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Greater trochanteric pain syndrome shoe insert study

Do shoe inserts (orthotics) affect walking and provide pain relief in individuals with greater trochanteric pain syndrome

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12618001854224
Enrollment
50
Registered
2018-11-14
Start date
2019-04-01
Completion date
2019-06-19
Last updated
2020-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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 f

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.

Sponsors

Vasyli
Lead SponsorCommercial sector/Industry

Study design

Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

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)

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026