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Testing the feasibility of comparing foot orthoses and education added to usual care versus usual care alone for people with ankle osteoarthritis

A randomised feasibility trial comparing the addition of foot orthoses and education to usual care compared to usual care alone for people with ankle osteoarthritis

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12625001216404
Enrollment
40
Registered
2025-11-04
Start date
2025-11-10
Completion date
Unknown
Last updated
2025-11-10

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

Conditions

None listed

Brief summary

Ankle osteoarthritis is a serious health problem that causes disabling pain and limits performance of daily, recreational and occupational activities; however, little is known about how to manage it. The aim of this study is to establish the feasibility of conducting a full-scale randomised controlled trial investigating the addition of foot orthoses and education to usual care, compared to usual care alone for people with ankle osteoarthritis, and to collect quantitative and qualitative data to inform a future RCT. Key feasibility outcomes include consent rate, participant attendance at initial orthoses and education appointment, intervention fidelity and rate of completion of 3-month outcome measures. Findings from this study will improve the management of ankle osteoarthritis by establishing the feasibility of running a full-scale randomised controlled trial to investigate foot orthoses and education in this population.

Interventions

Usual care plus foot orthoses and education intervention: Participants will receive two pairs of prefabricated contoured foot orthoses with inbuilt arch support and varus wedging that are fitted to participants and the shoes they most commonly wear. Participants will be offered up to 3 face-to-face appointments to fit the orthoses and make adjustments for comfort. They will be provided with verbal and written information on using and adapting to the orthoses, and encouraged to wear the orthoses

Usual care plus foot orthoses and education intervention: Participants will receive two pairs of prefabricated contoured foot orthoses with inbuilt arch support and varus wedging that are fitted to participants and the shoes they most commonly wear. Participants will be offered up to 3 face-to-face appointments to fit the orthoses and make adjustments for comfort. They will be provided with verbal and written information on using and adapting to the orthoses, and encouraged to wear the orthoses as much as possible. Participants will also receive verbal and written education (specifically designed for the study) about their ankle OA including information about the anatomy of the ankle; explaining ankle OA, symptoms, diagnosis, imaging and contributing factors; guidelines for OA management and physical activity; the role and importance of exercise; and strategies to manage symptoms. The first appointment will be approximately 1 hour in length, and the following up appointments will be approximately 30 minutes in length. Appointments will be separated by approximately 1-2 weeks. Participants will be asked to continue with their usual care of their ankle OA, in addition to following the education provided and using the orthoses. They will receive weekly emails over the 3-month study period to maintain engagement and collect information on orthoses wear time (adherence), usual care and any treatment-related adverse events. The intervention will be delivered by physiotherapists with over 5 years of musculoskeletal clinical experience. Physiotherapists will record appointment attendance, details of the orthoses and any adverse events. Fidelity delivering the foot orthoses and education intervention will be observed by a researcher not involved in the delivery of the intervention.

Sponsors

The University of Queensland
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator)

Eligibility

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

Inclusion criteria

a) aged 18 years or older b) ankle joint pain on most days for the last 3 months c) a clinical diagnosis of ankle OA d) greater than or equal to Kellgren & Lawrence scale OA grade 2 at the subtalar and/or talocrural joints e) able to understand verbal and written English

Exclusion criteria

a) pain elsewhere in the body that is currently more severe than their ankle pain b) currently wearing contoured foot orthoses c) ankle arthroscopy/debridement or intra-articular injection in the last 3 months d) previous ankle arthrodesis or total ankle joint replacement on the affected ankle

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026