Clinical trial NCT05685160: 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
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Intermetatarsal Bursitis
Morton Neuroma
Intermetatarsal Neuroma
Keywords: Forefoot pain
Metatarsalgia
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: The Danish Rheumatism Association
name: Hvidovre University Hospital
name: Bispebjerg Hospital
name: Gentofte Hospital
First posted: 2023-01-13
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a diagnostic study with a patient and a control group.
Primary purpose: DIAGNOSTIC

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.

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)

Primary outcomes:
measure: Incidence of intermetatarsal bursitis on MRI
timeFrame: 8 weeks
measure: Incidence of intermetatarsal bursitis on US
timeFrame: 8 weeks
measure: Incidence of Morton's neuroma on MRI
timeFrame: 8 weeks
measure: Incidence of Morton's neuroma on US
timeFrame: 8 weeks
measure: Incidence of other pathology on MRI
timeFrame: 8 weeks
measure: Incidence of other pathology on US
timeFrame: 8 weeks
measure: Incidence of normal findings on MRI
timeFrame: 8 weeks
measure: Incidence of normal findings on US
timeFrame: 8 weeks
Secondary outcomes:
measure: Opening toes
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Department of Radiology
Study officials:
References: