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Trial registered on ANZCTR


Registration number
ACTRN12620000385943
Ethics application status
Approved
Date submitted
7/02/2020
Date registered
20/03/2020
Date last updated
20/03/2020
Date data sharing statement initially provided
20/03/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Shoe inserts for lateral hip pain: The GluTeS Trial
Scientific title
Clinical predictors of foot orthoses efficacy for greater trochanteric pain syndrome
Secondary ID [1] 299537 0
None
Universal Trial Number (UTN)
Trial acronym
GluTeS (Gluteal Tendinopathy and Shoe Inserts)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Greater trochanteric pain syndrome 314790 0
Lateral hip pain 314791 0
Gluteal tendinopathy 314792 0
Trochanteric bursitis 314793 0
Condition category
Condition code
Musculoskeletal 313129 313129 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 313130 313130 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The objectives of this study are to (i) determine whether a 12-week trial of foot orthoses intervention can improve symptoms in participants with a clinical diagnosis of greater trochanteric pain syndrome and (ii) identify clinical predictors of foot orthoses efficacy in this patient population.

Participants will be fitted with prefabricated contoured shoe inserts (foot orthoses) from a commercially available range (Vasyli International, Labrador, Australia). The inserts are manufactured from ethylene-vinyl acetate (EVA) and are available in low, medium and high density, with inbuilt arch support and varus wedging. Participants will be provided with two pairs of contoured inserts, fitted to their usual footwear. They will also receive a pair of contoured sandals from the Vionics shoe range (Vionics International, San Francisco, USA).

A physiotherapist who has been trained in prescription of the foot orthoses will fit the contoured inserts to each participant using a previously developed prescription algorithm that emphasises comfort. Comfort is maximised through selecting the most suitable density and can be enhanced through the addition of forefoot, rear foot or heel wedges, and gentle heat moulding if required. Participants will be advised to gradually increase their wear time over the first 1-2 weeks to accommodate to the inserts. They will be advised to start off wearing them for 1 hour per day, and to increase this by one hour per day over the following two weeks, until they can tolerate them for a whole day. After this, they will be encouraged to wear the inserts as often as possible for the remaining 12-week intervention period. They will also be advised that for the first two weeks, they should only use the shoe inserts for sport if they are comfortable to walk in, and don’t cause them any discomfort during sport. They will be advised to slowly increase the wear time for sport until they are used to them and are encouraged to try them over a number of practice sessions first. To maximise wear time, they will also be encouraged to wear the Vionic sandals during times that they do not normally wear enclosed footwear. Participants will be given written instructions regarding their use of the inserts and sandals.

The orthoses intervention will be delivered face-to-face at the La Trobe University Biomechanics Laboratory at Visit 1. One week after fitting the shoe inserts, the participant will be contacted via telephone by the same physiotherapist who prescribed the intervention to ensure that the participant is tolerating the inserts and troubleshoot any issues that they are having with the inserts if required. If any issues cannot be resolved via the telephone consult, they will be asked to return to the Laboratory for further evaluation. Participants will be provided with a logbook to document adherence to the intervention and any adverse events over the 12-week intervention period.
Intervention code [1] 315791 0
Treatment: Devices
Comparator / control treatment
No comparator
Control group
Uncontrolled

