A stiff carbon fibre shoe insert is being tested against a fake identical-looking insert to see if it can ease the pain of big toe osteoarthritis. This matters because osteoarthritis of the big toe joint is a common, progressive condition that makes walking painful, yet almost no high-quality trials have tested whether simple shoe inserts actually help. The condition is more common in women and becomes more disabling with age. The trial will recruit 438 NHS patients across 25 sites, randomly assigning them to either a carbon fibre insert or a biomechanically inert sham insert that looks the same. The primary outcome is foot function at three months, measured by a standard patient questionnaire. If the carbon fibre insert proves clinically effective and cost-effective, the impact could be rapid and practical. This is a cheap, non-invasive intervention that podiatry and orthotic services could implement immediately. The National Institute for Health and Care Excellence has identified this as a research gap, so positive results are likely to change clinical guidance. For patients, it could mean less pain when walking without needing surgery, injections, or expensive custom orthotics.
View original technical description
Background Painful osteoarthritis (OA) of the first metatarsophalangeal joint (1st MTPJ) is a progressive, lifelong condition that becomes more prevalent with age. It is more common in women. Few studies have investigated whether 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 big toe 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? Aim To investigate the effectiveness of carbon fibre inserts compared with sham inserts in people with symptomatic 1st MTPJ OA on outcomes of function, pain, health-related quality of life and healthcare costs. Design Multicentre, parallel group, participant-blinded sham-controlled randomised controlled trial (RCT) with internal pilot, embedded process evaluation and cost-effectiveness evaluation. Setting NHS podiatry, orthotic, physiotherapy, and orthopaedic/foot and ankle surgery units based across secondary and community care. Participants People (n=438) with painful 1st MTPJ OA seeking treatment through the NHS. Inclusion criteria: aged 18 years and over, pain score >4 (numerical rating scale (NRS) 0-10) in the index toe joint present for at least 12 weeks. People with bilateral disease will be included but only one toe joint, the most painful, will be randomised. Exclusion criteria: plantar MTPJ pain; diagnosis/suspicion of other arthritis/arthropathy/ fibromyalgia; history of foot surgery in last year; injection therapy or prescribed insole use in last 3 months; moderate/severe (grade 3/4) hallux valgus. Health Technologies Intervention: Carbon fibre shoe-stiffening inserts. Control: Biomechanically inert sham inserts designed to look identical to carbon fibre shoe inserts. Outcomes Collected at baseline pre-randomisation, one, three, six and 12 months, and agreed in close partnership with patients. Primary: function at three months post-randomisation, as measured using the Manchester Oxford Foot Questionnaire (MOxFQ) standing/walking subscale. Secondary: foot related QoL: MOxFQ total score; sMOxFQ Pain and Social interaction sub-scales; average pain whilst walking in index 1st MTPJ recalled over the last week (NRS); average pain intensity in foot recalled over last week (NRS); health-related quality of life (HRQoL) (EQ-5D-5L); participant reported insole adherence; use of analgesic medication; healthcare resource use; adverse events. Timelines for delivery Total 42 months. Set-up six months; 18 months recruitment based on 25 sites recruiting an average of 1 patient/site/month, follow-up 12 months post-randomisation; four months analysis and reporting. Potential impact and Dissemination Results will have an important impact on patients experiencing this disabling and under-researched condition. This trial addresses a research need identified by National Institute for Health and Care Excellence (NICE) thus findings are likely to change guidance. If cost-effective, this simple intervention can be rapidly implemented across services. We will include publications in high impact factor journals that are relevant to the field, conference presentations and wider circulation of findings via patient, family, and professional networks.
Plain English summaries and category classifications on this site are generated by AI and may not perfectly reflect the original research.
Is something wrong? Let us know