Gluteal TendinopathyNCT05516563
LEAP-Ireland Feasibility Trial of Exercise and Education for Gluteal Tendinopathy
A study testing EDucation and eXercise intervention in people with Gluteal Tendinopathy and Trochanteric Bursitis, run by Royal College of Surgeons, Ireland at 1 site in Ireland.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 70 years
- Conditions the study is for
- Gluteal Tendinopathy, Trochanteric Bursitis, Greater Trochanteric Pain Syndrome
- What is being tested?
- EDucation and eXercise intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteIreland
- Study dates
- 27 Mar 2023to 30 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 21Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An EDucation and eXercise Intervention (EDX-Ireland) for Gluteal Tendinopathy in an Irish Setting: a Feasibility Randomised Controlled Trial (LEAP-Ireland Trial)
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.
Read the detailed description
Study design: A two-arm assessor-blinded feasibility RCT will be conducted, incorporating a Study Within a Trial (SWAT) and embedded qualitative research. The CONSORT statement for pilot and feasibility randomised studies will be followed in the conduct and reporting of this trial.
Participants: Patients with gluteal tendinopathy in Ireland can present to their GP, self-refer to private physiotherapy, or attend secondary care rheumatology clinics. Various recruitment sources will be targetted in this feasibility trial, including: community recruitment, GP practices, sports medicine physicians and secondary care rheumatology or musculoskeletal triage clinics to establish optimal recruitment methods for a full-scale RCT. The following recruitment sources in the greater Dublin area will be notified of the study, provided with study information and a meeting arranged with the trial manager, if they are interested in being a recruitment source.
Procedure: Potential participants will initially be informed of the trial through the recruitment sites (hospitals and GPs), social media or through sports/leisure clubs and organisations. A study invitation letter will be sent out to all recruitment sites. This will also include a participant information sheet providing details of the study, participant eligibility criteria, and clear instructions on how to participate.
If participants indicate a willingness to hear more about the trial, the referral source will provide a leaflet/invitation with contact information of the trial manager and a link to the trial webpage and the Participant Information Leaflet. Interested participants will be initially screened via a phone screening procedure to ensure their eligibility. Those who progress through phone screening, will be invited to schedule an appointment for physical screening with the trial manager.
Once a person has successfully passed physical screening, an appointment will be made for them to attend for a hip MRI by the trial manager. Presence of MRI-confirmed gluteal tendinopathy will deem the person eligible for study inclusion. Participants will be informed that they can withdraw at any stage from the trial.
Participants will be randomised to one of two groups
- 6 physiotherapy sessions of exercise and education over 8 weeks
- Usual Care
Experienced registered physiotherapists will deliver the EDX-Ireland intervention. Load management information, exercises and a diary for recording treatment adherence will be provided to the EDX-Ireland group through PhysiApp and Physitrack, Physitrack is an online exercise management system used by physiotherapists for exercise prescription (www.physitrack.com). PhysiApp is the companion platform used by patients to access video-based exercises and education prescribed. As part of the SWAT, the EDX group will be randomly allocated to one of two groups. Both groups will use the PhysiApp for the home exercises but Group A will use the PhysiApp to record their exercise adherence, while Group B will use the paper-based diary format provided by their physiotherapist.
Co-interventions: Participants will be advised not to use other types of treatments, other than the usual care that their referring practitioner has provided, during the 8-week period if possible. Any additional healthcare use will be recorded at both 8-week and 3-month follow-up for cost-effectiveness analysis.
Clinical and Patient Reported Outcomes (PROs) to be collected at baseline, 8 weeks and 3 months are mapped to the LEAP trial and core domains identified by an international consensus group in tendinopathy.
- Being tested
- EDucation and eXercise intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EDucation and eXercise interventionOther
The exercise programme includes 3 key streams:
- Low-load isometric abduction
- Functional loading
- 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
| Study group | Role | What they receive |
|---|---|---|
| EDucation and eXercise intervention (EDX) | Active comparator | 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. Receives: Other: EDucation and eXercise intervention |
| Usual Care | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success of different patient recruitment methods (including community recruitment, primary care and secondary care)
Number of participants recruited using different recruitment methods, and the number retained at the 8-week and 3-month time-points will be recorded.
Measured: Through study completion, an average of 1 year
Usual care treatment/recommendations for Gluteal Tendinopathy in Ireland
The constituents of care received from the referral source (GP, orthopedics, rheumatologists, musculoskeletal triage physiotherapists) for Gluteal Tendinopathy in Ireland will be assessed at baseline for all those allocated to the usual care arm
Measured: Through study completion, an average of 1 year
Cost-effectiveness information of Gluteal Tendinopathy in Ireland
Healthcare costs change from baseline, at 8 weeks and 3 months (including pain medication usage, GP visits, investigations, attendance at physiotherapy/other healthcare practitioners or hospital attendance) by trial participants for their hip pain will be recorded.
