BigTOE Trial
Research type
Research Study
Full title
Big Toe OstEoarthritis (BigTOE) Trial: Inserts
IRAS ID
346977
Contact name
Michael Backhouse
Contact email
Sponsor organisation
University of Warwick
Duration of Study in the UK
2 years, 11 months, 30 days
Research summary
Arthritis of the big toe joint, where the big toe joins the rest of the foot, is very common. It causes pain, swelling and stiffness in the joints, which can often get worse when walking. Living with big toe joint arthritis can affect people’s day to day activities and impact on whether they can work and enjoy other activities and hobbies. We do not know the best way of helping people living with painful big toe arthritis. Some types of shoe inserts may help reduce pain which might make it easier to walk and do daily activities. We are running a large research study (a clinical trial) to find out if shoe inserts can help people with big toe arthritis. We do not know if one type of shoe insert is better than another for people with this arthritis. We will test two different types of shoe inserts to find out if they reduce pain, help people walk and have a better quality of life.
Participants will be asked to wear some inserts in their shoe for the affected foot. They will be asked to complete four more questionnaires over the next 12 months. These will ask about the pain in their toe and feet, their walking and daily activities, and if their health has changed over time. They will be asked how they are getting on with wearing their shoe inserts.
The trial will run in NHS outpatient clinics in community and secondary care that treat people with arthritis of the big toe joint. The aim is to run the trial with different services and any clinician responsible for the diagnosis and treatment of people with arthritis of the big toe joint can recruit participants.REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
24/YH/0240
Date of REC Opinion
18 Dec 2024
REC opinion
Further Information Favourable Opinion