search
Back to results

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

Primary Purpose

Gluteal Tendinopathy, Trochanteric Bursitis, Greater Trochanteric Pain Syndrome

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
EDucation and eXercise intervention
Sponsored by
Royal College of Surgeons, Ireland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gluteal Tendinopathy

Eligibility Criteria

35 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    No Intervention

    Arm Label

    EDucation and eXercise intervention (EDX)

    Usual Care

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    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.
    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
    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.

    Secondary Outcome Measures

    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.
    VISA Gluteal (VISA-G)
    VISA Gluteal (VISA-G) is a self-reported questionnaire specifically developed to measure disability associated with gluteal tendinopathy.
    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.
    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.
    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.
    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%).
    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'.
    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.
    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.
    Isometric Hip Abductor Muscle Strength
    Isometric Hip Abductor Muscle Strength will be tested in supine using a hand-held dynamometer.

    Full Information

    First Posted
    July 27, 2022
    Last Updated
    December 5, 2022
    Sponsor
    Royal College of Surgeons, Ireland
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT05516563
    Brief Title
    LEAP-Ireland Feasibility Trial of Exercise and Education for Gluteal Tendinopathy
    Official Title
    An EDucation and eXercise Intervention (EDX-Ireland) for Gluteal Tendinopathy in an Irish Setting: a Feasibility Randomised Controlled Trial (LEAP-Ireland Trial)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 10, 2023 (Anticipated)
    Primary Completion Date
    January 10, 2023 (Anticipated)
    Study Completion Date
    January 31, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Royal College of Surgeons, Ireland

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Gluteal Tendinopathy, Trochanteric Bursitis, Greater Trochanteric Pain Syndrome

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    A feasibility randomised controlled trial
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    64 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    EDucation and eXercise intervention (EDX)
    Arm Type
    Active Comparator
    Arm Description
    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.
    Arm Title
    Usual Care
    Arm Type
    No Intervention
    Arm Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    EDucation and eXercise intervention
    Intervention Description
    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
    Primary Outcome Measure Information:
    Title
    Success of different patient recruitment methods (including community recruitment, primary care and secondary care)
    Description
    Number of participants recruited using different recruitment methods, and the number retained at the 8-week and 3-month time-points will be recorded.
    Time Frame
    Through study completion, an average of 1 year
    Title
    Usual care treatment/recommendations for Gluteal Tendinopathy in Ireland
    Description
    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
    Time Frame
    Through study completion, an average of 1 year
    Title
    Cost-effectiveness information of Gluteal Tendinopathy in Ireland
    Description
    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.
    Time Frame
    Baseline, 8 weeks and 3 months
    Secondary Outcome Measure Information:
    Title
    Pain severity - Numeric Pain Rating scale (NPRS)
    Description
    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.
    Time Frame
    baseline, and at 8weeks, and 3months
    Title
    VISA Gluteal (VISA-G)
    Description
    VISA Gluteal (VISA-G) is a self-reported questionnaire specifically developed to measure disability associated with gluteal tendinopathy.
    Time Frame
    baseline, and at 8weeks, and 3months
    Title
    Patient-Specific Functional Scale (PSFS)
    Description
    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.
    Time Frame
    baseline, and at 8weeks, and 3months
    Title
    Patient Health Questionnaire-9 (PHG-9)
    Description
    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.
    Time Frame
    Baseline, 8 weeks and 3 months
    Title
    The EuroQol 5-D-5L
    Description
    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.
    Time Frame
    Baseline, 8 weeks and 3 months
    Title
    The Central Sensitisation Inventory (CSI)
    Description
    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%).
    Time Frame
    Baseline, 8 weeks and 3 months
    Title
    Global Rating of Change (GROC)
    Description
    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'.
    Time Frame
    Baseline, 8 weeks and 3 months
    Title
    Pain Catastrophising Scale
    Description
    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.
    Time Frame
    Baseline, 8weeks, and 3 months
    Title
    Pain Self-Efficacy Questionnaire
    Description
    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.
    Time Frame
    Baseline, 8 weeks and 3 months
    Title
    Isometric Hip Abductor Muscle Strength
    Description
    Isometric Hip Abductor Muscle Strength will be tested in supine using a hand-held dynamometer.
    Time Frame
    Baseline, 8 weeks and 3 months

    10. Eligibility

    Sex
    All
    Gender Based
    Yes
    Gender Eligibility Description
    3:1
    Minimum Age & Unit of Time
    35 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Helen P French, PhD
    Phone
    01 4022258
    Email
    hfrench@rcsi.ie
    First Name & Middle Initial & Last Name or Official Title & Degree
    Sania Almousa, PhD
    Email
    saniaalmousa@rcsi.ie

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    Citations:
    PubMed Identifier
    31493863
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    29720374
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    27139495
    Citation
    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.
    Results Reference
    background

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs