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Trial registered on ANZCTR


Registration number
ACTRN12612001126808
Ethics application status
Approved
Date submitted
19/10/2012
Date registered
22/10/2012
Date last updated
23/11/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Physiotherapy versus corticosteroid injection for chronic lateral hip pain: a randomized clinical trial.
Scientific title
To compare the short and long term effectiveness of a specific physiotherapy programme and corticosteroid injection in the management of people with gluteal muscle tendinopathy.
Secondary ID [1] 280696 0
Nil
Universal Trial Number (UTN)
U1111-1131-9517
Trial acronym
The LEAP [LatErAl hiP pain] Project
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gluteal tendinopathy 286730 0
Condition category
Condition code
Musculoskeletal 287030 287030 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1: Eight Week Physiotherapy Exercise Intervention. This group will receive detailed advice and education on tendon care (handouts, DVD and oral explanation by the treating physiotherapist), as well as a comprehensive exercise programme, to be performed both at home daily and in the form of individual supervised exercise sessions at the physiotherapy clinic. The exercises will include functional retraining, targeted strengthening for the hip and thigh muscles, as well as exercises using Pilates equipment (i.e. a Reformer). The participant will attend an initial 1 hour physiotherapy session in Week 1, where assessment, education and training of the exercises will occur. In Week 2, the participant will attend a half hour session to reinforce all information, assess progress and technique and continue exercise progressions. For the remaining 6 weeks, the participant will attend two half hour sessions per week at the physiotherapy clinic for re-assessment of responses and progress, and progression of the exercise programme as able. There will be 14 sessions in total. The prescribed home exercise programme will consist of no more than four exercises, in order to facilitate compliance, and will be performed daily, taking no more than 15 to 20 minutes. Response to the exercises will be re-assessed at each physiotherapy session in order to modify and progress the home exercises as appropriate to the individual.

Arm 2: A single ultrasound guided Corticosteroid injection (Celestone (1 ml) or Kenacort (1 ml ), with Bupivacaine (2 ml)) around the tendons at the hip, performed under ultrasound guidance by an experienced sports physician or radiologist, as well as receiving basic advice on tendon care.

Arm 3: Patients will attend a single half hour session with a trial physiotherapist of their choice, where they will be advised to adopt a wait and see policy in which they will be given advice on how to take care of their condition themselves and assurance that the condition will resolve over time. Taking over the counter pain relief medication will be permitted should the patient feel it is required.
Intervention code [1] 285108 0
Rehabilitation
Intervention code [2] 285246 0
Treatment: Drugs
Intervention code [3] 285912 0
Treatment: Other
Comparator / control treatment
Arm 3 of the study is a Wait and See approach, in which no active intervention is involved. This is considered to be the control.
Control group
Active

