| ISRCTN | ISRCTN81014195 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN81014195 |
| IRAS number | 346977 |
| Secondary identifying numbers | CPMS 56204, NIHR Evaluation, Trials and Studies Co-ordinating Centre (NETSCC) Grant Codes: NIHR157097 |
- Submission date
- 14/11/2024
- Registration date
- 18/12/2024
- Last edited
- 18/12/2024
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Musculoskeletal Diseases
Plain English Summary
Background and study aims
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 whether they can work, what type of work they can do, and their enjoyment of other activities and hobbies. The best way of helping people living with painful big toe arthritis is not known. Some types of shoe inserts may help reduce pain which might make it easier to walk and do daily activities. This is a large research study (a clinical trial) to find out if shoe inserts can help people with big-toe arthritis. It is also unknown if one type of shoe insert is better than another for people with big-toe arthritis. This study 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.
Who can participate?
People over 18 years old who have painful arthritis in their big toe joint
What does the study involve?
Participants will be asked to wear an insert in their shoes for their affected feet. They will also be asked to complete four more questionnaires over the next 12 months. These will ask about the pain in their toes 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 your shoe inserts. They may also be asked to take part in a short interview with a researcher, but they do not have to do this if they do not want to.
What are the possible benefits and risks of participating?
Benefits:
The team cannot promise that this research study will help you directly. The information from this study will help the NHS decide if these shoe inserts could help other people with painful big-toe arthritis in the future.
Risks:
The shoe inserts are already used in NHS hospitals and clinics. There are no expected serious risks to participants. Some people may experience discomfort whilst getting used to their inserts, for example, skin irritation or blisters. If this continues, or foot symptoms become worse, participants should contact their healthcare practitioner or the clinical team who gave them to them. One possible disadvantage of taking part is the inconvenience of having to complete questionnaires. The research team have worked with people with big-toe arthritis to make sure the questionnaires are as short as possible.
Where is the study run from?
The study is led by a research team at Warwick Clinical Trials Unit at the University of Warwick. The team includes experts in clinical trials, statistics, health economics and people with big-toe arthritis (patient representatives).
When is the study starting and how long is it expected to run for?
June 2024 to July 2027. The study is due to begin recruitment in early 2025. The last questionnaires are anticipated to be collected in July 2027.
Who is funding the study?
National Institute for Health and Care Research Health Technology Assessment (NIHR HTA) Programme. The study is sponsored by the University of Warwick.
Who is the main contact?
Mrs Lauren Betteley, Clinical Trial Manager, bigtoetrial@warwick.ac.uk
Contact information
Principal Investigator
Warwick Clinical Trials Unit, University of Warwick
Coventry
CV4 7AL
United Kingdom
 ORCID ID |
0000-0003-0056-8467 |
|---|---|
| Phone | +44 (0)2476 575111 |
| Michael.backhouse@warwick.ac.uk |
Public, Scientific
Warwick Clinical Trials Unit, University of Warwick
Coventry
CV4 7AL
United Kingdom
| ORCID ID |
0009-0007-6072-2581 |
|---|---|
| Phone | +44 (0)2476 575111 |
| bigtoetrial@warwick.ac.uk |
Study information
| Study design | Randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Home, Internet/virtual, Telephone |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Big Toe OstEoarthritis (BigTOE) Trial: Inserts |
| Study acronym | BigTOE |
| Study hypothesis | For people living with painful first metatarsophalangeal joint (MTPJ) osteoarthritis (OA), shoe inserts of different compositions may improve foot function, foot pain, health-related quality of life (HRQoL), and other health-related outcomes over three months and are cost-effective over one year. |
| Ethics approval(s) |
Submitted 18/10/2024, Yorkshire & The Humber - Sheffield Research Ethics Committee (NHS Blood and Transplant Blood Donor Centre, Holland Drive, Newcastle upon Tyne, NE2 4NQ, United Kingdom; +44 (0)2071048139, (0)2071048135, (0)207 104 8210; sheffield.rec@hra.nhs.uk), ref: 24/YH/0240 |
| Condition | Joint Disorders (Inflammatory); first metatarsophalangeal joint (MTPJ) osteoarthritis (OA) |
| Intervention | 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 baseline data collection is completed. Randomisation will be conducted by minimisation with a random factor in a 1:1 ratio and stratified by recruitment site, whether one or both feet have OA disease (unilateral/bilateral). This means neither the participant nor the clinical team can choose which group participants will be put in, ensuring the shoe inserts can be compared fairly. After getting a shoe insert fitted, the research team at the University of Warwick will get in touch with the participants to ask them to fill out follow-up questionnaires. These will be due after one, three, six and 12 months. Participants will be sent a text message to let them know these are due and sent an email link so they can complete them online. Paper questionnaires which can be completed and returned to the study team by freepost will also be available. Additional texts will be sent to check if the questionnaire has been received and also to remind them to complete it if not yet been returned. Qualitative interviews Interviews will be conducted with participants and healthcare practitioners who consent to interview to explore experiences of taking part in the trial. |
| Intervention type | Device |
| Pharmaceutical study type(s) | Not Applicable |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Shoe inserts |
| Primary outcome measure | Foot function is measured using the Manchester Oxford Foot Questionnaire (MOxFQ) standing/walking subscale at 3 months |
| Secondary outcome measures | 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 |
| Overall study start date | 01/06/2024 |
| Overall study end date | 31/07/2027 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Main trial recruitment target: 438; Additional unique interview consents (decliners / HCPs): 28 |
| Participant 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 |
| Participant 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) |
| Recruitment start date | 17/02/2025 |
| Recruitment end date | 31/07/2026 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
St Georges Hospital
Corporation Street
Stafford
ST16 3SR
United Kingdom
Tremona Road
Southampton
SO16 6YD
United Kingdom
729 the Ridge
St. Leonards-on-sea
TN37 7PT
United Kingdom
4-6 Nuffield Road
Nuffield Industrial Estate
Poole
BH17 0RB
United Kingdom
Salisbury
SP2 8BJ
United Kingdom
Torquay
TQ2 7AA
United Kingdom
High Heaton
Newcastle upon Tyne
NE7 7DN
United Kingdom
Headington
Oxford
OX3 9DU
United Kingdom
180-194 High Street
Teddington
TW11 8HU
United Kingdom
Millshaw Park Lane
Leeds
LS11 0DL
United Kingdom
Coventry
CV2 2DX
United Kingdom
St Georges Hospital
Corporation Street
Stafford
ST16 3SR
United Kingdom
Southampton
SO16 6YD
United Kingdom
Sponsor information
Hospital/treatment centre
Research & Impact Services, University House
Coventry
CV4 8UW
England
United Kingdom
| Phone | +44 (0)2476575733 |
|---|---|
| sponsorship@warwick.ac.uk | |
| Website | https://warwick.ac.uk/ |
"ROR" |
https://ror.org/01a77tt86 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- NIHR Health Technology Assessment Programme, HTA
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/07/2028 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal |
| IPD sharing plan | The data sharing plans for the current study are unknown and will be made available at a later date |
Editorial Notes
14/11/2024: Study's existence confirmed by National Institute for Health and Care Research (NIHR) (UK).
