Joint Disorders (Inflammatory)
Conditions
Interventions
Participants will be randomly allocated to receive one of two different types of insert. Each insert is made of different materials. Randomisation will take place after informed consent is given and b
Sponsors
University of Warwick
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: To be eligible to be included in the BigTOE Trial, patients must meet all of the following criteria: 1. Diagnosis of 1st MTPJ OA in one or both feet 2. Activity-related joint pain =4 on a 0-10 (NRS) in 1st MTPJ present for at least three months 3. Aged =18 years at the time of randomisation 4. Willing to provide written informed consent
Exclusion criteria
Exclusion criteria: Any of the following:- 1. Pain primarily on the plantar (underside) aspect of the 1st MTPJ, suggestive of sesamoid pathology 2. Morning joint-related stiffness or morning stiffness that lasts longer than 30 minutes 3. Clinical suspicion or previous diagnosis of: 3.1. Inflammatory arthritis: rheumatoid, psoriatic, reactive, enteropathic, or axial spondyloarthritis 3.2. Connective tissue disease: Systemic Lupus Erythematosus, systemic sclerosis, Sjogren's, polymyositis, or dermatomyositis 3.3. Septic arthritis in index joint 3.4. Crystal arthropathy (gout, or calcium pyrophosphate crystal deposition (pseudogout)) 4. History of surgery or clinically important trauma to the foot and ankle in either foot in the last 12 months 5. Planned foot and ankle surgery in either foot within the next 12 months 6. Corticosteroid injection therapy in the index foot within the last three months 7. Used an insole, prescribed by a health professional, within the last three months 8. Have moderate or severe grade 3 or 4 hallux valgus (bunions) using the Manchester Scale 9. Previous randomisation in the present trial (i.e. for contralateral 1st MTPJ)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Foot function is measured using the Manchester Oxford Foot Questionnaire (MOxFQ) standing/walking subscale at 3 months | — |
Secondary
| Measure | Time frame |
|---|---|
| The following secondary outcome measures are assessed at baseline, 1, 3, 6 and 12 months: 1. Foot-related quality of life (QoL) is measured using the Manchester Oxford Foot Questionnaire (MOxFQ) standing/walking subscale 2. Pain is measured using average pain intensity in the index 1st MTPJ & index foot recalled over the last week using a Numerical Rating Scale (NRS) 3. Health-related quality of life is measured using the EQ-5D-5L 4. Insert adherence is measured using participant-reported adherence 5. Analgesic use is measured using participant-reported analgesic use 6. Healthcare resource use is measured using participant-reported healthcare resource use 7. Global rating of change is measured using a Global Rating of Change (GROC) NRS 8. Adverse events are measured using Adverse Event and Serious Adverse Event forms 9. Normal shoe insert outcomes are measured using participant-reported problems with shoe inserts | — |
Countries
England, United Kingdom
Contacts
Public ContactLauren Betteley
Outcome results
None listed