LEAP-Ireland Feasibility Trial of Exercise and Education for Gluteal Tendinopathy
Launched by ROYAL COLLEGE OF SURGEONS, IRELAND · Aug 23, 2022
Trial Information
Current as of July 01, 2025
Recruiting
Keywords
ClinConnect Summary
The LEAP-Ireland Feasibility Trial is studying a treatment approach called Education and Exercise (EDX) to help people with gluteal tendinopathy, a common cause of hip pain. This condition affects mainly women over the age of 40 and can lead to persistent discomfort. The trial aims to see if providing just six sessions of this treatment, instead of the usual 14, is effective in improving pain and function for patients in Ireland. Additionally, the study will compare using a smartphone app for tracking exercise with traditional paper diaries to see which helps participants stick to their exercise plans better.
To be eligible for this trial, participants must be between 35 and 70 years old, experience hip pain for at least three months, and have certain signs of tendinopathy confirmed by MRI. Those who have received a cortisone injection in the past year or have other specific health issues may not qualify. Participants can expect to engage in a structured program for eight weeks that focuses on exercise and education to help manage their pain. This study is currently recruiting, and your involvement could help improve treatments for others with similar conditions in the future.
Gender
ALL
Eligibility 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
About Royal College Of Surgeons, Ireland
The Royal College of Surgeons in Ireland (RCSI) is a prestigious educational and research institution dedicated to advancing surgical practice and healthcare through innovative research, education, and clinical excellence. As a clinical trial sponsor, RCSI plays a pivotal role in conducting cutting-edge research that aims to improve surgical outcomes and patient care. With a commitment to fostering collaboration among healthcare professionals, researchers, and industry partners, RCSI is at the forefront of developing evidence-based interventions and therapies that address critical health challenges. Through its rigorous scientific approach and adherence to ethical standards, RCSI strives to contribute significantly to the advancement of medical knowledge and the enhancement of surgical practices globally.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Dublin, , Ireland
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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