Intermetatarsal Bursitis in Patients with Rheumatoid Arthritis

Not Applicable

Active, not recruiting

• Conditions: Intermetatarsal Bursitis; Rheumatoid Arthritis
• Interventions: Diagnostic Test: Magnetic resonance imaging; Diagnostic Test: Ultrasound; Drug: Corticosteroid injection; Other: Clinical foot evaluation; Other: Picture of the feet

• Registration Number: NCT05698563
• Lead Sponsor: Rigshospitalet, Denmark

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2023-01-13
• Study Start: 2023-01-18
• Study First Submitted QC: 2023-01-24
• Study First Posted: 2023-01-26
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-13
• Last Update Posted: 2024-11-15
• Primary Completion: 2025-02
• Study Completion: 2025-05

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 105

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Magnetic resonance imaging	Patients with other rheumatic diseases and absence of forefoot pain.
Patient group	Ultrasound	Patients with rheumatoid arthritis and forefoot pain.
Patient group	Clinical foot evaluation	Patients with rheumatoid arthritis and forefoot pain.
Patient group	Magnetic resonance imaging	Patients with rheumatoid arthritis and forefoot pain.
Patient group	Corticosteroid injection	Patients with rheumatoid arthritis and forefoot pain.
Control group	Ultrasound	Patients with other rheumatic diseases and absence of forefoot pain.
Patient group	Picture of the feet	Patients with rheumatoid arthritis and forefoot pain.
Control group	Picture of the feet	Patients with other rheumatic diseases and absence of forefoot pain.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Incidence of opening toes	1 day	Presence of opening toes/V-sign/spreading toes.

Trial Locations

Locations (1)

Rigshospitalet Glostrup; 🇩🇰 Glostrup, Denmark