have an appropriate level of expertise to confirm that it is of an acceptable scientific standard. https
(Mellor et al, 2018)nt/361/bmj.k16623. Images of the exercises with detailed descriptions are provided in the original LEAP trial publication byMellor et al (2018)in a supplemental table.We have added the following text ''Additionally, the LEAP-Ireland trial did not entail use of a sliding platform with spring resistance during weeks 3-8; resistive exercise band was used to provide resistance.Details of the exercise programme with images, used in the LEAP trial are available in Supplemental Table2of the LEAP trial(Mellor et al, 2018).'' 4. The education component explains relevant basic anatomy, terminology related to bursitis, tendinitis and tendinopathy, risk factors, sitting, sleeping and standing postures and walking advice and load modification