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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 35
Maximum Age: 70
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Ireland
RCSI
RECRUITING
Dublin
Contact Information
Primary
Helen P French, PhD
hfrench@rcsi.ie
01 4022258
Backup
Sania Almousa, PhD
saniaalmousa@rcsi.ie
Time Frame
Start Date: 2023-03-27
Estimated Completion Date: 2024-12-30
Participants
Target number of participants: 64
Treatments
Active_comparator: EDucation and eXercise intervention (EDX)
EDX-Ireland will involve 6 face-to-face education and exercise sessions on a individualised basis with a physiotherapist, delivered over eight weeks. This will be supplemented by a home based exercise programme.
No_intervention: Usual Care
Participants will continue to follow what they have done so far for their hip pain, or what their doctor has suggested/prescribed. If a participant is referred to physiotherapy as part of the usual care treatment, waiting time will be recorded.~Participants will receive a written information leaflet on the pathology of gluteal tendinopathy and general advice on symptom management.
Related Therapeutic Areas
Sponsors
Leads: Royal College of Surgeons, Ireland

This content was sourced from clinicaltrials.gov