New trial tests cheap and simple solution for toe osteoarthritis relief

A new clinical trial has begun, led by the University of Warwick and University Hospitals Coventry and Warwickshire (UHCW) NHS Trust, to improve the basic mobility and quality of life of people with osteoarthritis of their big toe joint by using specially designed shoe inserts to manage their pain.

Osteoarthritis affects close to 600 million people worldwide, and 17% of people over 50 in the UK suffer with osteoarthritis of the foot. The most common joint affected is the first metatarsophalangeal joint, the joint connecting your big toe to the rest of your foot. It can lead to persistent foot pain, which results in difficulty walking and often limits the activities people are able to do. Relieving pain and increasing mobility for this condition is the focus of the new BigTOE Trial.

Patient Beverly Henderson, who has helped researchers to shape the trial, described osteoarthritis of her foot as: “Like the inside of your shoe being ‘on fire.’ Pain radiates down from the toe. Your footwear doesn’t fit. You end up buying two pairs of the same shoes one a size larger than the other - just to walk. You’re unable to walk so you can’t prepare food, get a drink, or find and take medication. You’ll try anything to make the toe comfortable and maybe walk.”

Osteoarthritis of the foot is common and disabling but there is limited evidence on how to treat it, with NICE guidelines focusing on weight management and exercises and, ultimately, surgery. The BigTOE Trial is looking for another solution, testing whether shoe inserts can limit the impact of the affected joint and improve the person’s mobility that is often limited by foot pain.

Chief Investigator for the trial Dr Michael Backhouse, Associate Professor at Warwick Medical School and part of UHCW’s Institute for Applied & Translational Technologies in Surgery (IATTS), said: "Osteoarthritis is a complex condition that affects the entire joint and can have a profound impact on people's daily lives. When it occurs in the foot and ankle, it can be especially challenging, not least because there is currently limited evidence to guide effective treatment. This new trial aims to change that, offering hope of clearer answers for both patients and clinicians.

“This trial, co-designed by patients and a team of experts from the UK and Australia, directly addresses a NICE recommendation for research – to evaluate devices for painful foot osteoarthritis. If effective, these inserts would be a cheap and simple solution to a common disabling problem and one that could be rapidly implemented in the NHS.”

This £1.9m trial, funded by the National Institute for Health and Care Research (NIHR), has just opened its first sites in Leeds, Kingston, Cornwall, Oxford, Tameside, Torbay, Mid Yorkshire, Northumbria, Dorset, Salford, Rochdale and Bradford. Soon, a total of 30 sites across the country will trial the shoe inserts.

Brian Welsh, Principal MSK Podiatrist and Dr Jill Halstead PhD, Clinical Lead for Research, BigTOE Trial leads at Leeds Community Healthcare NHS Trust, said: “We are excited to be hosting the BigTOE study. We have lots of people referred with painful and debilitating osteoarthritis of their big toe, the treatment options for this are limited and we don’t know which one’s work. This can leave people unable to work and prevent them from partaking in their normal activities, with the only remaining option being joint surgery.

“This trial will help us understand what type of insoles work best for people and has the potential to offer an alternative treatment to joint surgery.”

Emily Neville, Senior Orthotist, PI, and BigTOE Trial lead at Oxford University Hospitals NHS Trust said: “There is a distinct lack of research in the speciality of Orthotics so it is brilliant to be able to take part in a trial that will have a direct influence on Orthotic prescriptions provided on the NHS. I hope that this trial will provide sound evidence for the provision of a simple solution for patients with big toe Osteoarthritis.”

The BigTOE Trial will conclude in late 2027, at which point the results will reveal whether the shoe inserts have improved foot function, foot pain, health-related quality of life and have shown their cost-effectiveness over a one-year period and whether they present a quick-to-adopt solution that could help millions.

ENDS

Notes To Editors

University of Warwick Press Contact:

Matt Higgs, PhD | Media & Communications Officer (Press Office)

Email: Matt.Higgs@warwick.ac.uk | Phone: +44(0)7880 175403

Animation Credit: BigTOE Trial

About University of Warwick:

Founded in 1965, the University of Warwick is a world-leading institution known for its commitment to era-defining innovation across research and education. A connected ecosystem of staff, students and alumni, the University fosters transformative learning, interdisciplinary collaboration, and bold industry partnerships across state-of-the-art facilities in the UK and global satellite hubs. Here, spirited thinkers push boundaries, experiment, and challenge conventions to create a better world.

About NIHR:

The mission of the National Institute for Health and Care Research (NIHR) is to improve the health and wealth of the nation through research. 

We do this by:

• funding high quality, timely research that benefits the NHS, public health and social care
• investing in world-class expertise, facilities and a skilled delivery workforce to translate discoveries into improved treatments and services
• partnering with patients, service users, carers and communities, improving the relevance, quality and impact of our research
• attracting, training and supporting the best researchers to tackle complex health and social care challenges
• collaborating with other public funders, charities and industry to help shape a cohesive and globally competitive research system
• funding applied global health research and training to meet the needs of the poorest people in low- and middle-income countries.

NIHR is funded by the Department of Health and Social Care. Our work in low- and middle-income countries is principally funded through UK international development funding from the UK government.

The BigTOE trial 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. For more details on the BigTOE trial - https://warwick.ac.uk/bigtoe 

26 August 2025