Measured: Baseline, 8 weeks and 3 months
Secondary outcomes (10)
Pain severity - Numeric Pain Rating scale (NPRS)
Pain severity will be ascertained using a Numeric Pain Rating scale (NPRS) under two conditions of pain on activity/loading and pain in the last week. The NPRS is an 11-point scale with anchors of no pain at 0 and worst pain at 10.
Measured: baseline, and at 8weeks, and 3months
VISA Gluteal (VISA-G)
VISA Gluteal (VISA-G) is a self-reported questionnaire specifically developed to measure disability associated with gluteal tendinopathy.
Measured: baseline, and at 8weeks, and 3months
Patient-Specific Functional Scale (PSFS)
The Patient-Specific Functional Scale (PSFS) is a self-reported, patient-specific measure, designed to assess functional change in patients with musculoskeletal conditions. It has the advantage of being specific to an individual, who is asked to identify three important activities they are unable to perform or are having difficulty with because of their hip problem. They rate the current level of difficulty associated with each activity on an 11- point scale.
Measured: baseline, and at 8weeks, and 3months
Patient Health Questionnaire-9 (PHG-9)
The Patient Health Questionnaire (PHQ-9) is a valid and reliable self-reported questionnaire for measurement of depressive symptoms. It contains nine questions with a score range of 0-27. A score of ≥5 indicates mild depressive symptoms, ≥10 moderate, ≥15 moderately severe and ≥ 20 severe.
Measured: Baseline, 8 weeks and 3 months
The EuroQol 5-D-5L
The EuroQol 5-D-5L is a generic measure of health-related quality of life (HR-QOL). It includes domains of mobility, personal care, usual activities, pain and anxiety/depression that best describe their health status, as well as a single index value for health status.
Measured: Baseline, 8 weeks and 3 months
The Central Sensitisation Inventory (CSI)
The Central Sensitisation Inventory (CSI) is a self-reported screening instrument designed to identify presence of centrally-mediated pain sensitisation. It comprises 25 questions related to symptoms associated with Central Sensitisation. A cut-off score of '40' of '100' yielded good sensitivity (81%).
Measured: Baseline, 8 weeks and 3 months
Global Rating of Change (GROC)
The Global Rating of Change (GROC) is an 11-point ordinal scale which is completed by the patient based on their perceived overall change in their hip condition and allows patients to consider factors that they consider important for their clinical situation. It is anchored by 'very much better' and 'very much worse'.
Measured: Baseline, 8 weeks and 3 months
Pain Catastrophising Scale
The Pain Catastrophising Scale (PCS) is a valid and reliable 13-item self-report measure, which asks about thoughts and feelings associated with pain. It produces a total score, and three subscale scores, which assess rumination, magnification and helplessness.
Measured: Baseline, 8weeks, and 3 months
Pain Self-Efficacy Questionnaire
The Pain Self-Efficacy Questionnaire (PSEQ) is a self-reported questionnaire that assesses the confidence that people have in performing activities when they are in pain. It contains 10 items answered on a 7-point Likert scale. It provides clinicians with a quick and easy guide as to how a patient may respond to an activity upgrade or exercise program.
Measured: Baseline, 8 weeks and 3 months
Isometric Hip Abductor Muscle Strength
Isometric Hip Abductor Muscle Strength will be tested in supine using a hand-held dynamometer.
Measured: Baseline, 8 weeks and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2022
- Study start27 Mar 2023
- Primary completion20 Dec 2024
- Study completion30 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Gluteal TendinopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A feasibility randomised controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal College of Surgeons, Ireland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05516563
- Sponsor's protocol ID
- RoyalCSILeapIreland
- Status last verified
- May 2024
- First submitted
- 27 Jul 2022
- Last updated
- 20 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
French HP, Woodley SJ, Fearon A, O'Connor L, Grimaldi A. Physiotherapy management of greater trochanteric pain syndrome (GTPS): an international survey of current physiotherapy practice. Physiotherapy. 2020 Dec;109:111-120. doi: 10.1016/j.physio.2019.05.002. Epub 2019 Jun 2.
PubMed 31493863Mellor R, Bennell K, Grimaldi A, Nicolson P, Kasza J, Hodges P, Wajswelner H, Vicenzino B. Education plus exercise versus corticosteroid injection use versus a wait and see approach on global outcome and pain from gluteal tendinopathy: prospective, single blinded, randomised clinical trial. BMJ. 2018 May 2;361:k1662. doi: 10.1136/bmj.k1662.
PubMed 29720374Mellor R, Grimaldi A, Wajswelner H, Hodges P, Abbott JH, Bennell K, Vicenzino B. Exercise and load modification versus corticosteroid injection versus 'wait and see' for persistent gluteus medius/minimus tendinopathy (the LEAP trial): a protocol for a randomised clinical trial. BMC Musculoskelet Disord. 2016 Apr 30;17:196. doi: 10.1186/s12891-016-1043-6.
