US and MRI of the Forefoot: Intermetatarsal Bursitis or Morton's Neuroma

NCT ID: NCT05685160

Last Updated: 2024-11-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-14

Study Completion Date

2027-03-31

Brief Summary

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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.

Detailed Description

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In a group of patients with intermetatarsal pain found by an orthopedic surgeon, the investigators want to assess the incidences of intermetatarsal bursitis and Morton's neuroma, using diagnostic imaging; ultrasound and MRI.

The hypothesis is, that intermetatarsal bursitis is an overlooked diagnosis in patients with metatarsalgia. As a result of sparse literature and lack of knowledge about this condition with symptoms mimicking Morton's neuroma, a part of patients diagnosed with Morton's neuroma, suffers from intermetatarsal bursitis instead.

Additionally, the investigators want to evaluate the clinical sign opening toes.

Based on clinical photos of the feet, the investigators want to document the presence of opening toes and investigate if there is a correlation with either intermetatarsal bursitis and/or Morton's neuroma.

Conditions

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Intermetatarsal Bursitis Morton Neuroma Intermetatarsal Neuroma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

This is a diagnostic study with a patient and a control group.
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Patient group

Patients with intermetatarsal pain have ultrasound and MRI done

Group Type EXPERIMENTAL

MRI with contrast

Intervention Type DIAGNOSTIC_TEST

MRI of the forefoot with contrast (Gadovist)

Ultrasound

Intervention Type DIAGNOSTIC_TEST

Ultrasound imaging of the forefoot

Control group

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

Group Type ACTIVE_COMPARATOR

MRI with contrast

Intervention Type DIAGNOSTIC_TEST

MRI of the forefoot with contrast (Gadovist)

Ultrasound

Intervention Type DIAGNOSTIC_TEST

Ultrasound imaging of the forefoot

Interventions

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MRI with contrast

MRI of the forefoot with contrast (Gadovist)

Intervention Type DIAGNOSTIC_TEST

Ultrasound

Ultrasound imaging of the forefoot

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The Danish Rheumatism Association

OTHER

Sponsor Role collaborator

Hvidovre University Hospital

OTHER

Sponsor Role collaborator

Bispebjerg Hospital

OTHER

Sponsor Role collaborator

Gentofte Hospital

UNKNOWN

Sponsor Role collaborator

Rigshospitalet, Denmark

OTHER

Sponsor Role lead

Responsible Party

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Sif Binder Larsen

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of Radiology

Copenhagen, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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H-20067346

Identifier Type: -

Identifier Source: org_study_id

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