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

January 5, 2023 updated by: Sif Binder Larsen, Rigshospitalet, Denmark

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

75

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 Contact

Study Locations

  • Denmark
      • Copenhagen, Denmark, 2100
        • Recruiting
        • Department of Radiology
        • Contact:

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

Genders Eligible for Study

All

Description

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)

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patient group
Patients with intermetatarsal pain have ultrasound and MRI done
Diagnostic test: MRI with contrast
MRI of the forefoot with contrast (Gadovist)
Diagnostic test: Ultrasound
Ultrasound imaging of the forefoot
Active Comparator: Control group
Healthy individuals (no forefoot pain) undergo ultrasound and MRI scan of the forefoot.
Diagnostic test: MRI with contrast
MRI of the forefoot with contrast (Gadovist)
Diagnostic test: Ultrasound
Ultrasound imaging of the forefoot

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 closest to dorsal surface of foot. Compressible. Activity on power/color doppler.
8 weeks
Incidence of Morton's neuroma on MRI
Time Frame: 8 weeks
Low to Intermediate signal in T1 and T2. Contrast enhancement of the nodular focus.
8 weeks
Incidence of Morton's neuroma on US
Time Frame: 8 weeks
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
Time Frame: 8 weeks
Other pathology than intermetatarsal bursitis or Morton's neuroma.
8 weeks
Incidence of other pathology on US
Time Frame: 8 weeks
Other pathology than intermetatarsal bursitis or Morton's neuroma.
8 weeks
Incidence of normal findings on MRI
Time Frame: 8 weeks
When no findings is observed.
8 weeks
Incidence of normal findings on US
Time Frame: 8 weeks
When no findings is observed.
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Opening toes
Time Frame: 8 weeks
Presence of opening toes/V-sign/spreading toes.
8 weeks

Collaborators and Investigators

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

Sponsor

Rigshospitalet, Denmark

Collaborators

Hvidovre University Hospital
Bispebjerg Hospital
The Danish Rheumatism Association
Gentofte Hospital

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)

June 14, 2021

Primary Completion (Anticipated)

January 1, 2024

Study Completion (Anticipated)

March 1, 2024

Study Registration Dates

First Submitted

December 6, 2022

First Submitted That Met QC Criteria

January 5, 2023

First Posted (Estimate)

January 13, 2023

Study Record Updates

Last Update Posted (Estimate)

January 13, 2023

Last Update Submitted That Met QC Criteria

January 5, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-20067346

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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.

Clinical Trials on Morton Neuroma

Clinical Trials on MRI with contrast

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Luxembourg

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe