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

NCT05516563 | Completed

• 1 other identifier: RoyalCSILeapIreland
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Gluteal Tendinopathy; Trochanteric Bursitis; Greater Trochanteric Pain Syndrome

Outcome Measures

Primary Outcomes (3)

• 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.

  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

  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.

  Baseline, 8 weeks and 3 months

Secondary Outcomes (10)

• Pain severity - Numeric Pain Rating scale (NPRS)

  baseline, and at 8weeks, and 3months

• VISA Gluteal (VISA-G)

  baseline, and at 8weeks, and 3months

• Patient-Specific Functional Scale (PSFS)

  baseline, and at 8weeks, and 3months

• Patient Health Questionnaire-9 (PHG-9)

  Baseline, 8 weeks and 3 months

• The EuroQol 5-D-5L

  Baseline, 8 weeks and 3 months

Study Arms (2)

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.

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.

Interventions

EDucation and eXercise intervention OTHER

The 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

EDucation and eXercise intervention (EDX)

Eligibility Criteria

• Age: 35 Years - 70 Years
• Gender Eligibility Details: 3:1
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Royal College of Surgeons, Ireland: lead

Study Sites (1)

RCSI

Dublin, Dublin, D02 YN77, Ireland

Location

Related Publications (4)

• 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.

  PMID: 31493863 BACKGROUND

• Mellor 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.

  PMID: 29720374 BACKGROUND

• Mellor 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.

  PMID: 27139495 BACKGROUND

• Almousa 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.

  PMID: 39045032 DERIVED

MeSH Terms

Interventions

Educational Status

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A feasibility randomised controlled trial

Study Record Dates

• First Submitted: July 27, 2022
• First Posted: August 25, 2022
• Study Start: March 27, 2023
• Primary Completion: December 20, 2024
• Study Completion: January 30, 2025
• Last Updated: January 20, 2026

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share

Locations

IE (1)