BigTOE Inserts
Key information
Title:
Big Toe OstEoarthritis Trial: Inserts (BigTOE Inserts)
Chief Investigator: Associate Professor Michael Backhouse
Co-Chief Investigator: Professor Julie Bruce
Sponsor: University of Warwick
Funder: NIHR Health Technology Assessment Programme
Registration Number: NIHR157097
Hypothesis:
For people living with painful 1st MTPJ OA, shoe inserts of different compositions may improve foot function, foot pain, HRQoL, and other health-related outcomes over three months and are cost-effective over one year.
Sample size:
438
Primary outcome:
Assess foot function at 3 months post-randomisation, measured using the Manchester Oxford Foot Questionnaire (MOxFQ) standing/walking subscale.
Duration:
1st June 2024 - 30th November 2027.

Students are required to complete a formative assessment at the end of each block. Students are given the right to sit summative assessments based on completion of formative assessments, engagement with the programme and attendance. Summative assessments are at the end of year one, end of year two and in the final year.
Due to the pressures on car parking capacity on campus it is not possible to provide dedicated parking for students. Students can access Pay-and-Display spaces and Pay-on-Foot car parks.Further information about parking on campus.
Yes, first year students are normally placed in Tocil with other Postgraduate students. There is also off campus Warwick Accommodation available.
Contact Us:
Chief Investigator: Associate Professor Michael Backhouse
Co-Chief Investigator: Professor Julie Bruce
Trial Manager: Lauren Betteley
Tel: 02476 575111
Email: BigToeTrial@warwick.ac.uk