Outcomes
Primary outcome [1] 321663 0
Perceived overall change in the participant's lateral hip pain will be assessed a Global Rating of Change Scale (GRCS). This will be a 7-point Likert scale (‘much better’, ‘better’, ‘a little better’, ‘same’, ‘a little worse’, ‘worse’, ‘much worse’)
Timepoint [1] 321663 0
12 weeks post-intervention commencement
Secondary outcome [1] 375797 0
Perception of pain (usual and on aggravating activity) using 11 point numerical rating scale (NRS)
Timepoint [1] 375797 0
Baseline, 6 weeks and 12 weeks post-intervention commencement
Secondary outcome [2] 375798 0
Victorian Institute of Sport Assessment-Gluteal Tendon (VISA-G
Timepoint [2] 375798 0
Baseline, 6 weeks and 12 weeks post-intervention commencement
Secondary outcome [3] 375799 0
The Patient Reported Gluteal Tendon Evaluation (PRGTE)
Timepoint [3] 375799 0
Baseline, 6 weeks and 12 weeks post-intervention commencement
Secondary outcome [4] 375800 0
Hip disability and Osteoarthritis Outcome Score (HOOS)
Timepoint [4] 375800 0
Baseline, 6 weeks and 12 weeks post-intervention commencement
Secondary outcome [5] 375801 0
International Physical Activity Questionnaire (IPAQ)
Timepoint [5] 375801 0
Baseline, 6 weeks and 12 weeks post-intervention commencement
Secondary outcome [6] 375802 0
EuroQoL (EQ-5D™)
Timepoint [6] 375802 0
Baseline, 6 weeks and 12 weeks post-intervention commencement
Secondary outcome [7] 375803 0
Pain Catastrophizing Scale (PCS)
Timepoint [7] 375803 0
Baseline, 6 weeks and 12 weeks post-intervention commencement
Secondary outcome [8] 376781 0
Gait parameters using the Gaitrite® system. Composite secondary outcome. Parameters will include: walking speed (cm/s), step length (cm), stride length (cm), base of support (cm), cadence, single/double support time (s)
Timepoint [8] 376781 0
Baseline (pre and post- orthoses prescription), 12 weeks post-intervention commencement
Secondary outcome [9] 376783 0
Hip muscle strength will be assessed using the Commander II hand-held dynamometer (extension) and the ForceFrame (abduction, adduction, internal rotation, external rotation)
Timepoint [9] 376783 0
Baseline, 12 weeks post-intervention commencement
Secondary outcome [10] 376784 0
40m self-paced walk test
Timepoint [10] 376784 0
Baseline, 12 weeks post-intervention commencement
Secondary outcome [11] 376785 0
Treatment adherence (collected via logbook and qualitative process evaluation of barriers/enablers to foot orthoses use)
Timepoint [11] 376785 0
Over 12-week intervention period
Secondary outcome [12] 376791 0
Use of co-interventions (collected via logbook and qualitative interviews)
Timepoint [12] 376791 0
Over 12-week intervention period
Secondary outcome [13] 376792 0
Adverse events (collected via logbook and qualitative interviews). Only minor adverse events are anticipated such as blisters from unaccustomed orthoses use.
Timepoint [13] 376792 0
Over 12-week intervention period
Secondary outcome [14] 377809 0
Perceived overall change in the participant's lateral hip pain will be assessed using a Global Rating of Change Scale (GRRC). This will be a 7-point Likert scale (‘much better’, ‘better’, ‘a little better’, ‘same’, ‘a little worse’, ‘worse’, ‘much worse’).
Timepoint [14] 377809 0
6 weeks post-intervention assessment
Secondary outcome [15] 380125 0
30 second single leg stance test
Timepoint [15] 380125 0
Baseline, 12 weeks post-intervention commencement
Secondary outcome [16] 380126 0
step-up test
Timepoint [16] 380126 0
Baseline, 12 weeks post-intervention commencement

Eligibility
Key inclusion criteria
(i) aged 18 years or older;
(ii) symptoms for at least 3 months;
(iii) primary pain located over the lateral hip;
(iv) average pain intensity over the previous week of 3 or more on an 11-point numerical rating scale; and
(v) GTPS diagnosis confirmed via clinical assessment: (a) pain reproduced on palpation of the greater trochanter; (b) pain reproduced on the Flexion, Abduction and External Rotation (FABER) test; (c) pain on one of the following: single leg stance test, resisted hip abduction, external de-rotation test.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(i) Signs of intra-articular hip pathology; (ii) previous hip surgery on the symptomatic side; (iii) low back or other lower limb injury requiring management by a medical professional, or time off sport, work or leisure over the last three months; (iv) any neurological disorders; (v) any form of systemic arthritis; (vi) currently regularly wearing contoured shoe inserts; (vii) any foot disorder precluding wearing of shoe inserts; (viii) corticosteroid injection into hip region within previous 3 months; (x) currently undergoing treatment including physiotherapy, osteopathy or chiropractic; (ix) low-English speaking proficiency such that unable to comprehend study assessment requirements.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Efficacy
Statistical methods / analysis
A classification and regression tree (CART) will be used to determine which baseline variables and interactions are best able to predict those who have a successful outcome after 12 weeks of foot orthoses intervention. This non-parametric, multi-variable modelling technique generates a clinically useful decision tree, whereby all baseline predictors and their potential cut-off points are considered in successive nodes, until a stopping rule is reached. The order of variables at each successive node represents the strength of that variable as a predictor of the outcome so that the first node represents the baseline variable that is most associated with the outcome (success). A maximum of three levels will be established. A receiver-operating characteristic (ROC) curve will be used to assess the accuracy of the model.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
22/06/2020
Actual
Date of last participant enrolment
Anticipated
25/06/2021
Actual
Date of last data collection
Anticipated
1/10/2021
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 28233 0
3086 - La Trobe University

