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Trial registered on ANZCTR


Registration number
ACTRN12618001854224
Ethics application status
Approved
Date submitted
3/11/2018
Date registered
14/11/2018
Date last updated
21/01/2020
Date data sharing statement initially provided
14/11/2018
Date results information initially provided
21/01/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Greater trochanteric pain syndrome shoe insert study
Scientific title
Do shoe inserts (orthotics) affect walking and provide pain relief in individuals with greater trochanteric pain syndrome
Secondary ID [1] 296262 0
nil known
Universal Trial Number (UTN)
U1111-1221-6970
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Greater trochanteric pain syndrome 309932 0
Gluteal tendinopathy 309933 0
Buritis 309934 0
Lateral hip pain 309935 0
Hip tendinopathy 309936 0
Condition category
Condition code
Musculoskeletal 308708 308708 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 308709 308709 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a two-phase, single-blinded randomised cross-over trial.
Phase one:
Participants will have their foot postured assessed and both a sham and intervention orthotic fitted by a physiotherapist with 15 years of experience, 6 in using orthotics in research.

Both orthotics will be made of ethylene-vinyl acetate by Vasyli off the shelf orthotics: https://www.vasylimedical.com/

The sham orthotic will be a flat shoe insert. The intervention orthotic will be fitted individually assessed and fitted to maximise comfort using a VAS scale with “not comfortable at all” = 0 and “most comfortable I can imagine” = 10." for the forefoot, midfoot, arch and heel, taking into account the support the person feels.

Participants will have their gait assessed three times via Vicon 3 dimensional gait analysis system on a single day.
Time (T) 1: a baseline gait assessment with the participants wearing their preferred shoes
T2: Gait assessment using either sham or intervention orthotic
T3: Gait assessment using the alternative orthotic.
The order of the sham or active orthotic use will be randomised, with a 30 minute active washout period between T2 and T3 during which time participants will wear their own shoes without any orthotics in situ.

Phase 2:
Following the gait assessment participants will wear the orthotic they had for T3 for the next four weeks. They will be asked to wear the orthotic as much as possible when they are awake.
Participants will be provided with a diary to track the use of their orthotics.
Intervention code [1] 312593 0
Treatment: Devices
Intervention code [2] 312596 0
Rehabilitation
Comparator / control treatment
Participants will act as their own control during phase 1.
During phase 2 all participants will be randomised into using either the sham or intervention orthotic.

All participants will receive the appropriate education during phase 2.. Participants will be provided with a purpose designed paper based education pack. This will provide general strategies that people can use to minimise their hip pain by knowing how to reduce the compression of their gluteal tendons during sitting, standing and lying. Participants will also have one minimum 15minutes one-on-one session with a registered physiotherapists or a final year physiotherapy student to help the participant understand the education. This time will be spent personalizing the content of the pack to the individual. This will occur at the University of Canberra on the day of testing.
Control group
Active

Outcomes
Primary outcome [1] 307684 0
External hip adduction moment at midstance (second peak)

Timepoint [1] 307684 0
Day 0 (day of initial testing)
Day 28 (4 weeks after day of testing)

Primary outcome [2] 307685 0
Pain measured via numeric rating scale (NRS)
Timepoint [2] 307685 0
Day 0 (day of testing)
Day 28 (4 weeks after day of testing)
Primary outcome [3] 307686 0
Global rating of change (GROC)
Timepoint [3] 307686 0
Day 28 (4 weeks after day of testing)
Secondary outcome [1] 352562 0
Assessment of quality of life D8
Timepoint [1] 352562 0
Day 0
day 28
Secondary outcome [2] 352563 0
VISA-G
Timepoint [2] 352563 0
Day 0
Day 28
Secondary outcome [3] 352564 0
Harris Hip Score
Timepoint [3] 352564 0
Day 0
Day 28
Secondary outcome [4] 352565 0
OARSI hip pain tool
Timepoint [4] 352565 0
Day 0
Day 28

Eligibility
Key inclusion criteria
3/12 history of lateral hip pain of => to 3/10 on most days of the preceding week.

