TerminatedNot Applicable

Intermetatarsal Bursitis in Patients With Rheumatoid Arthritis

Stopped: The study was stopped due to health-related issues in the research group, that hindered inrolement of patients.

Denmark3 participantsStarted 2023-01-18

Plain-language summary

The aim of the study is to investigate the incidence and clinical implications of intermetatarsal bursitis (IMB) in patients with rheumatoid arthritis (RA). The hypothesis is that IMB is a cause of pain in patients with RA.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age \> 18 years * Forefoot pain and diagnosed with RA (patient group) * Diagnosed with an axial arthritis (control group) Exclusion Criteria: * Age \<18 years * Open wounds or ongoing infection in the forefoot at the time of examination * Persons with a history of significant trauma in the forefoot, e.g. any fracture or previous surgeries in the forefoot * Persons who have previously received intermetatarsal treatment (Morton's neuroma or IMB) in the same foot, e.g. injection within 6 months or operation at any time * Exclusion from MRI scan only: * Persons with contraindications to participate in MRI scan * Persons with severely impaired renal function (GFR \<30 ml/min)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Incidence of intermetatarsal bursitis on MRI

Timeframe: 8 weeks

Incidence of intermetatarsal bursitis on US

Timeframe: 8 weeks

Incidence of other pathology on MRI

Timeframe: 8 weeks

Incidence of other pathology on US

Timeframe: 8 weeks

Change in Visual Analogue Score (VAS) score

Timeframe: At inclusion, 1 and 3 month(s) post treatment

Trial details

NCT IDNCT05698563

SponsorRigshospitalet, Denmark

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-02-14

View on ClinicalTrials.gov More Intermetatarsal Bursitis trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Incidence of intermetatarsal bursitis on MRI

Timeframe: 8 weeks

Incidence of intermetatarsal bursitis on US

Timeframe: 8 weeks

Incidence of other pathology on MRI

Timeframe: 8 weeks

Incidence of other pathology on US

Timeframe: 8 weeks

Change in Visual Analogue Score (VAS) score

Timeframe: At inclusion, 1 and 3 month(s) post treatment