CompletedNot Applicable

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

Ireland65 participantsStarted 2023-03-27

Plain-language 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.

Who can participate

Age range35 Years – 70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Aged between 35-70 years * Lateral hip pain for at least 3 months, of ≥ 4/10 on an 11-point numeric rating scale on most days of the last 3 months * Tenderness on palpation of the greater trochanter * Reproduction of pain on at least one of following diagnostic clinical tests: (FADER test, FADER with Static muscle test (internal rotation) at end of range (FADER-R), FABER test, passive hip Adduction in side lying (ADD) test, adduction with resisted isometric abduction (ADD-R), and single leg stand (SLS) for 30 seconds * Demonstrated tendon pathology on MRI * Access to a computer, smartphone or tablet with internet connection Exclusion Criteria: * Previous cortisone injection in the region of the lateral hip in the last 12 months * Physiotherapy (including regular appropriate Pilates) for lateral hip pain in the last 3 months * Lumbar spine or lower limb surgery in the last 6 months * Any known advanced hip joint pathology where groin pain is the primary complaint and/or where groin pain is experienced at an average intensity of ≥2 on most days of the week, or Kellgren-Lawrence score of \>2 (mild) on X-Ray * If the following clinical criteria for the diagnosis of hip osteoarthritis (American College Rheumatology) are fulfilled: * Self-reported hip pain with either hip internal rotation \<15° and hip flexion ≤115° or ≥15° hip internal rotation and pain on hip internal rotation * Μorning stiffness ≤ 60 minutes * Αge ≥ 50 years * Hip joint flexion i…

What they're measuring

Success of different patient recruitment methods (including community recruitment, primary care and secondary care)

Timeframe: Through study completion, an average of 1 year

Usual care treatment/recommendations for Gluteal Tendinopathy in Ireland

Timeframe: Through study completion, an average of 1 year

Cost-effectiveness information of Gluteal Tendinopathy in Ireland

Timeframe: Baseline, 8 weeks and 3 months

Trial details

NCT IDNCT05516563

SponsorRoyal College of Surgeons, Ireland

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-12-20

View on ClinicalTrials.gov More Gluteal Tendinopathy trials

Plain-language summary

Who can participate

Age range35 Years – 70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Success of different patient recruitment methods (including community recruitment, primary care and secondary care)

Timeframe: Through study completion, an average of 1 year

Usual care treatment/recommendations for Gluteal Tendinopathy in Ireland

Timeframe: Through study completion, an average of 1 year

Cost-effectiveness information of Gluteal Tendinopathy in Ireland

Timeframe: Baseline, 8 weeks and 3 months