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

Morton Neuroma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05685160
• Other study ID #: H-20067346
• Status: Recruiting
• Phase: N/A
• Start date: June 14, 2021
• Est. completion date: March 2024

Study information

• Verified date: January 2023
• Source: Rigshospitalet, Denmark
• Contact: Sif B Larsen, MD
• Phone: +45 21457551
• Email: binderlarsen[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: March 2024
• Est. primary completion date: January 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Bursitis
• Intermetatarsal Neuroma
• Morton Neuroma
• Neuroma

Intervention

Diagnostic Test:
• MRI with contrast
MRI of the forefoot with contrast (Gadovist)
• Ultrasound
Ultrasound imaging of the forefoot

Locations

Country	Name	City	State
Denmark	Department of Radiology	Copenhagen

Sponsors (5)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark	Bispebjerg Hospital, Gentofte Hospital, Hvidovre University Hospital, The Danish Rheumatism Association

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Incidence of Morton's neuroma on MRI	Low to Intermediate signal in T1 and T2. Contrast enhancement of the nodular focus.	8 weeks
Primary	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
Primary	Incidence of other pathology on MRI	Other pathology than intermetatarsal bursitis or Morton's neuroma.	8 weeks
Primary	Incidence of other pathology on US	Other pathology than intermetatarsal bursitis or Morton's neuroma.	8 weeks
Primary	Incidence of normal findings on MRI	When no findings is observed.	8 weeks
Primary	Incidence of normal findings on US	When no findings is observed.	8 weeks
Secondary	Opening toes	Presence of opening toes/V-sign/spreading toes.	8 weeks