Positive clinical assessment:
- pain on palpation of the greater trochanter
- A positive result to two or more of FABER test, 30 second single leg stance test, Resisted de-rotation test (FADDIR)
Minimum age
18 Years
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Low back pain for >2/10
Evidence of hip joint pathology on clinical tests
Lumbar radiculopathy
Systemic inflammatory disease
Bone cancer or metastasis
Unable to communicate in English

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)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Participants undergo a crossover randomisation for the biomechanical evaluation of the use of orthotics on day 0. The second orthotic that participants use during assessment becomes the orthotic that they go home with for the following four weeks.
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Demographics - summary statistics
Analysis - mixed model linear regression

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)
ACT,NSW
Recruitment postcode(s) [1] 24360 0
2617 - University Of Canberra

Funding & Sponsors
Funding source category [1] 300857 0
University
Name [1] 300857 0
University of Canberra
Address [1] 300857 0
University of Canberra
UCRISE
11 Kirinari St
Bruce, ACT
Australia, 2617
Country [1] 300857 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Vasyli
Address
Global Footcare Australia
26 Ereton Drive
Labrador
Queensland 4214
Australia
Country
Australia
Secondary sponsor category [1] 300409 0
None
Name [1] 300409 0
Address [1] 300409 0
Country [1] 300409 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301632 0
University of Canberra Human Research Ethics Committee
Ethics committee address [1] 301632 0
11 Kirinari St, Bruce ACT 2617
Ethics committee country [1] 301632 0
Australia
Date submitted for ethics approval [1] 301632 0
18/08/2018
Approval date [1] 301632 0
29/08/2018
Ethics approval number [1] 301632 0
20180227

Summary
Brief summary
People who have hip pain frequently report pain with walking and climbing stairs or hills. We want to know if using shoe inserts (orthotics) can change the level of discomfort that people with hip pain report. Using the Gait Laboratory at the University of Canberra, we will evaluate if real or sham shoe inserts changes the way people walk. Further, we’ll give people a shoe insert to use for four weeks to see if this helps with their hip pain and their walking, and reassess them after this time. Our hypothesis is that the use of shoe inserts will reduce hip pain with walking.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 87598 0
Dr Angela Fearon
Address 87598 0
Room 13, Clinical Education and Research Centre
Faculty of Health
University of Canberra Hospital.
PO Box 11. Woden, ACT 2607.

University of Canberra Hospital.
20 Guraguma St. Bruce, ACT 2617.
Country 87598 0
Australia
Phone 87598 0
+61468494799
Fax 87598 0
Email 87598 0
Angie.Fearon@Canberra.edu.au
Contact person for public queries
Name 87599 0
Dr Angela Fearon
Address 87599 0
Room 13, Clinical Education and Research Centre
Faculty of Health
University of Canberra Hospital.
PO Box 11. ... Woden, ACT 2607.

University of Canberra Hospital.
20 Guraguma St. Bruce, ACT 2617.
Country 87599 0
Australia
Phone 87599 0
+61468494799
Fax 87599 0
Email 87599 0
Angie.Fearon@Canberra.edu.au
Contact person for scientific queries
Name 87600 0
Dr Angela Fearon
Address 87600 0
Room 13, Clinical Education and Research Centre
Faculty of Health
University of Canberra Hospital.
PO Box 11. ... Woden, ACT 2607.

University of Canberra Hospital.
20 Guraguma St. Bruce, ACT 2617.
Country 87600 0
Australia
Phone 87600 0
+61468494799
Fax 87600 0
Email 87600 0
Angie.Fearon@Canberra.edu.au

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:
Gait biomechanics data
clinical tests data
When will data be available (start and end dates)?
Data will be available 12 months post-publication of research findings. We do not foresee the need to have an end date.
Available to whom?
Data will be provided on a case by case bases.
Available for what types of analyses?
Meta-analysis
How or where can data be obtained?
Data will be available either from the journal, the University of Canberra, or the principal researcher.
What supporting documents are/will be available?
Informed consent form
Ethical approval
Other
'Other' documents specified
Ethics application form
Please request what is required and we will do our best to provide the information.
How or where can supporting documents be obtained?
Type [1] 98 0
Other
Citation [1] 98 0
Link [1] 98 0
Email [1] 98 0
Other [1] 98 0
Ethics application
Type [2] 99 0
Ethical approval
Citation [2] 99 0
Link [2] 99 0
Email [2] 99 0
Other [2] 99 0
Type [3] 100 0
Informed consent form
Citation [3] 100 0
Link [3] 100 0
Email [3] 100 0
Other [3] 100 0
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary