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

November 13, 2024 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

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
75

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Denmark
      • Copenhagen, Denmark, 2100
        • Department of Radiology

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Rigshospitalet, Denmark

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 14, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 6, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 5, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 13, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 15, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 13, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

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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