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Enrolling by Invitation

NCT Number: NCT05685160

US 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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

MRI with contrast

Diagnostic Test

MRI of the forefoot with contrast (Gadovist)

Ultrasound

Diagnostic Test

Ultrasound imaging of the forefoot

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. Incidence of other pathology on MRI

    Time frame: 8 weeks

    Other pathology than intermetatarsal bursitis or Morton's neuroma.

  6. Incidence of other pathology on US

    Time frame: 8 weeks

    Other pathology than intermetatarsal bursitis or Morton's neuroma.

  7. Incidence of normal findings on MRI

    Time frame: 8 weeks

    When no findings is observed.

  8. Incidence of normal findings on US

    Time frame: 8 weeks

    When no findings is observed.

Secondary outcomes

  1. Opening toes

    Time frame: 8 weeks

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

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Collaborators

  • Bispebjerg Hospital
  • Gentofte Hospital
  • Hvidovre University Hospital
  • The Danish Rheumatism Association

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2026
Study completion
2027
First posted
Jan 13, 2023
Registry last updated
Nov 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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