PubMed 27139495French HP, Almousa S, Mellor R, Grimaldi A, Bennett K, Doyle F, McCarthy GM, McDonough SM, Ryan JM, Lynch K, Sorensen J, Vicenzino B. EDucation and eXercise for gluteal tendinopathy in an Irish context (EDX-Ireland): findings from the LEAP-Ireland feasibility randomised controlled trial. Musculoskelet Sci Pract. 2026 Jun 26;85:103607. doi: 10.1016/j.msksp.2026.103607. Online ahead of print.
PubMed 42372389Almousa S, Vicenzino B, Mellor R, Grimaldi A, Bennett K, Doyle F, McCarthy GM, McDonough SM, Ryan JM, Lynch K, Sorensen J, French HP. An EDucation and eXercise intervention for gluteal tendinopathy in an Irish setting: a protocol for a feasibility randomised clinical trial (LEAP-Ireland RCT). HRB Open Res. 2024 Jun 28;6:76. doi: 10.12688/hrbopenres.13796.2. eCollection 2023.
PubMed 39045032
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An EDucation and eXercise Intervention (EDX-Ireland) for Gluteal Tendinopathy in an Irish Setting: a Feasibility Randomised Controlled Trial (LEAP-Ireland Trial)
- ClinicalTrials.gov ID
- NCT05516563
- Acronym / sponsor ID
- RoyalCSILeapIreland
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Royal College of Surgeons, IrelandUniversity, hospital or other
- Study start
- 27 Mar 2023 (actual)
- Primary completion
- 20 Dec 2024 (actual)
- Study completion
- 30 Jan 2025 (actual)
- First posted
- 25 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Study design: A two-arm assessor-blinded feasibility RCT will be conducted, incorporating a Study Within a Trial (SWAT) and embedded qualitative research. The CONSORT statement for pilot and feasibility randomised studies will be followed in the conduct and reporting of this trial.
Participants: Patients with gluteal tendinopathy in Ireland can present to their GP, self-refer to private physiotherapy, or attend secondary care rheumatology clinics. Various recruitment sources will be targetted in this feasibility trial, including: community recruitment, GP practices, sports medicine physicians and secondary care rheumatology or musculoskeletal triage clinics to establish optimal recruitment methods for a full-scale RCT. The following recruitment sources in the greater Dublin area will be notified of the study, provided with study information and a meeting arranged with the trial manager, if they are interested in being a recruitment source.
Procedure: Potential participants will initially be informed of the trial through the recruitment sites (hospitals and GPs), social media or through sports/leisure clubs and organisations. A study invitation letter will be sent out to all recruitment sites. This will also include a participant information sheet providing details of the study, participant eligibility criteria, and clear instructions on how to participate.
If participants indicate a willingness to hear more about the trial, the referral source will provide a leaflet/invitation with contact information of the trial manager and a link to the trial webpage and the Participant Information Leaflet. Interested participants will be initially screened via a phone screening procedure to ensure their eligibility. Those who progress through phone screening, will be invited to schedule an appointment for physical screening with the trial manager.
Once a person has successfully passed physical screening, an appointment will be made for them to attend for a hip MRI by the trial manager. Presence of MRI-confirmed gluteal tendinopathy will deem the person eligible for study inclusion. Participants will be informed that they can withdraw at any stage from the trial.
Participants will be randomised to one of two groups
- 6 physiotherapy sessions of exercise and education over 8 weeks
- Usual Care
Experienced registered physiotherapists will deliver the EDX-Ireland intervention. Load management information, exercises and a diary for recording treatment adherence will be provided to the EDX-Ireland group through PhysiApp and Physitrack, Physitrack is an online exercise management system used by physiotherapists for exercise prescription (www.physitrack.com). PhysiApp is the companion platform used by patients to access video-based exercises and education prescribed. As part of the SWAT, the EDX group will be randomly allocated to one of two groups. Both groups will use the PhysiApp for the home exercises but Group A will use the PhysiApp to record their exercise adherence, while Group B will use the paper-based diary format provided by their physiotherapist.
Co-interventions: Participants will be advised not to use other types of treatments, other than the usual care that their referring practitioner has provided, during the 8-week period if possible. Any additional healthcare use will be recorded at both 8-week and 3-month follow-up for cost-effectiveness analysis.
