NCT05685160

Brief Summary

The aim of this study is to investigate the incidence of intermetatarsal bursitis and Morton's neuroma in patients with metatarsalgia (i.e. pain in the forefoot) and control subjects by diagnostic imaging with ultrasound and MRI.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
10mo left

Started Jun 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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

Study Progress86%
Jun 2021Mar 2027

Study Start

First participant enrolled

June 14, 2021

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

December 6, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 13, 2023

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Expected
Last Updated

November 15, 2024

Status Verified

November 1, 2024

Enrollment Period

4.6 years

First QC Date

December 6, 2022

Last Update Submit

November 13, 2024

Conditions

Intermetatarsal BursitisMorton NeuromaIntermetatarsal Neuroma

Keywords

Forefoot painMetatarsalgia

Outcome Measures

Primary Outcomes (8)

  • 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 closest to dorsal surface of foot. Compressible. Activity on power/color doppler.

    8 weeks

  • Incidence of Morton's neuroma on MRI

    Low to Intermediate signal in T1 and T2. Contrast enhancement of the nodular focus.

    8 weeks

  • Incidence of Morton's neuroma on US

    Hypoechoic mass between metatarsal heads closest to plantar surface of foot. Non-compressible. The interdigital nerve can be seen entering the mass. Close relation to the interdigital artery.

    8 weeks

  • Incidence of other pathology on MRI

    Other pathology than intermetatarsal bursitis or Morton's neuroma.

    8 weeks

  • Incidence of other pathology on US

    Other pathology than intermetatarsal bursitis or Morton's neuroma.

    8 weeks

  • Incidence of normal findings on MRI

    When no findings is observed.

    8 weeks

  • Incidence of normal findings on US

    When no findings is observed.

    8 weeks

Secondary Outcomes (1)

  • Opening toes

    8 weeks

Study Arms (2)

Patient group

EXPERIMENTAL

Patients with intermetatarsal pain have ultrasound and MRI done

Diagnostic Test: MRI with contrastDiagnostic Test: Ultrasound

Control group

ACTIVE COMPARATOR

Healthy individuals (no forefoot pain) undergo ultrasound and MRI scan of the forefoot.

Diagnostic Test: MRI with contrastDiagnostic Test: Ultrasound

Interventions

MRI with contrastDIAGNOSTIC_TEST

MRI of the forefoot with contrast (Gadovist)

Control groupPatient group
UltrasoundDIAGNOSTIC_TEST

Ultrasound imaging of the forefoot

Control groupPatient group

Eligibility Criteria

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

You may qualify if:

  • Age \> 18 years
  • Pain in an intermetatarsal space (patient group)

You may not qualify if:

  • Age \<18 years
  • Open wounds or ongoing infection in the forefoot at the time of examination
  • Persons with contraindications to participate in MRI scan
  • 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 treatment for Morton's neuroma in the same foot, e.g. injection (within 6 months) or operation (anytime)
  • Persons with severely impaired renal function (GFR \<30 ml/min)
  • Persons with a systemic inflammatory condition like rheumatoid arthritis, due to clinically silent intermetatarsal bursitis in this group (control group)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Radiology

Copenhagen, 2100, Denmark

Location

MeSH Terms

Conditions

Morton NeuromaMetatarsalgia

Interventions

Magnetic Resonance ImagingUltrasonography

Condition Hierarchy (Ancestors)

Foot DiseasesMusculoskeletal DiseasesJoint DiseasesNeuralgiaPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

TomographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Model Details: This is a diagnostic study with a patient and a control group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 6, 2022

First Posted

January 13, 2023

Study Start

June 14, 2021

Primary Completion

January 1, 2026

Study Completion (Estimated)

March 1, 2027

Last Updated

November 15, 2024

Record last verified: 2024-11

Locations

DK(1)