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: TBC
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.
This study is funded by the NIHR Health Technology Assessment (HTA) Programme (NIHR134398). The views expressed are those of the author(s) and not necessarily those of the NIHR or the Department of Health and Social Care.
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