Intermetatarsal Bursitis in Patients With Rheumatoid Arthritis

Study Overview
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Brief Summary
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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.

Detailed Description
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Within the recent years more research have focused on IMB in patients with rheumatologic disorders. There is emerging evidence that IMB is an inflammatory alteration in line with synovitis in patients with RA, and presence of IMB have been linked to the early stages of RA, especially due to the focus of the published literature. The clinical implications of the presence of IMB for the patients are yet to be understood. Limited studies have linked the occurrence of IMB to foot impairment, but no studies have been conducted investigating the direct association between forefoot pain and the presence/absence of IMB.

Official Title
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Clinical Implication of Intermetatarsal Bursitis in Patients With Rheumatoid Arthritis

Conditions
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Intermetatarsal Bursitis, Rheumatoid Arthritis

Intervention / Treatment
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* Diagnostic Test: Magnetic resonance imaging
* Diagnostic Test: Ultrasound
* Drug: Corticosteroid injection
* Other: Clinical foot evaluation
* Other: Picture of the feet


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This is a prospective diagnostic study, including a patient and a control group. There is a treatment option with standard treatment for the patient group, if there is indication based on the diagnostic imaging.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Patient group<br>Patients with rheumatoid arthritis and forefoot pain. | Diagnostic Test: Magnetic resonance imaging<br>* MRI scan with contrast of the foot or feet<br>* Other names: MRI;Diagnostic Test: Ultrasound<br>* Ultrasound scan of the feet<br>* Other names: US;Drug: Corticosteroid injection<br>* Administered ultrasound guided to patients with intermetatarsal bursitis<br>Other: Clinical foot evaluation<br>* An examination of the feet<br>Other: Picture of the feet<br>* To evaluate the presence of V-sign/spreading toes<br>|
| Other: Control group<br>Patients with other rheumatic diseases and absence of forefoot pain. | Diagnostic Test: Magnetic resonance imaging<br>* MRI scan with contrast of the foot or feet<br>* Other names: MRI;Diagnostic Test: Ultrasound<br>* Ultrasound scan of the feet<br>* Other names: US;Other: Picture of the feet<br>* To evaluate the presence of V-sign/spreading toes<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of intermetatarsal bursitis on MRI | High intensity on T2 weighted images, low signal on T1. Thin peripheral enhancement on T1 contrast enhanced pictures. | 8 weeks | 
| Incidence of intermetatarsal bursitis on US | Hypoechoic mass between metatarsal heads. Activity on power/color doppler. | 8 weeks | 
| Incidence of other pathology on MRI | Other than intermetatarsal bursitis | 8 weeks | 
| Incidence of other pathology on US | Other than intermetatarsal bursitis | 8 weeks | 
| Change in Visual Analogue Score (VAS) score | Pain score related to the foot pain | At inclusion, 1 and 3 month(s) post treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of opening toes | Presence of opening toes/V-sign/spreading toes. | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Forefoot pain