Funding & Sponsors
Funding source category [1] 304027 0
University
Name [1] 304027 0
La Trobe University
Country [1] 304027 0
Australia
Funding source category [2] 304970 0
Commercial sector/Industry
Name [2] 304970 0
Vasyli Medical
Country [2] 304970 0
Australia
Primary sponsor type
University
Name
La Trobe University
Address
La Trobe University,
Cnr. Kingsbury Drive & Plenty Road
Melbourne, VIC 3086
Country
Australia
Secondary sponsor category [1] 304205 0
None
Name [1] 304205 0
Address [1] 304205 0
Country [1] 304205 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304518 0
La Trobe University Human Research Ethics Committee
Ethics committee address [1] 304518 0
La Trobe University HREC
Cnr. Kingsbury Drive & Plenty Road
Melbourne, VIC 3086
Ethics committee country [1] 304518 0
Australia
Date submitted for ethics approval [1] 304518 0
08/11/2018
Approval date [1] 304518 0
21/02/2019
Ethics approval number [1] 304518 0
HEC18499

Summary
Brief summary
Greater trochanteric pain syndrome (GTPS), also referred to as gluteal tendinopathy, is a painful, debilitating disorder of the hip. Symptoms arise primarily from pathology of one or more of the soft tissues located over its lateral aspect, including the gluteal muscles, tendons and bursae. People with GTPS frequently demonstrate lower physical activity levels, lower workforce participation, and lower quality of life. Walking is the most common aggravating activity, with over 50% of those with GTPS experiencing symptoms after just a few minutes. Fatigue of the gluteal muscles/tendons is considered to be the primary cause of pain during walking. Foot orthoses are contoured shoe inserts worn in everyday footwear that have been shown to improve pain in people with foot and knee symptoms. Therapeutic effects of foot orthoses are hypothesised to occur through either biomechanical, neuromuscular or load attenuation mechanisms. Pilot data acquired by our team from healthy adults demonstrates that unmodified ‘off-the-shelf’ foot orthoses reduce gluteal muscle activity during gait by up to 37%. Therefore, it is plausible that foot orthoses, by reducing gluteal muscle activity, may have positive effects on pain in people with GTPS. The primary aims of this study are to: (i) evaluate changes in pain and function after 12 weeks of foot orthoses use, and (ii) identify clinical predictors of foot orthoses efficacy in individuals with GTPS. The secondary aim is to undertake a process evaluation, through qualitative interviews, to determine barriers and enablers of foot orthoses use in this patient population.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 97234 0
Ms Rita Kinsella
Address 97234 0
La Trobe Sport and Exercise Medicine Research Centre
Department of Physiotherapy, Podiatry and Prosthetics and Orthotics
La Trobe University
Cnr. Kingsbury Drive & Plenty Road
Melbourne, VIC 3086.
Country 97234 0
Australia
Phone 97234 0
+61 3 9479 5332
Fax 97234 0
Email 97234 0
[email protected]
Contact person for public queries
Name 97235 0
Rita Kinsella
Address 97235 0
La Trobe Sport and Exercise Medicine Research Centre
Department of Physiotherapy, Podiatry and Prosthetics and Orthotics
La Trobe University
Cnr. Kingsbury Drive & Plenty Road
Melbourne, VIC 3086.
Country 97235 0
Australia
Phone 97235 0
+61 3 9479 5332
Fax 97235 0
Email 97235 0
[email protected]
Contact person for scientific queries
Name 97236 0
Rita Kinsella
Address 97236 0
La Trobe Sport and Exercise Medicine Research Centre
Department of Physiotherapy, Podiatry and Prosthetics and Orthotics
La Trobe University
Cnr. Kingsbury Drive & Plenty Road
Melbourne, VIC 3086.
Country 97236 0
Australia
Phone 97236 0
+61 3 9479 5332
Fax 97236 0
Email 97236 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified
Clinical data
When will data be available (start and end dates)?
Data will be available for 7 years following publication of results
Available to whom?
For researchers on a case by case basis
Available for what types of analyses?
Systematic Reviews and Meta-Analysis
How or where can data be obtained?
Data will be available from journal publications and from the Principal Investigator via email request: [email protected]


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
5288Ethical approval  [email protected]



Results publications and other study-related documents

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