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
Summary:
Osteoarthritis (OA) of the first metatarsophalangeal joint (1st MTPJ) is a painful condition that becomes more prevalent with age. Few studies have investigated whether carbon fibre shoe inserts can help reduce pain, improve function and quality of life. This will be the first UK study to investigate these inserts for people with painful 1st MTPJ OA.
Research question: What is the clinical and cost-effectiveness of carbon fibre inserts compared to sham inserts, for people with painful 1st MTPJ OA?
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.
Contact Us:
Chief Investigator: Associate Professor Michael Backhouse
Co-Chief Investigator: Professor Julie Bruce
Trial Manager: Lauren Betteley
Tel: 02476 575849
Email: BigToeTrial@warwick.ac.uk