Outcomes
Primary outcome [1] 287367 0
Pain Numerical Rating Scale: An 11 point scale
anchored by no pain at all at 0 and worst pain
imaginable at 10 will be used to rate the worst
and average level of pain severity the patient
experienced in the past week.
Timepoint [1] 287367 0
Baseline, 4 weeks, 8 weeks, 12 weeks, 26 weeks and 52 weeks
Primary outcome [2] 287369 0
Global Rating of Change Score - an 11-point scale in which the participant is asked to rate their perceived overall change in condition of their hip from the time that they began the study until the present, as Worse, No Change, or Better
Timepoint [2] 287369 0
4 weeks, 8 weeks, 12 weeks, 26 weeks and 52 weeks
Secondary outcome [1] 298008 0
The Lateral Hip Pain Questionnaire
Timepoint [1] 298008 0
Baseline, 4 weeks, 8 weeks, 12 weeks, 26 weeks and 52 weeks
Secondary outcome [2] 298009 0
The Patient Specific Functional Scale. Patients are asked to identify up to five activities they are unable to perform or are having difficulty with because of their problem. They are then asked to rate the current level of difficulty associated with each activity on an 11-point scale.
Timepoint [2] 298009 0
Baseline, 4 weeks, 8 weeks, 12 weeks, 26 weeks and 52 weeks
Secondary outcome [3] 298010 0
The EuroQOL questionnaire. The participant indicates in tick boxes which statements about mobility, personal care, usual activities, pain and anxiety/depression best describe their health status.
Timepoint [3] 298010 0
Baseline, 4 weeks, 8 weeks, 12 weeks, 26 weeks and 52 weeks
Secondary outcome [4] 298011 0
Active painfree hip abductor muscle strength, measured using a hand-held dynamometer
Timepoint [4] 298011 0
Baseline, 8 weeks
Secondary outcome [5] 298012 0
Active Lag of hip abduction, measured with an inclinometer
Timepoint [5] 298012 0
Baseline, 8 weeks
Secondary outcome [6] 298348 0
The Pain Catastrophising Scale (labelled the Pain Thoughts Scale), The Patient Health Questionnaire-9, the Pain Self-Efficacy Questionnaire, the Active Australia Survey are incorporated into one booklet to explore the psychological aspects of chronic lateral hip pain
Timepoint [6] 298348 0
Baseline, 4 weeks, 8 weeks, 12 weeks, 26 weeks, 52 weeks
Secondary outcome [7] 298537 0
Economic costs data, obtained from a modified version of the Osteoarthritis Costs and Consequences Questionnaire.
Timepoint [7] 298537 0
Baseline, 3 months, 6 months, 12 months
Secondary outcome [8] 299612 0
VISA-G: is an equivalent to the other VISA questionnaires (for Achilles and Patellar tendinopathy), which consists of 8 items, covering pain and function. Total possible score is 100, which represents a perfect score.
Timepoint [8] 299612 0
Baseline, 4 weeks, 8 weeks, 12 weeks, 26 weeks, 52 weeks

Eligibility
Key inclusion criteria
Subjects will be included in the study if they experience lateral hip pain, worst over the area of the greater trochanter, which has been present for a minimum of three months. There should be tenderness on palpation of the greater trochanter and reproduction of lateral hip pain on at least one of 5 diagnostic clinical tests, as well as demonstrated tendon pathology on MRI.
Minimum age
35 Years
Maximum age
70 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Subjects will be excluded if they have any significant groin pain or known hip joint pathology, significant lower back pain, or known lumbar pathology, previous surgery to the back or hips, any other lower limb pathology that may impact on their ability to participate in an exercise programme, any systemic diseases affecting the muscular or nervous system, any systemic inflammatory diseases, presence of tumour, any factors that would preclude them from having an Magnetic Resonance Imaging (MRI) (e.g., pregnancy, pacemaker, claustrophobia), previous cortisone injection around the greater trochanter (lateral hip) in the last 12 months, or physiotherapy intervention for lateral hip pain in the last 3 months, any allergy to corticosteroids, any phobia of needles, and obesity (BMI>30).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Recruitment via advertisements in local newspapers, medical and physiotherapy clinics, and flyers. Respondents will undergo an initial phone screening and then a physical examination, as well as MRI/XRay investigation to confirm diagnosis before inclusion. Concealed allocation by a computerised randomisation schedule developed by an off-site independent central trial unit (Queensland
Clinical Trial Centre)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated randomisation schedule
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Pragmatic, single-blind, multi-centre randomised controlled trial
Phase
Phase 4
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,VIC
Recruitment postcode(s) [1] 5406 0
4000
Recruitment postcode(s) [2] 5544 0
3000

Funding & Sponsors
Funding source category [1] 285467 0
Government body
Name [1] 285467 0
National Health and Medical Research Council Programme Grant
Address [1] 285467 0
National Health and Medical Research Council
GPO Box 1421
Canberra ACT 2601
Country [1] 285467 0
Australia
Primary sponsor type
Individual
Name
Professor Bill Vicenzino
Address
School of Health and Rehabilitation Sciences
Therapies Building 84A
Therapies Road
University of Queensland
St Lucia QLD 4072
Country
Australia
Secondary sponsor category [1] 284320 0
None
Name [1] 284320 0
Address [1] 284320 0
Country [1] 284320 0
Other collaborator category [1] 276892 0
University
Name [1] 276892 0
Professor Kim Bennell
Address [1] 276892 0
Centre for Health, Exercise and Sports Medicine,
School of Health Sciences,
University of Melbourne,
Berkeley St.,
Parkville, Victoria, 3052
Country [1] 276892 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287479 0
Medical Research Ethics Committee (MREC)
Ethics committee address [1] 287479 0
The University of Queensland
Cumbrae-Stewart Building
Research Road
Brisbane Qld 4072 Australia
Ethics committee country [1] 287479 0
Australia
Date submitted for ethics approval [1] 287479 0
10/07/2012
Approval date [1] 287479 0
22/10/2012
Ethics approval number [1] 287479 0
2012000930

