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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]

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

Condition category

Condition code

Musculoskeletal

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]

Rehabilitation

Intervention code [2]

Treatment: Drugs

Intervention code [3]

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]

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]

Baseline, 4 weeks, 8 weeks, 12 weeks, 26 weeks and 52 weeks

Primary outcome [2]

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]

4 weeks, 8 weeks, 12 weeks, 26 weeks and 52 weeks

Secondary outcome [1]

The Lateral Hip Pain Questionnaire

Timepoint [1]

Baseline, 4 weeks, 8 weeks, 12 weeks, 26 weeks and 52 weeks

Secondary outcome [2]

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]

Baseline, 4 weeks, 8 weeks, 12 weeks, 26 weeks and 52 weeks

Secondary outcome [3]

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]

Baseline, 4 weeks, 8 weeks, 12 weeks, 26 weeks and 52 weeks

Secondary outcome [4]

Active painfree hip abductor muscle strength, measured using a hand-held dynamometer

Timepoint [4]

Baseline, 8 weeks

Secondary outcome [5]

Active Lag of hip abduction, measured with an inclinometer

Timepoint [5]

Baseline, 8 weeks

Secondary outcome [6]

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]

Baseline, 4 weeks, 8 weeks, 12 weeks, 26 weeks, 52 weeks

Secondary outcome [7]

Economic costs data, obtained from a modified version of the Osteoarthritis Costs and Consequences Questionnaire.

Timepoint [7]

Baseline, 3 months, 6 months, 12 months

Secondary outcome [8]

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]

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

Sex

Both males and females

Can healthy volunteers participate?

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

1/03/2013

Actual

4/04/2013

Date of last participant enrolment

Anticipated

Actual

15/10/2015

Date of last data collection

Anticipated

27/10/2016

Actual

9/11/2016

Sample size

Target

201

Accrual to date

Final

205

Recruitment in Australia

Recruitment state(s)

QLD,VIC

Recruitment postcode(s) [1]

4000

Recruitment postcode(s) [2]

3000

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

National Health and Medical Research Council Programme Grant

Address [1]

National Health and Medical Research Council
GPO Box 1421
Canberra ACT 2601

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Other collaborator category [1]

University

Name [1]

Professor Kim Bennell

Address [1]

Centre for Health, Exercise and Sports Medicine,
School of Health Sciences,
University of Melbourne,
Berkeley St.,
Parkville, Victoria, 3052

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Medical Research Ethics Committee (MREC)

Ethics committee address [1]

The University of Queensland
Cumbrae-Stewart Building
Research Road
Brisbane Qld 4072 Australia

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

10/07/2012

Approval date [1]

22/10/2012

Ethics approval number [1]

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

Prof Bill Vicenzino

Address

School of Health and Rehabilitation Sciences
Therapies Building 84A
Therapies Road
University of Queensland
St Lucia QLD 4072

Country

Australia

Phone

+61 7 3365 2781

Fax

b.vicenzino@uq.edu.au

Contact person for public queries

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

Phone

+61 7 3365 2781

Fax

+61 7 33651622

b.vicenzino@uq.edu.au

Contact person for scientific queries

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

Phone

+61 7 3365 2781

Fax

+61 7 33651622

b.vicenzino@uq.edu.au

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	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.	2016	https://dx.doi.org/10.1186/s12891-016-1043-6
Dimensions AI	Hip abductor muscle activity during walking in individuals with gluteal tendinopathy	2017	https://doi.org/10.1111/sms.12942
Embase	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.	2018	https://dx.doi.org/10.1136/bmj.k1662
Embase	In gluteal tendinopathy, education + exercise improved outcomes vs corticosteroid injection or wait strategy.	2018	https://dx.doi.org/10.7326/ACPJC-2018-169-4-022
Embase	Perspectives and experiences of people who were randomly assigned to wait-and-see approach in a gluteal tendinopathy trial: A qualitative follow-up study.	2021	https://dx.doi.org/10.1136/bmjopen-2020-044934
Dimensions AI	Education plus exercise for persistent gluteal tendinopathy improves quality of life and is cost-effective compared with corticosteroid injection and wait and see: economic evaluation of a randomised trial	2022	https://doi.org/10.1016/j.jphys.2022.11.007

N.B. These documents automatically identified may not have been verified by the study sponsor.

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