NCT05698563

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 13, 2023

Completed
5 days until next milestone

Study Start

First participant enrolled

January 18, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 26, 2023

Completed
19 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 14, 2023

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 12, 2024

Completed
Last Updated

September 22, 2025

Status Verified

September 1, 2025

Enrollment Period

27 days

First QC Date

January 13, 2023

Last Update Submit

September 16, 2025

Conditions

Intermetatarsal BursitisRheumatoid Arthritis

Keywords

Forefoot pain

Outcome Measures

Primary Outcomes (5)

  • 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 Outcomes (1)

  • Incidence of opening toes

    1 day

Study Arms (2)

Patient group

OTHER

Patients with rheumatoid arthritis and forefoot pain.

Diagnostic Test: Magnetic resonance imagingDiagnostic Test: UltrasoundDrug: Corticosteroid injectionOther: Clinical foot evaluationOther: Picture of the feet

Control group

OTHER

Patients with other rheumatic diseases and absence of forefoot pain.

Diagnostic Test: Magnetic resonance imagingDiagnostic Test: UltrasoundOther: Picture of the feet

Interventions

Magnetic resonance imagingDIAGNOSTIC_TEST

MRI scan with contrast of the foot or feet

Also known as: MRI
Control groupPatient group
UltrasoundDIAGNOSTIC_TEST

Ultrasound scan of the feet

Also known as: US
Control groupPatient group
Corticosteroid injectionDRUG

Administered ultrasound guided to patients with intermetatarsal bursitis

Patient group
Clinical foot evaluationOTHER

An examination of the feet

Patient group
Picture of the feetOTHER

To evaluate the presence of V-sign/spreading toes

Control groupPatient group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \> 18 years
  • Forefoot pain and diagnosed with RA (patient group)
  • Diagnosed with an axial arthritis (control group)

You may not qualify if:

  • 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
  • Persons with contraindications to participate in MRI scan
  • Persons with severely impaired renal function (GFR \<30 ml/min)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rigshospitalet Glostrup

Glostrup Municipality, 2600, Denmark

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Magnetic Resonance ImagingUltrasonographyAdrenal Cortex Hormones

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

TomographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Outcome assessor is blinded to type of patient they are examining.
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 13, 2023

First Posted

January 26, 2023

Study Start

January 18, 2023

Primary Completion

February 14, 2023

Study Completion

December 12, 2024

Last Updated

September 22, 2025

Record last verified: 2025-09

Locations

DK(1)