Summary
Brief summary
Lateral hip pain is very common in the community and particularly in active women. Some studies state that 1 in 4 women over 55 have this problem. The pain at the side of the hip, or lateral gluteal region, can be very debilitating and often affects sleep, walking, going up stairs, prolonged sitting and getting up after sitting. The management of lateral hip pain is difficult and the pain can persist for months or even years. Previously this was incorrectly diagnosed as bursitis, but recent medical imaging research using ultrasound and MRI has shown the problem is usually due to tendinopathy or a tear in the tendons of the muscles at the side of the hip called the gluteus medius and gluteus minimus. The bursitis (a collection of fluid) appears to be secondary to the tendon injury. Common approaches to management include a corticosteroid injection or a physiotherapy program, yet there is a lack of quality research regarding which is more effective, or if in fact these treatments are any better than adopting a wait and see approach to allow the condition to resolve spontaneously. The purpose of this study is to compare the effects of three possible approaches to treating long standing lateral hip pain: (a) a single cortisone injection, (b) an eight-week physiotherapy exercise program and (c) adopting a wait and see approach. The results will contribute to the development of improved and more effective exercise treatment programs to manage this condition.
Trial website
Trial related presentations / publications
Grimaldi A, Mellor R, Nicolson P, Hodges P, Bennell K, Vicenzino B. Utility of clinical tests to diagnose MRI-confirmed gluteal tendinopathy in patients presenting with lateral hip pain. Br J Sports Med. 2016 Sep 15. pii: bjsports-2016-096175. doi: 10.1136/bjsports-2016-096175 [Epub ahead of print]
Mellor R, Grimaldi A, Wajswelner H, Hodges P, Abbot 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 randomized clinical trial. BMC Musculoskeletal Disord. 2016 Apr 30: 17(1): 196. doi: 10.1186/s12891-016-1043-6.
Grimaldi A, Mellor R, Hodges P, Bennell K, Wajswelner H, Vicenzino B. Gluteal Tendinopathy: A review of mechanisms, assessment and management. Sports Medicine. 2015 Aug 4(8): 1107-19. doi: 10.1007/s40279-015-0336-5.
Public notes

Contacts
Principal investigator
Name 34332 0
Prof Bill Vicenzino
Address 34332 0
School of Health and Rehabilitation Sciences
Therapies Building 84A
Therapies Road
University of Queensland
St Lucia QLD 4072
Country 34332 0
Australia
Phone 34332 0
+61 7 3365 2781
Fax 34332 0
Email 34332 0
b.vicenzino@uq.edu.au
Contact person for public queries
Name 17579 0
Prof Professor Bill Vicenzino
Address 17579 0
School of Health and Rehabilitation Sciences
Therapies Building 84A
Therapies Road
University of Queensland
St Lucia QLD 4072
Country 17579 0
Australia
Phone 17579 0
+61 7 3365 2781
Fax 17579 0
+61 7 33651622
Email 17579 0
b.vicenzino@uq.edu.au
Contact person for scientific queries
Name 8507 0
Prof Professor Bill Vicenzino
Address 8507 0
School of Health and Rehabilitation Sciences
Therapies Building 84A
Therapies Road
University of Queensland
St Lucia QLD 4072
Country 8507 0
Australia
Phone 8507 0
+61 7 3365 2781
Fax 8507 0
+61 7 33651622
Email 8507 0
b.vicenzino@uq.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary