Feasibility of Exercise and Education for Hip Pain
An EDucation and eXercise Intervention (EDX-Ireland) for Gluteal Tendinopathy in an Irish Setting: a Feasibility Randomised Controlled Trial (LEAP-Ireland Trial)
NA · Royal College of Surgeons, Ireland · NCT05516563
This study is testing a program of exercise and education to see if it can help people with hip pain from gluteal tendinopathy feel better and move more easily.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 64 (estimated) |
| Ages | 35 Years to 70 Years |
| Sex | All |
| Sponsor | Royal College of Surgeons, Ireland (other) |
| Locations | 1 site (Dublin) |
| Trial ID | NCT05516563 on ClinicalTrials.gov |
What this trial studies
This trial investigates the feasibility of an education and exercise intervention for patients suffering from gluteal tendinopathy, a common cause of lateral hip pain. It aims to recruit participants from various sources, including general practices and sports medicine clinics, to assess optimal recruitment methods for a larger study. Participants will receive a structured program of education and exercise over a specified period, with outcomes measured through pain and functional assessments. The study will follow rigorous guidelines to ensure quality and reliability in its findings.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 35-70 with persistent lateral hip pain and confirmed tendon pathology.
Not a fit: Patients with advanced hip joint pathology or those who have received recent cortisone injections may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could provide a non-invasive treatment option for patients with gluteal tendinopathy, potentially reducing pain and improving function.
How similar studies have performed: Previous studies, such as the LEAP trial in Australia, have shown positive outcomes with similar education and exercise interventions for gluteal tendinopathy.
Eligibility criteria
Show full inclusion / exclusion criteria
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 is \<90°, bilaterally * Lumbar radiculopathy or pain in another body location that is greater than the hip pain (NRS) * Known advanced knee pathology or restricted knee range of motion (must have minimum 90° flexion and full extension, bilaterally) * Any systemic diseases affecting the muscular or nervous system, and uncontrolled diabetes * Fibromyalgia * Use of cane or walking aid * Malignant tumour (current or in the past 6 months) * Systemic inflammatory disease * Any factors that would 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 * If the participant is unable to write, read or comprehend English * Unable or unwilling to use technology for exercise prescription and adherence
Where this trial is running
Dublin
- RCSI — Dublin, Ireland (RECRUITING)
Study contacts
- Study coordinator: Helen P French, PhD
- Email: hfrench@rcsi.ie
- Phone: 01 4022258
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Gluteal Tendinopathy, Trochanteric Bursitis, Greater Trochanteric Pain Syndrome