Clinical and Patient Reported Outcomes (PROs) to be collected at baseline, 8 weeks and 3 months are mapped to the LEAP trial and core domains identified by an international consensus group in tendinopathy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A feasibility randomised controlled trial
| Arm | Type | Receives |
|---|---|---|
| EDucation and eXercise intervention (EDX) | Active comparator | Other: EDucation and eXercise interventionEDX-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. |
| Usual Care | No intervention | –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. |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (21 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EDucation and eXercise interventionThe 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 | Other | EDucation and eXercise intervention (EDX) |
Primary outcome
Success of different patient recruitment methods (including community recruitment, primary care and secondary care)
Time frame: Through study completion, an average of 1 year
Number of participants recruited using different recruitment methods, and the number retained at the 8-week and 3-month time-points will be recorded.
Usual care treatment/recommendations for Gluteal Tendinopathy in Ireland
Time frame: Through study completion, an average of 1 year
The constituents of care received from the referral source (GP, orthopedics, rheumatologists, musculoskeletal triage physiotherapists) for Gluteal Tendinopathy in Ireland will be assessed at baseline for all those allocated to the usual care arm
Cost-effectiveness information of Gluteal Tendinopathy in Ireland
Time frame: Baseline, 8 weeks and 3 months
Healthcare costs change from baseline, at 8 weeks and 3 months (including pain medication usage, GP visits, investigations, attendance at physiotherapy/other healthcare practitioners or hospital attendance) by trial participants for their hip pain will be recorded.
10 secondary outcomes
Pain severity - Numeric Pain Rating scale (NPRS)
Time frame: baseline, and at 8weeks, and 3months
VISA Gluteal (VISA-G)
Time frame: baseline, and at 8weeks, and 3months
Patient-Specific Functional Scale (PSFS)
Time frame: baseline, and at 8weeks, and 3months
Patient Health Questionnaire-9 (PHG-9)
Time frame: Baseline, 8 weeks and 3 months
The EuroQol 5-D-5L
Time frame: Baseline, 8 weeks and 3 months
The Central Sensitisation Inventory (CSI)
Time frame: Baseline, 8 weeks and 3 months
Global Rating of Change (GROC)
Time frame: Baseline, 8 weeks and 3 months
Pain Catastrophising Scale
Time frame: Baseline, 8weeks, and 3 months
Pain Self-Efficacy Questionnaire
Time frame: Baseline, 8 weeks and 3 months
Isometric Hip Abductor Muscle Strength
Time frame: Baseline, 8 weeks and 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2026.
- Background: PubMed 31493863French HP, Woodley SJ, Fearon A, O'Connor L, Grimaldi A. Physiotherapy management of greater trochanteric pain syndrome (GTPS): an international survey of current physiotherapy practice. Physiotherapy. 2020 Dec;109:111-120. doi: 10.1016/j.physio.2019.05.002. Epub 2019 Jun 2.
- Background: PubMed 29720374Mellor R, Bennell K, Grimaldi A, Nicolson P, Kasza J, Hodges P, Wajswelner H, Vicenzino B. Education plus exercise versus corticosteroid injection use versus a wait and see approach on global outcome and pain from gluteal tendinopathy: prospective, single blinded, randomised clinical trial. BMJ. 2018 May 2;361:k1662. doi: 10.1136/bmj.k1662.
- Background: PubMed 27139495Mellor R, Grimaldi A, Wajswelner H, Hodges P, Abbott JH, Bennell K, Vicenzino B. Exercise and load modification versus corticosteroid injection versus 'wait and see' for persistent gluteus medius/minimus tendinopathy (the LEAP trial): a protocol for a randomised clinical trial. BMC Musculoskelet Disord. 2016 Apr 30;17:196. doi: 10.1186/s12891-016-1043-6.
- Derived from this study: PubMed 42372389French HP, Almousa S, Mellor R, Grimaldi A, Bennett K, Doyle F, McCarthy GM, McDonough SM, Ryan JM, Lynch K, Sorensen J, Vicenzino B. EDucation and eXercise for gluteal tendinopathy in an Irish context (EDX-Ireland): findings from the LEAP-Ireland feasibility randomised controlled trial. Musculoskelet Sci Pract. 2026 Jun 26;85:103607. doi: 10.1016/j.msksp.2026.103607. Online ahead of print.
- Derived from this study: PubMed 39045032Almousa S, Vicenzino B, Mellor R, Grimaldi A, Bennett K, Doyle F, McCarthy GM, McDonough SM, Ryan JM, Lynch K, Sorensen J, French HP. An EDucation and eXercise intervention for gluteal tendinopathy in an Irish setting: a protocol for a feasibility randomised clinical trial (LEAP-Ireland RCT). HRB Open Res. 2024 Jun 28;6:76. doi: 10.12688/hrbopenres.13796.2. eCollection 2023.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EDucation and eXercise intervention in people with Gluteal Tendinopathy and Trochanteric Bursitis, run by Royal College of Surgeons, Ireland at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success of different patient recruitment methods (including community recruitment, primary care and secondary care) (time frame: Through study completion, an average of 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05516563, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2026.