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

NCT05516563 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2026-01-20

No results posted yet for this study

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.

Conditions

  • Gluteal Tendinopathy
  • Trochanteric Bursitis
  • Greater Trochanteric Pain Syndrome

Interventions

OTHER

EDucation and eXercise intervention

The exercise programme includes 3 key streams: 1. Low-load isometric abduction 2. Functional loading 3. Abductor loading: Graduated abductor loading, designed to improve load tolerance by applying progressively higher loads across the abductor muscles. Daily exercise will be completed three days a week at a 'hard' to 'very hard' level, alternating with three 'light' days and one rest day. The clinic day will constitute one of the 'hard' days. Education will be delivered via a 20 minute video which focusses on understanding and managing lateral hip pain ( ie pain associated with gluteal tendinopathy). Education will also be tailored to each patient on attendance with the physiotherapist at the 6 clinic visits

Sponsors & Collaborators

  • Royal College of Surgeons, Ireland

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
35 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-27
Primary Completion
2024-12-20
Completion
2025-01-30

Countries

  • Ireland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05516563 on ClinicalTrials.gov