Intermetatarsal BursitisNCT05685160
US and MRI of the Forefoot: Intermetatarsal Bursitis or Morton's Neuroma
A study testing MRI with contrast and Ultrasound in people with Intermetatarsal Bursitis and Morton Neuroma, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Intermetatarsal Bursitis, Morton Neuroma, Intermetatarsal Neuroma
- What is being tested?
- MRI with contrast and Ultrasound
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteDenmark
- Study dates
- 14 Jun 2021to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age > 18 years
- Pain in an intermetatarsal space (patient group)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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.
- Being tested
- MRI with contrast, Ultrasound
- Keywords
- Forefoot pain, Metatarsalgia
- Medical subject headings
- Morton Neuroma, Metatarsalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI with contrastDiagnostic test
MRI of the forefoot with contrast (Gadovist)
UltrasoundDiagnostic test
Ultrasound imaging of the forefoot
| Study group | Role | What they receive |
|---|---|---|
| Patient group | Experimental | Patients with intermetatarsal pain have ultrasound and MRI done Receives: Diagnostic Test: MRI with contrast; Diagnostic Test: Ultrasound |
| Control group | Active comparator | Healthy individuals (no forefoot pain) undergo ultrasound and MRI scan of the forefoot. Receives: Diagnostic Test: MRI with contrast; Diagnostic Test: Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of intermetatarsal bursitis on MRI
High intensity on T2 weighted images, low signal on T1. Thin peripheral enhancement on T1 contrast enhanced pictures.
Measured: 8 weeks
Incidence of intermetatarsal bursitis on US
Hypoechoic mass between metatarsal heads closest to dorsal surface of foot. Compressible. Activity on power/color doppler.
Measured: 8 weeks
Incidence of Morton's neuroma on MRI
Low to Intermediate signal in T1 and T2. Contrast enhancement of the nodular focus.
Measured: 8 weeks
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.
Measured: 8 weeks
Incidence of other pathology on MRI
Other pathology than intermetatarsal bursitis or Morton's neuroma.
Measured: 8 weeks
Incidence of other pathology on US
Other pathology than intermetatarsal bursitis or Morton's neuroma.
Measured: 8 weeks
Incidence of normal findings on MRI
When no findings is observed.
Measured: 8 weeks
Incidence of normal findings on US
When no findings is observed.
Measured: 8 weeks
Secondary outcomes (1)
Opening toes
Presence of opening toes/V-sign/spreading toes.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2023
- Study start14 Jun 2021
- Primary completionJan 2026 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intermetatarsal BursitisStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This is a diagnostic study with a patient and a control group.
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- The Danish Rheumatism Association, Hvidovre University Hospital, Bispebjerg Hospital, Gentofte Hospital
- Responsible party
- Principal investigator, Sif Binder Larsen, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05685160
- Sponsor's protocol ID
- H-20067346
- Status last verified
- Nov 2024
- First submitted
- 6 Dec 2022
- Last updated
- 15 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound and MRI of the Forefoot: Intermetatarsal Bursitis or Morton's Neuroma
- ClinicalTrials.gov ID
- NCT05685160
- Acronym / sponsor ID
- H-20067346
- Keywords
- Forefoot pain, Metatarsalgia
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- The Danish Rheumatism Association, Hvidovre University Hospital, Bispebjerg Hospital, Gentofte Hospital
- Study start
- 14 Jun 2021 (actual)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 13 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a diagnostic study with a patient and a control group.
| Arm | Type | Receives |
|---|---|---|
| Patient group | Experimental | Diagnostic Test: MRI with contrast, Diagnostic Test: UltrasoundPatients with intermetatarsal pain have ultrasound and MRI done |
| Control group | Active comparator | Diagnostic Test: MRI with contrast, Diagnostic Test: UltrasoundHealthy individuals (no forefoot pain) undergo ultrasound and MRI scan of the forefoot. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age > 18 years
- Pain in an intermetatarsal space (patient group)
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRI with contrastMRI of the forefoot with contrast (Gadovist) | Diagnostic test | Control group, Patient group |
| UltrasoundUltrasound imaging of the forefoot | Diagnostic test | Control group, Patient group |
Primary outcome
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.
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.
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.
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.
Incidence of other pathology on MRI
Time frame: 8 weeks
Other pathology than intermetatarsal bursitis or Morton's neuroma.
Incidence of other pathology on US
Time frame: 8 weeks
Other pathology than intermetatarsal bursitis or Morton's neuroma.
Incidence of normal findings on MRI
Time frame: 8 weeks
When no findings is observed.
Incidence of normal findings on US
Time frame: 8 weeks
When no findings is observed.
1 secondary outcome
Opening toes
Time frame: 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2024.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI with contrast and Ultrasound in people with Intermetatarsal Bursitis and Morton Neuroma, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 15 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of intermetatarsal bursitis on MRI (time frame: 8 weeks). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2024.