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.
