LEAP-Ireland Feasibility Trial of Exercise and Education for Gluteal Tendinopathy

Greater Trochanteric Pain Syndrome Clinical Trial

Official title: An EDucation and eXercise Intervention (EDX-Ireland) for Gluteal Tendinopathy in an Irish Setting: a Feasibility Randomised Controlled Trial (LEAP-Ireland Trial)

Status Recruiting

Clinical Trial Summary

Gluteal tendinopathy, a degenerative condition of the gluteal tendons, is a common cause of lateral hip pain. It is three times more common in women, affecting up to 25% of those aged over 40 years. Research evidence supporting the most effective interventions remains limited. A 2018 landmark three-arm RCT (LEAP trial) in Australia compared EDucation on load management plus eXercise (EDX) against corticosteroid injection (CSI), and a 'wait-and see' control on pain and global improvement in 205 individuals with gluteal tendinopathy (Mellor et al, 2016; 2018). Results showed superior and significant positive effects in the EDX group, compared with CSI and wait-and-see groups at 8 weeks and 1 year. A total of 14 EDX sessions was provided over 8 weeks in LEAP, but in the public healthcare system in Ireland, typically 5-6 physiotherapy treatments are provided.

Therefore, whilst the LEAP trial demonstrated positive effects for EDX, implementation into clinical practice in Ireland is questionable as 6 or less treatment sessions are typically provided in public and private settings in Ireland (French et al, 2020). This two-arm feasibility RCT aims to evaluate the feasibility of conducting a future RCT of a reduced dose (6 sessions) of a recently proven efficacious physiotherapy treatment of EDucation plus eXercise (EDX-Ireland) to usual care for gluteal tendinopathy in an Irish setting. A Study Within A Trial will evaluate if exercise adherence is improved with use of a smartphone app compared with paper-based diaries.

Clinical Trial Description

Study design: A two-arm assessor-blinded feasibility RCT will be conducted, incorporating a Study Within a Trial (SWAT) and embedded qualitative research. The CONSORT statement for pilot and feasibility randomised studies will be followed in the conduct and reporting of this trial.

Participants: Patients with gluteal tendinopathy in Ireland can present to their GP, self-refer to private physiotherapy, or attend secondary care rheumatology clinics. Various recruitment sources will be targetted in this feasibility trial, including: community recruitment, GP practices, sports medicine physicians and secondary care rheumatology or musculoskeletal triage clinics to establish optimal recruitment methods for a full-scale RCT. The following recruitment sources in the greater Dublin area will be notified of the study, provided with study information and a meeting arranged with the trial manager, if they are interested in being a recruitment source.

Procedure: Potential participants will initially be informed of the trial through the recruitment sites (hospitals and GPs), social media or through sports/leisure clubs and organisations. A study invitation letter will be sent out to all recruitment sites. This will also include a participant information sheet providing details of the study, participant eligibility criteria, and clear instructions on how to participate.

If participants indicate a willingness to hear more about the trial, the referral source will provide a leaflet/invitation with contact information of the trial manager and a link to the trial webpage and the Participant Information Leaflet. Interested participants will be initially screened via a phone screening procedure to ensure their eligibility. Those who progress through phone screening, will be invited to schedule an appointment for physical screening with the trial manager.

Once a person has successfully passed physical screening, an appointment will be made for them to attend for a hip MRI by the trial manager. Presence of MRI-confirmed gluteal tendinopathy will deem the person eligible for study inclusion. Participants will be informed that they can withdraw at any stage from the trial.

Participants will be randomised to one of two groups

1. 6 physiotherapy sessions of exercise and education over 8 weeks

2. Usual Care

Experienced registered physiotherapists will deliver the EDX-Ireland intervention. Load management information, exercises and a diary for recording treatment adherence will be provided to the EDX-Ireland group through PhysiApp and Physitrack, Physitrack is an online exercise management system used by physiotherapists for exercise prescription (www.physitrack.com). PhysiApp is the companion platform used by patients to access video-based exercises and education prescribed. As part of the SWAT, the EDX group will be randomly allocated to one of two groups. Both groups will use the PhysiApp for the home exercises but Group A will use the PhysiApp to record their exercise adherence, while Group B will use the paper-based diary format provided by their physiotherapist.

Co-interventions: Participants will be advised not to use other types of treatments, other than the usual care that their referring practitioner has provided, during the 8-week period if possible. Any additional healthcare use will be recorded at both 8-week and 3-month follow-up for cost-effectiveness analysis.

Clinical and Patient Reported Outcomes (PROs) to be collected at baseline, 8 weeks and 3 months are mapped to the LEAP trial and core domains identified by an international consensus group in tendinopathy. ;

Related Conditions & MeSH terms

• Bursitis
• Gluteal Tendinopathy
• Greater Trochanteric Pain Syndrome
• Tendinopathy
• Trochanteric Bursitis

• NCT number: NCT05516563
• Study type: Interventional
• Source: Royal College of Surgeons, Ireland
• Contact: Helen P French, PhD
• Phone: 01 4022258
• Email: hfrench@rcsi.ie
• Status: Recruiting
• Phase: N/A
• Start date: March 27, 2023
• Completion date: December 30, 2024