Intermetatarsal Bursitis in Patients With Rheumatoid Arthritis

September 16, 2025 updated by: Sif Binder Larsen, Rigshospitalet, Denmark

Clinical Implication of Intermetatarsal Bursitis in Patients With Rheumatoid Arthritis

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

3

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Glostrup Municipality, Denmark, 2600
        • Rigshospitalet Glostrup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of intermetatarsal bursitis on MRI
Time Frame: 8 weeks
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
Time Frame: 8 weeks
Hypoechoic mass between metatarsal heads. Activity on power/color doppler.
8 weeks
Incidence of other pathology on MRI
Time Frame: 8 weeks
Other than intermetatarsal bursitis
8 weeks
Incidence of other pathology on US
Time Frame: 8 weeks
Other than intermetatarsal bursitis
8 weeks
Change in Visual Analogue Score (VAS) score
Time Frame: At inclusion, 1 and 3 month(s) post treatment
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
Time Frame: 1 day
Presence of opening toes/V-sign/spreading toes.
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rigshospitalet, Denmark

Collaborators

The Danish Rheumatism Association

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 18, 2023

Primary Completion (Actual)

February 14, 2023

Study Completion (Actual)

December 12, 2024

Study Registration Dates

First Submitted

January 13, 2023

First Submitted That Met QC Criteria

January 24, 2023

First Posted (Actual)

January 26, 2023

Study Record Updates

Last Update Posted (Actual)

September 22, 2025

Last Update Submitted That Met QC Criteria

September 16, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-22033815

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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