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

Primary Purpose

Intermetatarsal Bursitis, Morton Neuroma, Intermetatarsal Neuroma

Status
Recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
MRI with contrast
Ultrasound
Sponsored by
Rigshospitalet, Denmark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Intermetatarsal Bursitis focused on measuring Forefoot pain, Metatarsalgia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Department of RadiologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Patient group

Control group

Arm Description

Patients with intermetatarsal pain have ultrasound and MRI done

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

Outcomes

Primary Outcome Measures

Incidence of intermetatarsal bursitis on MRI
High intensity on T2 weighted images, low signal on T1. Thin peripheral enhancement on T1 contrast enhanced pictures.
Incidence of intermetatarsal bursitis on US
Hypoechoic mass between metatarsal heads closest to dorsal surface of foot. Compressible. Activity on power/color doppler.
Incidence of Morton's neuroma on MRI
Low to Intermediate signal in T1 and T2. Contrast enhancement of the nodular focus.
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.
Incidence of other pathology on MRI
Other pathology than intermetatarsal bursitis or Morton's neuroma.
Incidence of other pathology on US
Other pathology than intermetatarsal bursitis or Morton's neuroma.
Incidence of normal findings on MRI
When no findings is observed.
Incidence of normal findings on US
When no findings is observed.

Secondary Outcome Measures

Opening toes
Presence of opening toes/V-sign/spreading toes.

Full Information

First Posted
December 6, 2022
Last Updated
January 5, 2023
Sponsor
Rigshospitalet, Denmark
Collaborators
The Danish Rheumatism Association, Hvidovre University Hospital, Bispebjerg Hospital, Gentofte Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05685160
Brief Title
US and MRI of the Forefoot: Intermetatarsal Bursitis or Morton's Neuroma
Official Title
Ultrasound and MRI of the Forefoot: Intermetatarsal Bursitis or Morton's Neuroma
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 14, 2021 (Actual)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
March 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rigshospitalet, Denmark
Collaborators
The Danish Rheumatism Association, Hvidovre University Hospital, Bispebjerg Hospital, Gentofte Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intermetatarsal Bursitis, Morton Neuroma, Intermetatarsal Neuroma
Keywords
Forefoot pain, Metatarsalgia

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This is a diagnostic study with a patient and a control group.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
75 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patient group
Arm Type
Experimental
Arm Description
Patients with intermetatarsal pain have ultrasound and MRI done
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Healthy individuals (no forefoot pain) undergo ultrasound and MRI scan of the forefoot.
Intervention Type
Diagnostic Test
Intervention Name(s)
MRI with contrast
Intervention Description
MRI of the forefoot with contrast (Gadovist)
Intervention Type
Diagnostic Test
Intervention Name(s)
Ultrasound
Intervention Description
Ultrasound imaging of the forefoot
Primary Outcome Measure Information:
Title
Incidence of intermetatarsal bursitis on MRI
Description
High intensity on T2 weighted images, low signal on T1. Thin peripheral enhancement on T1 contrast enhanced pictures.
Time Frame
8 weeks
Title
Incidence of intermetatarsal bursitis on US
Description
Hypoechoic mass between metatarsal heads closest to dorsal surface of foot. Compressible. Activity on power/color doppler.
Time Frame
8 weeks
Title
Incidence of Morton's neuroma on MRI
Description
Low to Intermediate signal in T1 and T2. Contrast enhancement of the nodular focus.
Time Frame
8 weeks
Title
Incidence of Morton's neuroma on US
Description
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.
Time Frame
8 weeks
Title
Incidence of other pathology on MRI
Description
Other pathology than intermetatarsal bursitis or Morton's neuroma.
Time Frame
8 weeks
Title
Incidence of other pathology on US
Description
Other pathology than intermetatarsal bursitis or Morton's neuroma.
Time Frame
8 weeks
Title
Incidence of normal findings on MRI
Description
When no findings is observed.
Time Frame
8 weeks
Title
Incidence of normal findings on US
Description
When no findings is observed.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Opening toes
Description
Presence of opening toes/V-sign/spreading toes.
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sif B Larsen, MD
Phone
+45 21457551
Email
binderlarsen@gmail.com
Facility Information:
Facility Name
Department of Radiology
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sif B Larsen, MD
Phone
+45 21457551
Email
binderlarsen@gmail.com

12. IPD Sharing Statement

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

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