Intermetatarsal Bursitis in Patients with Rheumatoid Arthritis

Rigshospitalet

Status: Active, not recruiting

Conditions: Intermetatarsal Bursitis; Rheumatoid Arthritis

Treatments: Other: Picture of the feet; Diagnostic Test: Ultrasound; Drug: Corticosteroid injection; Other: Clinical foot evaluation; Diagnostic Test: Magnetic resonance imaging

Study type: Interventional

Funder types: Other

Identifiers

NCT05698563

H-22033815

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 105 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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105 participants in 2 patient groups

Patient group

Other group

Description:

Patients with rheumatoid arthritis and forefoot pain.

Treatment:

Diagnostic Test: Magnetic resonance imaging

Other: Clinical foot evaluation

Drug: Corticosteroid injection

Diagnostic Test: Ultrasound

Other: Picture of the feet

Control group

Other group

Description:

Patients with other rheumatic diseases and absence of forefoot pain.

Treatment:

Diagnostic Test: Magnetic resonance imaging

Diagnostic Test: Ultrasound

Other: Picture of the feet